In quick start to new year’s M&A, Arvelle Therapeutics hands reins to Angelini as it nears EU approval for cenobamate

Mark Altmeyer, Arvelle

January 4, 2021 08:32 AM ESTUpdated 09:10 AM

In quick start to new year's M&A, Arvelle Therapeutics hands reins to Angelini as it nears EU approval for cenobamate

Kyle Blankenship

Managing Editor

With a team of Axovant veterans leading the way, CNS startup Arvelle Therapeutics is nearing approval for licensed epilepsy med cenobamate in the EU after snagging an FDA approval in late 2019. Looking to take its first med to market, Arvelle has agreed to hand the reins to Italy’s Angelini Pharma in the first big biopharma buyout of 2021.

Angelini will pay $610 million post-approval with $350 million in sales milestones to acquire Switzerland’s Arvelle, a team helmed by three veterans from the Vivek Ramaswamy outfit that expects an EU nod for cenobamate this year, the companies said Monday.

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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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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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ENDPOINTS CAREERS

Lead Manager / Associate Director of Statistical Genetics

Deep Genomics

Boston, MA, USA

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November 30, 2021 07:25 AM EST

Publisher's note

Introducing Endpoints Studio, a new way to advertise with Endpoints-crafted branding campaigns

Arsalan Arif

Publisher & Founder

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

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 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.

Tillman Gerngross (Adagio)

November 29, 2021 07:04 AM ESTUpdated 02:20 PM

Tillman Gerngross on Omicron: 'It is a grim situation...we’re going to see a significant drop in vaccine efficacy'

John Carroll

Editor & Founder

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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ENDPOINTS CAREERS

Executive Director - Data Analysis - Science & Technology

Alexandria Real Estate Equities

Pasadena, CA

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Incorporating External Data into Clinical Trials: Comparing Digital Twins to External Control Arms

Unlearn.AI

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

November 30, 2021 11:53 AM EST

Pharma

Marketing

MarketingRx roundup: AbbVie’s Humira TV turns focus to HS skin condition; Sanofi amps parenting policy

Beth Snyder Bulik

Senior Editor

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.