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Vertex Receives Australian TGA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat People With Cystic Fibrosis Ages 12…

Posted: March 26, 2021 at 6:01 pm

LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Australian Therapeutic Goods Administration (TGA) has approved the use of TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for people with cystic fibrosis (CF) ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation worldwide. Up to 90% of people living with CF worldwide have at least one F508del mutation.

We are delighted the TGA has approved TRIKAFTA for eligible people living with CF in Australia and will continue working with the Australian government to bring this important medicine to patients as quickly as possible, said Reshma Kewalramani, M.D., Chief Executive Officer and President, Vertex. It is our goal to develop and provide treatments for all people with CF around the world, and today is another significant milestone on that journey.

CF affects approximately 3,500 people in Australia. It is caused by a defective and/or missing CFTR protein resulting from mutations in the CFTR gene.

Cystic fibrosis is a complex, progressive, devastating disease that causes severe damage to the lungs, digestive system and other organs in the body. It is a condition that significantly affects not only the patient, but also those who care for them, with people living with cystic fibrosis spending multiple hours every day on treatment and requiring daily care from a family member or loved one, said Professor John Wilson AM, Head, Cystic Fibrosis Service, Alfred Health. The approval of any new treatment option for people living with cystic fibrosis is always welcome news. This new treatment is for patients ages 12 years and older with at least one F508del mutation and means more patients can potentially benefit from a medicine that targets the underlying cause of the disease, for the first time.

The TGA approval of TRIKAFTA was based on the results of four global Phase 3 studies, which included multiple trial sites and patients from Australia.

About Cystic Fibrosis

Cystic Fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 80,000 people globally. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes one from each parent to have CF. While there are many different types of CFTR mutations that can cause the disease, the vast majority of all people with CF have at least one F508del mutation. These mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working and/or too few CFTR proteins at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the early 30s.

About TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor)

In Australia, TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

The complete product information (PI) can be found on http://www.tga.gov.au.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of cell and genetic therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 11 consecutive years on Science magazine's Top Employers list and a best place to work for LGBTQ equality by the Human Rights Campaign.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Reshma Kewalramani, M.D., and Professor John Wilsonin this press release, and statements regarding our expectations for the eligible patient population in Australia, including patients not previously eligible for treatment with a CFTR modulator. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support a license extension for TRIKAFTA in Australia, and other risks listed under the heading Risk Factors in Vertex's annual report filed with the Securities and Exchange Commission and available through the company's website at http://www.vrtx.com and on the SECs website at http://www.sec.gov. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

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Vertex Receives Australian TGA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat People With Cystic Fibrosis Ages 12...

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Life Edit Therapeutics Announces Award from Cystic Fibrosis Foundation – Business Wire

Posted: at 6:01 pm

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Life Edit Therapeutics Inc, a next generation gene-editing company, today announced that it has received an award from the Cystic Fibrosis Foundation to identify potential gene editing approaches to treat certain patients with cystic fibrosis (CF). The award will enable Life Edit to screen its library of proprietary base editors for a potential treatment targeting people with CF that are not able to be treated by existing small molecule treatments due to what are known as nonsense genetic mutations (also known as stop mutations). This award is part of the Cystic Fibrosis Foundations Path to a Cure initiative that was launched in October 2019 to address and treat the underlying cause of CF.

Due in large part to the efforts of the CF Foundations support for the development of new medicines, there are now effective therapies available to most people living with the disease, but there remain as many as 7% of patients with CF for whom recent medical advances are not effective, said Mitchell Finer, Ph.D., Chief Executive Officer, Life Edit Therapeutics. Were looking forward to working with the CF Foundation to leverage the unique benefits that our platform offers to develop a highly targeted gene editing approach for these individuals. We believe our science and this approach can be applied across a range of diseases, which will be our focus as we work to build a pipeline of life-changing therapies for severe genetic diseases like CF.

Dr. Allie Crawley, Principal Investigator for the project and member of the Life Edit team, continued by saying, We are thankful to be a part of the Path to a Cure initiative from the CF Foundation which is focused on curing cystic fibrosis by addressing the underlying cause of the disease. We believe our base editor technology has potential to make a great impact in the lives of cystic fibrosis patients with nonsense mutations and are excited about the opportunity to begin early research in this development.

