J&J pitches its S1P1 MS drug into the regulatory ring as the competition heats up fast

March 20, 2020 09:10 AM EDT

J&J pitches its S1P1 MS drug into the regulatory ring as the competition heats up fast

John Carroll

Editor & Founder

The S1P1 rivalry in the multiple sclerosis arena is about to heat up substantially.

Six months after beating out Aubagio in a head-to-head study, J&J has teed up its marketing application for ponesimod. If approved the drug, a big prize in their $30 billion Actelion buyout, will go up against Novartis’ rival Mayzent as well as ozanimod from Bristol Myers — which is facing a looming PDUFA date.

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At the Inflection Point for the Next Generation of Cancer Immunotherapy

Willem Overwijk, Ph.D.

Vice President, Oncology Research, Nektar Therapeutics

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

November 30, 2021 07:15 AM EST

R&D

'This is not going to be good': Moderna CEO Bancel warns of a 'material drop' in vaccine efficacy as Omicron spreads

John Carroll

Editor & Founder

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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November 30, 2021 04:51 PM ESTUpdated 05:10 PM

FDA+

Coronavirus

FDA adcomm narrowly votes in favor of Merck's antiviral for outpatient Covid-19

Zachary Brennan

Senior Editor

With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.

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Deep Genomics

Boston, MA, USA

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Philip Dormitzer, new GSK global head of vaccines R&D

November 30, 2021 08:30 AM ESTUpdated 03:30 PM

People

GlaxoSmithKline poaches Pfizer's viral vaccines lead in rush to capitalize on future of mRNA

Kyle Blankenship

Managing Editor

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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November 30, 2021 07:25 AM EST

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November 30, 2021 03:57 PM EST

Pharma

Appeals court puts the final nail in the coffin for Tecfidera patent, adding to Biogen's burgeoning setbacks

Max Gelman

Editor

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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November 30, 2021 07:33 AM EST

R&D

FDA+

How to use registry data to support FDA decision making: Agency explains in new guidance

Zachary Brennan

Senior Editor

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.

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November 30, 2021 10:48 AM EST

People

R&D

As lead drug runs into a wall, Deciphera slims down its pipeline, puts 140 jobs on the chopping block

Amber Tong

Senior Editor

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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November 30, 2021 10:37 AM EST

FDA+

FDA cancels ODAC meeting this week to review two more dangling accelerated approvals — but won't explain why

Zachary Brennan

Senior Editor

The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.