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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...
AstraZeneca’s hypophosphatasia enzyme therapy stumbles in pivotal phase
AstraZeneca’s experimental enzyme replacement therapy efzimfotase alfa produced mixed outcomes in three late-stage trials in hypophosphatasia, a rare genetic bone disorder. The results mark...
Immunology M&A: Biogen to buy Apellis for $5.6B
Biogen agreed to acquire Apellis Pharmaceuticals for about $5.6 billion, expanding the Massachusetts-based biotech’s immunology and rare-disease portfolio with two marketed assets. The deal gives...
Sleep medicine M&A: Lilly agrees to buy Centessa for $6.3B
Eli Lilly agreed to acquire Centessa Pharmaceuticals for about $6.3 billion in upfront cash, adding a clinical-stage portfolio of orexin receptor 2 (OX2R) agonists for sleep-wake disorders. The...
Oncology: Active surveillance consensus for low-grade NMIBC
A global consensus statement backs active surveillance as a management strategy for patients with low-grade non-muscle-invasive bladder cancer (LG-NMIBC). The approach aims to reduce overtreatment...
Gene therapy/wound care: Hydrogel + AAV8-sTβRII reduces skin scarring
Researchers reported a gene therapy approach that combines a poly-(HA-GMA) hydrogel with AAV8-sTβRII to reduce late-stage fibrosis and minimize skin scarring. The report emphasized that the...
Diagnostics: Caris shares surge after finalized Achieve I multi-cancer early detection results
Caris Life Sciences’ shares rose after the company released finalized Achieve 1 study results for its multi-cancer early detection test, Caris Detect. The Achieve I study enrolled 3,014 patients,...
Dealmaking for rare neurodegeneration: Korsana to go public via reverse merger
Korsana Biosciences is moving to the public markets via a reverse merger with Cyclerion Therapeutics, bringing a large-scale financing package and a pipeline lead for Alzheimer’s disease. The...
Regulatory & policy: FDA looks to reduce data burden to start new drug trials
U.S. FDA Commissioner Marty Makary said the agency wants to speed new drug trials by cutting the amount of data required to initiate studies in the U.S., removing most non-safety components from...