Despite tremendous progress in advancing therapeutics to help people with CF live longer and healthier lives, there remain unmet needs to help all those living with this disease. Approximately 13% of people living with CF have nonsense mutations. These mutations cause the cells to stop the production of the cystic fibrosis transmembrane conductance regulator (CFTR) protein midway through the process, resulting in shortened, non-functional protein.

As part of the $400,000 award from the Foundation, Life Edit will explore its large collection of adenine base editors, or A-base editors, that can potentially be used to correct the six most common, Class I, cystic fibrosis nonsense mutations to restore CFTR function in vivo. A unique feature of the base editors under development by Life Edit is their small size which will allow in vivo delivery with Adeno-associated viruses (AAV) vectors to specific tissue types in the lungs. As part of the agreement, Life Edit will benefit from materials, resources, and expertise from the Cystic Fibrosis Foundation.

About Cystic Fibrosis

Cystic fibrosis (CF) is a rare genetic disease found in more than 30,000 people in the U.S. CF is a hereditary disease that affects the lungs and digestive system that is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that affect the production of the CFTR protein. When the CFTR protein is not made correctly, it affects the balance of salt and fluids inside and outside of the cell. This imbalance leads to thick, sticky mucus in the lungs, pancreas, and other organs. In the lungs, the mucus clogs the airways and traps germs, like bacteria, leading to infections, inflammation, respiratory failure, and other complications. CF is a progressive, genetic disease that causes persistent lung infections and limits the ability to breathe over time.

About Genome Editing and Life Edit Therapeutics Platform

Genome editing technologies have revolutionized the way cell and gene therapies and regenerative medicines are discovered and developed by allowing genetic material to be removed, added, or altered at specific locations in the genome. While these technologies are in widespread use experimentally, enzymes that offer broader coverage and greater specificity are needed for creating novel cell and gene therapies.

To meet the need for better genome editing approaches, Life Edit Therapeutics has built one of the worlds largest and most diverse arrays of novel RNA-guided nucleases (RGNs) and base editors that are active in mammalian cells. These RGNs were developed using AgBiomes proprietary collection of more than 90,000 microbes and their complete genomes. Life Edit Therapeutics is investigating these proprietary RGNs, which are sourced exclusively from non-pathogenic organisms, to develop new gene editing tools with higher fidelity, novel functionality, reduced immune response risk, and easier delivery. Life Edit Therapeutics nuclease collection also has a broad range of Protospacer Adjacent Motifs (PAMs) short sequences that must follow the targeted DNA sequence in order for the enzyme to make cuts that offer unprecedented access to genomic loci of interest. The Life Edit Therapeutics RGNs offer flexible editing options which encompass knock-out and knock-in capabilities, transcriptional regulation, and base editing when coupled with its proprietary deaminases.

Life Edit Therapeutics next generation editing systems will propel the development of novel human therapeutics by enabling ex vivo engineering for cell therapies and regenerative medicines and in vivo delivery of gene therapies. In addition to developing its own pipeline of gene therapies, Life Edit Therapeutics will continue to build its platform of novel nucleases, provide gene editing expertise to strategic partners and ElevateBios portfolio companies, and form other third-party partnerships to discover and develop new therapies.

About Life Edit Therapeutics Inc.

Life Edit Therapeutics is a next-generation gene editing company that has built a highly innovative genome editing platform with one of the worlds largest and most diverse collections of novel RNA-guided nucleases (RGNs) and base editors. Life Edit Therapeutics next generation editing systems will propel the development of novel human therapeutics by enabling ex vivo engineering for cell therapies and regenerative medicines and in vivo delivery of gene therapies. The company is continuing to strengthen the platform, developing a pipeline of in vivo gene therapies to address severe genetic disease, and sharing its expertise through strategic partnership. Life Edit is an ElevateBio portfolio company. For more information visit lifeeditinc.com.

