Elon Musk’s SpaceX is raising up to $1 billion at $44 billion valuation – CNBC

A SpaceX Falcon 9 rocket carrying the company's Crew Dragon spacecraft is launched on the Demo-2 mission with NASA astronauts Robert Behnken and Douglas Hurley onboard.

NASA/Bill Ingalls

Space Exploration Technologies, Elon Musk's reusable rocket and satellite internet venture, is in talks to raise $500 million to $1 billion in series N funding at a valuation of $44 billion, according to documents reviewed by CNBC and people familiar with the company's fundraising activity.

The funding would help SpaceX begin commercial operations of its Starlink satellite broadband service and to conduct suborbital and orbital test flights of its Starship and SuperHeavy booster launch vehicle.Bloomberg previously reported on the fundraising plans.

SpaceX is telling investors its Starlink business is going after a $1 trillion total addressable market including bringing satellite broadband to any location on Earth, to ships at sea and aircraft in flight.The company has launched more than 450 satellites since after first deploying constellations of satellites for Starlink in November. Company officials expect to start generating revenue from the service this year.

SpaceX aims to make interplanetary transportation from the Earth to the moon and Mars a reality with its reusable rockets.The company also has ambitions to use Starship for rapid long-distance air travel on Earth, making long-haul flights in under an hour.

SpaceX previous investors included those who backed Musk's car company, Tesla. Shared investors have included Peter Thiel's Founders Fund, Baillie Gifford and Valor Equity Partners. SpaceX has a myriad of other investors, including Fidelity, Gigafund and Google.

Gigafund, which was founded by SpaceX board member Luke Nosek, is expected to participate significantly in the new round.

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Elon Musk's SpaceX is raising up to $1 billion at $44 billion valuation - CNBC

How Much Is SpaceX Worth and How Does It Make Money? – Barron’s

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With astronauts Bob and Doug floating in orbit, Morgan Stanleys Adam Jonas, along with other research staff at the Wall Street broker, tried to answer the question: What is SpaceXs valuation?

SpaceX is, of course, the private company that launched NASA astronauts Bob Behnken and Doug Hurleyaffectionately referred to as Bob and Doug by NASA Mission Controlinto space. The pair were the first NASA astronauts to launch from U.S. soil since 2011 and the first to be carried on a commercial built spacecraft sitting atop a commercially built rocket.

Its an incredible feat for the company founded by Tesla (ticker: CEO) founder Elon Musk in 2002. Whats more amazing is the rocket launched was captured for reuse and the spacecraft will be reused as well.

Bob and Doug are slated to come back to Earth on Aug. 2, 2020.

SpaceXs unique technology makes the company difficult to value. And because SpaceX isnt publicly traded, analysts dont have all the data they normally would to build models and predict a financial future.

Both problems are reflected in Morgan Stanleys valuation of SpaceX. We update our hypothetical [discounted cash flow] valuation range for SpaceX, valuing the company between [roughly] $200 million and $175 billion, wrote the team of analysts in a Monday research report.

(Discounted cash flow is a valuation technique that estimates all the cash a company can generate in the future and determines what that cash is worth today.)

Thats a wide range of outcomes. Lets look at Morgan Stanleys base case, which values the company at $50 billion, making it one of the top 10 publicly traded aerospace and defense franchises.

Impressive, but its a stealth $50 billion. Many public equity investors arent sure what SpaceX does to generate value beyond its contracts with the government for space launch. Those alone cant account for $50 billion.

Its space launch business alone wouldnt, either. We view SpaceX as four companies, writes Morgan Stanley. First, SpaceX launches things into space. Second, SpaceX creates Starlink satellites. The company, eventually, plans to offer space-based high speed internet connectivity for a fee using those satellites. SpaceXs third business is travel: ultra fast, rocket-based travel from any point on earth to another. Its last business is deep space exploration.

The majority of the companys value in Morgan Stanleys base case comes from SpaceXs Starlink satellites. That business, according to Morgan Stanley, is worth about $42 billion. Its launch business is a $1 billion business and its travel business is worth about $9 billion, according to their research. Deep space exploration, for now, is valued at zero. The difference between $50 billion and those figures is cash on hand, about $3.4 billion, and the cost required to develop a hypersonic flying machine.

Starlink will cost hundreds of billions of dollars to develop but, based on Morgans math, the business model will work with a subscription fee as low as $50 a monthcomparable with land-based internet providers. Morgan estimates up to $24 billion in Starlink annual free cash flow by 2040.

While investors cant own SpaceX stock, they can buy a basket of stocks to play similar trends.

Virgin Galactic (ticker: SPCE) is working on hypersonic travel and space tourism. Its valued at $4.5 billion. Morgan Stanleys Jonas covers Galactic stock, rating shares the equivalent of Buy. He has a $24 price target for shares, close to where the stock is trading at currently.

To own a space launch company, look at Aerojet Rocketdyne (AJRD). Aerojet supplies rocket components to defense and government entities. Its enterprise value is $2.7 billion.

Starlink is difficult to replicate but there are satellite communications providers such as Maxar Technologies (MAXR) and Iridium Communications (IRDM). Those companies arent worth what Morgan Stanley suggests Starlink is worth and they dont do exactly the same thing.

Finally, to invest in deep space, consider defense stalwart Lockheed Martin (LMT), the company that built the Hubble Space Telescope.

The five stocks in Barrons SpaceX basket are up about 27%, collectively, year to date, better than comparable returns of the Dow Jones Industrial Average and S&P 500.

Space, it appears, is hot again. SpaceX hopes it stays that way.

Write to Al Root at allen.root@dowjones.com

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How Much Is SpaceX Worth and How Does It Make Money? - Barron's

Watch The SpaceX Crew Dragon’s Return To Earth LIVE This Sunday On ‘Space Launch Live: Splashdown’ – Science Fiction

Discovery Channel Science Channel

Following the record ratings of their coverage of the SpaceX Crew Dragon launch in May, Discovery and Science are teaming up again to cover the crafts return next weekend. The telecast will be called Space Launch Live: Splashdown. The astronauts plan to land at sea, something that hasnt been done since 1975. This was the first US crew to voyage to outer space in a privately built craft. The SpaceX Crew Dragon was propelled by the SpaceX Falcon 9 rocket. The destination was the International Space Station. Bob Behnken and Doug Hurley were the astronauts aboard and they will also be the two-man crew of the return journey. Walton Goggins narrated the first two-hour special.

This special will be made in partnership with the Washington Post and its staff writer Christian Davenport, one of the countrys leading chroniclers of the space industry. Davenport will co-host the special, which will also include commentary from current and former astronauts including Mike Massimino and Garrett Reisman, top engineers and other special guests, including adventurer and avid explorer Josh Gates. TV personality Chris Jacobs will pick up where he left off as host of the live return, and Emmy-winning journalist David Kerley will also return as part of the reporting team. (via Deadline)

Science Channels EVP Multiplatform Programming, Factual & Head of Content, Scott Lewers, stated:

This is the type of coverage that viewers can only find on Discovery and Science Channel. With the incredible access of The Washington Post, we spent over a year documenting SpaceXs journey to become the first private company to launch American astronauts into space and were excited to see their safe return back to Earth. Our live coverage will take viewers inside their incredible journey home.

The plan is for the SpaceX Crew Dragon to splashdown in the Atlantic Ocean. It is reported that temperatures on the outside of the craft can reach 3,500 degrees Fahrenheit due to the friction of reentry.

