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The Latest Biotech & Pharma Updates
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Biotech & Pharma Updates | December 10 - 11, 2025
🧬 Zealand Pharma + OTR Therapeutics partner on metabolic disease therapeutics with $20M upfront + $2.5B biobucks, Amgen's Uplizna (inebilizumab) wins FDA approval for generalized myasthenia gravis targeting CD19-positive B cells, Xcell Biosciences + Culture Biosciences partner to advance cell therapy quality through AI and machine learning, Eli Lilly's retatrutide (triple hormone receptor agonist) achieves 26.6% weight loss in Ph3 obesity trial, Aukera Therapeutics emerges from stealth with CHF 4.5M ($5.63M) funding for neurological RAPTOR inhibitor development, Prolynx raises $70M Series A for longer-lasting obesity drugs with less frequent dosing, European legislators agree on major pharma policy overhaul reducing drug exclusivity periods + strengthening supply chains
Biotech & Pharma Updates | December 9 - 10, 2025
🧬 FDA approves Fondazione Telethon's gene therapy for Wiskott-Aldrich syndrome - first gene therapy approved from a non-profit sponsor, Formation Bio + Lynk Pharmaceuticals partner on TYK2 inhibitor LNK01006 with $605M total deal value, InduPro Therapeutics + Sanofi partner on bispecific PD-1 agonist for autoimmune disorders with undisclosed equity investment, Roche's giredestrant (oral SERD) shows 30% risk reduction in Ph3 early estrogen receptor-positive breast cancer trial, PsiThera raises $47.5M Series A for AI-designed oral drugs for immune conditions, Great Point Partners acquires majority stake in Lenis Group - specialty pharmaceutical distributor in Central and Eastern Europe, FDA finalizes guidance on promotional materials for biologics and biosimilars requiring accurate + non-misleading advertising
Biotech & Pharma Updates | December 8 - 9, 2025
🧬 Pfizer vaults another attempt towards an obesity pill by partnering with YaoPharma on Ph1 asset YP05002 - $150M upfront + $1.94B biobucks, Roche's Gazyvaro (obinutuzumab) wins EU approval for lupus nephritis treatment following Ph3 trial success, Cellular Origins raises $40M Series A for cell therapy manufacturing automation platform, Eli Lilly selects Alabama for $6B API facility to produce weight-loss pill orforglipron, Bora Pharmaceuticals + Corealis Pharma form strategic alliance for end-to-end oral solid dose development and production, Sidera Bio raises $109M Series A, developing obesity GLP-1/GIP/FGF21 triple agonist, BioNTech and Bristol Myers Squibb report positive Ph2 data for pumitamig in triple-negative breast cancer, Novartis' ianalumab hits Ph3 endpoints in immune thrombocytopenia
Biotech & Pharma Updates | December 7 - 8, 2025
🧬 Mirum Pharmaceuticals acquires Bluejay Therapeutics for $620M to gain hepatitis D drug brelovitug nearing Phase 3 results, Dr. Reddy's + Immutep partner on phase 3 immunotherapy eftilagimod alpha - $20M upfront + $349.5M biobucks, Biogen + Stoke Therapeutics' zorevunersen shows 82% seizure reduction in Dravet syndrome patients through 24 months, Dyne Therapeutics' zeleciment rostudirsen (z-rostudirsen) shows strong Ph1/2 results in Duchenne muscular dystrophy, Pan Cancer T raises €10M ($11.64M) funding for TCR-T cell therapy trial, China launches first private insurance formulary featuring drugs from big pharma, Singapore allocates $28.5 billion over five years for deep tech research including AI and biotechnology development
Biotech & Pharma Updates | December 4 - 7, 2025
🧬 German court grants Halozyme preliminary injunction halting Merck & Co.'s Keytruda SC launch activities over patent dispute, Immortal Dragons + Etheros partner on aging disease drugs targeting oxidative stress with fullerene derivatives, FDA approves Ayrmid's Omisirge (omidubicel-onlv) as first cell therapy for severe aplastic anemia treatment, FDA lifts partial clinical hold on Vanda Pharmaceuticals' motion sickness drug tradipitant following dispute resolution, Protara raises $75M public offering to fund TARA-002 clinical development program, Vertex's Casgevy (exagamglogene autotemcel) hits Ph3 goals in children with sickle cell disease and beta thalassemia, Pfizer's Hympavzi shows Ph3 success reducing bleeding in hemophilia A and B patients with inhibitors