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Philadelphia Phillies: Adam Haseley still has time to win the starting CF job – Section 215

Posted: at 6:01 pm

When it was first announced that Adam Haseley would be missing a majority of this years Spring Training due to a groin injury, a good number of people wrote him off as unlikely to be the Philadelphia Phillies starting center fielder on Opening Day (myself included).

With such a fierce competition expected to take place out in CF this spring, many assumed the lost time would simply rule Haseley out of the Opening Day conversation. Throw in the fact that Joe Girardi hasnt seemed super keen on using Haseley in the past, and all signs pointed towards the former first-round pick starting off the season on the bench, or even on the IL.

However, despite the initial projections, Haseley is already back in action. Hell be available as a backup during the teams Tuesday night game against the Toronto Blue Jays, and has already been announced as a starter for the teams Wednesday afternoon game against the Detroit Tigers:

Obviously, thats all super good news. Haseley has struggled with lingering injuries in the past, so seeing him quickly rebound from this groin issue is a positive development in that regard. Additionally, theres still a full weeks worth of Spring Training ball left to be played. Haseley might be working with a bit of a disadvantage as he has limited time to find his swing again, but seven games could easily be enough time for Haseley to change the Phillies current plans out in center field.

The other main factor thats aiding Haseley in his attempt to be named the Opening Day center fielder is the fact that the rest of his competition hasnt exactly risen to the occasion. Scott Kingery has been a disaster at the plate (and could see time in AAA this year), Odubel Herrera has flashed some pop at times, but has also been a streaky hitter this spring, and Roman Quinn continues to look like the same ol Roman Quinn from years past.

Herrera is the frontrunner out in CF at the moment, but the Phillies would likely jump at the opportunity to exclude the controversial outfielder from their Opening Day roster to make way for a potentially surging Adam Haseley.

Haseleys swing looked solid during his first couple at-bats prior to the injury he even hit a leadoff home run to kick things off back in late February. If the young lefty can return to the lineup in a similar form, the odds of him overtaking the likes of Herrera and Quinn in the CF pecking order seem high.

Set to turn 25 in April, theres still a ton of potential left to be squeezed out of Haseley moving forward. However, the Philadelphia Phillies are desperately trying to crack the postseason this year, and their patience might be thin when it comes to the CF position. Herrera has shown enough promise this spring to deserve a few reps out there in the regular season, and I wouldnt even rule out a midseason upgrade via the trade market should Dave Dombrowski be unsatisfied with the results hes getting.

For the meantime, however, Haseley will likely be getting every opportunity in the world to win back the job over the next couple of days.

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Bader out: Who is the St. Louis Cardinals opening day CF? – ESPN 92.9 FM

Posted: at 6:01 pm

ST. LOUIS (KMOX) - St. Louis Cardinals center fielder Harrison Bader will be on the injured list to start the 2021 season due to soreness in his right forearm, announced manager Mike Shildt on Wednesday.

He says the 26-year-old will be out for "a solid four weeks at a minimum" after he receives a PRP injection. Bader was 3 for 28 this spring and Shildt says Bader feels he hasn't been able to consistently compete due to the soreness.

So who's the next man up? Here are some options:

Tyler O'NeillThe 2020 Gold Glover in left field has been the best hitter for St. Louis this spring. His 14 hits and 1.090 OPS both lead the team, but his 12 strikeouts are also the second-most for St. Louis.

Lane ThomasThomas might be the guy the Cardinals are most-hoping to prove himself worthy of a starting role. His speed and glove make him a natural in center, but he's still not making the best case at the plate. His on-base percentage is just .281 this spring and that coupled with a 12 strikeouts (tied with O'Neill) is not a good combo. He's got a handful of games to turn it around.

Dylan CarlsonThe prospective future of the Cardinals is going to be in the starting lineup one way or another. He already has more than 180 innings at centerfield in the majors and hasn't looked exposed by any means, but the metrics say he's much better in a corner outfield spot.

Carlson is starting in center for St. Louis in Wednesday's game and it's believed that he'll get the nod to start there come April 1.