SpaceX Founder and Chief Engineer Elon Musk expressed:

I think theres an argument that the return is more dangerous in some ways than the ascent.

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Space Launch Live: Splashdown will take place this Sunday, August 2, starting at 1pm EST.

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Watch The SpaceX Crew Dragon's Return To Earth LIVE This Sunday On 'Space Launch Live: Splashdown' - Science Fiction

Elon Musk says SpaceX will try launching a full-size Starship prototype ‘later this week,’ and the rocket may fly 150 meters high – MSN Money

Loren Elliott/Getty Images A prototype of SpaceX's Starship, called Mk 1, rocket is seen at the company's South Texas launch facility in Boca Chica on September 28, 2019. Loren Elliott/Getty Images

Anyone who said grain silos can't fly may be in for a surprise later this week.

SpaceX, the aerospace company founded by Elon Musk, is working feverishly to develop a potentially revolutionary rocket system called Starship in Boca Chica, a remote region in southeastern Texas that sits on the Gulf of Mexico. If Starship and its Super Heavy rocket booster end up being fully reusable, Musk has said, the system may reduce the cost of launching anything to space by about 1,000-fold.

But first, SpaceX has to see if its core designs for Starship works. To that end, the company is moving briskly to build, test, and launch prototypes. And according to Musk, the first such full-scale example may fly from a beachside launch site in a matter of days.

"Will attempt to fly later this week," Musk tweeted in response to a question about the status of a Starship prototype called SN5 (short for "serial number 5").

SN5 is the latest of several Starship prototypes that SpaceX has built in Texas. The previous versions have either crumpled during tests or, as was the case on May 29, catastrophically exploded. Each failure has taught SpaceX valuable lessons to inform design and material changes.

The steel vehicles don't have wing-like canards or nosecones attached in case something goes wrong in their earliest phases of testing, so they look more like flying fuel tanks or grain silos than rocket ships.

However, as last year's test launch of an early Starship prototype called Starhopper showed, the flights of such crude experimental vehicles (shown above) can easily impress: On August 27, Starhopper soared about 492 feet (150 meters) into the air, translated across a launch site, and landed on a nearby concrete pad.

The full-scale SN5 prototype may similarly soar nearly 500 feet (150 meters) in the air before attempting to land, according to regulatory documents released by the Federal Aviation Administration in September 2019, following an inquiry by Business Insider.

SpaceX on May 28 earned an FAA launch license to fly prototypes on a "suborbital trajectory," meaning the experimental spaceships could reach dozens of miles above Earth before returning and landing.

The company won't attempt such flights right off the bat, though. On Thursday, SpaceX asked the FCC for permission to use communicate with prototypes flying as high as 12.4 miles (20 kilometers) within the next seven months.

Nevertheless, SpaceX is pursuing a launch license for full-scale, orbital-class Starship-Super Heavy vehicles, part of which includes a new environmental review of its Boca Chica site.

Musk hopes Starship will launch a cargo mission to Mars in 2022, send a private crewaround the moonin 2023,return NASA astronautsto the lunar surface in 2024, and even beginsending people to Marsthe same year.

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Elon Musk says SpaceX will try launching a full-size Starship prototype 'later this week,' and the rocket may fly 150 meters high - MSN Money

Reasons Why Long-term Faith on Howmet Aerospace Inc. (HWM) Could Pay Off Investors – The InvestChronicle

Howmet Aerospace Inc. (HWM) is priced at $15.23 after the most recent trading session. At the very opening of the session, the stock price was $15.80 and reached a high price of $15.86, prior to closing the session it reached the value of $15.55. The stock touched a low price of $15.445.

Recently in News on July 23, 2020, Howmet Aerospace to Host Webcast and Announce Second Quarter 2020 Results. Howmet Aerospace Inc. (NYSE:HWM) will announce its second quarter 2020 financial results on Thursday, August 6, 2020. The press release and presentation materials will be available at approximately 8:00 AM ET on August 6, 2020, via the Investors section of the Howmet Aerospace website. A link to the press release will also be available via the Howmet Aerospace Twitter handle @HowmetAerospace at https://twitter.com/HowmetAerospace. You can read further details here

Howmet Aerospace Inc. had a pretty Dodgy run when it comes to the market performance. The 1-year high price for the companys stock is recorded $34.27 on 02/19/20, with the lowest value was $9.87 for the same time period, recorded on 05/14/20.

Price records that include history of low and high prices in the period of 52 weeks can tell a lot about the stocks existing status and the future performance. Presently, Howmet Aerospace Inc. shares are logging -42.00% during the 52-week period from high price, and 74.66% higher than the lowest price point for the same timeframe. The stocks price range for the 52-week period managed to maintain the performance between $8.72 and $26.27.

The companys shares, operating in the sector of Industrials managed to top a trading volume set approximately around 978398 for the day, which was evidently lower, when compared to the average daily volumes of the shares.

When it comes to the year-to-date metrics, the Howmet Aerospace Inc. (HWM) recorded performance in the market was -34.07%, having the revenues showcasing 43.85% on a quarterly basis in comparison with the same period year before. At the time of this writing, the total market value of the company is set at 6.87B, as it employees total of 41700 workers.

According to the data provided on Barchart.com, the moving average of the company in the 100-day period was set at 14.62, with a change in the price was noted -13.90. In a similar fashion, Howmet Aerospace Inc. posted a movement of -47.69% for the period of last 100 days, recording 4,314,092 in trading volumes.

Total Debt to Equity Ratio (D/E) can also provide valuable insight into the companys financial health and market status. The debt to equity ratio can be calculated by dividing the present total liabilities of a company by shareholders equity. Debt to Equity thus makes a valuable metrics that describes the debt, company is using in order to support assets, correlating with the value of shareholders equity The total Debt to Equity ratio for HWM is recording 1.51 at the time of this writing. In addition, long term Debt to Equity ratio is set at 1.22.

Raw Stochastic average of Howmet Aerospace Inc. in the period of last 50 days is set at 59.10%. The result represents improvement in oppose to Raw Stochastic average for the period of the last 20 days, recording 29.43%. In the last 20 days, the companys Stochastic %K was 44.79% and its Stochastic %D was recorded 58.94%.

Now, considering the stocks previous presentation, multiple moving trends are noted. Year-to-date Price performance of the companys stock appears to be encouraging, given the fact the metric is recording -34.07%. Additionally, trading for the stock in the period of the last six months notably deteriorated by -30.31%, alongside a downfall of -20.78% for the period of the last 12 months. The shares increased approximately by -5.47% in the 7-day charts and went down by 6.36% in the period of the last 30 days. Common stock shares were driven by 43.85% during last recorded quarter.

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Reasons Why Long-term Faith on Howmet Aerospace Inc. (HWM) Could Pay Off Investors - The InvestChronicle

Aerospace Valves Market Projected to Deliver Greater Revenues during the Forecast Period until 2026 – Kentucky Journal 24

GlobalAerospace Valves Marketwas valued US$ 3.40 Bn in 2017 and is expected to reach US$ 6.71 Bn by 2026 at a CAGR of about 8.87% during a forecast.Global Aerospace Valves Market is segmented into by valves, by material, by mechanism, by aviation, by an end user, and by region. Based on valves, aerospace valves market is classified into Fuel System Valves, Hydraulic System Valves, Air Conditioning System Valves, Ice & Rain Protection Valves, Pneumatic System Valves, Lubrication systems Valves & Water and Waste System Pumps. In material are parted into Aluminium, Titanium, Steel & Others. In mechanism are segmented into Poppet Valves, Pilot Valves, Flapper-nozzle Valves, Ball and Plug Valves & Others. In aviation are divided into Commercial Aviation, Military Aviation & Business, and General Aviation. In End, a user is distributed in Original Equipment Manufacturers (OEM) & Aftermarket. Geographically into North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Global Industry Analysis and forecast 2018-2026.

