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Multiple myeloma – FDA accelerated approval and next-gen CELMoDs
Bristol Myers Squibb’s Zenbexus (iberdomide) won U.S. FDA accelerated approval for adults with advanced multiple myeloma that has returned or progressed after at least one prior line of therapy,...
Multiple myeloma – China market entry for felzartamab
Biogen’s monoclonal antibody felzartamab received its first global approval in China for multiple myeloma. The therapy is slated for second-line use in combination with lenalidomide and...
Duchenne muscular dystrophy – Capricor shifts BLA after FDA adcomm setback
Capricor said it will amend its BLA for deramiocel following an FDA advisory committee controversy, aiming to move the therapy into a narrower indication tied to improved limb function in Duchenne...
Fabry gene therapy – PTC wins Sangamo assets in bankruptcy auction
PTC Therapeutics won a competitive bankruptcy auction for Sangamo’s Fabry gene therapy candidate ST-920 (isaralgagene civaparvovec). Under the deal, Sangamo is set to receive $111 million upfront,...
Hematology funding – Silence raises for siRNA divesiran after Phase 2 win
Silence Therapeutics priced an upsized public offering expected to raise about $175 million, with proceeds earmarked for its short interfering RNA (siRNA) programs including divesiran. The funding...
Diagnostic regulation – OraSure withdraws FDA submission for CT/NG test
OraSure Technologies withdrew its FDA 510(k) and CLIA waiver submission for the InteliQuick CT/NG point-of-care molecular test after discussions with the agency. The company expects the regulatory...
Diagnostics – Proteotype starts clinical studies for MCED CE-IVDR pathway
Proteotype Diagnostics plans a new multi-study clinical program to support its multicancer early detection (MCED) test, Enlighten, including a study geared toward its CE-IVDR submission. The...
Financing and workforce – Illumina raises debt and issues notes
Illumina secured a new $1 billion credit facility with Bank of America and simultaneously launched an underwriting agreement to sell $300 million in notes due 2029. The credit agreement replaces a...
Clinical development – ARDD expands longevity leadership lineup
Organizers of the Aging Research & Drug Discovery (ARDD) Meeting in Boston announced multiple featured speakers from the longevity ecosystem, including Pfizer’s Ariel Feldstein, Insilico Medicine...
Biotech corporate funding – AbCellera launches $200 million public offering
AbCellera Biologics launched an underwritten public offering targeting $200 million to fund its menopause antibody program. The company plans to raise proceeds through common shares and pre-funded...
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...