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Patient death disclosed in Pfizer’s Hympavzi hemophilia trial
Pfizer disclosed the death of a participant in a long‑term extension trial of Hympavzi (marstacimab), reporting a cerebellar infarction followed by a cerebral hemorrhage. The company communicated...
Sanofi shells out $2.2B for Dynavax: vaccine push accelerates
Sanofi agreed to acquire Dynavax Technologies for about $2.2 billion in cash in a deal announced Dec. 23–24, 2025. The transaction gives Sanofi immediate commercial rights to Dynavax’s hepatitis B...
FDA clears Wegovy pill: oral GLP‑1 enters obesity market
The U.S. Food and Drug Administration approved Novo Nordisk’s oral semaglutide formulation for weight management, clearing the first oral GLP‑1 pill for obesity and marking a new phase in the...
FDA greenlights Omeros’ Yartemlea: first TA‑TMA therapy approved
The U.S. FDA approved Omeros Corp.’s Yartemlea (narsoplimab) as the first treatment for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA). The decision establishes...
CMS to pilot GLP‑1 coverage: Medicare edges into obesity drugs
CMS announced a voluntary test model to allow Medicare Part D plans and state Medicaid programs to cover GLP‑1 drugs prescribed for weight management. The pilot aims to evaluate mechanisms to...
Asia deal wave: Harbour nets BMS tie‑up; Jacobio inks $1.9B AstraZeneca pact
Two major pharma deals out of Asia closed late in 2025: Harbour Biomed struck a multispecific antibody collaboration with Bristol Myers Squibb that includes roughly $90 million up front and...
Death in Hympavzi trial triggers safety probe — hemophilia program under scrutiny
Pfizer disclosed the death of a participant in a long‑term extension trial of Hympavzi (marstacimab), reporting a cerebellar infarction followed by cerebral hemorrhage. The company notified the...
Vyriad closes $25M tranche — in‑vivo CAR‑T candidate moves to clinic
Vyriad Inc. closed a $25 million final tranche to its Series B round, bringing total Series B proceeds to $85 million. The financing is earmarked to support first‑in‑human testing of VV‑169, an...
Early clinical starts: Enveda’s oral IBD drug and Simcere’s cancer candidate enter trials
Enveda Therapeutics secured FDA IND clearance and initiated a phase I trial of ENV‑6946, a first‑in‑class oral small molecule for inflammatory bowel disease. The move starts human testing for a...
Device approvals: FDA clears Crescom AI bone‑age tool; Edwards wins Sapien M3 nod
The FDA granted 510(k) clearance to Crescom’s MediAI‑BA, an AI‑powered pediatric and adolescent bone age analysis application, citing specialist‑level accuracy in prior trials. The device predicts...
Regulatory shakeup: court rejects FDA LDT rule — EU readies breakthrough devices pilot
A U.S. district court decision overturned the FDA’s final rule to regulate laboratory‑developed tests (LDTs), marking a major regulatory defeat for the agency and crystallizing 2025 as a...
Wegovy pill cleared: Novo Nordisk brings oral GLP‑1 to market
The FDA approved Novo Nordisk’s oral semaglutide formulation for weight loss and cardiovascular risk reduction, marking the first U.S. clearance of an oral GLP‑1 for obesity. The approval follows...
Sanofi buys Dynavax for $2.2 billion — bolsters vaccine lineup
Sanofi agreed to acquire Dynavax Technologies for $2.2 billion in cash to add Dynavax’s hepatitis B vaccine capabilities to its vaccine portfolio. The transaction expands Sanofi’s capabilities in...
Boehringer inks White House deal — $10 billion US investment and direct‑purchase pact
Boehringer Ingelheim struck an agreement with the U.S. administration to join the TrumpRx direct‑purchase platform and invest $10 billion in U.S. operations through 2028. The deal includes...
Jacobio signs $1.9B pact with AstraZeneca — pan‑KRAS asset outlicensed
Jacobio Pharmaceuticals outlicensed its phase I pan‑KRAS inhibitor JAB‑23E73 to AstraZeneca in a deal worth up to $1.915 billion. AstraZeneca gains global rights outside China and will jointly...
Harbour Biomed adds Bristol Myers Squibb collaboration — $90M up front, $1B+ milestones
Harbour Biomed announced a multispecific antibody collaboration with Bristol Myers Squibb that provides roughly $90 million up front and potential milestones exceeding $1 billion. The partnership...
Vyriad closes $25M tranche — series B reaches $85M to fund in‑vivo CAR‑T candidate
Vyriad closed a $25 million final tranche of its series B, bringing total Series B proceeds to $85 million. The company said the financing will support first‑in‑human testing of VV‑169, an in‑vivo...
Singlera Genomics inks EU distribution, research pact for cfDNA cancer assays
Singlera Genomics signed a research and distribution agreement with Pure Medical to commercialize its mTitan and mGuard cell‑free DNA methylation assays across select European countries. The deal...
Enveda’s ENV‑6946 clears IND — first‑in‑class oral for IBD enters phase I
Enveda Therapeutics received FDA IND clearance and initiated a phase I trial of ENV‑6946, a first‑in‑class oral small molecule intended to treat inflammatory bowel disease, including ulcerative...
Merck‑Daiichi lung trial paused: deaths prompt partial hold in phase III
Daiichi Sankyo reported a voluntary partial hold on recruitment and enrollment in the phase III IDeate‑Lung02 study of antibody‑drug conjugate ifinatamab deruxtecan after a higher‑than‑anticipated...