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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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A European Medicine Agency panel on Friday reaffirmed its decision not to renew the conditional marketing authorization for GSK’s multiple myeloma drug Blenrep.
President Joe Biden has long promised to stand up to Big Pharma, lower prescription drug prices and limit the power of drugmakers—a pledge he seems intent on keeping.
Merck’s HIF-2α inhibitor Welireg has been approved by the FDA to treat advanced renal cell carcinoma after treatment with PD-1 or PD-L1 and VEGF-TKI-based therapies.
Despite pricing concerns for bluebird bio’s FDA-approved sickle cell disease gene therapy, the biotech has inked a deal with an unnamed commercial payer “representing approximately 100 million covered lives” in the U.S.
A week after securing FDA approval, a European Medicines Agency committee has endorsed Vertex and CRISPR Therapeutics’ Casgevy for sickle cell disease and transfusion‑dependent beta thalassemia.
Amid falling COVID-19 revenues, Pfizer continues to invest in antibody-drug conjugates in a deal with Nona Biosciences worth $1 billion as its $43 billion Seagen buy closed on Thursday.
The regulator placed the clinical hold on the Chinese biotech’s trio of CAR-T cell therapy candidates after an inspection of its Durham, North Carolina manufacturing facility.
Despite the lack of a randomized clinical trial to support eflornithine’s efficacy, the regulator approved US WorldMeds’ oral maintenance treatment for high-risk neuroblastoma in adults and children.
At the urging of the Biden administration, Sanofi and AstraZeneca are pledging 230,000 additional doses of their respiratory syncytial virus infant immunization Beyfortus in January 2024.
The combination of Keytruda and an mRNA vaccine reduced the risk of death or relapse in patients with the most deadly form of skin cancer after three years in a Phase IIb study.