Beyond just the centerfield position, Bader's absence also means a roster spot has opened and a few other players could force their way into an opening day role over the next week:

John NogowskiDoes anyone else get a Matt Adams vibe? This 28-year-old first baseman has been making a lot of noise this spring and could force himself onto the opening day roster. He's also been taking reps in the outfield since first base seems to be pretty well covered in St. Louis.

Justin WilliamsHe's not a candidate for center field, but is certainly making a strong case for a bench role at the least. You've seen the Twitter highlights of him striping the ball for extra bases recently and he'll likely get as many at bats as the aforementioned outfield candidates to prove his worth.

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Cystic fibrosis treatment from Cary firm offers relief to adults afflicted with disease – WRAL Tech Wire

Posted: at 6:01 pm

RESEARCH TRIANGLE PARK Adults living with cystic fibrosis (CF) now have access to a new revolutionary therapy aimed at improving pulmonary function.

Chiesi USA(pronounced (key-A-zee), with U.S. headquarters in Cary, has launched its Bronchitol (mannitol) inhalation powder following approval by the U.S. Food and Drug Administration.

This is the first approved mucoactive agent for CF patients in nearly 30 years, Jon Zwinski, Chiesi USA CEO and general manager, told the North Carolina Biotechnology Center.

It is the only dry-powder inhaled mucoactive agent that is compact, discreet and portable, and does not require any nebulization, refrigeration or routine cleaning.

CF is a progressive, genetic diseasethat causes persistent lung infections and limits the ability to breathe over time. More than 30,000 people in the U.S. are living with CF (more than 70,000 worldwide).

Theres currently no cure.

In the LimeLight: Cary drug firm Chiesi USA names successor to longtime CEO

This new therapy is billed as an add-on maintenance therapy for patients 18 years of age and older, and Zwinski said it could make a big difference with symptoms.

Data from a global Phase 3 study evaluating the efficacy and safety of inhaled dry powder mannitol in adults with CF has been published online in theJournal of Cystic Fibrosis.

In the multicenter, double-blind, randomized, parallel-group, controlled study of 423 adults with CF, subjects received either mannitol 400mg or mannitol 50mg (the control), twice daily via dry powder inhaler for 26 weeks. Authors concluded that the 400mg dose significantly improved lung function compared with the control group.

Thanks to evolving treatments over the years, many patients are now living longer, more active lives, Zwinski said.

Until a cure is found, it is critical to continue to provide options to patients so they can find the right treatment that fits their needs both for their disease and for their lifestyle.

Bronchitol was developed by Pharmaxis Ltd., and Chiesi is now its exclusive distributor in the United States and 11 countries in Europe. Bronchitol is also approved and marketed in Australia, Europe, Russia, and several other countries.

Chiesi is the American subsidiary of family-owned Chiesi Farmaceutici of Parma, Italy.

Globally, the parent companysportfolio of nine marketed drugs is focused on acute cardiovascular care, neonatology, CF and other rare diseases. Chiesi is best known for Curosurf (poractant alfa), a lung surfactant for treating respiratory distress syndrome in premature infants.

In the U.S., it focuses on acute cardiology, neonatology and CF.

Its roots stateside go back to 2004, when Cornerstone BioPharma Holdings was formed in Cary to develop respiratory drugs. Through a reverse merger with Critical Therapeutics of Lexington, Mass., in 2008, Cornerstone became a publicly traded company and changed its name to Cornerstone Therapeutics.

Chiesi became a majority shareholder of Cornerstone in 2009. Five years later, it bought the remaining shares, taking Cornerstone private as its wholly owned U.S. subsidiary.

In 2019, it moved into its new headquarters, the top two floors of a new, six-story, office building 55,000 square feet in all overlooking the Koka Booth Amphitheater and Symphony Lake in Regency Woods II.

At the time, the company said it planned to double its 130-person Cary staff in the next 10 years.

Zwinski said its still on target.

Over the next few years, we expect Chiesi USA will experience steady revenue and employee growth in both Cary and Boston, he said. This growth would be linked to strong performance expected from our growing portfolio of marketed products, launch of new specialty pipeline programs and support for our emerging rare-disease business unit.

