Pharmacologic Substance – Page 14

BridgeBio Shifts Filing Plans After Phase 3 Success in Rare Disease Drug BBP-418

2 months ago talkbio0Tagged Acoramidis, Approved, BBP-418, Biological Markers, BridgeBio, commercial, disease drug, File (record), Infrequent, Limb-girdle muscular dystrophy type 2A, NDA, New Drug Application, Phase 3 success, Ribitol, United States Food and Drug Administration

BridgeBio; BBP-418; Phase 3 success; limb-girdle muscular dystrophy type 2I/R9; FDA filing; rare disease drug; NDA (New Drug Application); ribitol; full approval; biomarker; acoramidis; commercial strategy

GSK Secures Exclusive Rights to Syndivia’s Preclinical Prostate Cancer ADC in $357 Million Deal

2 months ago talkbio0Tagged asset, GeminiMab technology, Licensing, Malignant neoplasm of prostate, Metastatic castration-resistant prostate cancer, milestone payments, Oncology Pipeline, Preclinical, SmithKline Beecham, Syndivia, therapeutic autologous dendritic cells

GSK; Syndivia; ADC; prostate cancer; metastatic castration-resistant prostate cancer; exclusive licensing; oncology pipeline; GeminiMab technology; milestone payments; preclinical asset

Unlocking Japan’s Potential in Rare Disease Drug Development: Recent Progress and Challenges (2025)

2 months ago talkbio0Tagged Clinical Trials, drug lag, Drugs, Orphan, innovation, Japan, pharmaceutical partnerships, Rare Diseases, regulatory approval

rare disease; Japan; orphan drug; drug lag; innovation; regulatory approval; pharmaceutical partnerships; clinical trials

Novartis CEO on $12B Avidity Deal: ‘Could Have Been Twice as Big’

2 months ago talkbio0Tagged Acquisition, Avidity Biosciences, financial outlook, growth strategy, Merger, Neuromuscular Diseases, Novartis, RNA, SpinCo ', Vas Narasimhan

Novartis; Avidity Biosciences; Vas Narasimhan; merger; acquisition; biotech; RNA therapeutics; $12 billion deal; neuromuscular diseases; SpinCo; financial outlook; growth strategy

FDA Approves Syndax’s First-in-Class Menin Inhibitor with Black-Box Warning; Updates on GSK’s ADC Deal

2 months ago talkbio0Tagged Acute leukemia, Antibody-Drug Conjugates, Approved, black-box warning, Chromosomal translocation, differentiation syndrome, KMT2A gene, Leukemia, Myelocytic, Acute, Menin Inhibitor, oncology drug approval, Revuforj, revumenib, SmithKline Beecham, Syndax, United States Food and Drug Administration

Syndax; Revuforj; revumenib; FDA approval; menin inhibitor; black-box warning; acute leukemia; KMT2A translocation; differentiation syndrome; acute myeloid leukemia (AML); GSK; antibody-drug conjugate (ADC); oncology drug approval

Novartis to Acquire RNA Drugmaker Avidity Biosciences in $12 Billion Deal

2 months ago talkbio0Tagged 2026, Acquisition, AOC, Avidity Biosciences, Closed, Muscular Dystrophy, Duchenne, Muscular Dystrophy, Facioscapulohumeral, MYOTONIC DYSTROPHY 1, Neuromuscular Diseases, Novartis, Platform, RNA therapeutics, SpinCo ', xRNA

Novartis; Avidity Biosciences; acquisition; RNA therapeutics; neuromuscular diseases; Duchenne muscular dystrophy; myotonic dystrophy type 1; facioscapulohumeral muscular dystrophy; AOC platform; SpinCo; biotech; xRNA strategy; 2026 closing

FDA Approves GSK’s Blenrep for Multiple Myeloma Treatment, Marking a Market Return

2 months ago talkbio0Tagged Approved, Blenrep, bortezomib, dexamethasone, Multiple Myeloma, SmithKline Beecham, United States Food and Drug Administration

Blenrep; GSK; FDA Approval; Multiple Myeloma; Bortezomib; Dexamethasone

FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront

2 months ago talkbio0Tagged Chugai, Complete Response Letter, methionine, Myopia, Ophthalmology specialty, Pediatric brand name, Renalys, SYD-101, Sydnexis, United States Food and Drug Administration

FDA; SYD-101; Sydnexis; myopia; pediatric; complete response letter; Chugai; Renalys; acquisition; $98M; ophthalmology

Inhibrx to Seek FDA Approval in 2026 After Strong Phase 2 Data for Bone Cancer Drug Ozekibart

2 months ago talkbio0Tagged Anti-DR5 Agonistic Monoclonal Antibody INBRX-109, Biological Factors, Chondrosarcoma, Infrequent, Inhibrx, Liver, Malignant Bone Neoplasm, Malignant Neoplasms, ozekibart, Progression-Free Survival, Receptors, Tumor Necrosis Factor, Member 10b, Submission, Toxicity aspects, United States Food and Drug Administration

Inhibrx; FDA submission; ozekibart; INBRX-109; chondrosarcoma; bone cancer; phase 2 clinical trial; progression-free survival; death receptor 5; biologics license application; rare cancer; liver toxicity

Moderna Halts Development of CMV Vaccine After Phase 3 Failure

2 months ago talkbio0Tagged Clinical trial failure, Congenital Cytomegalovirus Infection, Cytomegalovirus Infections, Effectiveness, Moderna, mRNA-1647 cytomegalovirus vaccine, Phase 3 trial, Vaccines

Moderna; CMV vaccine; mRNA-1647; Phase 3 trial; Congenital cytomegalovirus; Vaccine efficacy; Clinical trial failure