ENTITY – Talk Bio

FDA Approves New Indication and Monthly Dosing for Regeneron’s Eylea HD

2 hours ago talkbio0Tagged aflibercept, Approved, dosing, Eylea, Hodgkin Disease, Macular retinal edema, monthly, Ophthalmology specialty, Pre-filled Syringe, Regeneron, Retinal Diseases, Retinal Vein Occlusion, United States Food and Drug Administration

FDA approval; Eylea HD; Regeneron; macular edema; retinal vein occlusion; monthly dosing; ophthalmology; aflibercept; retinal diseases; pre-filled syringe

AI Proteins Raises $41.5M Series A to Accelerate AI-Designed De Novo Miniprotein Therapeutics

6 hours ago talkbio0Tagged AI Proteins, Artificial Intelligence, BioCapital, Biotechnology, de novo miniproteins, Drug Discovery, Religious Missions, Santé Ventures, Series A financing, Synthetic Biology, therapeutic protein

AI Proteins; Series A financing; de novo miniproteins; protein therapeutics; artificial intelligence; drug discovery; Mission BioCapital; Santé Ventures; synthetic biology; biotechnology

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib in TKI Pre-treated Advanced ROS1-positive NSCLC

6 hours ago talkbio0Tagged acceptance, ARROS-1 trial, Breakthrough Therapy, Clinical Nurse Specialists, Identifier, New Drug Application, Non-Small Cell Lung Carcinoma, Nuvalent, orphan drug designation, PDUFA, Penetration, pre-treated, Protein-tyrosine kinase inhibitor, ROS1-positive, United States Food and Drug Administration, zidesamtinib

Nuvalent; zidesamtinib; FDA acceptance; New Drug Application (NDA); ROS1-positive NSCLC; tyrosine kinase inhibitor (TKI) pre-treated; ARROS-1 trial; PDUFA date; CNS penetration; breakthrough therapy designation; orphan drug designation

Novartis Raises Sales Targets for Key Cancer Drugs, Tweaks Yearly Growth Guidance

11 hours ago talkbio0Tagged cancer drugs, Drug Industry, Kisqali, leukemia, Malignant neoplasm of breast, Novartis, peak sales, Pluvicto, sales guidance, Scemblix

Novartis; Kisqali; Scemblix; Pluvicto; sales guidance; peak sales forecast; cancer drugs; breast cancer; leukemia; pharmaceutical industry

PBMs and FTC Battle in Court Over In-House Insulin Pricing Challenge Intensifies

11 hours ago talkbio0Tagged administrative proceedings, antitrust lawsuit, Caremark Rx, drug affordability, Express Scripts, Insulin, PBMs, Pricing, rebate schemes, United States Federal Trade Commission

PBMs; FTC; insulin pricing; rebate schemes; antitrust lawsuit; administrative proceedings; drug affordability; Caremark Rx; Express Scripts; OptumRx

Agios’ Sickle Cell Trial Falls Short as Mitapivat Fails to Significantly Reduce Pain Crises

11 hours ago talkbio0Tagged Agios, Anemia, Sickle Cell, Clinical Trials, hemoglobin response, mitapivat, pain crises, Pyrukynd, Rise Up trial

Agios; mitapivat; Pyrukynd; sickle cell disease; pain crises; clinical trial; Rise Up trial; hemoglobin response

Profluent Raises $106M to Accelerate Frontier AI Models for Programmable Biology, Backed by Jeff Bezos

11 hours ago talkbio0Tagged AI biotech, Altimeter Capital, Bezos Expeditions, Biological Factors, Clustered Regularly Interspaced Short Palindromic Repeats, Drug Development, Funding, Jeff, Profluent, Programmable Biology, Protein Atlas, protein design, Synthetic Biology

Profluent; AI biotech; protein design; programmable biology; Jeff Bezos; Altimeter Capital; $106M funding; Bezos Expeditions; CRISPR; biologics; Protein Atlas; synthetic biology; drug development

GSK and LTZ Therapeutics Announce $50M Partnership to Develop First-in-Class Myeloid Cell Engagers for Cancer

11 hours ago talkbio0Tagged Biotechnology, engagers, hematologic cancers, Immunotherapy, letrozole, Myeloid Progenitor Cells, Neoplasms, preclinical programs, SmithKline Beecham, Solid Neoplasm, strategic collaboration, upfront

GSK; LTZ Therapeutics; myeloid cell engagers; oncology; hematologic cancers; solid tumors; immunotherapy; strategic collaboration; biotechnology; $50 million upfront; preclinical programs

MediKarma Scales Its Clinical And Commercial Acumen With Appointment Of Dr. Scott Howell As Chief Clinical Officer And Angela Breton As Chief Revenue Officer

23 hours ago talkbio0Tagged AI-driven, Angela Breton, Chief Clinical Officer, Chief Revenue Officer, MediKarma, Patient data, Platform, proactive care, Scott Howell

MediKarma; Scott Howell; Angela Breton; Chief Clinical Officer; Chief Revenue Officer; AI-driven platform; patient data; proactive care

Japan Approves Anti-CD19 Monoclonal Antibody UPLIZNA for Suppression of Relapse in Immunoglobulin G4-Related Disease (IgG4-RD)

23 hours ago talkbio0Tagged Anti-CD19 Monoclonal Antibody, Approved, IgG4-RD, IgG4-Related Disease, Immunoglobulin IgG4, inebilizumab, Japan, Ministry of Health, MITIGATE trial, Mitsubishi Tanabe Pharma, Relapse, Uplizna, Visual Suppression, Welfare

UPLIZNA; Inebilizumab; Anti-CD19 monoclonal antibody; IgG4-related disease (IgG4-RD); Immunoglobulin G4; Japan approval; Relapse suppression; MITIGATE trial; Mitsubishi Tanabe Pharma; Ministry of Health, Labour and Welfare