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Merck‑Moderna cancer vaccine sustains 49% melanoma risk cut at 5 years — durable adjuvant effect
Five‑year follow‑up data show that adding a Merck‑Moderna cancer vaccine candidate to Keytruda maintained a 49% reduction in risk of recurrence or death in melanoma patients, improving the...
GSK buys Rapt for $2.2B — bets on long‑acting anti‑IgE
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to add ozureprubart, a long‑acting anti‑IgE monoclonal antibody for food allergy, to its pipeline. Ozureprubart is in a Phase IIb prestIgE...
AstraZeneca pays up to $630M for China CAR‑T rights
AstraZeneca agreed to pay up to $630 million to acquire China rights to Abelzeta Pharma’s C‑CAR031 (AZD5851), an autologous CAR‑T targeting glypican‑3 for hepatocellular carcinoma. The deal gives...
Qiagen mulls sale: shares jump on buyout chatter
Qiagen shares surged after Bloomberg reported the company is working with advisers and has held talks with potential suitors about a possible sale. The report cited unnamed people with knowledge...
Valneva withdraws U.S. chikungunya filing amid safety probe
Valneva announced it has voluntarily withdrawn its U.S. submissions for Ixchiq, its chikungunya vaccine, after the FDA placed a clinical hold on a post‑marketing study following a newly reported...
CMS backs Illumina test — reimbursement opens precision oncology door
The Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay under PLA code 0543U at $2,989.55 per test, effective Jan. 1, 2026. The...
Capricor updates BLA amid FDA review of HOPE‑3 topline data
Capricor Therapeutics issued a regulatory update on its Biologics License Application for Deramiocel after the FDA reviewed topline data from the HOPE‑3 study. Deramiocel is an investigational...
Merck, Moderna cancer vaccine sustains 49% melanoma risk cut at 5 years
Five‑year follow‑up data show adding Merck and Moderna’s investigational cancer vaccine to Keytruda sustained a 49% reduction in risk of recurrence or death in melanoma, reinforcing the...
Astellas restarts XLMTM push with MyoAAV capsid gene therapy
Astellas Gene Therapies licensed ASP2957 (MyoAAV3.8‑MHCK7‑hMTM1), a MyoAAV capsid‑based gene therapy developed by Kate Therapeutics, and launched the Phase I/II VALOR trial in X‑linked myotubular...
Guardant and Merck partner on companion diagnostics for trials
Guardant Health struck a multi‑year deal with Merck to provide liquid and tissue biopsy assays to help enroll patients in Merck’s global clinical studies. The agreement lets Merck deploy...
Cepheid wins FDA clearance for Xpert GI panel — enters syndromic PCR market
Cepheid received 510(k) clearance for its Xpert GI Panel, a rapid multiplex PCR assay that detects and distinguishes 11 gastrointestinal pathogens from stool in about 74 minutes on GeneXpert...
GSK agrees to buy Rapt for $2.2B – adds long‑acting anti‑IgE
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to add ozureprubart, a long‑acting anti‑IgE monoclonal antibody, to its immunology pipeline. The deal terms call for $58 per Rapt share and...
AstraZeneca pays up to $630M for China rights to Abelzeta CAR‑T
AstraZeneca struck an agreement to secure China rights for Abelzeta’s C‑CAR031—an autologous, glypican‑3 (GPC3)‑targeting CAR‑T for liver cancer—under a deal worth up to $630 million. The...
CMS sets $2,989.55 rate — Illumina wins reimbursement for TruSight
The US Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989.55 per test, effective Jan. 1, 2026. CMS specified payment...
Valneva pulls chikungunya shot from U.S. after FDA safety probe
Valneva voluntarily withdrew its chikungunya vaccine’s U.S. filings after learning the FDA placed a clinical hold tied to a newly reported serious adverse event outside the U.S. The company...
Merck–Moderna vaccine: 49% reduction in melanoma recurrence at 5 years
Five‑year follow‑up data show adding Merck & Co. and Moderna’s cancer vaccine candidate to Keytruda delivered a sustained 49% reduction in the risk of recurrence or death in melanoma patients. The...
Astellas restarts XLMTM effort with MyoAAV capsid—first‑in‑human VALOR trial
Astellas Gene Therapies licensed a MyoAAV capsid‑based gene therapy (ASP2957) for X‑linked myotubular myopathy (XLMTM) via a deal tied to Kate Therapeutics’ technology. ASP2957 encodes human MTM1...
Parse and Graph Therapeutics partner to build immune‑cell perturbation atlas
Parse Biosciences and Graph Therapeutics announced a strategic collaboration to generate a large‑scale immune cell perturbation atlas. Parse will apply its GigaLab single‑cell whole‑transcriptome...
Engineered living 'glue' detects GI bleeding and delivers therapy in IBD models
A Nature Biotechnology team engineered nonpathogenic E. coli with a bleeding‑inducible circuit that secretes a barnacle‑derived adhesive protein (CP43K) plus the gut‑healing factor TFF3. In mouse...
FDA clears IND for D3 Bio’s KRAS G12D inhibitor D3S‑003
D3 Bio announced FDA IND clearance for D3S‑003, a small‑molecule inhibitor targeting KRAS G12D, enabling a first‑in‑human Phase I trial in patients with advanced solid tumors harboring the...