(C) N.C. Biotech Center

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Vertex Pharma (VRTX) Receives CHMP Positive Opinion for KAFTRIO in Combination With Ivacaftor to Treat People With CF With At Least One F508del…

Posted: at 6:01 pm

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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation worldwide. If the European Commission follows the recommendation, the majority of people with CF in Europe will be eligible for the medicine.

The CHMP positive opinion was based on the results from a global Phase 3 study (Study 445-104) evaluating the triple combination therapy in CF patients ages 12 years and older who are heterozygous for the F508del-CFTR mutation and a CFTR gating mutation (F/G) or a residual function mutation (F/RF). The study was conducted by Vertex to complement the prior Phase 3 trials, which showed positive results for ivacaftor/tezacaftor/elexacaftor in combination with ivacaftor in people ages 12 years and older with CF with two F508del mutations (F/F) or one F508del mutation and one minimal function mutation (F/MF) genotype. It showed statistically significant and clinically meaningful improvements in primary and key secondary endpoints, including lung function in patients treated with ivacaftor/tezacaftor/elexacaftor in combination with ivacaftor.

Todays opinion is an important step towards bringing this medicine to any patient with at least one F508del mutation, including those with a gating or residual function mutation who were not previously eligible for the triple combination therapy, said Nia Tatsis, Ph.D., Executive Vice President, Chief Regulatory and Quality Officer at Vertex.

In Europe, KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is currently licensed for the treatment of people with CF ages 12 years and older with an F/F or F/MF genotype.

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Vertex Pharma (VRTX) Receives CHMP Positive Opinion for KAFTRIO in Combination With Ivacaftor to Treat People With CF With At Least One F508del...

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Complaining about Cleveland Indians handling of Amed Rosario in CF – Factory of Sadness

Posted: at 6:01 pm

Think the Cleveland Indians will solve the conundrum known as centerfield before Opening Day?

Call Kenny Lofton, because I think hed be a safety bet than what were looking at now.

As we still gnash or teeth together over the Indians indecision at the position, heres wherecenter field stands ahead of Opening Day, which is just nine days away.

Additionally here are mmy best guess as to who the Tribe will send out to cover the pasture at Detroits Comerica Park.

With Amed Rosario due around $2.4 million, hes going to make the team and center field looks like the place the former top prospect can get at bats.

Defensively, theres obviously a concern. Rosario notably made three errors in his center field debut last week. Since then, hes done a good job of making the routine plays.

With him out there, the Tribe will be walking a tight rope, but theres only way to get big-league reps once the season starts, and thats by playing him.

The Tribes decision to not move Rosario to center at the onset of Spring Training may haunt the club through the entire season. Yes, they had to find out if Andres Gimenez could start every day at shortstop, but the usually smart front office couldnt figure out that Gimenez had already beaten out Rosario for the job just six months ago while in New York. Why wouldnt he be able to do it again?

So youve got Terry Francona talking about making Rosario comfortable, which is why they teased him at shortstop to begin Cactus League play. Comfortable!? How comfortable was he when they sent him to center field halfway through camp and he made three errors, on a game that was broadcast back in Cleveland, no less?

Woof.

Playing Rosario in center field is actually a good idea. Hes athletic enough to make the switch. Oscar Mercado notably switched from shortstop to center field in the minors. Defense isnt his issue.

How and why the Indians continue to drag their feet at the position remains a mystery, but I guess it really isnt.

They coveted Bradley Zimmer over Clint Frazier in the trade that brought Andrew Miller to Cleveland back in 2016. It was, a bit of misstep.

Im rooting for Zimmer because I think he can be fine defensively and because the Tribe is invested him. That said, you dont need to be Billy Beane to know hes not going to stop striking out and hes not going to hit enough to make him a viable, every-day starter.

With just over a week until Opening Day, I think Ben Gamel makes the team. The five-year vet came up through the minors playing center field and appeared in 10 games at the position last season while with the Brewers.

Lifetime, hes a .261 hitter (.720 OPS). Hes an insurance policy should Rosario just look lostwhich is a possibility.

Jordan Luplow really struggled during the truncated 2020 campaign and hes been hurt for a good chunk of Spring Training.

