Monthly Archives: October 2019

Han says he will end Taiwan labor reforms to allow ‘bosses to ask for more overtime – Taiwan News

Posted: October 24, 2019 at 10:56 am

TAIPEI (Taiwan News) The erstwhile acting mayor of Kaohsiung and Kuomintang (KMT) presidential candidate, Han Kuo-yu (), doubled down on his proposal to abolish recent labor reforms at a rally in Chiayi County on Monday (Oct. 21).

At a campaign event in Pingtung on Oct. 16, an audience member called for the abolition of "one fixed day off, one flexible day off" () labor reforms, and Han responded he would review it. While visiting a temple in Pingtung's Neipu Township on Oct. 17, claiming widespread dissatisfaction with the formula, he pledged he would abolish it once he takes office as president on Jan. 11.

Han, who is on a three-month sabbatical from his post as mayor, claimed, "Since the implementation of the one fixed day off, one flexible day off policy, business owners and laborer friends have complained. So, I repeat that if I have the opportunity to be president of the Republic of China, I will take the initiative to abolish one fixed day off, one flexible day off."

At an election rally in Chiayi County on Monday, Han said that "framing it all under one decree no longer meets the current needs of the diversified labor environment," reported ETtoday. He stressed that, "Laborers want to make more money and bosses want to be able to ask employees to work overtime together," and called for it to be both "reviewed and abolished."

Revised just last year, the formula stipulates that employees must have one mandatory day off and one flexible day off per seven days, but has been unpopular both with business groups and labor activists. The government has defended the measure as a balanced way of protecting workers interests.

On Oct. 17, the Ministry of Labor responded by saying the measure had improved the quality of life by giving workers two days off per week, while still maintaining their right to work overtime. The ministry demanded Han explain whether he wanted to return to the previous system where workers might only get one day free per week, or whether he wanted to force employees to take two days off without the possibility of overtime.

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First Thai female Theravada monk named one of BBCs 100 most influential women – Global Voices

Posted: at 10:56 am

Dhammananda Bhikkhuni (Source: thaibhikkuni.com)

This article is from Prachatai, an independent news site in Thailand, and is republished on Global Voices as part of a content-sharing agreement.

Dhammananda Bhikkhuni, the first Thai woman to be ordained as a Theravada monk and current abbess of Songdhammakalyani Monastery, has been listed as one of the BBCs 100 Women in 2019.

While Thailand has around 300,00 Buddhist monks, women are still mostly barred from being ordained on Thai soil. In 1928, after the attempted ordination of two women, Prince Bhujong Jombunud Sirivahano, then the Supreme Patriarch of Thailand, issued an edict forbidding monks from ordaining women as monks or novices. The Sangha Supreme Council of Thailand also issued two rulings in 1984 and 1987 forbidding the ordination of women. However, the Sangha Act of 1962, the secular law governing Thai monastics, and the 1992 amendment do not prohibit the ordination of women.

Moreover, the National Human Rights Commission of Thailand (NHRC) ruled in 2015 that the Sangha Supreme Councils prohibition of the ordination of women is a violation of the Convention on the Elimination of all Forms of Discrimination against Women (CEDAW), to which Thailand is a state party. NHRC also ruled that such prohibition is in violation of the Thai Constitution and the International Covenant on Civil and Political Rights (ICCPR), both of which protect freedom of religion.

Dhammanandas efforts to re-establish the Theravada bhikkhunilineage in Thailand have been met with resistance from both the laity and monks who are against ordaining women, most of whom have claimed that the ordination of women is not possible as the Theravada bhikkhuni lineage has already died out. Bhikkhuni refers to a fully ordained female monastic. Despite the lack of secular law prohibiting the ordination of women, bhikkunis are seen as a foreign tradition and the two main Buddhist orders in Thailand have yet to officially accept ordained women as part of the Sangha the Buddhist community of monastics.

Dhammananda is currently the abbess of the Songdhammakalyani Monastery in Nakhon Pathom, founded by her mother Voramai Kabilsingh, who was ordained as a monk in the Taiwanese Dharmaguptaka lineage in 1971, receiving the religious name Ta Tao Fa Tzu. The monastery is currently Thailands only all-female temple. Varanggana Vanavichayen, the first woman to be ordained as a monk on Thai soil, was ordained at the Songdhammakalyani Monastery in 2002.

