Frank Vinluan is senior biopharma reporter for MedCity News. He previously held business reporting positions at Xconomy, The Seattle Times, The Des Moines Register, and the Triangle Business Journal.
LinkedIn: https://www.linkedin.com/in/frankvinluan/
Twitter: @frankvinluan
Merck has been acquiring assets that could help make up for the coming revenue decline as its top product, the cancer drug Keytruda, drops off the patent cliff. Terns Pharmaceuticals’ lead product candidate, in development for treating a type of leukemia, could offer dosing and efficacy advantages over the Novartis drug Scemblix.
Gilead Sciences is acquiring Ouro Medicines, a startup developing T cell engagers for a range of autoimmune diseases. Separately, Gilead is negotiating a deal with Galapagos to share in the development and potential commercialization of the Ouro drug.
How to turn analytics into actual policy outcomes.
Novartis already markets the PI3Kα inhibitor Piqray for breast cancer, but acquiring a Synnovation Therapeutics subsidiary brings an early clinical program that the pharma company claims could be best in the class of next-generation therapies for the target. Competitors include Eli Lilly, Relay Therapeutics, and OnKure Therapeutics.
FDA approval of Icotyde covers the treatment of adults and adolescents with moderate-to-severe plaque psoriasis. This once-daily pill, developed by partners Johnson & Johnson and Protagonist Therapeutics, offers an easier dosing option compared to injectables and is projected to become a blockbuster seller across several immunological indications.
Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but there is a "lack of substantial evidence" that warrants exploration about the reasons for trial failures to identify the appropriate patients for the eye drop. AbbVie holds an option to collaborate on reproxalab's commercialization.
Structure Therapeutics’ aleniglipron, a once-daily oral GLP-1 drug, led to an average 16% weight loss measured at 44 weeks. Based on these results, the biotech is preparing for Phase 3 testing expected to begin in the second half of this year.
Arbiter’s Anjali Jameson on hospital and payer alignment.
Leucovorin is now approved for cerebral folate deficiency months after FDA Commissioner Marty Makary claimed the decades-old generic drug had promise for treating autism. The FDA’s review was based on published literature and real-world evidence.
Waiv, formerly the diagnostics division of AI biotech Owkin, developed AI-enabled testing technologies that found use in clinical settings and in cancer drug research. Spinning out as an independent company enables Waiv to pursue its own growth strategy, co-founder and CEO Meriem Sefta said.
The FDA said consolidating safety reporting into a single platform, the Adverse Event Monitoring System (AEMS), will increase transparency and reduce costs. But like the legacy systems it replaces, AEMS reports are unverified so causation and frequency of events cannot be determined.
Vima Therapeutics is expanding to Parkinson’s disease following early clinical results showed proof of concept for its drug in isolated dystonia, a rare neurological movement disorder. The startup says its drug could address the biology underpinning many movement disorders.
Zelis highlights how employers, payers, and consumers are integrating digital tools to manage healthcare costs.
Povetacicept, a Vertex Pharmaceuticals immunology drug designed to block two targets, met the main goal of a Phase 3 clinical trial in the rare kidney disease immunoglobulin A nephropathy. The fusion protein came from Vertex’s acquisition of Alpine Immune Sciences, and analysts say the drug has best-in-class potential.
GSK licensed to Alfasigma global rights to linerixibat, a drug developed to treat the rare liver disease primary biliary cholangitis (PBC). The move follows Alfasigma’s 2025 voluntary market withdrawal of Ocaliva, a PBC drug that had sparked safety concerns from U.S. and European regulators.
Petrelintide posted Phase 2 results showing tolerability comparable to a placebo, but average weight loss that was less than what analysts expected. The Zealand Pharma drug, in development under a partnership with Roche, is a peptide engineered to activate the amylin receptor.
Day One Biopharmaceuticals is Servier’s biggest acquisition yet, topping the $2.4 billion it paid to buy Shire’s cancer business in 2018. Day One markets Ojemda, approved for treating pediatric low-grade glioma, the most common type of brain cancer in children.
The Series B extension brings Atavistik Bio’s Series B financing to $160 million. The startup’s lead program is in development for hereditary hemorrhagic telangiectasia (HHT), an inherited bleeding disorder.