Functional Concept – Page 3

Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay

3 weeks ago talkbio0Tagged Application procedure, dosing, Eylea HD, IL31RA gene, Interval, PDUFA, Regeneron, Retinal Diseases, Supplement, United States Food and Drug Administration

Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases

ImmuneOnco and Instil Bio’s PD-L1xVEGF Bispecific Antibody Shows Promising Results in Phase 2 Lung Cancer Trial

3 weeks ago talkbio0Tagged Bio, Combined, Frequency of Responses, IMM2510/AXN-2510, ImmuneOnco, Instill - dosing instruction imperative, Malignant neoplasm of lung, Non-Small Cell Lung Carcinoma, PD-L1xVEGF, Pharmacotherapy, safety profile

ImmuneOnco; Instil Bio; IMM2510/AXN-2510; PD-L1xVEGF bispecific antibody; NSCLC; Phase 2 clinical trial; response rate; safety profile; chemotherapy combination; lung cancer

Novo Nordisk Appoints New CEO and Reduces 2025 Sales Guidance

3 weeks ago talkbio0Tagged CEO, Changing, drug competition, growth outlook, guidance cut, Leadership, Maziar Mike Doustdar, Nordisk, Obesity, Sales - occupational activity, Transition Mutation

Novo Nordisk; CEO change; Maziar Mike Doustdar; 2025 sales guidance cut; growth outlook; leadership transition; obesity drug competition

Novo Nordisk Names Insider Maziar Mike Doustdar as New CEO Amid Growth Challenges

3 weeks ago talkbio0Tagged Appointments, CEO, Drug Industry, drug market, growth outlook, international operations, Leadership Change, Maziar Mike Doustdar, Nordisk, Obesity

Novo Nordisk; Maziar Mike Doustdar; CEO appointment; leadership change; pharmaceutical industry; growth outlook; obesity drug market; international operations

Merck & Co. Targets $3B in Cost Savings Through Restructuring, Including Job Cuts

3 weeks ago talkbio0Tagged cost-cutting, Financial savings, Investments, Manufacturing, Merck & Co., R&D, restructuring, restructuring charges, Target

Merck & Co.; cost-cutting; $3 billion savings; restructuring; job cuts; 2027 target; restructuring charges; R&D; manufacturing investments

Sarepta Therapeutics Faces FDA Crackdown after Third Patient Death; George Tidmarsh Named Top FDA Drug Regulator; Multiple Drugs Rejected; Pharma Invests Billions in US Manufacturing

1 month ago talkbio0Tagged drug rejection, ELEVIDYS, gene therapy, George Tidmarsh, Liver Failure, Acute, pharmaceutical manufacturing, reshoring, Study on Hold, United States Food and Drug Administration

Sarepta Therapeutics; FDA; gene therapy; Elevidys; acute liver failure; clinical hold; George Tidmarsh; drug rejection; reshoring; pharmaceutical manufacturing

Avalyn Pharma Raises $100M to Advance Inhaled Lung Disease Drugs

1 month ago talkbio0Tagged AP01, AP02, aspects of adverse effects, Avalyn, Clinical Trials, drug safety, Holdings, inhaled lung disease, nintedanib, Pharma, pirfenidone, Pulmonary Fibrosis, Series D, SNCG gene, Suvretta Capital Management

Avalyn Pharma; $100 million Series D; inhaled lung disease medications; pulmonary fibrosis; AP01; AP02; pirfenidone; nintedanib; clinical trials; drug safety; side effects; Suvretta Capital Management; SR One; Novo Holdings

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

1 month ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy

Sarepta Reports Third Patient Death in Gene Therapy Studies for Limb-Girdle Muscular Dystrophy

1 month ago talkbio0Tagged AAVS1 gene, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophies, Limb-Girdle, Patient Death, Safety, Study on Hold, United States Food and Drug Administration, vector

Sarepta Therapeutics; limb-girdle muscular dystrophy; SRP-9004; gene therapy; patient death; acute liver failure; FDA clinical hold; AAV vector; Elevidys; safety concerns

RFK Jr. Reshuffles Top HHS Leadership, Replacing Chief of Staff and Deputy Chief

1 month ago talkbio0Tagged Buckham, Changing, CHARGE Syndrome, chief of, federal, Hannah Anderson, Health Policy, Heather Flick Melanson, Leadership, RFK Jr., Shakeup, Staff, TMEM79 gene

RFK Jr.; HHS; leadership shakeup; chief of staff; Heather Flick Melanson; Hannah Anderson; Matt Buckham; staff changes; federal health policy