Amino Acid, Peptide, or Protein

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

14 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

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

22 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

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

1 day 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

Roche Bags EU Nod for SC Formulation of Lunsumio, Re-Igniting Bispecific Battle with Tepkinly

2 days ago talkbio0Tagged Antibodies, Bispecific, Approved, Clinical Research, Conditional, EU, GO29781, Lunsumio, Lymphoma, Follicular, marketing authorisation, Relapsed/Refractory, Roche (company), subcutaneous, Tepkinly

Roche; Lunsumio; subcutaneous; EU approval; conditional marketing authorisation; follicular lymphoma; bispecific antibody; Tepkinly; CD20xCD3; relapsed/refractory; GO29781 study

Zymeworks Pivots to Royalty-Driven Model After Strong Ziihera Data in Gastric Cancer

2 days ago talkbio0Tagged Biological Factors, buyback, erbB-2 Receptor, Jazz, Malignant neoplasm of stomach, milestone payments, Regulatory Filing, Royalty-Driven Model, Strategy, Ziihera, Zymeworks

Zymeworks; royalty-driven model; Ziihera; gastric cancer; HER2; biologics; milestone payments; stock buyback; biotech strategy; Jazz Pharmaceuticals; regulatory filing

Jazz and Zymeworks Bispecific Antibody Zanidatamab Delivers Practice-Changing Results in Stomach Cancer Study

3 days ago talkbio0Tagged Antibodies, Bispecific, erbB-2 Receptor, gastroesophageal adenocarcinoma, Jazz, Malignant neoplasm of stomach, orphan drug designation, Overall Survival, Pharmacotherapy, Phase 2 trial, Phase 3, practice-changing, Progression-Free Survival, Zanidatamab, Zymeworks

Jazz Pharmaceuticals; Zymeworks; zanidatamab; bispecific antibody; HER2; gastroesophageal adenocarcinoma; stomach cancer; phase 2 trial; phase 3 HERIZON-GEA-01; overall survival; progression-free survival; chemotherapy; practice-changing; Orphan Drug designation

Merck Continues Cuts: 204 Employees Laid Off in New Jersey

3 days ago talkbio0Tagged Biopharma Industry, Cautionary Warning, cost-cutting, Dosage Forms, Gardasil, global workforce reduction, Keytruda, layoffs, Merck, New Jersey, Rahway, restructuring

Merck; layoffs; New Jersey; Rahway; pharmaceutical; cost-cutting; restructuring; WARN notice; global workforce reduction; Keytruda; Gardasil; biopharma industry

Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed

3 days ago talkbio0Tagged Anemia, Sickle Cell, Biosimilars, Commissioner 's National Priority Voucher, Drug Approval, drug price, eli lilly, erbB-2 Receptor, Malignant neoplasm of lung, Obesity, Priority Review, public health medicine (field), Tuberculosis, Drug-Resistant, United States Food and Drug Administration, voucher program

FDA; Commissioner’s National Priority Voucher; priority review; drug approval; voucher program; Eli Lilly; Novo Nordisk; her2 lung cancer; obesity drugs; drug-resistant tuberculosis; sickle cell disease; biosimilars; public health; drug pricing; regulatory controversy

Genmab Discontinues ProfoundBio-Derived ADC GEN1107 After Acquisition, Paralleling J&J’s Ambrx Buyout Area Developments

3 days ago talkbio0Tagged AbbVie, Acquisition, Ambrx, Antibody-Drug Conjugates, Drug Development, GEN1107, Genmab, J&J, Johnson and Johnson, Neoplasms, ProfoundBio, PTK7, PTK7 protein, human

Genmab; ProfoundBio; antibody-drug conjugate (ADC); GEN1107; PTK7; Ambrx; Johnson & Johnson (J&J); oncology; drug development; biotech acquisition; AbbVie lawsuit

Sandoz Launches Tyruko (Natalizumab-Sztn), First Tysabri Biosimilar, in US After JCV Assay Delays

3 days ago talkbio0Tagged Approved, Biological Assay, Biosimilars, JC Virus, JCV, Leukoencephalopathy, Progressive Multifocal, Multiple Sclerosis, Polpharma Biologics, Progressive, sandoz, Tyruko, Tysabri, United States Food and Drug Administration

Sandoz; Tyruko; Tysabri biosimilar; natalizumab-sztn; multiple sclerosis (MS); biosimilar launch; JCV assay; progressive multifocal leukoencephalopathy (PML); FDA approval; Polpharma Biologics