Get the Daily Brief
Latest Biotech News
Pfizer’s monthly obesity shot expands clinical readouts
Pfizer presented more detailed efficacy data supporting monthly dosing for berobenatide, its acquired obesity GLP-1 receptor agonist from Metsera. In the VESPER-3 mid-stage study, patients...
Roche obesity pipeline advances with combination trial start
Roche plans to launch a Phase 2 trial combining petrelintide and enicepatide, positioning the company to test whether its two obesity injectables can deliver differentiated efficacy with an...
Amgen? No — Ebola diagnostics and WHO response scaling
The World Health Organization unveiled a six-month Bundibugyo Ebola response plan focused on scaling point-of-care molecular testing in Africa while strengthening reference labs. WHO said the...
Roche develops research-use Bundibugyo Ebola PCR assay
Roche reported it has rapidly developed a research-use-only PCR test targeting Bundibugyo Ebola virus to support response efforts amid an ongoing outbreak in the Democratic Republic of Congo and...
Fulcrum exits sickle cell program after FDA concern and restructuring
Fulcrum Therapeutics discontinued development of its sickle cell disease candidate pociredir after the FDA raised concerns about the benefit-risk profile in an update that included safety signals...
Oscotec sells cancer-resistance bet via $665M Agios deal
Agios Pharmaceuticals agreed to potentially pay $665 million for global rights to advance Oscotec’s cevidoplenib, an oral SYK inhibitor positioned for immune thrombocytopenia with a Phase 3-ready...
Supreme Court ruling bolsters ‘skinny label’ generics strategy
The U.S. Supreme Court unanimously sided with Hikma in a “skinny label” patent case involving Hikma’s generic version of Amarin’s Vascepa. The ruling held Hikma’s product did not infringe on...
Forbion executive hire signals continued biotech investing push
Forbion said it brought John McDonald aboard as an operating partner with responsibility for business development and M&A, after McDonald previously served in similar roles at Novo Nordisk,...
Medable launches program to scale agentic AI in clinical development
Medable launched an Agentic Accelerator Program designed to help life sciences companies deploy agentic AI across clinical development workflows. The program offers onboarding, integration...
Obesity drug safety updates and next-gen incretin risk signals
Eli Lilly shared additional safety and tolerability details for retatrutide, its next-generation obesity medicine, as new data emerged from a late-stage program disclosed at major scientific...
Dual GLP-1/obesity pipeline competition heats up with monthly dosing
Pfizer defended its once-monthly obesity GLP-1 strategy with new mid-stage data for berobenatide after patients transitioned from weekly to monthly dosing. The results, presented at the American...
Pfizer bolsters obesity case with regulatory and commercial framing
Ahead of continued decision-making around berobenatide’s positioning in obesity and diabetes, Pfizer expanded its argument for the drug at ADA with additional context on tolerability and prior...
Roche and Zealand amylin analogs advance into obesity combination programs
Roche and Zealand brought fresh attention to their amylin analog obesity franchises at ADA, highlighting tolerability considerations for petrelintide and signaling continued clinical development...
Roche obesity strategy moves to combination trial plans
Roche said it plans to start a Phase 2 trial combining petrelintide with enicepatide in obesity during 2026. The company framed the pairing as a path toward differentiation on both safety and...
Ebola outbreak response: WHO scales point-of-care molecular diagnostics
The World Health Organization unveiled a six-month plan to respond to the current Bundibugyo Ebola outbreak, centering on scaling point-of-care molecular diagnostics and strengthening reference...
Roche builds PCR test capability for Bundibugyo Ebola detection
Roche developed a research-use-only molecular PCR test to detect Bundibugyo Ebola virus amid the ongoing outbreak in parts of Africa. The work, positioned as a response-support tool, came as...
FDA review process pressure: House committee demands faster IND sign-off
A U.S. House Appropriations Committee directed the FDA to reform how it signs off on investigational new drug (IND) applications for new clinical trials. The committee cited concerns that...
Drug pricing policy debate: FDA voucher pilot draws scrutiny
Stakeholders told the U.S. FDA that the Commissioner’s National Priority Voucher (CNPV) pilot program, launched a year ago, has received mixed reviews as companies seek clearer expectations around...
Biotech restructuring: Fulcrum exits sickle cell development and slashes staff
Fulcrum Therapeutics discontinued development of its sickle cell disease candidate after concerns raised by the FDA, triggering a corporate restructure that eliminated most roles. The company...
Obesity drug safety signals in late-stage data
Eli Lilly disclosed updated safety and tolerability results for retatrutide, its next-generation obesity drug, including new arrhythmia and major cardiovascular complication counts. The data were...