talkbio – Page 8

US Government Shutdown Threatens to Stress an Already Depleted FDA

2 weeks ago talkbio0Tagged delays, Drug Approval, federal funding, Government Shutdown, public health medicine (field), regulatory, Staff, Surgical aspects, United States Food and Drug Administration, user fees

Government shutdown; FDA operations; drug approval delays; FDA staff cuts; user fees; public health; federal funding; regulatory delays

Novartis Receives FDA Approval for Rhapsido: First Oral BTK Inhibitor for Chronic Hives

2 weeks ago talkbio0Tagged Approved, Bruton 's tyrosine kinase inhibitor, BTKi, chronic hives, Chronic Spontaneous Urticaria, competition, Immunology, Novartis, Oral Therapy, remibrutinib, Rhapsido, United States Food and Drug Administration

Novartis; Rhapsido; FDA approval; Bruton’s tyrosine kinase inhibitor (BTKi); remibrutinib; chronic spontaneous urticaria (CSU); chronic hives; immunology; oral therapy; competition

AnaptysBio Announces Strategic Business Split to Create Two Public Companies, Sharpening Asset Focus

2 weeks ago talkbio0Tagged AnaptysBio, asset, biopharmaceutical development, business split, Immunology, Imsidolimab, Jemperli, public companies, restructuring, royalty management

AnaptysBio; business split; royalty management; biopharmaceutical development; Jemperli; imsidolimab; public companies; immunology treatments; asset value; restructuring

Star Therapeutics Raises $125M as Bleeding Disorder Therapy Enters Phase III

2 weeks ago talkbio0Tagged Antibody Therapy, Blood Coagulation Disorders, Infrequent, Phase 3 Clinical Trials, Series D financing, Star Therapeutics, VGA039

Star Therapeutics; Series D financing; bleeding disorders; VGA039; Phase III clinical trial; biotech funding; rare diseases; antibody therapy

Novo Nordisk Terminates $598M Heart Failure Cell Therapy Collaboration with Heartseed Amid Major Restructuring

2 weeks ago talkbio0Tagged Biotechnology, Cardiospermum grandiflorum, Cell Therapy, Collaboration termination, Diabetes, Heart failure, HS-001, Maziar Mike Doustdar, Nordisk, Obesity, strategic restructuring

Novo Nordisk; Heartseed; heart failure; cell therapy; HS-001; collaboration termination; strategic restructuring; Maziar Mike Doustdar; diabetes; obesity; biotechnology

Metsera’s New Obesity Data Raises Efficacy Profile, Key Side Effect Questions for Pfizer After Acquisition

2 weeks ago talkbio0Tagged aspects of adverse effects, Effectiveness, Glucagon-Like Peptide 1, MET-097i, Metsera, Obesity, Pfizer, Pfizer acquisition, Phase 2 trial, Weight Loss

Metsera; Pfizer; obesity drug; MET-097i; GLP-1; side effects; efficacy; Phase 2 trial; weight loss; Pfizer acquisition

Merck Makes Strong Case for Winrevair in Earlier-Stage Pulmonary Arterial Hypertension (PAH) Patients After Positive Phase 3 HYPERION Results

2 weeks ago talkbio0Tagged activin signaling, AKAP9 protein, human, Approved, Clinical Research, clinical worsening, early disease, Merck, PAH, Phase 3 trial, Sotatercept, United States Food and Drug Administration, Winrevair

Winrevair; Merck; HYPERION study; PAH; sotatercept; clinical worsening; early disease; activin signaling; FDA approval; Phase 3 trial

Crystalys Lands $205M to Advance Gout Drug Dotinurad

2 weeks ago talkbio0Tagged Crystalys Therapeutics, dotinurad, expansion, Generalized, Gout Suppressants

Crystalys Therapeutics; Gout Drug; Dotinurad; Global Expansion

Barinthus Biotherapeutics Announces Reverse Merger with Clywedog Therapeutics to Form New Metabolic Disease-Focused Company

2 weeks ago talkbio0Tagged Autoimmune Diseases, Barinthus, biotherapeutics, Board Composition, Clywedog Therapeutics, Delaware merger, lock-up, Menstruation, Metabolic Diseases, reverse merger, Scheme of Arrangement, Shareholder Ownership Structure, Topco, UK

Barinthus Biotherapeutics; Reverse Merger; Clywedog Therapeutics; Metabolic Diseases; Autoimmune Diseases; Topco; Shareholder Ownership Structure; UK Scheme of Arrangement; Delaware Merger; Self-Tender Offer; Lock-Up Period; Board Composition

AstraZeneca Plans Direct US Stock Listing While Maintaining UK Headquarters

2 weeks ago talkbio0Tagged American Depositary Receipts, AstraZeneca, Capital Markets, Drug Industry, headquarters, London, Nasdaq Stockholm, NYSE, shareholders, Stock exchange, U.S., UK

AstraZeneca; US stock listing; NYSE; London Stock Exchange; Nasdaq Stockholm; American Depositary Receipts; capital markets; pharmaceutical industry; shareholders; UK headquarters