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Driving factors of aerospace valves market are due to the increase in aircraft orders and short replacement cycles of aerospace valves. Increasing commercial aircrafts production, witnessing include introduction of lightweight valves, technological advancements for advanced analytical systems, a rise in air travel across the globe, Growing international trade between countries have increased the frequencies of cargo planes. Increases in the number of airport connections within the respective countries and rise in the use of aircraft in military applications will boost the market for aerospace valves market.

Global economic uncertainty and backlogs of aircraft deliveries can hamper the growth of aerospace valves market.In terms of Valves, Hydraulic system valves segment shares the largest market during the forecast period. Hydraulic system valves make quite efficient in transmitting power. Provides Ease and accuracy of control, Jet aircraft that operate at altitudes where there is not enough air pressure to assure a positive feed of fluid to the pump have hydraulic systems and its pressurized easy to generate linear and rotary motions in compact systems with high power. It also gives more power than pneumatic systems it has some characteristics that make it perfect for the market opportunity in theaerospace valve market.

In terms of End User, Aftermarket is projected to grow at fastest during the forecast period. Aftermarket advances the way to detect & address emerging aircraft problems via real-time monitoring, Helps prevent misunderstandings of verbal instructions, Relieves air traffic controllers from routine tasks that take up a significant part of their workload, replacement period for aerospace valves is not more than 3 to 4 years and these valves cannot be repaired or refurbished will boost the demand for aerospace valves market.

Among region, Asia Pacific region is expected to grow at the highest CAGR during the forecast period. Emerging economies and the tremendous increase in passengers traffic and flight hours, increased flight frequency along with rising preference of air travel, rise in disposal income, the region rapid changes in regulations to make aviation more advancing on the technology front and rise in disposal income can lead to better market expansion in Aerospace Valves Market.

Honeywell, Parker Hannifin, Eaton, Woodward, Zodiac Aerospace, Triumph Group, Crissair, ITT Aerospace Controls, Aerocontrolex, Liebherr, United Technologies, Moog, Meggitt, Circor International, Porvair, Crane Aerospace, Sitec Aerospace, Valcor Engineering, Ram Company, Marotta Controls, Precision Fluid Controls, Lakshmi Technology And Engineering Industries Limi, Nutek Aerospace Corporation and Dynex/Rivett.The scope of the Report Global Aerospace Valves Market:Global Aerospace Valves Market: By ValvesFuel System ValvesHydraulic System ValvesAir Conditioning System ValvesIce & Rain Protection ValvesPneumatic System ValvesLubrication systems ValvesWater and Waste System PumpsGlobal Aerospace Valves Market: By MaterialAluminiumTitaniumSteelOthersGlobal Aerospace Valves Market: By MechanismPoppet ValvesPilot ValvesFlapper-nozzle ValvesBall and Plug ValvesOthersGlobal Aerospace Valves Market: By AviationCommercial AviationMilitary AviationBusiness and General AviationGlobal Aerospace Valves Market: By End UserOriginal Equipment Manufacturers (OEM)AftermarketGlobal Aerospace Valves Market: By RegionNorth AmericaEuropeAsia PacificMiddle East & AfricaLatin AmericaKey Player analyzed in the Global Aerospace Valves Market:HoneywellParker HannifinEatonWoodwardZodiac AerospaceTriumph GroupCrissairItt Aerospace ControlsAerocontrolexLiebherrUnited TechnologiesMoogMeggittCircor InternationalPorvairCrane AerospaceSitec AerospaceValcor EngineeringRam CompanyMarotta ControlsPrecision Fluid ControlsLakshmi Technology And Engineering Industries LimiNutek Aerospace CorporationDynex/Rivett

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Aerospace Valves Market Projected to Deliver Greater Revenues during the Forecast Period until 2026 - Kentucky Journal 24

Global Aerospace Defense Market Expected to reach highest CAGR by 2025: Boeing, Airbus, Lockheed Martin, United Technologies, General Electric – Owned

Aimed at providing report readers with a discerning picture of the current market scenario dominant in the Aerospace & Defense market, this holistic report output encapsulating historic as well as current market developments are poised to specifically grab the pulse of the Aerospace & Defense market.

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The study encompasses profiles of major companies operating in the Aerospace & Defense Market. Key players profiled in the report includes:BoeingAirbusLockheed MartinUnited TechnologiesGeneral Electric

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The report specifically hovers over vital, market specific details concerning both historical as well as current scenario, such that readers can seamlessly grab ready-to-use information from a singular, compact documentation on the Aerospace & Defense market.This section of the report further aims to enlighten report readers about various market influencers with a thorough overview of barrier analysis as well as an opportunity mapping that collectively influence and decide the upcoming growth trajectory of the Aerospace & Defense market in all favorable terms.

By the product type, the market is primarily split into CybersecurityHomeland SecurityBorder Security

By the end-users/application, this report covers the following segments LandAirSea

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As the report makes further progress, it unveils a real-time scenario of the market, besides also shedding substantial light on other historical developments that had influenced sustainable revenue flow in the Aerospace & Defense market. Minute details about lucrative business strategies, trouble-shooting approach as well as customer enticing tactics have been thoroughly addressed in this section of the report such that readers can well comprehend real developments to ascertain an-evidence based business strategy, with ample competitive edge, such that market players can definitely cement their lead despite the high intensity in the Aerospace & Defense market.

Global Aerospace & Defense Geographical Segmentation Includes: North America (U.S., Canada, Mexico) Europe (U.K., France, Germany, Spain, Italy, Central & Eastern Europe, CIS) Asia Pacific (China, Japan, South Korea, ASEAN, India, Rest of Asia Pacific) Latin America (Brazil, Rest of L.A.) Middle East and Africa (Turkey, GCC, Rest of Middle East)

These details are indicated in the report to allow market players undertake a systematic analytical review of the Aerospace & Defense market to arrive at logical conclusions governing the growth trajectory of the Aerospace & Defense market and their subsequent implications on the growth of the aforementioned market.

Some Major TOC Points: Chapter 1. Report Overview Chapter 2. Global Growth Trends Chapter 3. Market Share by Key Players Chapter 4. Breakdown Data by Type and Application Chapter 5. Market by End Users/Application Chapter 6. COVID-19 Outbreak:Aerospace & Defense Industry Impact Chapter 7. Opportunity Analysis in Covid-19 Crisis Chapter 9. Market Driving ForceAnd Many More

Global Aerospace & Defense Market Report: Research Methodology

Moving forward, report readers are also presented with a unique portfolio presentation that houses minute details about prominent market players. The report is a unique, one stop solution to unravel complexities concerning player specific information their asset, competitive edge, influential market specific decision that eventually harness a lucrative stance despite cut-throat competition in the Aerospace & Defense market.

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The report allows its readers to gain optimum cues about the market progression such that players can well comprehend potential opportunities as well as persistent challenges and probable threats in the Aerospace & Defense market. This dedicated research articulation on the Aerospace & Defense market structuresinclusive outlook of various drivers and threats that eventually impact the growth course in the Aerospace & Defense market.

