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Endocrine rare disease drug progress
Amylyx reported a Phase 3 success for avexitide (a GLP-1 receptor antagonist) in post-bariatric hypoglycemia, showing a 55% reduction in serious hypoglycemic events versus placebo in a pivotal...
FDA-regulated gene editing scrutiny in China
STAT+ revisited Huidagene’s gene editing trial decisions after a child’s death, with gene-editing experts dissecting how early trial data and presentation choices may have influenced risk...
Regulatory pathway for AI-enabled medical devices
The FDA opened a consultation on how it should regulate generative AI-enabled medical devices, aiming to refine risk assessment, premarket review expectations, and postmarketing monitoring. The...
FDA commissioner nomination
A source familiar with the decision says President Donald Trump is expected to nominate Heidi Overton to lead the FDA. If confirmed, the nomination would set the agenda for agency priorities...
Oncology franchise deals and pipeline readouts
AstraZeneca extended survival signals in lung cancer through a combination outcome involving Tagrisso and Hutchmed’s Orpathys, according to a deal-and-pipeline roundup. In parallel, AstraZeneca...
Next-generation immunotherapy outcomes in solid tumors
Updated Harmoni-6 data is raising questions for Akeso and Summit’s ivonescimab, with updated analysis showing that the PD-1/VEGF bispecific antibody’s progression-free survival benefit narrowed...
Big pharma dealmaking—dermatology acquisition and pipeline expansion
LEO Pharma agreed to acquire rights to dersimelagon from Tanabe Pharma in a deal potentially worth up to $435 million, adding a late-stage candidate targeting rare sunlight-sensitive skin...
Biopharma financing and U.S. scale-up for diagnostics
Craif raised $33 million in a Series D to accelerate a urine-based pancreatic cancer test toward U.S. clinical trial execution. The funding is aimed at scaling laboratory capacity in San Diego,...
CAR T program discontinuation and asset reversion
Janssen discontinued development of a CD20/CD19 CAR T therapy, prizloncabtagene autoleucel (C-CAR039), and Abelzeta Pharma regained rights to the program. Janssen’s decision reverses the earlier...
Venture and public-market momentum for AI-driven drug discovery
A large recap points to the acceleration of AI infrastructure investment in drug discovery, highlighting continued billion-dollar funding into end-to-end AI platforms. The piece emphasizes that...
Amylyx pivots to GLP-1 blockade and posts a Phase 3 win in PBH
Amylyx Pharmaceuticals reported positive top-line results from its Phase 3 Lucidity trial of avexitide, a GLP-1 receptor antagonist, in post-bariatric hypoglycemia (PBH). The study enrolled...
FDA IND goes live for Amygdala Neurosciences’ ALDH2 inhibitor
Amygdala Neurosciences secured FDA IND approval for ANS-858, a selective, reversible, orally bioavailable ALDH2 inhibitor. The program initially targets alcohol use disorder and substance use...
Leo Pharma buys Tanabe’s late-stage oral rare-skin drug
Leo Pharma agreed to acquire rights to dersimelagon from Tanabe Pharma in a deal potentially worth up to $435 million, adding a late-stage, oral candidate to its dermatology portfolio. Tanabe’s...
Argenx wins Phase 3 endpoint for subcutaneous Vyvgart Hytrulo in myositis subtype
Argenx reported a positive Phase 3 readout for Vyvgart Hytrulo (efgartigimod alfa) in immune-mediated necrotizing myopathy, a more aggressive myositis subtype with limited targeted treatment...
GSK backs out of its Verzenio? No—AstraZeneca halts a Phase 3 lung cancer trial
AstraZeneca ended a Phase 3 study of volrustomig, a lung cancer therapy it was evaluating in combination with chemotherapy, after an interim data check suggested survival goals would likely be...
CRISPR off-target nomination service expands at IDT
Integrated DNA Technologies advanced gene-editing safety workflows with UNCOVERseq, an off-target site nomination method designed to streamline the jump from high-throughput discovery to targeted...
Biotech innovation funding: Freenome lands fresh Wall Street coverage
TD Cowen initiated coverage of Freenome with a Buy rating and a $17 price target, citing differentiated liquid biopsy chemistry and commercial momentum through partnerships with Abbott and Roche....
Translational execution: Chilled platelets extend storage window
Researchers reported results from an adaptive clinical trial suggesting that refrigerated, cold-stored platelets can safely expand lifesaving platelet supplies for bleeding patients. The findings,...
Biotech governance and data quality: standardized subject IDs for CRO portfolios
A new industry schema proposal targets a recurring clinical-trial operations problem: duplicated or fragmented subject identifiers across CRO and sponsor portfolios. The authors describe a...
CAR-T portfolio reset: Janssen exits CD20/CD19 CAR T program
Janssen Biotech discontinued development of prizloncabtagene autoleucel (C-CAR039), an anti-CD20/CD19 bispecific CAR T therapy, prompting Abelzeta Pharma to regain rights. Abelzeta previously...