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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...
Guardant and Merck team on liquid‑tissue companion diagnostics for trials
Guardant Health and Merck entered a multi‑year partnership to use Guardant’s liquid and tissue biopsy assays to support enrollment in Merck’s global clinical studies and to co‑develop companion...
GSK agrees $2.2B deal: picks up Rapt’s long‑acting anti‑IgE
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to secure ozureprubart, a long‑acting anti‑IgE monoclonal antibody in Phase IIb development for food allergies. The deal gives GSK rights...
Boston Scientific to buy Penumbra: $14.5B move into thrombectomy
Boston Scientific announced a definitive agreement to acquire Penumbra for $14.5 billion in cash and stock to expand its cardiovascular and neurovascular portfolio. The deal brings Penumbra’s...
Capricor updates BLA after FDA review of HOPE‑3 topline results
Capricor Therapeutics issued a regulatory update on its Biologics License Application for Deramiocel — an investigational cell therapy for Duchenne muscular dystrophy — following FDA review of...
CMS OKs reimbursement for Illumina’s TruSight: $2,989.55 per test
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. Illumina said the...
Engineered bacteria secrete adhesive therapeutics: Living glue treats IBD in mice
Two complementary Nature Portfolio reports describe engineered nonpathogenic E. coli programmed with a blood‑inducible circuit to secrete a barnacle‑inspired adhesive protein (CP43K) and a...
Engineered UGA suppressor tRNA: Broadens AAV therapeutic reach
A Nature Biotechnology paper described an engineered UGA suppressor tRNA gene intended for disease‑agnostic delivery via AAV vectors. The suppressor tRNA enables readthrough of UGA stop codons in...
Scientists build bacteriophages with AI... Raises biosecurity questions
Researchers reported computational models capable of designing complete bacteriophage genomes from scratch, demonstrating that AI can generate functional viral constructs. The work illustrates...