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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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The FDA has a packed calendar this week, with six decisions on the docket, including ones for Merck’s Keytruda, BMS’s Krazati and Sarepta’s Elevidys.
Teva Pharmaceuticals lost its patent row with Amneal Pharmaceuticals on Monday as a New Jersey court ruled that some of Teva’s claims over its inhaler product ProAir HFA were improperly listed on the FDA’s Orange Book.
Seeking to target the lucrative obesity market, Merck is focusing its R&D efforts on next-generation GLP-1 therapies that offer additional benefits beyond weight loss, according to company executives.
Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, has proposed issuing a subpoena to Novo Nordisk President Doug Langa forcing him to testify regarding the company’s pricing for Wegovy and Ozempic.
Biogen recently bolstered its pipeline with a potential $1.8 billion acquisition of Human Immunology Biosciences, following other big players looking to cash in on a global immunology market estimated to grow to $257 billion by 2032.
This week, an FDA adcomm unanimously voted for the approval of Eli Lilly’s anti-amyloid antibody as thousands of layoffs continue to rattle the industry.
Plus, what to do if your offer is paused and how to manage work anxiety.
Stada announced Tuesday it has secured European rights from Alvotech to a clinical-stage biosimilar of Amgen’s blockbuster bone drugs Prolia and Xgeva.
While Sage Therapeutics’ drug candidate showed a slight difference compared to placebo in a mid-stage Huntington’s disease trial, William Blair analysts in a Tuesday note to investors said they “remain cautious” on dalzanemdor and “do not view the small numerical changes as definitive.”
Despite a surge in the financial markets, multiple Big Pharma companies have announced hundreds or even thousands of cuts. Experts hope for a better second half of the year.