However, the Thai authorities do not recognize the monastery as a Buddhist temple, and when Dhammananda and other monks from the monastery went to pay respect to the late King Bhumibol at the Dusit Maha Prasat Throne Hall, where his body lay in state, they were denied entry. The officials claimed that they were turned away on the grounds that it is illegal for women to wear the saffron robe under Thai Buddhism. 22 other female monks and novices were also turned away after being told that they would be only be allowed to pay their respect to the late King if they removed their robes and wore the regular black clothing of laypeople.

The BBCs 100 Women list includes those who had made the headlines or influenced important stories over the past 12 months, as well as those who have inspiring stories to tell, achieved something significant or influenced their societies in ways that wouldn't necessarily make the news.

The theme for 2019 is the Female Future and the list also includes Kuwaiti womens rights activist Alanoud Alsharekh, who works on the abolition of Kuwaits honour-killing law; Japanese model and author Yumi Ishikawa, founder of the #KuToo campaign against the requirement for women to wear high heels at work; sumo wrestler Hiyori Kon, who fought to change the rules which barred women from competing professionally in sumo; US congresswoman Alexandria Ocasio-Cortez, the youngest woman ever to serve in the US congress; Filipino journalist and press freedom advocate Maria Ressa, an outspoken critic of President Rodrigo Dutertes war on drugs; and Swedish environmental activist Greta Thunberg, whose school strike protests mobilized millions of young people around the world, forming the Fridays for future movement.

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One man had the answer for todays troubles: Gandhi | Opinion – Hindustan Times

Posted: at 10:56 am

In his recent remarks on Mahatma Gandhi and the contemporary world, United Nations (UN) Secretary-General Antnio Guterres said, Part of his genius lay in his ability to see the interconnectedness and the unity between all things. His political achievements included leading the movement that ended colonial rule in India, using peace, love and integrity to prevail. But his vision went far beyond politics to encompass human rights and sustainable development.

Today, I see how far we have come in the past century. After two terrible world wars, countries across Asia and Africa declared their independence. India won its freedom. And the India of today can be proud of its record of 17 successive free elections; of universal adult suffrage; of the abolition of untouchability; of the verve, passion and creativity that propel its young people towards enterprise and service, and much more.

Much of this was inspired by Gandhi and the moral authority of his philosophy of satyagraha. Because, while Gandhi fought for Indias Independence, for the rights of his disenfranchised compatriots, he stood, through the sheer moral force of his example, for a hope shared by those weary of war a hope of a better life. In his person and methods, Indias nationalism was, in effect, universalism.

In over a century since Gandhi returned to India, a billion people have been lifted out of poverty, more babies are surviving to become adolescents, more children are going to school, fewer have to live in fear of being targeted because of their race or sexuality.

But we cannot fail, in our appreciation for what has gone right, to recognise the ways in which we continue to fall short and, in some instances, have even reversed prior gains. Today, consensus enshrined in the Universal Declaration on Human Rights is fraying, even as the politics of fear and resentment takes root. Our world teeters on the brink of disaster brought on by anthropogenic climate change and unsustainable practices. Too many continue to go without, while too much is owned by too few. Privilege still determines opportunity. The structures of power and injustice Gandhi fought against mutated, but they are still there, creating yawning disparities in income, wealth, education, health, personal safety, access to finance and opportunity. And to set off once again on the path to greater prosperity and freedom for all, to leave no one behind, we must turn, once again, to Gandhi.

If the Sustainable Development Goals (SDGs), that all nations are committed to achieving by 2030, are the worlds toughest to-do list, it is Gandhi who provides us with the tools to check the list off. These 17 SDGs mark a recognition of the interconnectedness of the challenges we face today and we can only solve them together.

Our old lenses do not quite fit we need multifocals, perhaps, to look into the future, informed by the past, and grounded in the present. Gandhis endless innovation and tinkering, his reconciliation of tradition and a deeply egalitarian modernity, signpost the paths not yet taken the ones we must now take.