In 2019 he crushed left-handed pitching to a tune of a .381 batting average and a 1.181 OPS. The Indians had Luplow play a few inning in center field on Monday. I dont think theyre going to ignore what he did against southpaws just because his 2020 was out of whack.

When Luplow was at his best two seasons back, he mostly platooned in right field. However, the Indians look to be committed to Josh Naylor in right field, and Naylor hits lefties about as well as he hits right-handers.

Frankly, at this point, Im not ruling out a trade. The Reds are DESPERATE for a shortstop. Cincy fans should feel that theyve been slapped in the face because theyre team hasnt trade for Rosario.

How Daniel Johnson wasnt given a true shot to make the club is another failure of the organization thus far in 2021. All the prospect has done is hit at the minor-league level (.284, .804 OPS). Hes mostly been thought of as a corner outfielder, but hes played over 100 games in center field during four seasons in the minor.

The Tribe went through an outfield situation in summer camp last season that resulted in Johnson being sent to the alternate site. They heavily complimented the prospect, much like they did when they demoted him last week.

At this point, what the heck are they waiting for?

As for Oscar Mercado, the job was his, but he had a dreadful time in spring training.

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Who Plays CF to Kickoff the Season for the Indians Remains a Mystery – Sports Illustrated

Posted: at 6:01 pm

The Indians have had plenty of time to figure out what nine players are worthy of being in the team's starting lineup come next week at Comerica Park in Detroit.

For the most part, the lineup is set and ready. The club hasn't announced who is going to play first base (my guess is Bobby Bradley), but other than that the infield is pretty well good to go.

You've got Cesar Hernandez, who inked another one-year deal with the Tribe, playing second, Andres Gimenez at short, Jose Ramirez at third and Roberto Perez behind the plate.

Franmil Reyes, who is expected to hit 40+ homers in 2021, will DH, and two of the outfielders look like it will be Eddie Rosario (okay that one is a lock) and Josh Naylor, who did enough late last year and in camp to earn a spot in a corner outfield spot.

That leaves center field, a position that suddenly is completely vacant with the regular season closing in.

The team made the decision to send down Oscar Mercado on Sunday, which means he's out to start the season in center, and it seems we are down to three to who starts at the important spot.

The three candidates are Bradley Zimmer, Amed Rosario and Ben Gamel.

Zimmer is a player who has shown flashes, but has suffered two things that have ended plenty of Major League careers - injuries and inconsistency.

Last year in 20 games with the MLB Indians Zimmer hit just .162 with one homer and three RBI.

He's only played 100 games or more once in his career, and that was his rookie season of 2017 when he played in 101 games.

Rosario was one of the chips in the trade that sent SS Francisco Lindor to the New York Mets.

This is a stretch to put him in the lineup as the starting center fielder. He's never played the position and last week when he started a game in center he committed three errors, looking like MLB's version of the 'Bad News Bears.'

Listed as a shortstop, it remains to be seen if they truly think Rosario can play in center for any amount of games.

Rosario last season in 46 games hit .252 with four homers and 15 RBI.

Finally there is Ben Gamel, who came to the Indians from Milwaukee as a free agent spring training invite.

The 28-year-old last season hit ,237 with three homers and 10 RBI in 40 games.

Gamel hasn't played a ton in center, starting in just 37 games in center over the last three seasons, two with the Brewers and one in Seattle.

It's a stretch to think that he's suddenly going to hit .300 and play flawless in center, but it could come down to the journeyman getting the role because of the three he's the best option.

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Luan Santiago vows to win belts in the UFC, PFL: Id beat them all up – MMA Fighting

Posted: at 6:01 pm

Luan Santiago will fight Benoit Saint-Denis in the main event of Brave CF 49, which goes down Thursday in Bahrain, and aims to go big in 2021, starting with a win over undefeated Saint-Denis (6-0, 1 no-contest).

I know him, and nothing he does impresses me, Santiago said in an interview with MMA Fighting. Hes undefeated, good on the ground and on the feet, but we're colliding and I wont let him stay on his feet. Its the law of nature, survival of the fittest, and Im the strongest. Hell come in, well clash, and Ill drop him on his butt.

