May 30, 2024 – Talk Bio

Regulatory Tracker: Lilly’s Retevmo Secures Pediatric Cancer FDA Nod ###

11 months ago talkbio0Tagged Accelerated, Approved, Eli, Eli Lilly, LIBRETTO-121 trial, Malignant Childhood Neoplasm, Malignant neoplasm of thyroid, RET-altered, Retevmo, selpercatinib, Solid Neoplasm, United States Food and Drug Administration

Retevmo, Eli Lilly, FDA approval, pediatric cancer, RET-altered, thyroid cancer, solid tumors, accelerated approval, LIBRETTO-121 trial, selpercatinib

BioNTech Secures $145M from CEPI to Expand mRNA Vaccine Production in Africa

11 months ago talkbio0Tagged Africa, BioNTech, CEPI, equity, mRNA Vaccine, public health medicine (field), Vaccines

BioNTech, CEPI, mRNA vaccine production, Africa, vaccine equity, public health security

Immunovant Shifts Focus to Next-Generation FcRn Inhibitor IMVT-1402, Delaying Batoclimab Development ###

11 months ago talkbio0Tagged Autoimmune Diseases, Batoclimab, Biological Factors, FCGRT gene, FcRn, Immunovant, IMVT-1402, Inhibitor, Roivant

Immunovant, IMVT-1402, FcRn inhibitor, Batoclimab, Autoimmune diseases, Vyvgart, Roivant, Biopharmaceuticals

Senior Manager Commercial Analytics Respiratory: Key Requirements and Responsibilities

11 months ago talkbio0Tagged biopharmaceutical industry, commercial, respiratory division, Sales - occupational activity, Senior - Suffix, Strategic Planning, tools

Senior Manager Commercial Analytics Respiratory, biopharmaceutical industry, commercial analytics, therapeutic areas, respiratory division, strategic planning, sales tools.

Biohaven’s Phase I Data for Lead Protein Degrader Falls Short of Investor Expectations ###

11 months ago talkbio0Tagged Autoimmune Diseases, Expectations, immunoglobulin G, investor, Myasthenia Gravis, Phase I Clinical Trials, protein degrader, Rheumatoid Arthritis

Biohaven, BHV-1300, Protein degrader, IgG reduction, Phase I study, Investor expectations, Autoimmune disorders, Rheumatoid arthritis, Myasthenia gravis

Biotech Roundup: Compugen, Nxera Milestone Payments; Insmed Seeks $650M Offering

11 months ago talkbio0Tagged AstraZeneca, Bio, BMS, Breyanzi, Burning Mouth Syndrome, Celcuity, Compugen, K-ras Oncogene, luteolin-7-O-diglucuronide 4'-O-glucuronosyltransferase activity, milestone payments, Nordisk, Novartis, Nxera, United States Food and Drug Administration

Compugen, Nxera, milestone payments, Insmed, $650M offering, biotech, pharmaceuticals, Celcuity, Weave Bio, AstraZeneca, Novo Nordisk Foundation, FDA, LDT rule, BMS, Breyanzi, KRAS drug, Novartis

FDA Approves Amgen’s Bkemv, First Interchangeable Biosimilar to Soliris for Rare Blood Disorders ###

11 months ago talkbio0Tagged Alexion, amgen, Approved, AstraZeneca, Atypical, Atypical Hemolytic Uremic Syndrome, Biosimilars, Bkemv, Hemolytic-Uremic Syndrome, Infrequent, interchangeable, Paroxysmal, Paroxysmal nocturnal hemoglobinuria, PNH, Soliris, United States Food and Drug Administration

Bkemv, Soliris, FDA approval, Interchangeable biosimilar, Rare blood disorders, Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS), Amgen, AstraZeneca, Alexion Pharmaceuticals