Biologically Active Substance – Page 9

Septerna Halts Phase 1 Trial of SEP-786 Due to Unexpected Bilirubin Elevations

4 months ago talkbio0Tagged Agonist, Bilirubin, Clinical Trials, Discontinuation (procedure), Hypoparathyroidism, PTH1R gene, SEP-786, Septerna

Septerna, SEP-786, clinical trial discontinuation, hypoparathyroidism, bilirubin elevation, PTH1R agonist, biotech setback

Bristol Myers Squibb’s Opdualag Fails Phase 3 Trial in Adjuvant Melanoma Treatment

4 months ago talkbio0Tagged Clinical Trials, Failure (biologic function), Immunologic Adjuvants, Immunotherapy, Inhibitor, lymphocyte-activation gene 3 protein, human, melanoma, Myers, Opdualag, squibb

Opdualag, Bristol Myers Squibb, melanoma, clinical trial failure, LAG-3 inhibitor, immunotherapy, adjuvant treatment

Pfizer’s Talzenna-Xtandi Combo Shows Significant Survival Benefit in Advanced Prostate Cancer

4 months ago talkbio0Tagged Clinical Trials, Gene Mutation, Inhibitor, Metastatic castration-resistant prostate cancer, Overall Survival, PARP1 gene, recombinational repair, TALAPRO-2, Talzenna, Xtandi

Talzenna, Xtandi, metastatic castration-resistant prostate cancer (mCRPC), overall survival, TALAPRO-2 trial, PARP inhibitor, homologous recombination repair (HRR) gene mutations

Semaglutide Shows Promise in Reducing Alcohol Consumption, Small Study Reveals

4 months ago talkbio0Tagged addiction, Alcohol Use Disorder, Craving for alcohol, Glucagon-Like Peptide 1, semaglutide, Wegovy, Weight Loss Medication

semaglutide, Ozempic, Wegovy, alcohol use disorder, GLP-1 drugs, alcohol cravings, weight loss medication, addiction treatment

Axplora Invests €50M in GLP-1 Manufacturing Expansion at Mourenx, France

4 months ago talkbio0Tagged alpha 1-antitrypsin, Axplora, biology (field), CDMO, Chromatography, Diabetes, expansion, France, Glucagon-Like Peptide 1, Manufacturing, Mourenx, Obesity, production

Axplora, GLP-1, manufacturing expansion, Mourenx, France, CDMO, API production, chromatography, diabetes, obesity, biologic therapies

SpringWorks Therapeutics Secures FDA Approval for Gomekli to Treat NF1-Related Tumors

4 months ago talkbio0Tagged Approved, disease treatment, Gomekli, Infrequent, Inhibitor, MEK, mirdametinib, Neurofibromatosis 1, Plexiform, Plexiform Neurofibroma, SpringWorks, United States Food and Drug Administration

SpringWorks Therapeutics, Gomekli, mirdametinib, FDA approval, neurofibromatosis type 1 (NF1), plexiform neurofibromas (PN), rare disease treatment, MEK inhibitor

AnaptysBio’s Rosnilimab Shows Promising Results in Phase 2b Rheumatoid Arthritis Trial

4 months ago talkbio0Tagged Agonist, AnaptysBio, Autoimmune Diseases, Immunoregulation, PDCD1 gene, Rheumatoid Arthritis, Rosnilimab

Rosnilimab, PD-1 agonist, rheumatoid arthritis, Phase 2b trial, immune modulation, AnaptysBio, autoimmune disease

FDA Approves SpringWorks’ Gomekli for Adult and Pediatric NF1-PN Patients

4 months ago talkbio0Tagged Approved, Gomekli, Inhibitor, MEK, mirdametinib, neurofibroma, Plexiform, SpringWorks, United States Food and Drug Administration

Gomekli, mirdametinib, neurofibromatosis type 1, plexiform neurofibromas, FDA approval, SpringWorks Therapeutics, MEK inhibitor

FDA Issues Import Alerts for Two Chinese API Manufacturers Following Failed Inspections

4 months ago talkbio0Tagged alpha 1-antitrypsin, Chengdu, Chinese Language, Dosage Forms, Failed, import alert, innovation, Inspection (procedure), manufacturers, Quality, Science of Chemistry, United States Food and Drug Administration, Wuhu

FDA, import alert, Chinese API manufacturers, failed inspections, quality control, Wuhu Nuowei Chemistry, Chengdu Innovation Pharmaceutical

Novartis Acquires Anthos Therapeutics for $925M, Regaining Control of Promising Anticoagulant Abelacimab

4 months ago talkbio0Tagged abelacimab, Acquisition, Anthos, Anticoagulants, Atrial Fibrillation, cardiovascular pipeline, Cerebrovascular accident, Factor XI antibody, Novartis

Novartis, Anthos Therapeutics, acquisition, abelacimab, anticoagulant, Factor XI inhibitor, atrial fibrillation, stroke prevention, cardiovascular pipeline