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The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Partners. The readout also represents the second late-stage win for the Merck and Kelun-Biotech asset, called sac-TMT.
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After a sluggish 2025, biotech IPOs have roared back to life. Fueled by resilient stock performances and improving market sentiment, the total number of public debuts so far this year has already eclipsed 2025’s total.
Biopharma is entering its second-quarter earnings season riding high on a wave of massive deals and venture capital flow, plus a clearing of regulatory and policy overhangs. What can industry watchers expect to hear on the upcoming investor calls?
Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Akebia Therapeutics’s partner Otsuka Pharmaceutical Co. announced plans to terminate its global license agreements with Akebia for vadadustat.
BioSpace sat down with Axogen’s Chief Human Resources Officer Maria Martinez to understand why now is the best time to make the switch to pharma and biotech.
Kriya Therapeutics secured $270 million that will be used to advance its fully integrated gene therapy pipeline and expand engineering, manufacturing and computation.
Monday woes were shared by Bristol Myers Squibb and Synairgen, as their clinical trial candidates failed to perform as expected.
Clay Siegall resigned his role as president, CEO and a member of the board of directors of Seagen following domestic violence allegations. Roger Dansey will serve as interim CEO.
The changes are unlikely to help people in developing countries but could reduce innovation among biopharma companies and ultimately do more harm than good.
In addition to lowering of blood sugar, Mounjaro also enabled patients to lower their weight by 15 to 23 pounds. The drug compared well to other diabetes medications including Novo Nordisk’s semaglutide.
U.S. Food and Drug Administration(FDA) has granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.
FDA
The U.S. Food and Drug Administration (FDA) has approved Mitsubishi Tanabe Pharma America’s oral alternative to its own treatment for amyotrophic lateral sclerosis (ALS).
Achilles dosed the first patient in a Phase I/IIa advanced NSCLC trial, Logic Bio’s pediatric methylmalonic acidemia study is back up and running and another look at Roche’s TIGIT flop.