Were already seeing how his ideas today, in the 21st century, effect massive change. India has channelled his image and emphasis on cleanliness to implement one of the largest sanitation drives in the world. Gandhis innovations in staging non-violent protest today inform social movements, from Occupy to Fridays for Future, in New Delhi and New York and everywhere in between. His concept of trusteeship finds echoes in our concerns about economic inequality and of leaving no one behind. And his determination that the land we live off is not an inheritance from our forefathers, but in fact a loan from our children that we hold in trust for them, forms the core of modern ecological thought.

In his profoundly holistic vision of life is the blueprint for sustainable development a radical humanism that rejects untamed consumption and production and embraces needs over wants. Gandhis life and his prolific work touch on every aspect of human life caste, gender, religion, technology, the economy, literature, nationalism and colonialism and in his ruminations and experiments, we can find a greater truth: The personal is political, each individual has inherent dignity and worth, and, in these universal imperatives, is our path to a better future in which there is no politics without principles, commerce without morality, or science without humanity.

Today, on this UN Day, we recommit ourselves to those same ideals, which resonate so well with those enshrined in our United Nations Charter.

Renata Dessallien is the UN resident coordinator in India

The views expressed are personal

First Published:Oct 23, 2019 18:57 IST

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No to the sellout contract! Take the GM strike out of the hands of the UAW! – World Socialist Web Site

Posted: at 10:56 am

18 October 2019

With the tentative agreement announced Wednesday by the United Auto Workers, the struggle by 48,000 autoworkers at General Motors enters a new stage. If their struggle is not to be defeated, workers must mobilize against the UAW, which is collaborating with the auto companies to impose a contract that will set a new benchmark for exploitation for generations to come.

The Wall Street investors who stand behind General Motors have made clear their attitude toward the deal. We continue to believe that if this is ratified, it is a fairly solid outcome for GM, analyst Joseph Spak said. The financial implications of the deal dont look too onerous.

Reports that President Trump spoke to GM CEO Marry Barra and UAW President Gary Jones by phone on Wednesday demonstrate the extreme sensitivity of the entire ruling class to the outcome of this strike. A defeat of GM workers will not only set the standard for labor costs throughout the American economy, it will represent a major defeat for the entire working class.

Only a week ago, the UAW claimed in a statement that GM had not negotiated in good faith since day one. And yet, after more than 32 days on strike, the UAW has presented workers with a contract that, in almost all respects, is identical to GMs initial proposal from September.

In a press conference at GMs Renaissance Center in downtown Detroit, an evasive UAW Communications Director Brian Rothenberg lied through his teeth. After declaring that the contract would not only end perma-temps in the industry, but throughout the nation, he deliberately concealed the fact that the UAW had sanctioned a vast expansion of low paid, at-will employees.

Rothenberg was forced to acknowledge that the much-publicized promise by GM to invest billions in the United States and hire or retain 9,000 workers is not contained in the contract and is so much hot air.

The response of workers to the contract is overwhelmingly negative. The opposition to the deal that autoworkers have expressed on social media is only one indication of a brewing rebellion against the UAW.

Fearing a revolt, the UAW decided to keep workers on the picket line during the voting process. But the union is forcing workers to vote on the contract in an accelerated process that will leave them no time to adequately study the details and discuss the agreement among themselves. The full contract was not even released to GM National Council members, apparently out of fear that it could leak out to the membership.

Until the full contract has been released, the worst parts of the agreement remain unknown. But the official highlights released yesterday by the UAW already reveal massive concessions:

* Three out of the four plants GM slated for closure last year will remain closed. This includes the historic Lordstown plant, which once employed 4,500 workers. There are estimates that as many as 25,000 related jobs could be destroyed in the Youngstown area, which is already plagued by deindustrialization, poverty and the opioid epidemic. The Detroit-Hamtramck plant will, at some unspecified time, be re-tooled to manufacture a new model electric pickup truck, with only a fraction of the number of workers originally employed at the plant.

* Workers will receive only two wage increases of three percent over the four-year contract, failing to keep pace with inflation and further lowering their base wage rate in real terms.

* More than 2,000 higher-paid legacy workers will be pushed out of the plants by next February, by means of buyouts from the Special Attrition Program.

* The deal grants a blank check to GM on the number of temps it hires in its plants, requiring only that any decision be approved by the UAW.

* Temps will be hired in at full-time positions after three consecutive years of employment. This wording implies that temporary workers who are laid off and re-hired will start from the beginning.

