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CHO cells engineered to make amino acids — lower waste, simplify feeds
Researchers at the Technical University of Denmark engineered Chinese hamster ovary (CHO) cell lines that synthesize two essential amino acids (threonine and histidine) and lines that produce...
Quantum‑enabled proteins... engineered sensors reach living cells
A University of Oxford‑led team demonstrated that engineered proteins can exhibit optically detected magnetic resonance (ODMR) in living bacterial cells at room temperature, creating the first...
Astellas licenses MyoAAV capsid for XLMTM — low‑dose gene therapy enters clinic
Astellas Gene Therapies licensed Kate Therapeutics’ MyoAAV capsid and is developing ASP2957 (MyoAAV3.8‑MHCK7‑hMTM1) as a capsid‑engineered gene therapy for X‑linked myotubular myopathy (XLMTM)....
GSK pays $2.2B for Rapt: long‑acting food‑allergy bet
GSK agreed to acquire Rapt Therapeutics for $2.2 billion, taking ownership of ozureprubart, a long‑acting anti‑IgE monoclonal antibody in Phase IIb for food-allergy prophylaxis. The deal...
Pfizer exits ViiV stake: Shionogi expands HIV holdings
Pfizer is selling its minority stake in ViiV Healthcare to Shionogi, exiting a company it co‑founded with GSK in 2009. The move will shift ownership among existing minority shareholders while GSK...
Valneva pulls chikungunya from U.S.: safety probe prompts withdrawal
Valneva voluntarily withdrew its U.S. chikungunya vaccine application after the FDA placed a clinical hold linked to a newly reported serious adverse event outside the U.S. The company said the...
Medicare pivots on diagnostics: CMS pays Illumina test; MCED path emerges
Two developments moved diagnostic reimbursement and coverage: CMS granted Medicare reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989.55 per test, and a provision in the...
Merck‑Moderna vaccine holds at five years: durable melanoma benefit
Merck and Moderna reported sustained benefit from their personalized melanoma vaccine when added to Merck’s Keytruda, showing a continuing reduction in risk of recurrence or death at five years....
FDA agrees biomarker path for base editing: Beam wins accelerated route
Beam Therapeutics and FDA agreed that biomarkers evaluated over a year could support an accelerated approval application for BEAM‑302, Beam’s base‑editing candidate for alpha‑1 antitrypsin...
Corvus pill shocks markets: ITK inhibitor posts strong Phase I eczema data
Corvus Pharmaceuticals released Phase I data for soquelitinib, an oral ITK inhibitor, showing robust clinical activity in moderate‑to‑severe atopic dermatitis (AD). The cohort update demonstrated...
Tanabe pill clears Phase III: oral option for rare photodermatoses
Tanabe Pharma reported top‑line Phase III success for dersimelagon (MT‑7117), an oral melanocortin‑1 receptor agonist, in erythropoietic protoporphyria (EPP) and X‑linked protoporphyria (XLP). The...
Small biotechs advance: Boundless, Immunomic secure IND clearances
Boundless Bio received FDA IND clearance for BBI‑940, an oral kinesin degrader, with a first‑in‑human KOMODO‑1 trial for metastatic breast cancer planned in H1. Separately, Immunomic Therapeutics...
China remakes clinical trials: faster INDs open CRO, sponsor opportunities
Regulatory reforms in China have dramatically sped timelines for clinical trial approvals, shifting the country from one of the slowest to one of the fastest markets for IND review. U.S. analysts...
GSK buys Rapt — $2.2B for long‑acting anti‑IgE
GSK agreed to acquire Rapt Therapeutics for $2.2 billion, taking control of ozureprubart, a mid‑phase anti‑IgE monoclonal antibody designed to prevent food‑allergy reactions. The deal gives GSK...
Merck, Moderna: personalized melanoma vaccine holds at five years
Long‑term data show that adding Merck’s Keytruda to Moderna’s personalized neoantigen cancer vaccine sustained a roughly 49% reduction in risk of recurrence or death at five years, the companies...
CMS clears payment for Illumina test: $2,989 per genomic profile
The Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989 per test, effective Jan. 1, 2026, Illumina announced. The decision...
Congress writes Medicare path for MCED tests into spending bill
Legislative language in the federal appropriations package would create a streamlined Medicare coverage pathway for multi‑cancer early detection (MCED) tests following FDA approval, according to...
Beam may use biomarkers for accelerated approval — FDA nod opens path
Beam Therapeutics and the FDA agreed that biomarker changes assessed over one year could support an accelerated approval pathway for Beam’s BEAM‑302 base‑editing candidate for alpha‑1 antitrypsin...
Boundless wins IND for oral kinesin degrader — KOMODO‑1 to start H1
Boundless Bio announced FDA clearance of an investigational new drug (IND) for BBI‑940, an oral kinesin degrader, enabling a first‑in‑human trial (KOMODO‑1) in metastatic breast cancer slated to...
Insilico splits NLRP3 rights — $66M deal sparks China tie‑ups
Insilico Medicine agreed to a transaction that will split global rights for a brain‑penetrant NLRP3 inhibitor, generating roughly $66 million in total deal value and an upfront payment in the...