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The Latest Biotech & Pharma Updates
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?)
Biotech & Pharma Updates | November 24 - 25, 2025
🧬 AbbVie + adMare BioInnovations launch lab space award program for Quebec biotechs in key therapeutic areas, AstraZeneca's Imfinzi (durvalumab) lands FDA approval for perioperative gastric cancer and gastroesophageal junction cancer treatment, Novo Nordisk's amycretin shows competitive Ph2 weight loss results in type 2 diabetes patients, Zetagen Therapeutics raises $12.9M Series B1 for intratumoral treatments for breast cancer, Teva Pharmaceuticals receives European Commission approval for PONLIMSI and DEGEVMA (denosumab) biosimilars targeting bone conditions, Sarepta gets FDA approval to test immunosuppressive Elevidys regimen for non-ambulatory DMD patients
Biotech & Pharma Updates | November 23 - 24, 2025
🧬 Novartis receives FDA approval for Itvisma (onasemnogene abeparvovec-brve) gene therapy targeting spinal muscular atrophy in patients two years and older, Biogen + Dayra Therapeutics partner on oral macrocyclic peptides for immunology in $50M upfront plus milestones deal, MindImmune raises $30M Series A for inflammation-focused Alzheimer's therapy development, Phrontline Biopharma raises $60M Pre-A+ to develop bispecific and dual-payload ADCs, Kelun-Biotech's sacituzumab tirumotecan (sac-TMT) plus Merck & Co.’s Keytruda combo hits Ph3 endpoint in first-line non-small cell lung cancer, Gilead + Sprint Bioscience partner on TREX1 cancer program with $14M upfront + $400M biobucks, UK negotiates drug pricing deal with US - raising NHS cost-effectiveness thresholds for lower tariffs
Biotech & Pharma Updates | November 20 - 23, 2025
🧬 Eli Lilly becomes first pharmaceutical company to reach $1 trillion market valuation milestone, FDA approves Pfizer's Padcev and Merck & Co.'s Keytruda combo for perioperative muscle-invasive bladder cancer treatment, AstraZeneca invests $2B to expand Maryland manufacturing capacity and adding 300 jobs across two facilities, AGC Biologics + AAVantgarde manufacturing partnership for dual-vector gene therapies targeting inherited retinal disorders, Bayer's asundexian meets Ph3 endpoints for secondary stroke prevention Sorcero raises $42.5M Series B for AI-powered intelligence platform for life sciences, FDA to hire 1,000+ staff & launches communication program to accelerate drug review process
Biotech & Pharma Updates | November 19 - 20, 2025
🧬 Moderna secures $1.5B loan facility - targeting breakeven by 2028 amid pipeline reevaluation, Aspen Neuroscience raises $115M Series C for Parkinson's cell therapy development, Cassidy Bio launches with $8M seed funding to develop AI-driven gene editing platform, GSK + Quotient Therapeutics + ProFound Therapeutics partner on respiratory + liver disease targets in up to $7B potential deal value, Merck KGaA + Valo Health partner on Parkinson's target discovery using AI platform in up to $3B potential deal, Regeneron's Eylea HD wins FDA approval for retinal vein occlusion macular edema and monthly dosing expansion
Biotech & Pharma Updates | November 18 - 19, 2025
🧬 Eli Lilly opens fourth US Gateway Labs biotech incubator facility in Philadelphia, Novartis plans $771M North Carolina manufacturing hub expansion to add 700 jobs by 2028, Rafa Laboratories awarded $186M BARDA contract for intramuscular tranexamic acid injection development, Profluent raises $106M Series B, AI-driven protein design for therapeutics and agriculture, GSK + LTZ Therapeutics partner on myeloid cell engagers for cancer with $50M upfront, Bayer's Hyrnuo (sevabertinib) receives FDA accelerated approval targeting HER2-mutated non-small cell lung cancer, AstraZeneca + Sun Pharma partner to expand hyperkalaemia therapy access in India via dual branding, FDA grants full approval for Amgen's IMDELLTRA (tarlatamab) targeting extensive stage small cell lung cancer