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Global Aerospace Defense Market Expected to reach highest CAGR by 2025: Boeing, Airbus, Lockheed Martin, United Technologies, General Electric - Owned

cPDM in AeroSpace and Defence Market Leading 11 Key-Players Revenue, Shares, Sales and Forecasts Till 2026 | COVID19 Impact Analysis | Key Players:…

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cPDM in AeroSpace and Defence Market Leading 11 Key-Players Revenue, Shares, Sales and Forecasts Till 2026 | COVID19 Impact Analysis | Key Players:...

COVID-19 Update: Global Civil Aerospace Simulation and Training Market is Expected to Grow at a Healthy CAGR with Top players: CAE, FlightSafety…

Civil Aerospace Simulation and Training MarketResearch Report covers the present scenario and the growth prospects of Civil Aerospace Simulation and Trainingd Market for 2015-2026. The report covers the market landscape and its growth prospects over the coming years and discussion of the Leading Companies effective in this market. Civil Aerospace Simulation and Training Market has been prepared based on an in-depth market analysis with inputs from industry experts. To calculate the market size, the report considers the revenue generated from the sales of Civil Aerospace Simulation and Training globally

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Civil Aerospace Simulation and Training Market Segment by Consumption Growth Rate and Market Share byApplication:Manoeuvre, Defense,

Civil Aerospace Simulation and Training Market Covers following MajorKey Players:CAE, FlightSafety International, L-3 Link Simulation & Training, St. Jude Medical, Rockwell Collins, Thales, Airbus, ECA, FRASCA International, Lockheed Martin, SIMCOM Aviation Training,

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cPDM in AeroSpace and Defence to Witness Growth Acceleration During 2019-2025 – Owned

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cPDM in AeroSpace and Defence to Witness Growth Acceleration During 2019-2025 - Owned

Brodalumab for the Treatment of Psoriasis in Patients With HIV – Dermatology Advisor

Home Topics Psoriasis

Brodalumab may be an effective treatment for refractory psoriasis in patients with human immunodeficiency virus (HIV), suggests case study data published in Dermatologic Therapy.

Investigators described the case of a 62-year-old man with HIV who presented with worsening and persistent plaque psoriasis. His Psoriasis Area and Severity Index (PASI) score was 20.0, indicating moderate to severe disease. Erythema and scaling were observed in large areas on the scalp, trunk, and extremities. The patient was taking highly active antiretroviral therapy (HAART) for HIV and had serological evidence of past co-infection with hepatitis B and C. Thepatient had tried ultraviolet B phototherapy and cyclosporine for psoriasis. Cyclosporine was discontinued due to loss of efficacy and replaced with ustekinumab, which also became ineffective after 1 year.

The patient was started on brodalumab at the recommended dosage of 210 mg every 2 weeks. Marked improvement in plaque psoriasis was observed; a PASI score of 0 was achieved after 6 weeks of treatment. Sustained remission was observed at 6 months. Control of HIV was maintained, with no opportunistic infections or laboratory abnormalities over follow-up.

Data from this case suggest that brodalumab may be an option for patients with HIV who have exhausted other psoriasis therapies. However, administration of an IL-17 inhibitor to a patient with HIV must be done with caution, due to the role of IL-17 in preventing candidiasis. Patients with HIV are highly susceptible to Candida infection, although HAART decreases this susceptibility. The current patient did not experience candidiasis. [A]dditional experience is required before IL-17 inhibitors can be regarded as a standard therapy in moderate to severe HIV-associated psoriasis, investigators wrote.

Reference

Di Lernia V, Casanova DM, Ricci C. Brodalumab: another helpful option for HIV-positive psoriatic patients? [published online June 25, 2020]. Dermatol Ther. doi: 10.1111/dth.13895

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Brodalumab for the Treatment of Psoriasis in Patients With HIV - Dermatology Advisor

European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five…

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohns disease, ulcerative colitis, psoriatic arthritis and psoriasis.1

The approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June and is based on data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the SC and intravenous (IV) formulations of Remsima in people with active Crohns disease and ulcerative colitis, throughout a 1-year treatment period.2,3 Based on the results of the pivotal study, a 120 mg fixed dose of Remsima SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications.

Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany said: The subcutaneous formulation of Remsima (Remsima SC) has been shown to have very high efficacy, and favourable data, which are fully comparable to the efficacy and safety profile of the IV formulation. Todays approval marks an important progress for the gastroenterology community as it means that treatment can now be administered in significantly less time, thereby providing patients more flexibility and control over how they receive their treatment.

We are pleased to announce this important regulatory milestone earlier than we expected, with the European Commission prioritising review of this important new administration option. We will accelerate the launch process on a country-by-country basis in order to expand treatment options for patients with chronic inflammatory diseases such as inflammatory bowel disease and ankylosing spondylitis, said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We will do our best to make Remsima SC available as early as possible and hope this medication will contribute to minimising the risks involved with administering medical treatments during the COVID-19 pandemic.

Celltrion anticipates receiving approval of Remsima SC in 97 countries, including 31 countries in Europe.

-- ENDS --

Notes to Editors:

About Remsima (CT-P13) intravenous (IV) formulation1Remsima IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (RA) and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.

About Remsima CT-P13 subcutaneous (SC) formulation4,5A 120 mg fixed dose of Remsima SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation. Remsima SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

About CT-P13 (biosimilar infliximab)CT-P13 is developed and manufactured by Celltrion, Inc. and was the worlds first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra. CT-P13 is approved in more than 94 countries (as of July 2020) including the US, Canada, Japan and throughout Europe.

About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordable medications to promote patients access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us

Forward-looking statement disclaimerCertain information set forth in this press release contains statements related to our future business and financial performance, and future events or developments involving Celltrion Healthcare, that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as will, has potential to, brings, if approved, would, could, opportunity, hope, is considering the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Healthcare's management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand managements beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or managements estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

References

1 European Medicines Agency Summary of Product Characteristics (SmPC). Remsima.

2 Reinisch W, et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase 1 open-label randomised controlled trial in patients with active Crohns disease. European Crohns and Colitis Organisation 2019. Abstract no: A-1103.

3 Ben-Horin S, et al. A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohns disease and ulcerative colitis. Oral presentation (OP24). Presented at ECCO 2020.

4 Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (FRI0128). Presented at EULAR 2019.

5 Westhovens R, Wiland P, Zawadzki M et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (SAT0170). Presented at EULAR 2019.

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European Commission grants marketing authorisation for world's first subcutaneous formulation of infliximab, Remsima SC, for an additional five...

MC2 Therapeutics Announces US Food and Drug Administration Approval of Wynzora Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%)…

COPENHAGEN, Denmark, July 22, 2020 / B3C newswire / -- MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.

The FDA approval is based on the results of the US Phase 3 clinical trial (1) against active comparator Taclonex Topical Suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%). A total of 794 patients were randomized in this trial and the primary efficacy endpoint was the proportion of patients with PGA treatment success at week 8 defined as at least a 2-grade improvement from baseline in PGA to clear or almost clear. The difference in PGA treatment success to the active comparator was 14.6% (95% CI; 7.6%, 21.6%) in favor of Wynzora Cream.

Reduction of itch as defined by at least a 4-point improvement in the 11-point peak pruritus numeric rating scale (NRS) from baseline to week 4 was assessed among patients who had at least a peak pruritus NRS score of 4 at baseline. A higher proportion of patients achieved at least a 4-point improvement in the peak pruritus NRS score at week 4 in the Wynzora Cream group (60.3%) compared to vehicle (21.4%).

