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China opens faster trial routes — global CROs circle the market
Regulatory reforms in China have replaced slow, open‑ended IND approvals with an ‘implied approval’ framework and other measures that dramatically shortened review timelines, analysts said,...
GSK buys Rapt: $2.2B deal 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 in Phase IIb, to its allergy pipeline. The buyer expects the candidate to...
FDA issues MRD draft guidance: Accelerated approval path clarified
The U.S. Food and Drug Administration released draft guidance describing how measurable residual disease (MRD) negativity and complete response rates may be used to support accelerated approvals...
Erasca prices upsized offering: $225M cash infusion for RAS/MAPK programs
Erasca priced an upsized public offering of 22.5 million shares at $10 each, generating gross proceeds of approximately $225 million to fund its precision‑oncology programs targeting RAS/MAPK...
Corvus pill…phase I surge: Oral ITK inhibitor posts strong eczema readout
Corvus Pharmaceuticals reported positive Phase I data for soquelitinib, an oral ITK inhibitor, in moderate‑to‑severe atopic dermatitis cohorts, showing deepening responses at eight weeks and...
Illumina wins CMS reimbursement: TruSight Oncology gets $2,989 rate
CMS granted reimbursement for Illumina's TruSight Oncology Comprehensive assay at $2,989.55 per test, effective Jan. 1, 2026. The FDA‑cleared comprehensive genomic profiling test covers >500 genes...
Valneva withdraws U.S. chikungunya dossier: Safety concerns prompt exit
Valneva voluntarily withdrew its U.S. authorization for the chikungunya vaccine Ixchiq and pulled the associated post‑marketing study after the FDA placed the product under clinical hold following...
Congress moves MCED coverage: Medicare pathway included in spending bill
A provision in the federal spending package would create a streamlined Medicare coverage pathway for FDA‑approved multi‑cancer early detection (MCED) tests, enabling reimbursement without prior...
Insilico splits NLRP3 rights: $66M deal and China license accelerate ISM‑8969
Insilico Medicine agreed to a transaction that delivers a $10 million upfront and a broader $66 million‑value arrangement to carve up rights for its brain‑penetrant NLRP3 inhibitor, enabling a...
Beam…biomarkers for approval: FDA agrees biomarker‑based path in AATD
Beam Therapeutics said the FDA accepted a biomarker‑based accelerated‑approval approach for BEAM‑302, its base‑editing therapy for alpha‑1 antitrypsin deficiency (AATD). Regulators agreed that...
Engineered CHO cells cut feeds and wastes: Self‑sufficient amino‑acid producers
Danish researchers at DTU reported engineered Chinese hamster ovary (CHO) cell lines that synthesize threonine and histidine internally and exhibit reduced lactate and ammonia production....
GSK buys 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 antibody in Phase IIb, to its allergy and immunology pipeline. The deal gives GSK global rights...
FDA opens path: MRD negativity could back myeloma accelerated approvals
The U.S. Food and Drug Administration released draft guidance clarifying how measurable residual disease (MRD) negativity and complete response rates can support accelerated approval pathways for...
Erasca prices upsized offering — $225M gross proceeds
Erasca priced an upsized public offering of 22.5 million shares at $10.00 per share, generating expected gross proceeds of about $225 million and granting underwriters a 30‑day option on...
Corvus pill soars — ITK inhibitor posts strong Phase I eczema results
Corvus Pharmaceuticals reported positive Phase I results for soquelitinib, an oral ITK (IL‑2‑inducible T‑cell kinase) inhibitor, prompting a dramatic stock rally as clinicians and investors parsed...
Illumina wins CMS reimbursement — TruSight Oncology Comprehensive covered
The Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive (TSO) at $2,989.55 per test under PLA code 0543U, effective Jan. 1, 2026. The...
Valneva pulls chikungunya from U.S. after FDA safety probe
Valneva voluntarily withdrew its U.S. chikungunya vaccine application and halted related post‑marketing study activities after learning the FDA placed a clinical hold following a newly reported...
Beam wins biomarker path: FDA allows MRD‑style route for BEAM‑302
Beam Therapeutics said it agreed with FDA reviewers that validated biomarkers assessed over a year could support an accelerated approval pathway for BEAM‑302, its in vivo base‑editing candidate...
Merck, Guardant pair up — Companion diagnostics tied to global trials
Merck and Guardant Health announced a multi‑year collaboration to develop and commercialize companion diagnostics using Guardant’s liquid and tissue biopsy assays to help enroll patients in...
Appropriations bill would ease Medicare coverage for FDA‑approved MCED tests
Congressional negotiators included a provision in the current appropriations package that would create a streamlined pathway for Medicare coverage of FDA‑approved multi‑cancer early detection...