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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...
Pfizer discloses death in Hympavzi hemophilia trial — cerebellar infarct and cerebral hemorrhage
Pfizer reported a death in a long‑term extension trial of its hemophilia tissue factor pathway inhibitor antagonist Hympavzi (marstacimab). The company said the participant experienced a...
Wegovy pill cleared: Novo Nordisk lands first oral GLP‑1
The U.S. Food and Drug Administration approved Novo Nordisk’s oral semaglutide formulation for weight loss, marking the first oral GLP‑1 authorized for obesity. Regulators cleared the pill with...
Sanofi shells out $2.2B: buys Dynavax for hepatitis‑B vaccines
Sanofi agreed to acquire Dynavax Technologies for $2.2 billion in cash to bolster its vaccine portfolio, the companies said Wednesday. The deal adds Dynavax’s hepatitis B vaccine assets and...
Shionogi pays $2.5B: nabs FDA‑approved ALS drug from Tanabe
Shionogi & Co. agreed to acquire global rights to the FDA‑approved amyotrophic lateral sclerosis therapy edaravone in a $2.5 billion deal with Tanabe Pharma Corp. The transaction gives Shionogi...
Jacobio outlicenses pan‑KRAS: $1.9B deal with AstraZeneca
Jacobio Pharmaceuticals outlicensed its phase‑I pan‑KRAS inhibitor JAB‑23E73 to AstraZeneca in a deal worth up to $1.915 billion. The agreement grants AstraZeneca global rights outside China and...
Harbour Biomed inks BMS multispecifics pact: $90M upfront
Harbour Biomed closed a year‑end collaboration with Bristol Myers Squibb to develop multispecific antibodies, receiving about $90 million up front with potential milestones exceeding $1 billion....
Phase‑III recruitment paused: deaths hit Merck‑Daiichi lung ADC study
Daiichi Sankyo voluntarily placed a partial hold on recruitment in the phase‑III IDeate‑Lung02 study of the antibody‑drug conjugate ifinatamab deruxtecan after a higher‑than‑expected incidence of...
Pfizer reports trial death: Hympavzi hemophilia study under scrutiny
Pfizer disclosed the death of a participant in a long‑term extension trial of its hemophilia drug Hympavzi (marstacimab). The company said the patient experienced a cerebellar infarction followed...
Guardant360 CDx cleared in Japan: ESR1 companion for Lilly’s Inluriyo
Japan’s regulator cleared Guardant Health’s Guardant360 CDx as a companion diagnostic to identify ESR1 mutations and guide eligibility for Eli Lilly’s breast cancer drug Inluriyo. The approval...
Singlera signs EU distribution: cfDNA methylation assays head to Europe
Singlera Genomics signed a research and distribution agreement with Pure Medical to commercialize its cell‑free DNA methylation assays—mTitan and mGuard—across several Western European countries....