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After biotech sector pullback, venture capital turns to safer bets: 'flat is up'
The biotech industry is undergoing a deep adjustment triggered by external macroeconomic factors. Although venture capital firms have ample ammunition, they are becoming more selective in the face of uncertain capital markets: requiring startups to strictly control budgets, delay listing plans, and seek partnerships or acquisitions earlier. Investment preferences are also shifting from expensive platform companies to lower-risk, more product-focused enterprises.
How a 'Niche' ALS Drug Reached the FDA Review Threshold
A decade ago, Brown University undergraduates Justin Klee and Josh Cohen conceived a drug idea without funding or a laboratory. Today, their company, Amylyx Pharmaceuticals, has brought this ALS candidate drug, AMX0035, to the FDA approval threshold. This Wednesday, an FDA advisory committee will vote on the sufficiency of the evidence. Although data show a slowdown in patients' functional decline and an extension of survival by about five to seven months, FDA scientists' review documents note that the evidence is 'not particularly compelling' and question assumptions in the trial analysis. Amid strong calls from the patient community and regulatory caution, the FDA faces a difficult decision, with a final ruling expected by June 29.
AbbVie's Humira Exclusivity Ends: Two Decades of $20 Billion Market Monopoly Comes to a Close
In January 2023, the first Humira biosimilar will enter the U.S. market, marking the end of AbbVie's two-decade market exclusivity period that generated nearly $20 billion in revenue. This article reviews Humira's patent barriers, competitive landscape, and industry impact.
A Mission Under the Shadow of Family Heart Disease: Sek Kathiresan and One-Time Gene Therapy
Sekar Kathiresan's older brother died prematurely from heart disease, which drove him into the study of heart disease genetics and led him to found Verve Therapeutics, aiming to use gene-editing technology to develop a one-time drug to prevent heart disease. This article reviews his upbringing, scientific breakthroughs, and entrepreneurial journey.
