| | | |   | Hello, all. Damian here with a look at the next big FDA drug decision, a meditation on the word "biotech," and an update from the industry's increasingly busy attorneys. | | | Amylyx, ALS, and the next test of FDA independence It has been about 18 months since a panel of FDA advisers voted decisively against Aduhelm, Biogen’s treatment for Alzheimer’s disease, only for the agency to approve it anyway. Next week, that same panel will convene to review another closely watched medicine, setting in motion a crucial test of the FDA’s ability to withstand political pressure.
As STAT’s Nicholas Florko reports, the drug in question is a treatment for ALS, developed by the small biotech company Amylyx Pharmaceuticals. It has already been the subject of intense pressure from ALS patients and advocacy organizations, a campaign with roots in the “right to try” movement’s successful efforts to curtail FDA authority.
Amylyx’s supporting data comes from a single trial in which the drug showed a modest but statistically significant benefit for patients with ALS. The agency initially balked at the evidence, asking the company to complete another trial, but later relented and invited Amylyx to submit for approval while preparing a confirmatory study, according to the company.
That makes the FDA’s final decision, expected in June, potentially fraught. Approving the medicine could look like bowing to a coordinated campaign; rejecting it will undoubtedly lead to outrage.
Read more. | What do we mean when we say ‘biotech’? Once upon a time, biotech companies made biological medicines and pharma companies used chemicals to craft pills. After a few decades of pivots, megamergers, and emerging new industries, it is now functionally impossible to settle on just what “biotech” means, a confusing development with implications beyond simple semantics.
As STAT’s Kate Sheridan reports, the biotechnological identity crisis means that accurately measuring some of the critical elements that define an industry’s health — like the number of people it employs or the number of companies that exist and how much money they’ve raised — often means relying on idiosyncratic distinctions that are only getting hazier.
Take for instance Twist Bioscience, which doesn’t make therapeutics but was dubbed one of the “most innovative biotechnology companies of 2021.” Or diagnostics companies like Exact Sciences, which exist outside of most definitions of the word but play a key role in their local biotech ecosystems.
Read more. | 2022 STATUS List: The most definitive and consequential accounting of leaders in health, medicine, and science Meet the STATUS List — 46 individuals shaping the future of their fields. Drawn from sectors including biotechnology and diagnostics, as well as broader arenas like education and policy, each individual has taken extra steps to help others and build community in these often-divisive times. Explore the list. | 2022 is biotech’s year of resignation With biotech stocks down about 20% on the year, each passing month brings another wave of C-suite resignations and strategic reviews.
The latest comes from AnaptysBio, whose longtime leader Hamza Suria has stepped down from his roles as CEO and board member, the company said yesterday. The news comes about a week after AnaptysBio’s most advanced treatment missed all of its goals in a Phase 2 study in acne. AnaptysBio, which has lost about a quarter of its value this year, will now undergo “a strategic portfolio review,” the company said.
Suria’s resignation follows the departure of Quantum-Si CEO John Stark, who left after his company’s stock price fell nearly 60% since going public through a SPAC last year. Last month, two top executives from Cortexyme, whose investigational treatment for Alzheimer’s disease missed its goals in a trial last year, resigned from their positions. Days before, Sio Gene Therapies, formerly known as Axovant Sciences, said CEO Pavan Cheruvu had resigned “to pursue new opportunities,” just as the company “deprioritized” its most advanced pipeline treatment to conserve cash. | Everybody’s suing nowadays As a bevy of companies fight over Covid-19 vaccine patents and the titans of liquid biopsy go to court over intellectual property, a stalwart of cancer immunotherapy is mounting some litigation of its own.
Bristol Myers Squibb is suing AstraZeneca, claiming that the latter company’s PD-L1-targeting cancer treatment infringes patents related to its own Opdivo, which targets the related PD-1. According to the suit, posted by Reuters, Bristol is seeking damages and royalties. The company previously settled with Merck and Roche over their respective PD-1 and PD-L1 drugs.
Bristol’s move extends a busy season for the pharmaceutical industry’s patent attorneys. It began when Arbutus Therapeutics and Genevant sued Moderna, claiming the company used their delivery technology in its Covid-19 vaccine. Then Alnylam Pharmaceuticals sued both Pfizer and Moderna for allegedly borrowing from its intellectual property, only for Pfizer collaborator Acuitas to file suit against Arbutus and Genevant disputing their initial claims. Separately, Illumina is suing rival liquid biopsy player Guardant Health, claiming that the latter’s patents are based on work stolen from the genomics giant. | More reads - The biggest PBMs are handling more and more of the country’s drug price negotiations. STAT
- U.S. FDA advisers to discuss second Covid vaccine boosters in April. Reuters
- A small biotech throws in its IPO cards after market meltdown. Endpoints
- Wall Street sees signs battered biotech has turned a corner. Bloomberg
| Thanks for reading! Until tomorrow,  | | | |
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