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Latest Biotech News

CMS proposes Medicare pilots — testing most‑favored‑nation pricing for beneficiaries

December 24, 2025

The Centers for Medicare & Medicaid Services proposed two mandatory Medicare payment models designed to lower prices for branded drugs by benchmarking costs to prices paid in comparable countries....

Wegovy pill cleared: first oral GLP-1 for obesity

December 24, 2025

The FDA approved Novo Nordisk’s oral semaglutide formulation, marking the first pill version of Wegovy authorized for chronic weight management and cardiovascular risk reduction. The decision...

CMS proposes Medicare demos: Trump administration pushes MFN-style pricing

December 24, 2025

CMS proposed two mandatory Medicare demonstration programs intended to tie Medicare drug prices to international benchmarks, a policy derived from the administration’s most-favored-nation (MFN)...

Boehringer dealmaking: $10B US investment and CKD pill pact

December 24, 2025

Boehringer Ingelheim struck an agreement with the U.S. administration to join a government-run purchasing platform and pledged up to $10 billion in U.S. investments through 2028 to expand...

AstraZeneca scales KRAS push: big ex‑China deal with Jacobio

December 24, 2025

AstraZeneca paid $100 million up front to secure ex‑China rights to Jacobio Pharmaceuticals’ phase I pan‑KRAS inhibitor, in a deal worth up to roughly $1.9 billion in milestones. The agreement...

Aktis eyes public markets: radiopharma IPO to fund alpha programs

December 24, 2025

Aktis Oncology filed for an IPO to raise capital for its miniprotein radiopharmaceutical pipeline, aiming to fund ongoing US phase 1b trials and further target expansion. The company highlighted...

Patient death clouds Pfizer’s Hympavzi hemophilia program

December 24, 2025

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 communicated...

Phase III halt: Merck‑Daiichi pause lung cancer ADC trial after deaths

December 24, 2025

Daiichi Sankyo voluntarily placed a partial recruitment and enrollment hold on the phase III IDeate‑Lung02 study of the antibody‑drug conjugate ifinatamab deruxtecan following a...

Shionogi pays $2.5B for edaravone rights: rare‑disease buy expands portfolio

December 24, 2025

Shionogi agreed to acquire global rights to edaravone from Tanabe Pharma for $2.5 billion, securing an approved amyotrophic lateral sclerosis (ALS) therapy marketed in the U.S. as Radicava (oral...

MRD testing matures: pivotal trial readouts and commercial consolidation

December 24, 2025

Minimal residual disease (MRD) testing saw multiple high‑profile trial readouts and commercial consolidations in 2025, with the Phase III IMvigor011 trial using Natera’s Signatera test presenting...

FDA clears Wegovy pill — first oral GLP‑1 for obesity

December 23, 2025

The U.S. Food and Drug Administration approved Novo Nordisk’s oral formulation of semaglutide, branded as the Wegovy pill, for chronic weight management and cardiovascular risk reduction. The...

AstraZeneca fronts $100M for Jacobio pan‑KRAS — $1.9B deal

December 23, 2025

AstraZeneca agreed to acquire ex‑China rights to Jacobio Pharmaceuticals’ phase I pan‑KRAS inhibitor JAB‑23E73 in a deal worth up to $1.915 billion, with an immediate $100 million up‑front...

Boehringer joins TrumpRx.gov — $10B U.S. investment pledged

December 23, 2025

Boehringer Ingelheim struck an agreement with the U.S. administration to join the TrumpRx.gov direct‑purchase platform and pledged $10 billion of investment into U.S. research, development and...

Shionogi agrees $2.5B deal: acquires edaravone ALS franchise

December 23, 2025

Shionogi & Co. will acquire global rights to edaravone, an FDA‑approved therapy for amyotrophic lateral sclerosis (marketed as Radicava ORS and I.V. Radicava in the U.S.), under a $2.5 billion...

Feds charge six... $41M biopharma insider‑trading ring

December 23, 2025

Federal prosecutors unsealed charges against six individuals alleging insider trading and stock manipulation that targeted biopharma companies and generated roughly $41 million in illicit gains....

Samsung Biologics buys GSK’s Rockville plant — $280M deal

December 23, 2025

Samsung Biologics’ U.S. subsidiary signed a definitive agreement to acquire Human Genome Sciences’ Rockville, Maryland manufacturing site from GSK for $280 million, marking Samsung’s first U.S....

Guardant360 CDx approved in Japan: companion for Lilly’s Inluriyo

December 23, 2025

Japan’s regulators approved Guardant Health’s Guardant360 companion diagnostic to detect ESR1 mutations and guide use of Eli Lilly’s Inluriyo in breast cancer patients. The Japanese clearance...

Harbour Biomed adds BMS multispecific pact — $90M upfront, $1B+ milestones

December 23, 2025

Harbour Biomed announced a collaboration with Bristol Myers Squibb to develop multispecific antibodies, receiving about $90 million up front and potential milestones that could exceed $1 billion....

Aktis files to go public — funds radiopharma trials after Big Pharma backing

December 23, 2025

Aktis Oncology filed for an initial public offering to raise capital for clinical development of its miniprotein radiopharmaceuticals, following partnerships and investments from Eli Lilly,...

Signatera trial backs MRD‑guided immunotherapy — readout shifts diagnostic landscape

December 23, 2025

Multiple late‑stage readouts in 2025 strengthened the commercial and clinical case for minimal residual disease (MRD) testing; the Phase III IMvigor011 trial used Natera’s tumor‑informed Signatera...