Wynzora Cream is a novel topical treatment for plaque psoriasis which offers a unique combination of high efficacy, favorable safety and excellent treatment convenience in a single product, said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and lead principal investigator in the study.

Studies show that more than half of psoriasis patients are dissatisfied with their treatment and that a large proportion of patients are not treated at all (2).

The FDA approval marks an important milestone for patients with plaque psoriasis", stated Jesper J. Lange, CEO of MC2 Therapeutics and continued: "Our PAD Technology has uniquely enabled us to develop Wynzora Cream with no compromises. It drives the compelling efficacy and safety data of Wynzora Cream and transforms that data into impact for patients through a convenient formulation that allows patients to move on within minutes of a morning routine. It puts patients back in control of therapy and daily life."

Founder and Executive Chairman of MC2 Therapeutics, Mads Clausen concurred: "Wynzora is a prime example of what we envision PAD Technology can do to help patients, physicians and payers release the full potential of topical therapies in real world settings."

With the US approval, the recent submission of its marketing authorization application of Wynzora Cream in EU, and its ongoing interactions with payers, physicians and patient organizations MC2 Therapeutics is well on track to launch Wynzora Cream in major territories. In addition, MC2 Therapeutics continues development of its pipeline of new topical therapies within major chronic inflammatory indications such as atopic dermatitis, uremic pruritus, lichen sclerosus and dry eye.

About Plaque PsoriasisPsoriasis is a common, non-contagious, chronic skin disease, with no clear cause or cure. The negative impact of plaque psoriasis on peoples lives can be immense as it affects the appearance of the skin with red, scaly plaques. According to the National Psoriasis Foundation, itch is present in between 70 and 90 percent ofpsoriasispatients, and together with flaking and scaling, itching is the most burdensome symptom to patients (3,4,5). The appearance of flares of psoriasis can be unpredictable and affects people of all ages. With a reported prevalence of 2-4% of the population psoriasis constitutes a serious health problem with more than 100 million individuals affected worldwide. More than 90% of patients receiving treatment use topical drugs. Patients with psoriatic disease are at an elevated risk of developing other chronic and serious health conditions, including arthritis, cardiovascular diseases, metabolic syndrome, inflammatory bowel disease and depression (5).

About Wynzora Cream Wynzora Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. Wynzora Cream is based on PAD Technology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in a convenient-to-use aqueous formulation. In the phase 3 trials conducted at multiple sites in the US and the EU, Wynzora Cream has demonstrated a unique combination of compelling clinical efficacy, a favorable safety profile and high convenience. These features of Wynzora Cream hold promise to lead to less treatment discontinuation and overall better patient satisfaction in topical treatment of plaque psoriasis in the real-world setting.

Indication and UsageWynzora (calcipotriene and betamethasone dipropionate) Cream is a prescription medicine indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

Apply WynzoraCream to affected areas once daily for up to 8 weeks and not more than 100 grams per week. Patients should stop treatment when the plaque psoriasis is under control unless a healthcare provider gives other instructions.

Wynzora Cream is for use on skin only (topical). Do not get Wynzora Cream near or in your mouth, eyes, or vagina. Avoid using Wynzora Cream on your face, groin, or armpits, or if you have thinning of your skin (atrophy) at the treatment site.

It is not known if Wynzora Cream is safe and effective in children.

Important Safety InformationTell your healthcare provider about all your medical conditions and all the medicines you take, including any corticosteroid medicines and any other products containing calcipotriene.

Do not use other products containing calcipotriene or a corticosteroid medicine without talking to your healthcare provider first.

Wynzora Cream may cause side effects, including:

The most common side effects include upper respiratory infection, headache, and application site irritation. These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

This summary is not comprehensive. Visit http://www.wynzora.com to obtain the FDA-approved Full Prescribing Information.

About PAD TechnologyPAD Technology formulations are tailor-made to meet the target product profile for a selected product candidate. PAD Technology enables the mixing of oil and water into a cream using just a fraction of the emulsifier required in conventional creams and lotions. Key features of PAD Technology formulations are high penetration of active ingredients to the target tissue, improved solubility and stability of active ingredients, high tolerability and excellent treatment convenience.

About MC2 TherapeuticsMC2 Therapeutics is a privately held commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions. Using its PAD Technology it aims to set a new standard of treatment experience for patients and to release the full potential of novel topical drugs for the benefit of patients, physicians, payers and societies. PAD Technology is the basis for its innovative pipeline of drug candidates within atopic dermatitis, uremic pruritus, lichen sclerosus, and dry eye.

Contacts

MC2 TherapeuticsInvestors: Lonni Goltermann+45 2018 1111 This email address is being protected from spambots. You need JavaScript enabled to view it.

MediaEU: Molecule A/S: Mette Thorn Sorensen, +45 4138 4300 or This email address is being protected from spambots. You need JavaScript enabled to view it.US: Amy Phillips, +1 412.327.9499 or This email address is being protected from spambots. You need JavaScript enabled to view it.

References:

1. Clinical trial ID: NCT033087992. Armstrong et al. JAMA Dermatol. 2013;149(10):1180-11853. http://www.psoriasis.org/life-with-psoriasis/managing-itch (accessed July 13th, 2020)4. The Voice of the Patient, Psoriasis. FDA Public Meeting Report, 20165. WHO Global report on Psoriasis 2016

Keywords: Humans; betamethasone dipropionate, calcipotriol; calcipotriene; Prostaglandins A; Patient Satisfaction; Drug Users; United States Food and Drug Administration; Betamethasone; Calcitriol; betamethasone-17,21-dipropionate; Taclonex; Psoriasis; Drug Combinations; Treatment Outcome; Marketing

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MC2 Therapeutics Announces US Food and Drug Administration Approval of Wynzora Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%)...

Psoriasis Drug Being Used To Treat COVID-19; Why Itolizumab? – Inventiva

The year 2020 began with a not-so-great scenario that escalated rapidly into a pandemic that has crippled the functioning of the world. A lot has happened over the course of these past 4 months with a large number of people losing their lives to a microscopic virus. Coronavirus and COVID-19 are words that are familiar to every person in the world since it has made a huge impact on everything that rules peoples hectic lives; Business, economy and simply put, their way of living. The novelty of the virus is a research field in itself with scientists looking into its morphology and genetic structure, discovering new facts about this unknown microorganism. With most of the people who got affected being asymptomatic, scientists also have to work faster to detect the properties of this virus and easier ways to detect it to increase the number of people being tested per day. Therefore, it is a need of the hour for those susceptible to have a vaccine they can rely on that will be effective in helping them develop immunity against this virus. With the rush to develop a vaccine, many countries have applied for their drug compounds to be used for phase 3 or phase 4 trials. COVAX, an initiative by Gavi, a public-private partnership, to support the acceleration of the designing, development, and distribution of vaccines. With countries around the world trying to find a vaccine, about 130 vaccines are under testing in various phases. India is also actively taking part in this vaccine rush and has 2 possible drugs in different trial stages; Covaxin by Bharat Biotech and ZyCov-D by Zydus which are proving to be hopeful. Along with these two, Biocon, a global biopharma company based in Bangalore, recently announced that they have received a green flag from the Drug Controller General of India to release their novel biologic, Itolizumab (ALZUMAb) into the market for restricted emergency use in treating COVID-19 patients with moderate to severe complications.

But why is Itolizumab, a drug used in treating a chronic skin disease like psoriasis, being used to treat patients affected with COVID-19?