* Appendix K, the clause from the 2015 contract that enabled the secret memorandums of understanding that sanctioned the replacement of full-time workers with contractors at Lordstown and Lake Orion, has been enhanced to [identify] opportunities to retain work and add new work to UAW-represented GM locations, i.e., expand the use of contractors at less profitable facilities.

* The deal establishes a new joint labor-management National Committee on Advanced Technology to discuss the impact of future technologies on GMs labor force.

* The UAW-GM Center for Human Resources, exposed as a nexus of bribery and graft by the federal corruption probe, will be kept in all but name. The current building will be closed and sold off. But the joint programs themselves will be retained and eventually housed in a new facility, paid for by GM.

The sincere but mistaken hope of many autoworkers that the combined pressure of impending federal corruption indictments and the militancy of the rank-and-file would force the UAW to fight has been demonstrated to be an illusion.

From the beginning, the UAW pursued a definite strategy of wearing down workers on the picket line in order to impose a defeat. That is why the UAW kept Ford and Fiat Chrysler workers on the job, enforced a total information blockade, and strung the GM workers out on $250 per week in strike pay.

The UAW also sought to isolate GM workers from their brothers and sisters internationally by promoting toxic America-first nationalism.

After a group of Mexican GM workers were fired for courageously refusing to accept increases in production during the strike in the US and appealed directly to American autoworkers for support, the UAW responded by demanding the reallocation of products from Mexican plants to the United States. This whipsawing of workers in different countries enables global corporations like GM to pit workers against each other in a race to the bottom.

The UAW is attempting to shut down the strike at precisely the point where it is beginning to intersect with broader sections of workers, posing the possibility for a joint struggle by the entire working class. The tentative agreement was announced the day before the beginning of the strike by some 30,000 Chicago public school teachers. Last weekend, copper miners in the Southwest and UAW Mack Truck workers on the East Coast joined GM workers on strike.

In all of these struggles, the unions are playing an identical role. The Chicago Teachers Union, which called a strike only after it was unavoidable, is openly seeking to limit it to as short a duration as possible. Its sellout of the last strike in 2012 paved the way for the closure of dozens of schools by then-mayor Rahm Emanuel, Obamas former White House chief of staff.

By their own behavior, the trade unions have demonstrated that they cannot be reformed. They have exposed their own essence as bribed tools of corporate management, organically hostile to the interests of the workers they claim to represent.

GM workers must now draw the appropriate lessons and take the initiative out of the hands of the UAW.

A no vote is necessary. But that by itself is insufficient. The UAW will respond to a contract rejection by redoubling its campaign of lies and intimidation, as it did after the rejection of the Chrysler contract in 2015.

The urgent task for autoworkers is to form rank-and-file factory committees to take control of the struggle. These committees should make the following demands:

* No vote without time to study the contract! Workers must demand access to the full contract, not just the bogus highlights, and be given at least a full week to study it before voting. Workers should hold broad, democratic discussions on the contract, outside of the view and control of the union.

* For rank-and-file oversight of the balloting process! Autoworkers should insist that their rank-and-file committees have the authority to oversee voting, to ensure that there is no ballot-stuffing or vote-rigging, as is widely believed to have occurred during the ratification of the Ford contract in 2015.

* Expand the strike to Ford and Fiat Chrysler! Unite with the working class of different countries! Rank-and-file committees should be based on the principle of internationalism--that workers everywhere have the same basic interests.

* Committees should formulate their own demands for the strike, including a 40 percent pay raise, the restoration of COLA for current and retired workers, the abolition of the multi-tier wage and benefit system, the immediate conversion of all temps into full-time workers with full wages and benefits, the reopening of all closed plants and the re-hiring of laid-off workers.

* Autoworkers must defend the courageous GM workers in Silao, Mexico and demand the rehiring of those fired for supporting the US strike.

The attacks by General Motors in the US are part of a global strategy of the ruling class. The auto companies are preparing and already implementing a jobs bloodbath, which is part of the efforts of the ruling elites to organize a further redistribution of wealth from the working class to the rich.

The fight against GM is a fight against capitalism. The GM strike can and must be transformed into a powerful political movement of the working class armed with a socialist program, including the transformation of the global auto industry and the Wall Street banks into public enterprises under the collective ownership and democratic control of the working class.

