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FDA accelerated approval for Zenbexus expands CELMoDs in multiple myeloma
The FDA has granted accelerated approval to Bristol Myers Squibb’s Zenbexus (iberdomide) for adult patients with advanced multiple myeloma that has returned or is refractory to treatment, clearing...
Zenbexus approval as first-in-class CELMoDs franchise cornerstone
Bristol Myers Squibb’s Zenbexus (iberdomide) also marked the first global FDA nod for a CELMoDs protein-degradation approach in multiple myeloma, according to separate coverage highlighting the...
Industry supply chain: US manufacturing expansion in biologics and drugs
Major pharma is ramping up US manufacturing footprint, with recent announcements pointing to large, multi-year capacity builds for biologics and advanced modalities. The updates include...
Cell therapy funding and update: Capricor seeks FDA review after DMD setbacks
Capricor Therapeutics moved to preserve its Duchenne muscular dystrophy (DMD) regulatory path after an adverse FDA advisory committee outcome, saying it will seek FDA review of additional data and...
AI+biotech finance: Precision immunology startup Boulevard emerges from stealth with $65M
Boulevard Bio emerged from stealth with approximately $65 million in launch financing, backed entirely by Deerfield Management and its internal discovery engine, 3DC. The company is developing a...
Protein sequencing systems: Quantum-Si pushes Proteus launch to 2Q 2027 and cuts 20% staff
Quantum-Si disclosed it is laying off about 20% of its workforce and delaying the Proteus protein sequencing system launch to the second quarter of 2027. The proteomics company said the change is...
Rare disease gene therapy M&A: PTC outbids rivals for Sangamo’s Fabry asset
PTC Therapeutics won a competitive bankruptcy auction to acquire Sangamo’s Fabry disease gene therapy program, ST-920 (isaralgagene civaparvovec), for $111 million upfront with up to $100 million...
Regulatory/quality in oncology: EU regulators detail why Tavneos was pulled
European regulators described their skepticism about the data behind Amgen’s Tavneos (avacopan) in newly released documents, explaining the rationale for pulling the drug from the market in...
Diagnostic regulation: OraSure withdraws FDA submission for CT/NG point-of-care test
OraSure Technologies withdrew its FDA 510(k) and CLIA waiver submission for its InteliQuick CT/NG point-of-care molecular test after discussions with the agency. The company said the regulatory...
Clinical-stage financing: Silence Therapeutics upsizes $175M offering after Phase 2 “best-case” outcome
Silence Therapeutics priced an upsized public offering expected to raise about $175 million, following favorable Phase 2 pharmacology/primary endpoint results for divesiran in a rare leukemia. The...
Multiple myeloma – Zenbexus gets FDA accelerated approval
Bristol Myers Squibb won accelerated approval in the US for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj, plus dexamethasone, to treat adults with advanced multiple...
Multiple myeloma – Zenbexus approval explained as CELMoDs milestone
Bristol Myers’ Zenbexus approval was framed by investors and analysts as a “milestone” outcome for CELMoDs, the company’s new myeloma drug class acquired from Celgene. The FDA’s accelerated...
Myeloma – Biogen felzartamab receives first global approval in China
Biogen’s monoclonal antibody felzartamab received its first global approval in China for multiple myeloma. The therapy is authorized for second-line use for patients treated alongside lenalidomide...
Regulatory and reimbursement – ICER says Baxfendy not cost-effective
The Institute for Clinical and Economic Review (ICER) said AstraZeneca’s newly approved hypertension drug Baxfendy does not meet its cost-effectiveness bar at the company’s reported price. ICER’s...
Clinical development – Capricor seeks FDA review after adcomm setback
Capricor Therapeutics announced plans to amend its Duchenne muscular dystrophy (DMD) therapy filing after an FDA advisory committee setback. The company said it will ask the FDA to review...
Biotech funding – Boulevard emerges from stealth with $65m for autoimmune antibodies
Boulevard Bio ended stealth with about $65 million in launch financing from Deerfield Management to build an antibody pipeline focused on B cell-driven autoimmune disease. The company is advancing...
Gene therapy dealmaking – PTC wins $211m bid for Sangamo Fabry program
PTC Therapeutics won a $211 million bankruptcy auction for Sangamo’s Fabry gene therapy candidate, ST-920 (isaralgagene civaparvovec). Under the winning terms, Sangamo will receive $111 million...
Regulatory submissions – OraSure withdraws FDA filing for CT/NG molecular test
OraSure Technologies withdrew its US FDA submission for its InteliQuick CT/NG point-of-care molecular test following discussions with the agency, removing the planned 510(k) and CLIA waiver...
Funding and scale-up – Silence upsized $175m public offering for siRNA divesiran
Silence Therapeutics priced an upsized public offering expected to raise about $175 million as it advances its short interfering RNA (siRNA) pipeline. The financing was increased from an earlier...
Company funding – Aligned Marketplace raises $20m for primary care matching
Aligned Marketplace secured a $20 million Series A led by Venrock to expand its platform for matching self-insured employers with primary care clinics. The company said total funding to date is...