The SARS-CoV-2 virus affects individuals by triggering the immune system to generate a large number of cytokines which can attack the organs like lungs, etc. and can lead to multiple organ failure or death. Here is where Itolizumab seems to help the affected individuals.

Kiran Mazumder-Shaw, the Executive Chairperson of Biocon, said in a press release that this novel drug has been approved by the regulator, based on the promising data obtained from a pivotal two-arm, randomized trial involving 30 eligible patients across New Delhi and Mumbai. Out of these 30 patients, 20 were administered with Itolizumab with the best care, making them the test arm and the remaining 10 were not administered Itolizumab, making them the control arm. After a period of one month, the mortality rates were observed. The results were promising, as all 20 of the test arm patients experienced a full recovery. 3 patients out of the 10 in the control arm died.

Itolizumab proved itself to be efficient by meeting the key efficacy parameter of improving lung function without a hike oxygen flow as required by the patients in the control arm and also displayed suppression or reduction in the expression of clinical markers of inflammation. It has also worked tremendously in controlling moderate to severe ARDS (Acute Respiratory Distress Syndrome) induced by COVID-19 and has shown its efficacy in treating elder patients too. This clinical trial proved to be helpful in giving emergency treatment options to patients to reduce complications. Itolizumab, the psoriasis drug turned COVID-19 treatment, is shown to work best if administered before the cytokine release begins and helps to prevent the cytokine storm from intensifying.

This drug can be the best bet since it already is available in the market for the treatment of psoriasis, implying the fact that it is safe for human usage which has been proven by the 4 phase trials that were conducted before its release in 2013 by Biocon. Itolizumab acts by binding to the CD6 receptor and modulating it to prevent the T-lymphocyte activation thereby reducing the cytokine storm that turns into a deadly immune response.

Biocon is very well known for its unique biologics and pharmaceutical products in India and has a lot of global connections, Equillium being one of them. Equillium, a biotechnology company is planning to initiate a global study of this novel drug, Itolizumab, to make sure a large number of people get benefitted within a short period. Equillium is partnering with Biocon for Itolizumab in U.S., Canada, Australia, and New Zealand.

Bruce Steel, the co-founder, and CEO of Equillium said that they are working with Biocon to assess the further processes involved in accelerating the use of Itolizumab to treat COVID-19 patients in the U.S and abroad. The drug is being evaluated at present under two INDs for treating acute graft-vs-host disease and lupus nephritis, plus a clinical study in uncontrolled asthma in Australia and New Zealand.

Similarly, Itolizumab has been used to treat COVID-19 patients in Cuba too. The reports from Cuba were similar to the one obtained in the trial done in India and it shows a very low mortality rate in the patients who were administered with Itolizumab. The dosage being administered is a 25mg/5ml formulation at the rate of 4 vials per patient. Each vial costs Rs. 7,950. Therefore, the total dosage costs around Rs. 35,000.

The success and approval of Itolizumab show us that we can still hope for a better tomorrow with many individuals carrying out endless research works to find a solution. The efforts are enormous and we can only hope for them to be fruitful. With vaccines under trial and testing, the best we, as general citizens, can do is to stay calm and help others do the same. It is our responsibility to take enough care of our health and in this case, the health of our loved ones too.

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Psoriasis Drug Being Used To Treat COVID-19; Why Itolizumab? - Inventiva

Factbox: What progress is Britain making on post-Brexit trade deals? – Reuters UK

LONDON (Reuters) - Britain is negotiating several bilateral trade deals to come into effect once its exit from the European Union is complete at the end of the year.

FILE PHOTO: European Union and British flags flutter in front of a chancellery ahead of a visit of British Prime Minister Theresa May in Berlin, Germany, April 9, 2019. REUTERS/Hannibal Hanschke/File Photo

The Department for International Trade has prioritised deals with the EU, the United States, Japan, Australia and New Zealand. Heres where things stand:

Total trade value: 232.7 billion pounds (1)

Both sides have said they want a quick deal, but there are clear hurdles. The United States elects a new president in November, and the UK says there is no set timetable because it does not want time pressure to be used against it.

Two rounds of talks have taken place so far, with the third expected to begin on Monday. Both sides have described the talks as constructive and positive, but there are underlying tensions.

The United States imposed retaliatory tariffs on EU exports, including some from Britain, after a row over aircraft subsidies. Britain has demanded that those tariffs, which apply to a wide range of goods including Scotch whisky and tailored suits, be removed to show goodwill.

Other high-profile issues include whether a deal will give U.S. firms access to Britains state-funded healthcare system, and whether Britain will accept U.S. food hygiene standards. The British government says the National Health Service is not on the table, and food standards will not be lowered.

Total trade value: 673 billion pounds (1)

Britain and the European Union have held six formal rounds of talks on a trade agreement to form part of a deal on their future relationship when a status quo transition period expires at the end of this year.

Both sides agreed last month to speed up their talks but their positions are far apart, particularly on the level playing field guarantees of fair competition and on fisheries.

Britain said after the last round that an agreement could be reached in September; EU officials say the earliest any breakthrough could come is towards the end of August.

Total trade value: 18.6 billion pounds (1)

Britain said in its negotiating mandate, published on June 17, that it wanted an ambitious and comprehensive deal including a focus on technology, innovation and research and development.

The first round of talks was held remotely between June 29 and July 10. Trade minister Liz Truss said: Discussions between negotiators were productive and reflected our shared ambition to secure a comprehensive deal to boost trade and investment between our like-minded economies.

The next round of talks is planned for September.

Total trade value: 31.6 billion pounds (1)

Negotiations began in June. Both sides have said they want a deal to come into force by the end of 2020.

Tokyo wanted to conclude talks by the end of July, but Truss has since said she will not be bounced into signing a deal because of time pressure.

Britain says any deal with Japan should be at least as good as the one signed with the EU, and that that deal can be used as a template to speed the process up.

British analysis estimated that, in the long run, the trade deal could increase annual trade flows between both countries by 15.2 billion pounds and increase the size of the UK economy by 1.5 billion pounds.

Total trade value: 2.9 billion pounds (1)

Britain said in its negotiating mandate, published on June 17, that it wanted an ambitious and comprehensive deal supporting both governments Net Zero commitments on climate change.

The first round of trade talks began via videoconference on July 13 and concluded on July 24. Further rounds are expected in due course, Britain said.

(1) Office for National Statistics, UK total trade; all countries, non-seasonally adjusted, 2019, as of July 23.

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Reporting by William James and Elizabeth Piper; Editing by Kevin Liffey

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Factbox: What progress is Britain making on post-Brexit trade deals? - Reuters UK

Tony Blair calls for an investigation into Russian involvement in Brexit referendum – The New European

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PUBLISHED: 11:05 27 July 2020 | UPDATED: 11:50 27 July 2020

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Former prime minister Tony Blair. Photograph: Stefan Rousseau/PA.

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The former Labour prime minister said the probe was a matter of national security.

Speaking after Boris Johnson dismissed a parliamentary committees recommendation for an investigation, Blair said: Were still with one of the best security services in the world - youve got to build the capability to investigate what foreign governments are trying to do in interfering with our system and expose it and the more you expose it, the less effective it will be or the less it will happen.

I think it would be sensible to investigate what has happened but really, the most important thing is to create the capacity for the future, to make sure that you know whats going on in your democratic politics because this interference - and its only one aspect of cyber-security, by the way - this interference is going to be more and more widespread because the capabilities are much greater.

Blairs comments come after the Intelligence and Security Committee (ISC), a Westminster panel tasked with scrutinising Britains intelligence community, released a 50-page report detailing instances of Moscows interference in UK elections and institutions.