Tom Hall

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IR35: We need to get ready – Recruiter

Posted: at 10:56 am

IR35 will be rolled out in the private sector in six months time, on 6 April 2020, leaving recruiters and their clients just six months to get their house in order. Feedback from our members has been mixed, some feel they are ready, others havent yet begun looking at it. And who can blame them? Its difficult enough to see beyond the 31st of October let alone April next year.

The BBC cases show us how high the stakes can be, and how head-scratching complicated it can be to work out wherever an assignment falls inside or outside of IR35. Falling foul of the law next April will have big financial consequences, for agencies. Agencies supplying contractors could be financially liable for loss of tax if, after an enquiry, HMRC considers the engagement as falling inside of IR35. Meanwhile, agencies who can demonstrate knowledge in the area will undoubtedly be seen as more attractive for contractors and hirers.

IR35 wont wait for us

Thats despite our strong warning to ministers that now is completely the wrong time for more changes in business, and we need to protect our flexible labour market. Skipping over the Brexit uncertainty for a moment, next year will also welcome several new employment laws courtesy of the Good Work Plan itemised payslips and written statements for all, the key information document, the abolition of Swedish derogation, and holiday pay reference period changes from 12 to 15 weeks will all land on the same date. Thats a lot to deal with which is why getting to grips with IR35 early will make all the difference.

So what do you need to do?

The REC has been working hard to help members prepare. This has included a series of seminars across the country and there are more to follow. The IR35 hub contains helpful resources you can use to understand the changes, what needs to be done, and how to go about getting ready. As always our team is on hand to help should you need us.

We can help you with the other stuff too read up on the Good Work Plan changes that are coming into effect, and navigate the uncertainty with our Brexit hub.

With only six months to go, and what looks like an extremely bumpy journey to get there, getting ready for IR35 needs to be a top priority.

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Trudeau, Scheer and Singh haggle over potential minority government outcome in Monday’s election – TheRecord.com

Posted: at 10:56 am

"We are going to elect a government with Liberal MPs from right across the country. We will continue the hard work of investing in Canadians."

"Coalition" is not a dirty word, Singh said as he railed against Canada's electoral system, which gives the candidate with the most votes in each riding the victory.

Singh also criticized Trudeau for breaking his 2015 campaign promise that that election would be the last under the first-past-the-post system.

Singh said the system means that fewer than half of voters can choose a certain party, "and they get all the power, and that's wrong." Singh said Canadians often feel their vote doesn't matter, adding 60 per cent of Canadians "regularly" vote against the Conservatives.

"So it's wrong for the Conservatives to think that with less than 40 per of the power or vote they deserve all the majority of power. That's wrong," Singh said in Welland where former NDP MP Malcolm Allen is trying to take back his old seat of Niagara Centre from Liberal MP Vance Badawey.

Singh said he is committed to a "mixed-member proportional representation to make sure everyone's vote counts."

Singh started his day off at the popular Blue Star Restaurant in south Welland with Allen and Ontario NDP Leader Andrea Horwath. ."

Green Leader Elizabeth May said it was premature to talk of coalition governments as she also laid into Trudeau for not living up to the 2015 pledge to change the Canadian voting system.

"You don't actually start talking about coalitions until the election is over," she said in Qualicum Beach on Vancouver Island, where she was trying to add to her party's two seats and its chances of being a player in any possible post-election balance of power.

"We're prepared to work with and find ways to make Parliament work for Canadians. And to do that, Mr. Scheer is wrong in saying that he's got a new way in how Parliament works in a minority. Mr. Singh is wrong, saying he will only work with the Liberals."

Bloc Qubcois Leader Yves-Francois Blanchet reiterated his party's position that it isn't interested in propping up any minority government, and instead would be guided by one criteria: what is good for Quebec.

A day earlier, Blanchet offered more specifics.

"There is no question of the Bloc systematically supporting a government or a coalition or a party. It will be piece by piece. If it's good for Quebec, we'll be there," he said on Wednesday.

"If the Conservatives decide to support us on the single tax return, it'll go through. If the Conservatives imagine that the Bloc Qubcois will support the abolition of the carbon tax, it won't happen."

