November 5, 2025 – Talk Bio

FDA Rejects Biohaven’s Ataxia Drug Vyglxia, Forcing Company to Cut Costs After Second Approval Failure

2 months ago talkbio0Tagged Ataxia, Spinocerebellar, Biohaven, Clinical Trial Design, Drug Approval, external controls, IL31RA gene, In complete remission, R&D, Rejection, Troriluzole, United States Food and Drug Administration, Vyglxia

Biohaven; FDA rejection; Vyglxia; troriluzole; spinocerebellar ataxia; CRL (Complete Response Letter); clinical trial design; external controls; drug approval; R&D cuts

Metsera Bidding War Grips Obesity Drug Field as Novo Nordisk and Pfizer Escalate Offers

2 months ago talkbio0Tagged Acquisition, Antitrust, bidding war, Disputes, Dominance, Glucagon-Like Peptide 1, Legal, Market, Metsera, Novo Nordisk, Obesity, Pfizer

Metsera; obesity drugs; bidding war; Novo Nordisk; Pfizer; acquisition; GLP-1; antitrust; market dominance; legal disputes

FDA Unveils Long-Awaited Biosimilar Guidance to Accelerate Approvals and Cut Costs

2 months ago talkbio0Tagged Biopharmaceuticals, biosimilar guidance, biosimilarity, Clinical Research, Comparative Efficacy, draft guidance, Drug Costs, four-letter suffix, naming convention, United States Food and Drug Administration

FDA; biosimilar guidance; 2025 draft guidance; comparative efficacy study; analytical assessment; four-letter suffix; naming convention; biosimilarity; drug costs; biologic medicines

Novo Execs Face Skeptical Analysts Amid Metsera Buyout Drama

2 months ago talkbio0Tagged Acquisition, analysts, Antitrust, Buyout, CEO Mike, lawsuit, Metsera, Novo Nordisk, Obesity, Pfizer

Novo Nordisk; Metsera; acquisition; Pfizer; buyout; obesity drugs; analysts; lawsuit; antitrust; CEO Mike Doustdar

Jennifer Doudna’s Azalea Therapeutics Launches with $82M to Advance In Vivo CAR-T Using Novel CRISPR Delivery Technology

2 months ago talkbio0Tagged Autoimmune Diseases, Azalea Therapeutics, B-cell malignancies, Cancer Therapeutic Procedure, CAR-T, Clustered Regularly Interspaced Short Palindromic Repeats, EDV technology, Funding, Gene Modification, in vivo, Jennifer Doudna, Series A

Jennifer Doudna; Azalea Therapeutics; CRISPR; in vivo CAR-T; gene editing; EDV technology; cancer therapy; autoimmune disease; Series A funding; B-cell malignancies

Pfizer Cuts 11 R&D Programs amid Ongoing Revenue Declines and Cost Realignment Efforts

2 months ago talkbio0Tagged Cost Savings, COVID19 (disease), digital enablement, earnings, Pfizer, Q3, R&D, Revenue Decline, Seagen acquisition

Pfizer; R&D cuts; revenue decline; cost savings; Q3 2025 earnings; COVID-19 product sales; digital enablement; AI in R&D; Seagen acquisition

Lilly and Novo Nordisk Near White House Deal to Cut Obesity Drug Prices

2 months ago talkbio0Tagged drug price, Eli Lilly, Glucagon-Like Peptide 1, Medicare coverage, Novo Nordisk, Obesity, Trump administration, Wegovy, White House, Zepbound

Lilly; Novo Nordisk; White House; obesity drug prices; Medicare coverage; GLP-1 medications; Trump administration; Zepbound; Wegovy

Braveheart Bio Launches with $185 Million Series A, Appoints Biogen CEO Christopher Viehbacher as Chair

2 months ago talkbio0Tagged Andreessen Horowitz, BHB-1893, Biogen CEO, Braveheart Bio, Christopher Viehbacher, Forbion, Hypertrophic Cardiomyopathy, myosin inhibitor, OrbiMed, Series A financing

Braveheart Bio; Series A financing; hypertrophic cardiomyopathy; Christopher Viehbacher; Biogen CEO; cardiovascular drug development; BHB-1893; myosin inhibitor; Andreessen Horowitz; Forbion; OrbiMed

Candel Therapeutics Showcases Immunotherapy Leadership at SITC 2025, Highlighting Integration of Clinical Innovation, Multi-Omics, and AI for Solid Tumor Therapies

2 months ago talkbio0Tagged Artificial Intelligence, CAN-2409, Candel Therapeutics, enLIGHTEN Discovery Platform, Immunotherapy, Malignant neoplasm of prostate, Multiomics, Non-Small Cell Lung Carcinoma, Precision Medicine, SITC, Solid Neoplasm

Candel Therapeutics; SITC 2025; immunotherapy; CAN-2409; multi-omics; artificial intelligence; solid tumors; enLIGHTEN Discovery Platform; prostate cancer; non-small cell lung cancer; precision medicine

Syndeio Biosciences Appoints Aaron Koenig, M.D., as Chief Medical Officer (CMO)

2 months ago talkbio0Tagged Aaron Koenig, Alzheimer 's disease, Chief Medical Officer, Clinical Trials, CNS disorder, neuropsychiatric, neuroscience drug development, synaptic health, Syndeio Biosciences, zelquistinel

Syndeio Biosciences; Aaron Koenig; Chief Medical Officer; CNS disorders; synaptic health; neuroscience drug development; zelquistinel; Alzheimer’s disease; neuropsychiatric; clinical trials