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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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Biopharma and life sciences organizations strengthen their leadership teams and boards with these Movers & Shakers.
The FDA granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) for IPD and pneumococcal pneumonia Breakthrough Therapy Designation.
O’Neill, who has served as chief medical officer at Sarepta Therapeutics since 2018, said he is excited about the potential of Editas’ pipeline.
AbbVie and Genmab announced positive topline results from their Phase I/II trial for lymphoma treatment; Sanofi posted positive results from its Phase I/II trial for the treatment of ITP.
The revised operating plan also includes reductions in spending related to general and administrative expenses and investments in its research platform.
Drug pricing watchdog ICER issued a draft report on bluebird bio’s gene therapy betibeglogene autotemcel for beta-thalassemia. The report touted the therapy’s cost-effectiveness.
Pfizer and BioNTech will submit updated data to the FDA to support the Emergency Use Authorization (EUA) of COVID-19 vaccination boosters in children between the age of 5 and 11.
Protagonist disclosed the FDA issued a letter of intent to rescind the status for rusfertide based on concerns first raised in a clinical hold placed on the drug.
Ubix Therapeutics has announced a collaboration agreement with SK Biopharmaceuticals, and Engitix and Takeda are teaming up to develop a therapeutic for fibrostenotic IBD.
The AACR annual meeting concluded on April 13, showcasing hundreds of preclinical to late-stage information from ongoing studies on treatment candidates.