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Options: CVP and Gerhard Pfister gain massive influence look – The KXAN 36 News

Posted: at 10:56 am

The Greens and green liberals are the big winners. The President Regula Rytz (57) and Jrg Large (50) dominate the headlines.

But the secret election winner, Gerhard Pfister (57) and CVP are. your voters percentage remains practically stable. In the national Council and the lose of the Christian democratic peoples party has just two seats. They defended the Council of States is also its Bastion and could even win a mandate.

No left and no right-wing majority without CVP

is The Crucial point, however: The CVP is again to tip the scales. Not only, as hitherto, in the Council of States, but also in the national Council. The majority of the right of the SVP and the FDP is gone. Even with the Social or financial questions to the right ticking green liberal is nothing to make The Trio only comes to 98 seats.

But also to the left, the importance of the CVP to grow SP, and Green occupy just 67 seats. And in Eco-topics, the Alliance of SP, Green, and GLP-83-is also a losing battle.

This means: Without CVPs nothing going on! Pfister is the majority buyer to the king-maker. Especially since the group is much more closed than in the past. The power of the center party even stronger.

Green Federal Council only with Pfisters blessing

Even at the Federal Council elections, none comes more to the CVP. If the Greens get a seat at the expense of the FDP, depends on whether Pfister lowers his thumb, or stands.

For the Moment, he is not likely to shake the foundations of the current distribution of seats, however, sooner or later, the CVP will want to have back in the Bundesrat your position of power by can make a deal with the Left and Right. As long as four representatives from the SVP and the FDP govern, does not work. Therefore, it would be for Pfister tempting to take the FDP a seat and it to the Green plug.

CVP is the climate compromise and the forging

the most important templates in the Parliament Pfister will leave even more on the CVP-stamp. Examples?

In the case of the AHV Reform, it needs to finally go forward. The crucial point is not whether the womens pension age is increased to 65 years, but at what price. The Federal Council wants to raise 700 million Swiss francs, to the disadvantages of women cushion. Right, this is too much, the Left to little. It now depends on Pfister on which side you are oriented. When it comes to climate protection the CVP to the bridge Builder is. The upcoming CO2 legislation, you will need to have the left-green demand rush of steam, so as to keep the FDP in the boat. The SVP has already announced the Referendum. Pfister is forging the climate compromise.In transport policy, the CVP is in the right direction. Flows even more money in roads or rails? With the railway Fund Fabi and the road Fund, NAF, the base is placed, but in the different development steps will be decided, how much money and where it flows. New the Velopolitik add: transport Minister Simonetta Sommaruga wants to strengthen the role of the Federal government. Pfister draws, he makes with the left-Green-Green Switzerland for Cycling. Conservative weakened

Pfister himself was not available for VIEW. He makes in Venice (I), a piccola pausa from the strenuous election campaign, as he tweeted.

General Secretary Gianna Luzio (39) confirmed the increase in the power: The CVP will be able to take the national Council increasingly to the role it holds in the Council of States already, and constructive solutions for the benefit of Switzerland and its population.

The Form of rigid alliances and blocks, whether to the left or right was not misleading. The CVP will have to find the political center for all your sustainable solutions Partner, says Luzio.

Almighty Pfister in the new Parliament will not be. In socio-political issues, the Parliament is ticking progressive. It is more difficult for the conservative forces CVP and SVP also in the agriculture policy.

the ruler of the middle can not turn in any case, and rule as he wants, shows, of all things, the CVP-prestige project: In the case of the abolition of the marriage penalty, he must reckon with new hurdles. Here, the evidence suggests that the SP, the greens, FDP and the green-liberal will prevail. You want to tax the spouse in the future, individually best.

campaign work

What had not have Gerhard Pfister listen to before the elections, everything. The CVP will be in addition to the SVP, the big loser and fall under the magic 10-percent mark, certified surveys. Pfister politicize with his subjects, the people passing by and put up with the Social Media campaign on the wrong horse.

It was not to be, As only the Federal Council, the party, the CVP lost only minimal. Long faces were seen at the SVP, FDP and SP. Obviously, Pfister and co. have got some things right. As his party moved with 77 lists in the election battle record. This flood of candidates mobilised on the Basis of quite obvious. To operate mainly because all the candidates had to agree, in spite of a hopeless situation actively in the election.