He doesnt have the experience I have and doesnt train like I do. We train to kill, and well run through anyone. Ill knock him out. He cant take my hand. Hell get hit, try to take me down and get frustrated, and thats when Ill finish him.

Santiago (15-4) is a former Brave CF lightweight champion, and currently competes at 165 pounds in the Bahrain-based promotion. More than three years into his run under the companys banner, "Miau's" goal is to prove hes the worlds best welterweight.

No matter where I am, Brave, PFL or UFC, my goal is to beat everyone up and become the best in the world in this division, said Santiago, who won a decision over Gadzhimusa Gadzhiev in his most recent appearance in November 2019 and afterward had three fights canceled.

I always train to beat the best, he added. Im outspoken, but I hit hard, too. I talk the talk and back it up. Id beat them all up. Theres no difference to me, theyd get beat up the same way. Ill prove Im the best in the world in what I do.

The UFC welterweight division currently is dominated by undefeated Nigerian Nightmare Kamaru Usman, who finished Gilbert Burns this past weekend. The 170-pound class includes the likes of Jorge Masvidal, Colby Covington, Leon Edwards and Stephen Thompson. The PFL welterweight seasons were won by Ray Cooper III and Magomed Magomedkerimov.

I have no doubt that if I get in there [in the UFC], no matter if its a top-10 or 15, Id be the man to make a difference in the division, he said. Id show why Im here. Top-10 or 15, UFC or PFL, it doesnt matter. Ive fought tougher fighters. I went through hell and pain to run through anyone thats on my way. Anyone, no hesitation. Its just a matter of time.

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Luan Santiago vows to win belts in the UFC, PFL: Id beat them all up - MMA Fighting

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Phillies CF situation still uncertain midway through spring – That Balls Outta Here

Posted: March 16, 2021 at 3:00 am

The Philadelphia Phillies have a dilemma regarding who will be their starting center fielder at the start of their very important 2021 season. With just 14 spring training games to go, no player has yet to take the bull by the horns and claim the position.

Scott Kingery or Adam Haseley with Roman Quinn coming in as a platoon option for left-handed pitching seemed to be the most feasible center field scenario entering spring training. Well, Kingery has looked as lost at the plate, as he was last year. And while both Haseley and Quinn have looked like plausible options, unexpected production from other names in camp are beginning to gain traction as playing time competition.

A former No. 1 overall pick out of high school, Mickey Moniak was touted highly by scouts as a five-tool outfielder who would eventually be a perennial 20-25 homer guy with all the speed and hitting ability to become a star. Well, it hasnt happened yet, and fans that follow the minor league system are well aware of Moniaks struggles at the plate, specifically the piling of strikeouts and weak contact. That being said, he still fared okay as one of the youngest players at each stage of his career.

This spring, weve seen a filled-out version of Moniak that is putting the club on notice, launching a pair of homers early, and going 6-for-14 in spring training. He looks comfortable, confident, and powerful early on and all the other tools are still there. I love that the guy is reminding everyone of the player he can be, and all signs point to future success. Id put him ahead of a few of the other options the Phillies have, based on pedigree and ability to make adjustments.

Odubel Herrera is another surprise. He continues to flash All-Star abilities he showed during a rebuilding era of Phillies baseball. There have been talks about simply allowing Herrera to play his way on the team, or into a trade, but its hard to cut a guy when hes showing this kind of promise. Launching balls into the stratosphere and playing a solid center field usually gets a guy a job, but Herrera has more to prove than his ballplaying ability to stick around.

Herrera might be better suited to getting a fresh start somewhere else, but at the very least, El Torito is putting pressure on others to outperform him. Among those include Kingery, who haswork to do to justify even having a spot on the 26-man roster. Going 3-for-22 with 10 strikeouts is not a good way to be in the front offices good graces. Whats more, the Phillies have a significant investment in a guy like Moniak, so they may be willing to give him a go at some point during the season if not to open it.

Its just nice to see some serious competition at a position thats been missing a legitimate star in center field since the Shane Victorino days.

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Phillies CF situation still uncertain midway through spring - That Balls Outta Here

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