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LEO Pharma buys late-stage rare-disease oral asset from Tanabe
LEO Pharma agreed to license worldwide rights to Tanabe Pharma’s late-stage oral drug dersimelagon for erythropoietic protoporphyria and X-linked protoporphyria in a deal worth up to $435 million....
Amylyx posts Phase 3 win for GLP-1 antagonist avexitide after bariatric surgery
Amylyx Pharmaceuticals reported a Phase 3 success for avexitide (a GLP-1 receptor antagonist) in patients with post-bariatric hypoglycemia, positioning the company to seek regulatory approval for...
Argenx’s Vyvgart Hytrulo hits Phase 3 signal in autoimmune myositis
Argenx said its subcutaneous Vyvgart Hytrulo (efgartigimod alfa) met statistical significance in a Phase 3 myositis study focused on immune-mediated necrotizing myopathy, a subtype with no...
BioMarin buys Alesta Therapeutics in $275M push toward rare bone disease
BioMarin Pharmaceutical agreed to acquire Alesta Therapeutics for $275 million upfront, aiming to expand in the rare bone disease market and intensify competition with AstraZeneca in that segment....
Bristol Myers loses courtroom shield in Breyanzi delayed-approval suit
A US court cleared the path for a lawsuit accusing Bristol Myers Squibb of delaying FDA approval of Breyanzi to avoid milestone payments tied to its 2019 Celgene acquisition. The trustee suit,...
EyePoint’s wet AMD Phase 3 insert fails primary goal vs Eylea
EyePoint’s Phase 3 LUGANO results for Duravyu (vorolanib intravitreal insert) missed the primary endpoint of non-inferiority versus standard-of-care Eylea (aflibercept) in wet age-related macular...
Reverse-merger surge: Slate and Fulcrum combine to fund migraine pipeline
Slate Medicines will merge with Fulcrum Therapeutics in a reverse-merger structure as the companies reposition for migraine drug development. The transaction follows Fulcrum’s discontinuation of...
Regulatory timing reform push for US first-in-human trials
US stakeholders are moving to shorten pre-IND timelines and streamline early trial setup, with a focus on making first-in-human (FIH) programs launch faster and with less unnecessary work....
Precision oncology collaboration: Thermo Fisher and KYAN partner on tumoroid-based drug response testing
Thermo Fisher Scientific signed a memorandum of understanding with KYAN Technologies to advance functional precision oncology using patient-derived tumoroids. The collaboration will evaluate...
Microbiome culturing startup Bac 3 Gel aims to boost species recovery from complex samples
Bac 3 Gel is positioning its synthetic mucus-mimicking biomaterial platform as a way to grow harder-to-culture microbiome communities at higher yield than conventional bioreactor approaches. In an...
Obesity drug concept with potential muscle-preservation angle
Enveda reported Phase 1 results for ENV-308, an oral compound designed to mimic exercise effects by targeting leptin biology and potentially preserving lean mass during weight loss. The company...
Myositis: FcRn antagonist expands with subcutaneous Vyvgart Hytrulo Phase 3 signal
Argenx said its subcutaneous FcRn antagonist Vyvgart Hytrulo hit a Phase 3 endpoint in a late-stage combined study of immune-mediated necrotizing myopathy (IMNM), a myositis subtype with limited...
Eye care: Eyepoint’s Duravyu Phase 3 strategy hits primary endpoint miss
Eyepoint disclosed that its Phase 3 trial of Duravyu (vorolanib intravitreal insert) for wet age-related macular degeneration failed to maintain vision outcomes with a less frequent injection...
FDA pathway timing pressure: US moves to cut pre-IND timelines
Industry and government stakeholders outlined a push to reduce the timeline required to file investigational drug applications, targeting pre-IND work as a major source of unnecessary delay. The...
CRO operations: new subject-ID schema aims to fix tracking fragmentation
A new standardized framework proposed by researchers in the CRO sector targets a recurring operational failure: study-specific subject ID conventions that fragment tracking across sponsor...
Biotech licensing: Leo Pharma pays up to $435M for Tanabe rare skin disease drug
Leo Pharma agreed to license a Tanabe Pharma oral therapy for a pair of genetic light-sensitive skin diseases, with payments totaling up to $435 million in upfront and near-term milestones. The...
Clinical development: AstraZeneca drops Phase 3 volrustomig lung cancer study
AstraZeneca halted a Phase 3 lung cancer trial of volrustomig after an interim data review indicated survival endpoints were unlikely to be met compared with an active comparator. The decision...
Gene editing tools: IDT expands CRISPR off-target nomination with UNCOVERseq
Integrated DNA Technologies (IDT) advanced its CRISPR safety workflow with UNCOVERseq, a method designed to streamline off-target site nomination for subsequent confirmation. In a benchmarking...
Oncology genomics operations: centralized processing for whole-genome data from frozen tumors
Researchers reported a standardized pathology and molecular workflow designed to turn frozen tumor samples collected across countries and sites into reliable whole-genome data. The Mutographs...
Platelet storage: chilled platelets can safely extend supplies up to 21 days
University of Pittsburgh researchers reported adaptive clinical trial results indicating that refrigerated, or chilled, platelets can remain effective for up to 21 days—potentially extending...