Aducanumab has its approval — now, let citizen-scientists come together to see if it works

July 14, 2021 05:35 PM EDTUpdated July 16, 10:36 AM

Aducanumab has its approval — now, let citizen-scientists come together to see if it works

Madhav Thambisetty

Adjunct professor of neurology at Johns Hopkins University School of Medicine

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

Editor’s Note: Madhav Thambisetty was an advisor on the FDA’s Peripheral and Central Nervous System Drugs advisory committee that voted overwhelmingly not to recommend Alzheimer’s drug aducanumab’s approval by the FDA. Thambisetty’s views in this op-ed are not reflections of the positions of the FDA or the NIH’s National Institute on Aging, where he is a section chief of the clinical and translational neuroscience section in the laboratory of behavioral neuroscience.

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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.

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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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.

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Deep Genomics

Boston, MA, USA

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November 29, 2021 10:06 AM ESTUpdated 01:19 PM

FDA+

Coronavirus

Like the flu vaccine every year, the FDA could move quickly on a variant-targeted Covid vaccine

Zachary Brennan

Senior Editor

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

November 27, 2021 06:00 AM EST

Weekly

Thanksgiving edition: Top 15 Endpoints stories of 2021; Can you name that vaccine?; Merck's Covid antiviral disappoints; FDA nominee's industry ties; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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November 26, 2021 08:35 AM ESTUpdated 12:53 PM

Bioregnum

Cell/Gene Tx