The document, dubbed the Russia report, claimed wealthy Russian figures with connection to president Vladimir Putin regularly donate to British political parties.

It called Russian involvement in British institutions the new normal and blasted successive governments for not wanting to address the issue of the 2016 vote with a 10-foot pole.

According to a survey by pollsters Opinium, almost half of the British public (49%) think that the Kremlin interfered in the 2016 vote, including 39% of those who voted for Leave and 63% who supported Remain.

Head of polling at Opinium, Adam Drummond, said: Although the EU referendum is the most obvious example, whats interesting is the consistent pattern across all election and referendums over the past five years where around half of voters believe that the Russian government interfered with our political process, and this belief is about twice as high among Remain voters as Leave voters.

That said, the fact that more believe it happened than did not happen and that 66% of UK adults put Russia in the threat category, suggests a degree of political consensus about the problem in the future.

Touching on the committees findings, Blair added: We live in a new world today where cyber-security is going to be a massive, massive question for government and there are governments that want to weaken the West; we know basically why they want to do it, and weve just got to make sure that they are all the time constrained.

Blair added that it would be foolish to think the referendum result was a consequence of Russian interference.

Almost four years after its creation The New European goes from strength to strength across print and online, offering a pro-European perspective on Brexit and reporting on the political response to the coronavirus outbreak, climate change and international politics. But we can only rebalance the right wing extremes of much of the UK national press with your support. If you value what we are doing, you can help us by making a contribution to the cost of our journalism.

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Tony Blair calls for an investigation into Russian involvement in Brexit referendum - The New European

Freedom of movement and the importance of being Brexit-ready – SME Magazine

SMEs thrive on attracting and retaining the brightest and best talent, but with forthcoming changes heralding the restriction of movement for EU citizens, they could find themselves unable to employ who they want, when they want to.

Lawyers are advising companies to get ready for the new immigration rules, knowing that failure to do so could have a dramatic effect on future growth and recruitment plans.

Following recent government announcements, it is clear that Brexit is still very much on the cards for the end of the year and companies need to prepare for the new immigration laws coming into force on January 1.

These laws mean that, to employ EU nationals currently not living in the UK after that, all business, no matter what size, will need a Sponsor Licence. This licence grants a company permission from the Home Office to employ overseas staff previously something only needed for non-EU workers.

According to figures from the Office for National Statistics, there is currently an estimated 2.31 million EU nationals working in the UK and these changes could affect many sectors reliant on attracting new talent and staff from overseas. Aldijana Hoad, director at immigration law firm OTB Legal acknowledges that with the country still in the grip of the Covid-19 crisis, Brexit is something far from our minds.

We understand that for some companies, the future is uncertain, and many are focusing to how to survive and operate in the future, so to have something else to think about right now is difficult, she said.

There were suggestions that the new immigration rules would be delayed because of Lockdown but the latest government guidance states they are still on track.

With this in mind, we want to stress how important it is for companies to apply for a Sponsor Licence now if they want to take on new EU nationals from overseas next year.

The rules are also being relaxed to allow bosses to employ overseas nationals with A-Level or equivalent standard skills from January.

Companies need to consider what the impact would be on their workforce and recruitment plans and subsequent delivery of goods and services

This compares to the degree level required previously when filling a vacancy and could see Sponsor Licence applications increase, as companies look to take on staff at different skill levels.

Aldijana said: With less than six months to prepare and an average two-month turnaround on the application process, its important to get started. Companies need to consider what the impact would be on their workforce and recruitment plans and subsequent delivery of goods and services, if there was a delay in getting a Sponsor Licence granted.

Over 15 per cent of Sponsor Licence Applications are refused due to issues such as companies not providing the required documents or not responding in a timely manner. If an application is refused, there is a cooling-off period of six months and a new application cant be made until after that date.

For companies currently employing EU nationals living in the UK, those individuals have until June 30, 2021 to apply to the Home Office for settled or pre-settled status under the EU Settlement Scheme. If they dont apply before then, they would lose their right to live and work here and would be illegally employed.

Its not just about attracting new staff but also protecting your existing workforce. It is vital for employers to complete right to work checks on anyone they take on as the consequence of employing someone illegally could be devastating, she said.

Penalties could be up to 20,000 per illegal worker, criminal sanctions, including up to five years imprisonment and/or an unlimited fine and companies could also face the loss of reputation as the Home Office publishes the names of businesses fined for employing illegal workers.

Our advice is to seek guidance to ensure everything is in order in good time, allowing you to protect the future of your business and your current workforce.

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Freedom of movement and the importance of being Brexit-ready - SME Magazine

Nigel Farage’s attempts to spark another ‘Brexit’ in Italy – The New European

PUBLISHED: 12:43 25 July 2020

Steve Anglesey

Gianluigi Paragone, the former Five Star Movement senator who is heading up the new 'No Europe for Italy' party. Picture: Andrea Ronchini/NurPhoto via Getty Images

Andrea Ronchini/NurPhoto

After Nigel Farages role in Brexit, STEVE ANGLESEY looks at why he might be tempted to try to pull off something similar in Italy.

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Mussolini can be quite funny, Nigel Farage told a Channel 4 reality show in 2014. I saw his granddaughter last week Pretty girl, pretty girl.

These are opinions Farage might want to keep on the QT now he appears to be acting as unofficial advisor to Italys version of the Brexit Party, which is due to launch this week. Since historians hold Mussolinis 20-year-long reign responsible for the deaths of one million of his countrymen, its just possible that not all Italians will chuckle along with Nigel at the thought of his memory.

Neither, youd imagine, would they be too impressed to learn that Hermann Kelly, who worked as a PR man for Farages EFDD grouping in the European parliament, used to refer to his boss as Il Duce (Thats just a bit of fun, isnt it, Nigel told Politico in 2018). Or to recall how in 2017, Farage was booed by Italian MEPs for comparing the EU to the mafia, later withdrawing his remark on the grounds of national sensitivities.

And you cannot see them looking too fondly on Farages speech in early March at the Daily Telegraphs Heroes of Brexit event, when he claimed Italys battle with Covid-19 presented a golden opportunity for Britain: This awful crisis and the way it is gripping parts of Italy makes a trade deal with the EU easier now than its ever, ever been. The collapsing Italian economy needs a deal with the UK desperately, he said.

None of this will matter much to Farage fanboy Gianluigi Paragone, the former Five Star Movement senator for who is heading up the new No Europe for Italy party names like Quitalia and Italexit having been deemed too Anglophone which is already polling around 7%. He calls Farage a true British patriot, hailing him for bringing the United Kingdom out of the European Union cage... the only one who sent away the technocrats from Brussels.

The former talk show host shares Farages awkward squad tendencies; public criticism of his partys fading commitment to Euroscepticism saw him kicked out of Five Star earlier this year. Paragone says the pair have discussed the present and future of a truly sovereign country which, even more so after Brexit, is able to give real answers to citizens in the midst of the post-Covid economic crisis.

Its hardly surprising to hear that Farage is interested in helping out. Along with the Denmark, Poland, the Netherlands and risibly Ireland, Italy is a country hes mentioned repeatedly as being prime for the next Brexit.

Until recently, the polls were firmly against him, with the Italian research institute Censis reporting late last year that only 25% believed leaving the EU was a good idea against 62% who thought it a bad idea. But the unions muddled response has been another silver lining from coronavirus for Farage; in April a Tecn poll put the numbers at an uncomfortable 51%-49% in favour of Remain.