Also, the CVP-dominated with a provocative Negative campaign on the Internet the headlines, what has helped the party perhaps. Or was there a Amherd effect? The defence Minister was named in a survey, after all, to the sympathetic councillor. (nmz)

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The American Journal of Managed Care Launches ‘Understanding the Comorbidities: Psoriasis and Metabolic Syndrome’ Video Series – Business Wire

Posted: at 10:53 am

CRANBURY, N.J.--(BUSINESS WIRE)--The American Journal of Managed Care (AJMC), the leading multimedia peer-reviewed journal dedicated to issues in managed care, presents its most recent Peer Exchange panel discussion, Understanding the Comorbidities: Psoriasis and Metabolic Syndrome. The video series features experts in the field of dermatology discussing psoriasis and metabolic syndrome and dissecting a variety of treatment options.

Led by Dr. Peter L. Salgo, the panel of experts featured in this educational video series will provide an understanding of these comorbid conditions and discuss the causal relation between psoriasis and metabolic syndrome, said Mike Hennessy Jr., president and CEO of MJH Life Sciences, parent company of AJMC.

Here are the four distinguished experts on the panel:

The Peer Exchange begins with a conversation that defines both psoriasis and metabolic syndrome. The experts also discuss the burdens of psoriasis in addition to the role that genetics play in this chronic systemic inflammatory disease. Next the experts shift the conversation to discuss an understanding of the increased risk of developing metabolic syndrome for patients with psoriasis, highlighting their connectivity. The causal relation between the two conditions will be analyzed as the experts dive deeper into the biologics used to treat psoriasis and review their efficacy in patients who also present with metabolic syndrome.

For more information and to view the video series, click here.

AboutThe American Journal of Managed Care

The American Journal of Managed Care(AJMC) is a multimedia peer-reviewed, MEDLINE-indexed journal that keeps industry leaders on the forefront of health policy by sharing digital research relevant to industry decision-makers. Other brands in theAJMCfamily includeThe American Journal of Accountable Care,Evidence-Based Oncology andEvidence-Based Diabetes Management. These comprehensive multimedia brands bring together stakeholder views from payers, providers, policymakers and other industry leaders in managed care. AJMC is a brand of MJH Life Sciences, the largest privately held, independent, full-service medical media company in the U.S. dedicated to delivering trusted health care news across multiple channels.

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Arcutis Biotherapeutics Announces Positive End-of-Phase 2 Meeting with FDA and Planned Initiation of Phase 3 Program for ARQ-151 for Plaque Psoriasis…

Posted: at 10:53 am

Arcutis Also Announces Enrollment of Last Patient in 52-Week Long-term Safety Study of ARQ-151 Cream as a Potential Topical Treatment for Plaque Psoriasis

WESTLAKE VILLAGE, CA / ACCESSWIRE / October 24, 2019 / Arcutis Biotherapeutics, Inc. (Arcutis), a privately held clinical-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced plans to initiate its Phase 3 program of ARQ-151 as a potential topical treatment for plaque psoriasis following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The Company anticipates initiating a Phase 3 clinical trial in the first half of 2020.

Frank Watanabe, Arcutis' President and Chief Executive Officer, commented: "We appreciate the collaborative interaction with the FDA to reach agreement on the key elements of our Phase 3 program that we intend to use to support the submission of a New Drug Application for ARQ-151 for plaque psoriasis. Based on our clinical data to date, we believe ARQ-151 has the potential to be both a best-in-class topical PDE4 inhibitor and the only topical PDE4 inhibitor approved for plaque psoriasis. We look forward to starting our Phase 3 program in the first half of next year."

The Company also announced that it has completed enrollment of a 52-week Phase 2 long-term safety study of ARQ-151 in plaque psoriasis. Topline results are expected in the first half of 2021. The Company expects this study to supply the 12-month safety data required for regulatory submissions. In the previous Phase 2b trial in plaque psoriasis, both tested doses of ARQ-151 were well tolerated and demonstrated rapid onset of effect with statistically significant superiority over vehicle. ARQ-151 is a topical cream formulation of roflumilast, a highly potent and selective Phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for once-a-day application to treat plaque psoriasis and atopic dermatitis.

