LAW – Page 2 – Talk Bio

Ionis Claims Curative Potential for Tryngolza in Severe Triglyceride Disease

2 weeks ago talkbio0Tagged Antisense Oligonucleotides, curative potential, Hypertriglyceridemia, Ionis, Pancreatitis, Acute, Phase 3 Clinical Trials, RNA-targeted therapy, Severe (severity modifier), Submission, Triglycerides, TRYNGOLZA, United States Food and Drug Administration

Ionis; Tryngolza; severe hypertriglyceridemia; curative potential; triglyceride reduction; acute pancreatitis; antisense oligonucleotide; FDA submission; Phase III trial; RNA-targeted therapy

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

4 weeks 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

Moderna Halts Development of CMV Vaccine After Phase 3 Failure

1 month 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

Drugmakers Push US Expansion After Trump’s 100% Pharma Tariff Threat

1 month ago talkbio0Tagged branded drugs, drugmakers, genentech, Manufacturing, Roche (company), Section 232, supply chain, Trump tariff, U.S.

Trump tariff; pharmaceuticals; US manufacturing; branded drugs; drugmakers; Genentech; Roche; Novo Nordisk; Section 232; supply chain

GSK, Spero Reveal Full Phase 3 Data for Oral Antibiotic Tebipenem HBr; Regulatory Filing Set for End of 2025

1 month ago talkbio0Tagged Complicated, cUTIs, HBr, IDWeek, non-inferiority, oral carbapenem, Phase 3 PIVOT-PO trial, Regulatory Filing, SmithKline Beecham, Spero Therapeutics, Submission, United States Food and Drug Administration, Urinary tract infection

GSK; Spero Therapeutics; tebipenem HBr; oral carbapenem; Phase 3 PIVOT-PO trial; complicated urinary tract infections (cUTIs); non-inferiority; IDWeek 2025; regulatory filing; FDA submission

EMD Serono Joins TrumpRx in Affordability Push; Roche Launches DTC Program

1 month ago talkbio0Tagged Affordability, CNPV, direct-to-consumer sales, Ditiocarb, Electromechanical dissociation, Fertility Agents, Fertilization in Vitro, Pergoveris, Programs - Publication Format, Roche (company), serono, tariffs, TrumpRx, White House Executive Order

EMD Serono; TrumpRx; IVF therapies; affordability; fertility drugs; Direct-to-Consumer sales; Roche; DTC program; White House Executive Order; Section 232 tariffs; CNPV program; Pergoveris

Satellos Advances Duchenne Pill Trial in Children; Idorsia Raises $81 Million

1 month ago talkbio0Tagged Child, Fund Raising, Idorsia, Indonesian language, Muscular Dystrophy, Duchenne, oral small-molecule therapy, Phase 2 clinical trial, SAT-3247, Satellos, Submission, United States Food and Drug Administration

Satellos; Duchenne muscular dystrophy; SAT-3247; Phase 2 clinical trial; children; FDA IND submission; oral small-molecule therapy; Idorsia; fundraising; biotech

Evommune Files for IPO to Fund Phase 2 Trials of Autoimmune Drug Candidates

2 months ago talkbio0Tagged autoimmune drugs, Chronic inflammatory disorder, EVO301, EVO756, Evommune, Funding, IPO, New York Stock Exchange, Phase 2 Trials, Series C financing

Evommune; IPO; Phase 2 trials; autoimmune drugs; EVO756; EVO301; chronic inflammatory diseases; biotech funding; New York Stock Exchange; Series C financing

Sanofi Challenges Novartis’ Dominance with Clinically Meaningful Pancreatic Tumor Data from AlphaMedix Phase II Trial

2 months ago talkbio0Tagged AlphaMedix, gastroenteropancreatic neuroendocrine tumors, GEP-NETs, Novartis, Orano, Overall Survival, Phase 2 Clinical Trials, Progression-Free Survival, radioligand therapy, Radiopharma, safety profile, sanofi

Sanofi; Novartis; radiopharma; AlphaMedix; Orano Med; gastroenteropancreatic neuroendocrine tumors; GEP-NETs; radioligand therapy; Phase II clinical trial; progression-free survival; overall survival; safety profile

AstraZeneca Appeals to Supreme Court in Final Attempt to Challenge Medicare Drug Price Negotiation Program

2 months ago talkbio0Tagged AstraZeneca, drug price, Farxiga, Inflation Reduction Act, Medicare, Myasthenic Syndromes, Congenital, Negotiation Program, Supreme Court

AstraZeneca; Medicare Drug Price Negotiation Program; Supreme Court; Inflation Reduction Act; Third Circuit; due process; pharmaceuticals; CMS; drug pricing; Farxiga