Pharmacologic Substance – Page 135

Sandoz Wins Historic FDA Approval for First Two Interchangeable Denosumab Biosimilars Targeting Amgen’s Blockbuster Bone Therapy

1 year ago talkbio0Tagged amgen, Approved, Biosimilars, Cancer-related skeletal events, denosumab, interchangeable, Jubbonti, Osteoporosis, patent litigation, Prolia, sandoz, Secondary malignant neoplasm of bone, United States Food and Drug Administration, Wyost, Xgeva

Sandoz, FDA approval, Denosumab biosimilars, Wyost, Jubbonti, Interchangeable, Prolia, Xgeva, Amgen, Osteoporosis, Bone metastases, Cancer-related skeletal events, Patent litigation

NICE Rejects Coverage for AstraZeneca and Daiichi Sankyo’s Breast Cancer Drug Enhertu Due to Cost-Effectiveness Concerns

1 year ago talkbio0Tagged AstraZeneca, Cost Effectiveness, Coverage rejection, Daiichi Sankyo, Enhertu, Health Services, National, Malignant neoplasm of breast, Nitroglycerin/Sodium Citrate/Ethanol Solution, Technology

NICE, Enhertu, AstraZeneca, Daiichi Sankyo, Breast cancer, Cost-effectiveness, Coverage rejection, Technology Appraisal, National Health Service (NHS)

Second Positive Phase 2 Trial Boosts Confidence in Alnylam’s RNAi Blood Pressure Med, Supporting Roche’s $2.8 Billion Biobucks Bet

1 year ago talkbio0Tagged Alnylam, blood pressure medication, Hypertension therapy, KARDIA-2, milestone payments, Partnership, RNA Interference, Roche (company), Systolic blood pressure reduction, Zilebesiran

Alnylam RNAi blood pressure medication, Zilebesiran, Phase 2 trial success, Systolic blood pressure reduction, Roche partnership, $2.8 billion milestone payments, Hypertension therapy, KARDIA-2 study

Novo Nordisk’s Ozempic Shows Promising Kidney Benefits for Diabetic Patients

1 year ago talkbio0Tagged Cardiovascular system, Chronic Kidney Diseases, Diabetes Mellitus, Non-Insulin-Dependent, Expanded use, FLOW trial, Ozempic, Novo Nordisk, Reduced risk, semaglutide

Ozempic, Novo Nordisk, Chronic kidney disease, Cardiovascular events, Expanded use, Semaglutide, FLOW trial, Reduced risk, Type 2 diabetes

Akero Reinforces Phase III FGF21 Analog Candidate with Enhanced Fibrosis Response Rates in MASH Data Update

1 year ago talkbio0Tagged Analog, Antibody-Drug, Efruxifermin, fibroblast growth factor 21, Fibrosis Response Rate, Improvements, metabolic dysfunction-associated steatohepatitis, Phase IIb HARMONY Study, Statistical Significance

Akero Therapeutics, FGF21 Analog, efruxifermin (EFX), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Phase IIb HARMONY Study, Fibrosis Response Rate, 96 Weeks, Statistically Significant Improvements

Bayer Acquires European Rights to BridgeBio’s Acoramidis for ATTR-CM Therapy

1 year ago talkbio0Tagged 2025, Acoramidis, Approved, ATTR-CM, Bayer, Blockbuster Potential, BridgeBio Pharma, Cardiovascular Infrastructure, Clarity, Clinical action, EMA Approval, European Rights, Exclusive License, Hope (emotion), investor, low-thirties, milestone payments, November 2024, PDUFA, Phase 3 Data, royalties, Split Strategy, Vyndaqel Rival

Bayer, BridgeBio Pharma, Acoramidis, ATTR-CM, Exclusive License, European Rights, Royalties, Milestone Payments, Phase 3 Data, Potential Approval, Low-Thirties Percent Royalties, EMA Approval 2025, PDUFA Action Date November 2024, Vyndaqel Rival, Blockbuster Potential, Cardiovascular Infrastructure, Investor Hopes for Clarity on Split Strategy.

“Regulating Hope Amidst Uncertainties: Novel ALS Treatments Face Complex Challenges”

1 year ago talkbio0Tagged Amyotrophic Lateral Sclerosis, Antisense Therapy, Approved, Clinical Trials, masitinib, Patient advocacy, regulatory uncertainty, Relyvrio, risk-benefit analysis, United States Food and Drug Administration

ALS Treatments, Regulatory Uncertainty, Clinical Trials, Relyvrio, Masitinib, Antisense Therapy, Risk-Benefit Analysis, FDA Approval, Patient Advocacy

J&J Scores First-Line Approval for Rybrevant Combination in Lung Cancer with EGFR Exon 20 Mutations

1 year ago talkbio0Tagged amivantamab-vmjw, Approved, carboplatin-pemetrexed chemotherapy, Disease Progression, EGFR Exon 20, first-line, Insertion Mutation, Johnson and Johnson, Mortality Risk, Non-Small Cell Lung Carcinoma, Objective Response Rate, ORR, Progression-Free Survival, Reduced, Rybrevant, United States Food and Drug Administration

Johnson & Johnson, Rybrevant (amivantamab-vmjw), FDA Approval, First-Line Treatment, Non-Small Cell Lung Cancer (NSCLC), EGFR Exon 20 Insertion Mutations, Carboplatin-Pemetrexed Chemotherapy, Phase 3 PAPILLON Study, Reduced Disease Progression or Mortality Risk, Improved Objective Response Rate (ORR) and Progression-Free Survival (PFS)