Biotech & Pharma Updates | December 3 - 4, 2025
🧬 Denali Therapeutics + Royalty Pharma strike $275M financing deal for Hunter syndrome drug tividenofusp alfa, OTR Therapeutics raises $100M Series A for advancing early-stage innovations into "globally impactful" therapies, Paradigm Health raises $78M Series B for AI-powered clinical trials platform expansion, AstraZeneca + Neurimmune partner on amyloidosis antibody NI009 in up to $780M deal, FDA approves Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) for relapsed or refractory marginal zone lymphoma, Buckland Group launches Quvara Medical CDMO after acquiring Becton Dickinson's U.K. manufacturing facility
Biotech & Pharma Updates | December 2 - 3, 2025
🧬 FDA proposes cutting fees for US-based early-stage trials + adding charges for overseas development, Triana Biomedicines raises $120M Series B to continue development of molecular glue degrader for ALK+ lung cancer, AtomVie invests $138M to expand Ontario radiopharmaceutical facility - creating 70 jobs for cancer treatments, Excelsior raises $95M Series A to progress AI-driven small molecule discovery platform, Next-gen CRO Avetra launches with 350-plus US sites + plans gastrointestinal program, Capricor Therapeutics' deramiocel hits primary endpoint in Ph3 trial for Duchenne muscular dystrophy cardiomyopathy, Harmony Biosciences' EPX-100 reduces seizures by 50% in Ph3 open-label study for Dravet syndrome, Terray Therapeutics + Bristol Myers Squibb achieve discovery milestone in AI-driven small molecule development partnership
Biotech & Pharma Updates | December 1 - 2, 2025
🧬 Bipartisan lawmakers introduce bill creating US biopharma manufacturing center to reduce foreign dependence, WuXi Biologics + Qatar Free Zones Authority sign MoU to establish first Middle East CRDMO center, ARCH + Parker Institute launch Medici Therapeutics - acquiring Nutcracker's $200M RNA programs, Axoltis Pharma raises €18M ($20.9M) Series A to develop ALS drug candidate NX210c, Fractyl Health's Revita shows sustained weight maintenance post-GLP-1 discontinuation in Ph2 REVEAL-1 obesity study, Roche's trontinemab shows 92% amyloid clearance in Ph1/Ph2 trial for Alzheimer's disease, House unanimously passes bill to revive FDA's expired rare pediatric disease priority review voucher program
Biotech & Pharma Updates | November 30 - December 1, 2025
🧬 UK agrees to pay 25% more for new drugs - thus exempting British pharmas from US tariffs, FDA launches agentic AI program for staff to assist with reviews + inspections + and surveillance tasks, European Investment Bank + Angelini partner to invest €150M ($174M) in European health startups over six years, Johnson & Johnson receives European Commission approval for IMAAVY (nipocalimab) FcRn blocker treating generalised myasthenia gravis, Akebia + Q32 Bio partnership on rare kidney disease complement inhibitor ADX-097 with $12M upfront plus $580M milestones, Juniper Biosciences raises $40M Seed to develop innovative radiopharmaceutical pipeline, Morphocell Technologies raises $50M Series A for tissue therapeutics organ replacement
Biotech & Pharma Updates | November 26 - 30, 2025
🧬 Novo Nordisk submits Wegovy (semaglutide) 7.2-mg dose application for obesity using priority voucher for expedited FDA review, Innovent Biologics' Pecondle (picankibart) wins China NMPA approval for moderate-to-severe plaque psoriasis targeting interleukin-23p19, Prestige Biopharma + Biosidus enter exclusive license agreement for Tuznue commercialization in Latin America, SK Biopharmaceuticals in-licenses radiopharmaceutical therapy candidate WT-7695 from Wisconsin Alumni Research Foundation (targeting carbonic anhydrase IX), Valneva reports positive Ph2 results for VLA15 Lyme disease vaccine candidate showing strong immune response, Enlivex Therapeutics raises $212M private placement for launching a prediction market token (while being a macrophage immunotherapy company?)