Those polls are expected to move away from Leave after Italy became one of the key beneficiaries of the EU recovery fund that was finally agreed on Tuesday morning prime minister Giuseppe Conte says it will receive 28% of the 675 billion available in grants and loans but Farage has good reason to stay interested. Not only does it look like his lucrative private jet trips to the USA will become far more infrequent after Thursday, November 3, but Italy represents some kind of spiritual homeland for Brexit.

It was after discussions with Five Star co-founder Gianroberto Casaleggio in Milan in January 2015 that Farage resolved to make Facebook and data the key battlegrounds for pro-Leave campaigning, telling the political scientists Matthew Goodwin and Caitlin Milazzo: If I was starting UKIP today would I spend 20 years speaking to people in village halls or would I base it on the [Five Star co-founder Beppe] Grillo model? I know exactly what I would do.

Casaleggios methods attracted the eye of Arron Banks too, making the Milan meeting a fatal first step on the road to Leave just 17 months on. The Brexit Party, which toppled Theresa May and appears to have forced Britain into the kind of Brexit that in 2016 existed only in the wildest dreams of the wildest Leavers, was founded in Five Stars image.

Banks can now be found working for crotchety right-winger Winston Peters in his flagging New Zealand general election campaign against hugely popular incumbent PM Jacinda Ardern, telling website Newshub Nation this week that he is determined to deliver Winston on steroids a happy warrior.

Far cry, isnt it, from the days after Barack Obama delivered his pro-Remain Get to the back of the queue speech in March 2016? Back then, Banks organisation responded with a Back Off, Barack! petition and Farage warned him to butt out of the Brexit debate.

Honestly, the cheek of these foreigners trying to interfere in the democratic process of other countries...

Almost four years after its creation The New European goes from strength to strength across print and online, offering a pro-European perspective on Brexit and reporting on the political response to the coronavirus outbreak, climate change and international politics. But we can only rebalance the right wing extremes of much of the UK national press with your support. If you value what we are doing, you can help us by making a contribution to the cost of our journalism.

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Nigel Farage's attempts to spark another 'Brexit' in Italy - The New European

Petition launched calling for European Union flag to be removed from outside Scottish Government buildings – HeraldScotland

A petition has been launched calling for the European Union flag to be taken down from outside Scottish Government buildings following Brexit.

The petition lodged on the Scottish Government site calls for the Scottish peoples view to be tested on the issue post-Brexit.

It comes after a move to stop flying the EU flag at the Scottish Parliament was shelved following a backlash from MSPs after ministers said that the flag should be flown in recognition of the contribution of EU national in Scotland.

READ MORE:EU negotiator warns post-Brexit trade deal unlikely

The Scotsman reports that Holyroods petition committee is now considering the issue after the petition was lodged by Philip Smith this month.

The petition reads: This petition is necessary to ensure the Scottish Government stops flying the flag of an organisation that the United Kingdom is no longer a member of, he states.

READ MORE:Iain Macwhirter: It's clear BoJo still doesnt get Scots (and its not the economy, stupid)

Although we have left the European Union, Scotland is still a member of the Commonwealth.

The petition should be allowed to test the Scottish peoples view on whether to have the Commonwealth flag flying in place of the European at Scottish Government buildings.

An example of where this has already taken place is Gibraltar which is now proudly flying the Commonwealth flag.

Responding to the petition, ministers told The Scotsman that the EU flag is flownto provide a concrete and visible expression of the value that we place on the contribution that EU nationals have made to our country.

The UK ceased to be a member of the European Union at the end of January, with talks continuing about the relationship after Brexit.The UKs chief negotiator, David Frost, said talks have not yet reached any agreement following intensified discussions between the two sides.

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Petition launched calling for European Union flag to be removed from outside Scottish Government buildings - HeraldScotland

Brexit shock: How Northern Ireland could return to EU after UK departure – Daily Express

Northern Ireland was at the centre of the Brexit negotiations last year when former Taoiseach Leo Varadkar and Prime Minister Boris Johnson decided to settle the dispute over the Northern Ireland backstop. They agreed to put up a customs border in the Irish Sea in a move called the Northern Ireland Protocol, which would protect the Good Friday Agreement and prevent tensions returning to the Irish border. This means Northern Ireland will stay in the customs union and single market, but will no longer be able to contribute to the governance of either.

However, Stormont will be able to vote on whether to maintain this system every four years with the issue seemingly resolved, the Withdrawal Agreement came into effect in January.

Yet, as post-Brexit trade talks are on the cusp of collapse this week after Britain threatened to walk away, theres concern that there has not been enough preparation for the new system that will come into place in the Irish Sea.

Professor Colin Harvey, from Queens University Belfast, wrote for Irish broadcaster RTE back in 2019 that Brexit could lead Northern Ireland to rejoin the EU.

He claimed Brexit has had a destabilising impact on relationships across these islands.

Prof Harvey continued: The border on the island becomes an external border of the EU after Brexit, will all the symbolism that this carries combined with the severe practical implications.

He added the border is still of profound concern to the Irish Government and the EU.

He also claimed that the decision of the Democratic Unionist Party (DUP) to back Brexit divided Northern Ireland along unionist and nationalists.

Consequently, the DUP ended up on the opposite side of the table as the Remainers who made up the majority of the Northern Irish public by 56 percent.

READ MORE:Micheal Martins fury with UK for showing bad faith in Brexit demand

The Ireland expert added the likelihood of Irish reunification had been increased by Brexit.

He suggested that this was because the foundational objectives of the EU chime well with the values underpinning the peace process of the Good Friday Agreement.

Prof Harvey then said: The Good Friday Agreement contains a mechanism that would allow Northern Ireland to return automatically to the EU.

It is likely that interest in this will intensify.

He added that Northern Irelands status rests on the principle of consent which Mr Johnson attempted to address by allowing Stormont to vote on the matter every four years.

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Prof Harvery continued: The EU has already provided clarification: the whole territory of a united Ireland would be part of the EU.

This opens a new dimension in the context of a society where a majority of people have voted to remain, and where many are profoundly worried about the impact of Brexit.

He pointed out how the arguments in favour of Irish unification will now include rejoining the EU, too.

Still, he conceded: The persuasiveness of this will depend on the type of Brexit that emerges, and much of this will have to be tested against what happens in practice.

He concluded: A no-deal Brexit or any form of hard Brexit will simply energise the unity discussion.

Prof Harveys piece in RTE was published just four days after Mr Johnson and Mr Varadkar claimed they saw a pathway to agreeing over Northern Ireland a pathway which led to the Northern Ireland Protocol.

However, Katy Hayward wrote in a blog post for LSE earlier this year that Stormonts consent on the Protocol did not have as much weight as previously thought.

She explained: In an effort to assure unionists in particular, the impression being given [by Westminster] is that, if they dont like the Protocol, they can invest efforts into getting rid of it via the democratic consent vote provided in Article 18.

The inclusion of Article 18 was itself an effort to assuage concerns in Northern Ireland (particularly those of unionists) that they would have no say over the Protocol.

She added: There are many aspects of it (e.g. articles on the protection of rights, safeguards and the Common Travel Area) that will apply regardless of how a majority of MLAs fall in a future consent vote.

To follow Prof Harveys logic, without consent in Northern Ireland for the post-Brexit arrangements, support for reunification and subsequently rejoining the EU could grow substantially.

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Brexit shock: How Northern Ireland could return to EU after UK departure - Daily Express