LAW – Talk Bio

CMS Unveils Negotiated Prices for Ozempic, Wegovy, and Other Drugs in Second Round of IRA Talks

17 hours ago talkbio0Tagged drug price, Effectiveness, Inflation Reduction Act, Medicare Part D, Myasthenic Syndromes, Congenital, negotiation, Ozempic, Prices, semaglutide, Wegovy

CMS; Ozempic; Wegovy; Inflation Reduction Act; drug price negotiation; Medicare Part D; semaglutide; negotiated prices; 2027 effective date

Pharma Faces Supreme Court Deadline as IRA Price Negotiation Takes Effect

1 day ago talkbio0Tagged AstraZeneca, Centers for Medicare & Medicaid Services, drug price, Farxiga, Inflation, Medicare, negotiation, petition, pharmaceutical lawsuits, price controls, SCOTUS, Supreme Court

Inflation Reduction Act; SCOTUS; drug price negotiation; AstraZeneca; Medicare; pharmaceutical lawsuits; Fifth Amendment; supreme court petition; Farxiga; Centers for Medicare & Medicaid Services; price controls

ASH 2025: Breakthroughs in In Vivo CAR-T Data from Kelonia; Phase 3 Wins for Lilly, J&J, and Novartis

2 days ago talkbio0Tagged 2025, Asymmetric Septal Hypertrophy, CAR-T, CAR-T therapy, Eli Lilly, in vivo, Kelonia Therapeutics, Multiple Myeloma, Novartis, Phase 3 trials

ASH 2025; in vivo CAR-T; Kelonia Therapeutics; KLN-1010; multiple myeloma; Johnson & Johnson; Lilly; Novartis; CAR-T therapy; Phase 3 trials

Bayer Stock Rallies as Next-Gen Blood Thinner Achieves Phase 3 Success

2 days ago talkbio0Tagged Bayer, blood thinner, earnings, Phase 3 trial, rally

Bayer; stock rally; blood thinner; Phase 3 trial; pharmaceuticals; earnings

US-Backed Group Reports Success with New Tuberculosis Treatment in Phase 2 Study

1 week ago talkbio0Tagged Clinical Trials, drug-resistant TB, linezolid, Phase 2 clinical trial, pretomanid, sorfequiline, SPaL, TB Alliance, Treatment Protocols, Tuberculosis, U.S., ultra-short regimen

tuberculosis; TB Alliance; Phase 2 clinical trial; sorfequiline; SPaL regimen; pretomanid; linezolid; drug-resistant TB; ultra-short regimen; US support; clinical trial results

Roche’s Oral SERD Giredestrant Delays Early Breast Cancer Recurrence in Late-Stage Trial

1 week ago talkbio0Tagged Adjuvant Therapy, Disease-Free Survival, ER-positive, giredestrant, HER2-negative, Malignant neoplasm of breast, Oral SERD, Phase 3 trial, recurrence prevention, Roche (company)

Roche; oral SERD; giredestrant; Phase 3 trial; early breast cancer; ER-positive; HER2-negative; disease-free survival; adjuvant therapy; recurrence prevention

Navigating JPM 2026: Biotech/Biopharma Trends, Policy Impacts, and Forward Outlook

1 week ago talkbio0Tagged Biopharma, dealmaking, Drug Discovery, financing strategy, Health Policy, innovation, JPM, trends qualifier

JPM 2026; biotech trends; biopharma trends; healthcare policy; AI in drug discovery; financing strategy; dealmaking; innovation

Diamyd Medical’s Pivotal Phase 3 Type 1 Diabetes Trial Clears Final Safety Review Ahead of Early Readout in March 2026

2 weeks ago talkbio0Tagged Accelerated, approval pathway, Data Safety, Diabetes Mellitus, Insulin-Dependent, DIAGNODE-3, Diamyd Medical, DSMB, fast-track designation, Genotype, HLA DR3-DQ2, interim readout, Monitoring Board, orphan drug designation, Phase 3 trial, precision therapy, safety review

Diamyd Medical; Type 1 Diabetes; Phase 3 trial; DIAGNODE-3; safety review; Data Safety Monitoring Board (DSMB); interim readout; March 2026; HLA DR3-DQ2 genotype; Orphan Drug Designation; Fast Track Designation; accelerated approval pathway; precision therapy

Neurocrine’s Phase 2 Depression Drug Fails Primary Endpoint in Major Takeda-Licensed Study

2 weeks ago talkbio0Tagged Biosciences, Clinical Trials, depression drug, Depressive disorder, Drug licensing, NBI-1070770, Neurocrine, pharmaceutical setbacks, Phase 2 Failure, psychiatry pipeline, Takeda

Neurocrine Biosciences; Takeda; NBI-1070770; Phase 2 failure; major depressive disorder; depression drug; psychiatry pipeline; clinical trial results; drug licensing; pharmaceutical setbacks

AnaptysBio Halts Phase 2 Ulcerative Colitis Trial; Lyell Immunopharma Secures CAR-T Rights

2 weeks ago talkbio0Tagged AnaptysBio, CAR-T therapy, Clinical Failure, Clinical Trials, Discontinuation (procedure), Lyell Immunopharma, News [Publication Type], Phase 2 trial, Rheumatoid Arthritis, Rosnilimab, Ulcerative Colitis

AnaptysBio; rosnilimab; ulcerative colitis; Phase 2 trial; clinical failure; trial discontinuation; Lyell Immunopharma; CAR-T therapy; licensing deal; biotech news; rheumatoid arthritis