Pharmaceutical and biotech news covering drug approvals, clinical trials, FDA decisions, and pharmaceutical industry developments.
Merck and Gilead Sciences announced positive topline results from two phase 3 trials of their combination HIV pill containing islatravir and lenacapavir. The trials, ISLEND-1 and ISLEND-2, met the primary endpoint for HIV treatment.
Tango Therapeutics reported that its drug vopimetostat combined with Revolution Medicines' daraxonrasib produced durable responses in most pancreatic cancer patients in an early-stage trial. The results build on recent unprecedented outcomes for Revolution's experimental drug in this hard-to-treat cancer.
Johnson & Johnson agreed to acquire Firefly Bio for $1 billion in cash. Firefly Bio is developing a proprietary Firelink degrader antibody conjugate platform for KRAS-driven cancers, which have limited treatment options. Mutant forms of KRAS are found in about 30% of all tumors and have been a challenging target for drug developers.
Shares of Zealand Pharma fell up to 26% on Monday after data from its experimental weight-loss drug survodutide raised safety concerns, despite meeting its primary endpoint in a trial.
Everest Medicines secured development, manufacturing, and commercialization rights for VIZZ (aceclidine ophthalmic solution 1.44%) in mainland China, Hong Kong, Macao, and Taiwan from Corxel Pharmaceuticals. VIZZ is developed by LENZ Therapeutics.
Thirty doctors from nine states were found guilty of accepting a Rs 2 crore trip to Paris and Monaco funded by pharma company AbbVie. The National Medical Commission sent a reminder on May 26 to six state councils that have not yet submitted action taken reports. The Department of Pharmaceuticals forwarded only 27 names to NMC, dropping three without explanation.
This commentary argues that the US FDA is embracing speed and efficiency in biotech regulation, citing recent leadership changes and AI integration. It contends that while biotech has achieved remarkable progress, aging clinical trial systems hinder innovation, and urges aggressive PDUFA reauthorization to support reforms like adaptive trial designs and real-world evidence.
Nurix Therapeutics shares jumped 43% on Monday after announcing a global collaboration with Roche to develop bexobrutideg, a BTK degrader. The deal is worth up to $3 billion, including a $700 million upfront payment.
Novo Nordisk agreed to provide Wegovy free of charge for Veru's Phase 2b PLATEAU trial studying enobosarm in older persons with obesity. Novo Nordisk also gained right of first negotiation if Veru later develops enobosarm alongside a Novo GLP-1 medicine. Oppenheimer maintained an outperform rating on Veru.
This commentary argues that a handful of Chinese biotech firms are poised to bring their own branded medications to Western markets within 10-15 years, citing a boom in outlicensing agreements. It suggests that these companies could emulate Pfizer's global success, with the US market being particularly lucrative due to high drug prices.