Howard Welgus, Arcutis' Chief Medical Officer, commented: "Because psoriasis is a chronic disease, it is critical to understand the efficacy, safety and tolerability of any new psoriasis treatment over an extended period. Thus, this long-term safety study is important to our understanding of ARQ-151's potential to address the unmet needs in topical treatment of psoriasis. Furthermore, this strategic clinical development approach to generating long-term safety data allows our Phase 3 studies to be of shorter duration."

The ARQ-151-202 study is a Phase 2, multi-center, open label study of the long-term safety of ARQ-151 0.3% cream in adult subjects with chronic plaque psoriasis involving up to 25% total body surface area (BSA), evaluated in two cohorts: 231 patients who have completed the ARQ-151-201 Phase 2b, randomized, controlled trial; and 102 previously untreated subjects. The qualifying subjects will apply ARQ-151 0.3% cream once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression. The primary outcome measures of the study are the occurrence of treatment emergent adverse events and the occurrence of serious adverse events.

About ARQ-151

ARQ-151 is a topical cream formulation containing roflumilast, a PDE4 inhibitor, that Arcutis is developing to treat plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis. PDE4 is an intracellular enzyme that regulates the production of pro-inflammatory and anti-inflammatory cytokines and cell proliferation. Roflumilast is a potent PDE4 inhibitor that was approved by the FDA for systemic treatment to reduce risk of exacerbation of chronic obstructive pulmonary disease (COPD) in 2011, and has shown greater potency based on IC50 values (a non-clinical measure of a drug's potency) than other PDE4 inhibitors.

About Psoriasis

Psoriasis is a common, non-contagious, immune disease that affects approximately 8.6 million patients in the United States. About 90% of psoriasis cases are plaque psoriasis, which is characterized by "plaques", or raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

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UCB psoriasis drug beats J&J’s second top-selling product in Phase III study – MedCity News

Posted: at 10:53 am

A drug made by Johnson & Johnson for psoriasis that is one of the biggest revenue generators in its portfolio could be under threat in the future following the success of a new competitor in a Phase III study.

Brussels-based UCB said Thursday that results of its BE VIVID study showed that its antibody, bimekizumab, was superior in its efficacy against J&Js Stelara (ustekinumab) in adult patients with moderate-to-severe chronic plaque psoriasis.

The company did not disclose the full results, which it said would be presented in due course, but stated that the trial met the primary endpoint of showing at least a 90 percent improvement in psoriasis area and severity index or PASI90 and an investigator global assessment score of clear or almost clear after 16 weeks. The safety profile was consistent with the Phase II BE ABLE studies.

BE VIVID randomizes patients to receive bimekizumab for one year, Stelara for one year with placebo at certain time points to maintain blinding or placebo for 16 weeks followed by bimekizumab for the remainder of the study period. Bimekizumab is an IgG1 antibody tat neutralizes IL-17A and IL-17F, two key cytokines that drive inflammation.

These encouraging first results provide strong evidence that bimekizumab has the potential to raise the bar for achieving skin clearance rates in patients, investigator Dr. Mark Lebwohl of New Yorks Icahn School of Medicine said in a statement. Achieving clear skin is of critical importance in positively impacting the lives of psoriasis patients.

Stelara, which was approved in 2009, was J&Js second largest product in 2018, accounting for about 6.3 percent of its total sales for the year, with global sales of about $5.2 billion, according to its 2018 annual report. U.S. patents for Stelara are expected to expire in 2023 due to a patent term extension, followed by expiration in Europe the following year. The companys top-selling product is the autoimmune disease drug Remicade (infliximab), which had sales of $5.3 billion and which already has biosimilar competitors.

In the Phase IIb BE ABLE 1 trial, which randomized patients to various dose levels of bimekizumab or placebo, patients treated with the drug showed a statistically significant dose-dependent response for PASI90, with 46.2-79.1 percent of patients achieving it, compared with 0 percent in the placebo arm. In addition, 27.9-60 percent of bimekizumab-treated patients achieved PASI100, also compared with 0 percent in the placebo arm. Treatment-emergent adverse events occurred among 126 of the 208 patients treated with bimekizumab, compared with 15 of 42 who received placebo.

Photo: juststock, Getty Images

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