Get the Daily Brief
Latest Biotech News
Valneva withdraws chikungunya vaccine from U.S. after FDA concerns
Valneva voluntarily withdrew its chikungunya vaccine’s U.S. application and stopped a halted post‑marketing study after learning the FDA placed a clinical hold tied to a newly reported serious...
GSK buys Rapt for $2.2B – adds long‑acting anti‑IgE
GSK agreed to acquire Rapt Therapeutics for $2.2 billion, securing ozureprubart, a long‑acting anti‑IgE monoclonal antibody in Phase IIb development for prophylactic protection against food...
Boston Scientific buys Penumbra in $14.5B deal – expands thrombectomy portfolio
Boston Scientific announced a $14.5 billion cash‑and‑stock acquisition of Penumbra, bringing mechanical thrombectomy, embolization and neurovascular devices into Boston Scientific’s cardiovascular...
CMS reimburses Illumina oncology test – $2,989 rate opens precision‑oncology access
The U.S. Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at a rate of $2,989.55 per test, effective Jan. 1, 2026. The...
Merck‑Moderna vaccine sustains 49% melanoma risk cut at 5 years
Five‑year follow‑up data show that a therapeutic vaccine co‑developed by Merck and Moderna, when added to Keytruda (pembrolizumab), maintained a roughly 49% reduction in risk of recurrence or...
Astellas relaunches XLMTM gene therapy effort with MyoAAV capsid
Astellas Gene Therapies announced a partnership and exclusive license with Kate Therapeutics/Novartis assets to develop ASP2957 (MyoAAV3.8‑MHCK7‑hMTM1), a MyoAAV capsid‑based gene therapy for...
Valneva withdraws U.S. chikungunya shot amid FDA safety probe
Valneva voluntarily withdrew its chikungunya vaccine application and suspended a post‑marketing study in the U.S. after learning the FDA placed the product on clinical hold linked to a newly...
Parse and Graph build immune perturbation atlas – single‑cell scale
Parse Biosciences and Graph Therapeutics struck a strategic partnership to create a large‑scale immune cell perturbation atlas using Parse’s GigaLab single‑cell sequencing and Graph’s...
Cepheid wins FDA 510(k) for Xpert GI panel – rapid syndromic stool testing
Cepheid secured FDA 510(k) clearance for its Xpert GI Panel, a multiplex PCR assay that detects 11 gastrointestinal pathogens directly from stool in about 74 minutes on GeneXpert systems upgraded...
Guardant and Merck partner to co‑develop companion diagnostics for trials
Guardant Health and Merck announced a multi‑year collaboration to use Guardant’s liquid and tissue biopsy platforms to support enrollment and biomarker stratification in Merck’s global clinical...
Weill Cornell wins $5.2M ARPA‑H grant to fast‑track lymphatic diagnostics
Weill Cornell Medicine received an initial two‑year $5.2 million ARPA‑H LIGHT program grant to develop LANTERN (Lymphatic Disease Advancements with Nanotechnology, Translational Epigenetics, and...
GSK buys Rapt for $2.2B — long‑acting anti‑IgE joins pipeline
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to add ozureprubart, a mid‑phase anti‑immunoglobulin E (IgE) antibody being developed to prevent food‑allergic reactions. The deal gives...
Boston Scientific to buy Penumbra for $14.5B — moves into thrombectomy
Boston Scientific agreed to acquire Penumbra in a $14.5 billion cash‑and‑stock transaction to shore up its cardiovascular and neurovascular portfolio. The deal buys Penumbra’s mechanical...
AstraZeneca pays up to $630M for China rights to GPC3 CAR‑T – global control secured
AstraZeneca agreed to acquire remaining China rights to Abelzeta Pharma’s C‑CAR031 (AZD5851), an autologous glypican‑3 (GPC3) CAR‑T for hepatocellular carcinoma, in a deal worth up to $630...
Valneva pulls chikungunya shot from U.S. — FDA safety probe prompts withdrawal
Valneva voluntarily withdrew its U.S. filings for the chikungunya vaccine Ixchiq and halted a suspended post‑marketing study after the FDA placed a clinical hold tied to a newly reported serious...
CMS backs Illumina CGP — reimbursement set at $2,989.55 per test
The U.S. Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989.55 per test (PLA code 0543U), effective Jan. 1, 2026. The...
Cepheid cleared for multiplex Xpert GI panel — rapid syndromic GI testing arrives
Cepheid obtained FDA 510(k) clearance for its Xpert GI Panel, a multiplex PCR assay that detects and differentiates 11 gastrointestinal pathogens on GeneXpert systems, positioning the company in...
Guardant, Merck partner on companion diagnostics — liquid biopsies to support trials
Guardant Health signed a multi‑year agreement with Merck to develop and commercialize companion diagnostics using Guardant’s liquid and tissue biopsy platforms to support patient enrollment across...
Qiagen shares jump on sale speculation — advisers engaged, suitors eyed
Qiagen shares surged more than 15% after Bloomberg reported the diagnostics and life‑science tools company is working with advisers and has received interest from potential buyers. Market chatter...
FDA clears D3 Bio IND for KRAS G12D inhibitor — first‑in‑human trial to start
D3 Bio announced FDA clearance of an investigational new drug (IND) application for D3S‑003, a KRAS G12D small‑molecule inhibitor, enabling a first‑in‑human Phase I trial in patients with advanced...