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Court blocks Agilent’s CRISPR patent bid, ending appeals in Synthego fight
The U.S. Supreme Court denied Agilent’s request to review invalidation of two CRISPR-related patents, effectively ending the company’s multi-year legal fight with Synthego. Synthego said the...
Federal procurement and regulatory scrutiny intersect with obesity pharma pricing and access
As U.S. regulators and payers tighten scrutiny around data generation and compliance, obesity drugmakers are also navigating complex access and pricing arrangements. Separate reporting points to...
Series B capital pours into Ambrosia as oral small-molecule GLP-1 moves toward Phase I
Ambrosia Biosciences secured $100 million in an oversubscribed Series B to advance its lead oral small-molecule GLP-1 candidate into Phase I trials. The financing, co-led by Blue Owl Healthcare...
Immunovant’s FcRn blocker batoclimab fails again in Phase 3 TED trials
Immunovant’s FcRn inhibitor batoclimab missed the primary endpoint in two Phase 3 trials in thyroid eye disease (TED), dealing another blow to the company’s attempt to commercialize the...
FDA tariff rumors raise new compliance and cost risks for drugmakers
U.S. reporting says the Trump administration is preparing a 100% tariff order on some imported patented medications and their active ingredients. Draft documents seen by outlets indicate the...
Lilly acquires Centessa for up to $7.8B, expanding sleep/wake neuroscience ambitions
Eli Lilly agreed to acquire Centessa Pharmaceuticals in a deal valued at about $7.8 billion, bringing the company’s orexin receptor 2 (OX2R) agonist portfolio into Lilly’s neuroscience...
Fosun gains NMPA approval to start trial of FXB-0871 in China
Fosun Pharmaceutical received NMPA approval to initiate a clinical trial of FXB-0871 (TEV-56278) for locally advanced or metastatic solid tumors. The regulatory green light authorizes the start of...
New gene therapy and trial-readiness milestones in early-stage pipeline
Several companies advanced early-stage translational programs with regulatory or preclinical platform milestones. Notably, Alltrna obtained Australian approval to start a Phase I trial of AP-003,...
Obesity drug approvals and competitive oral GLP-1 race
The FDA approved Eli Lilly’s oral GLP-1 weight-loss drug orforglipron (Foundayo), quickly intensifying the battle with Novo Nordisk’s oral semaglutide alternative. Multiple reports describe the...
Big pharma dealmaking: Biogen’s Apellis acquisition
Biogen agreed to buy Apellis Pharmaceuticals in a deal valued at about $5.6 billion, using the combination to expand its immunology and rare-disease portfolio and accelerate pipeline execution....
Big pharma dealmaking: Lilly’s Centessa acquisition and neuro pipeline expansion
Eli Lilly agreed to acquire Centessa Pharmaceuticals for about $6.3 billion up front, with additional consideration via contingent value rights, adding orexin receptor 2 (OX2R) agonist programs...
Clinical trial failures in immune/eye disease: Immunovant’s FcRn program
Immunovant’s batoclimab failed to meet primary endpoints in a pair of Phase 3 trials in thyroid eye disease, according to reporting tied to Roivant disclosures. The results mark another setback...
FDA and regulatory scrutiny: Tavneos liver injury warnings
The FDA issued new safety alerts tied to liver injury and deaths associated with Amgen’s Tavneos (avacopan), according to reports summarizing agency correspondence. The updates cite cases of...
Regulatory decision in CRISPR patent battle: Agilent vs Synthego
The US Supreme Court denied Agilent Technologies’ request to review invalidation of CRISPR-related patents tied to guide RNA chemical modifications, according to reporting grounded in a Synthego...
Cell therapy and gene editing access: FDA shifting to digital health tech guidance
The US FDA is seeking public feedback on advancing the use of digital health technologies in drug trials, according to reporting on an agency request that frames new guidance needs across CBER and...
Funding and company momentum: new seed financing for epigenetic protein interface drugs
Tippingpoint Biosciences raised an oversubscribed $4.5 million seed round to advance a drug discovery platform focused on epigenetic protein interfaces, according to reports. The company, spun out...
Precision oncology diagnostics: multi-cancer early detection results solidify Caris Detect outlook
Caris Life Sciences disclosed finalized results from the Achieve I study for its multi-cancer early detection test, Caris Detect, reporting sensitivity and specificity across stage I to stage IV...
Next-gen delivery and trial execution: NGS tumor profiling partnership
CellCarta and Pillar Biosciences entered a strategic partnership to provide NGS-based tumor profiling for oncology clinical trials. The collaboration combines Pillar’s OncoReveal kitted panels...
Obesity drugs: FDA clears Lilly’s oral GLP-1 Foundayo
The U.S. FDA approved Eli Lilly’s oral GLP-1 receptor agonist orforglipron, marketed as Foundayo, setting up direct commercial competition with Novo Nordisk’s oral obesity pill Wegovy. The...
Big obesity funding: Ambrosia lands $100M to scale oral GLP-1 program
Ambrosia Biosciences secured $100 million in an oversubscribed Series B round to advance an oral small-molecule GLP-1 candidate aimed at competing in the new oral obesity drug landscape. The...