LAW – Talk Bio

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

2 days 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

3 days 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 weeks 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

BioNTech and DualityBio Achieve Phase 3 Success with ADC Therapy for HER2-Positive Breast Cancer, Advancing Oncology Pipeline

1 month ago talkbio0Tagged Antibody-Drug Conjugates, BioNTech, DualityBio, HER2-positive carcinoma of breast, Market, Oncology Pipeline, pamirtecan, Phase 3 trial, Progression-Free Survival, trastuzumab

BioNTech; DualityBio; antibody-drug conjugate (ADC); HER2-positive breast cancer; trastuzumab pamirtecan; BNT323/DB-1303; phase 3 trial; progression-free survival; oncology pipeline; ADC market

Two Courts Reject Challenges to Inflation Reduction Act, Marking Major Win for Government

2 months ago talkbio0Tagged administrative law, AstraZeneca, constitutional challenge, Drug Negotiation Program, federal courts, Inflation, Ira (eukaryote), Medicare, Myasthenic Syndromes, Congenital, Third Circuit Court

Inflation Reduction Act; IRA; Medicare Drug Negotiation Program; AstraZeneca; federal courts; constitutional challenge; administrative law; Third Circuit Court; CMS; Medicare

Senate Drops Orphan Cures Act from Trump’s Tax Bill, Dealing Setback to Biopharma

4 months ago talkbio0Tagged Beak, Big Beautiful Bill, Biopharma, Drugs, Orphan, healthcare legislation, Infrequent, Ira (eukaryote), Mediation, Orphan Cures Act, Prices, reconciliation, Senate, Transplant Registry Unified Management Program

Orphan Cures Act; orphan drugs; Trump tax bill; biopharma; Senate; IRA price negotiations; rare diseases; Big Beautiful Bill; healthcare legislation; reconciliation bill

Pfizer’s Sasanlimab Shows 32% Reduction in Bladder Cancer Risk But Misses Secondary Endpoints in Phase 3 CREST Trial

6 months ago talkbio0Tagged BCG Vaccine, Event-Free Survival, Inhibitor, Invasive, Malignant neoplasm of urinary bladder, Non-Muscle, Non-Muscle Invasive Bladder Neoplasms, Overall Survival, PDCD1 gene, Phase 3 CREST trial, Sasanlimab, subcutaneous administration

Sasanlimab (PD-1 inhibitor), Bladder cancer risk reduction, Phase 3 CREST trial, BCG combination therapy, Non-muscle invasive bladder cancer (NMIBC), Event-free survival (EFS), Overall survival (OS) endpoint missed, Subcutaneous administration

New NIH grant rules override the Civil Rights Act of 1964, barring recipients from DEI activities

6 months ago talkbio0Tagged 1964, Changing, civil, Civil Rights Act, Condition, Diversity, federal, Israeli (population group), NIH, Policy, Protections, recipients, United States National Institutes of Health

United States National Institutes of Health, recipients, NIH, Policy, Diversity, Changing, Condition, civil, federal, civil, protections, recipients, Israeli (population group), Civil Rights Act, 1964

Amgen Secures Phase 3 Survival Data for Imdelltra in Small-Cell Lung Cancer, Strengthening Its Case for Full FDA Approval

6 months ago talkbio0Tagged amgen, Biological Factors, DLL3-targeting therapy, Imdelltra, Immunotherapy, Overall Survival, Phase 3 trial, SCLC, small-cell lung cancer

Imdelltra, Amgen, Small-cell lung cancer (SCLC), Phase 3 trial, Overall survival, DLL3-targeting therapy, Immunotherapy, Biopharmaceuticals

Alzheon Investigates Subgroup Data Following Phase 3 Trial of ALZ-801 in Alzheimer’s Disease

6 months ago talkbio0Tagged ALZ-801, Alzheimer 's disease, Amyloid-targeting therapy, Apolipoprotein E4, Genotype, Mental deterioration, Mild cognitive disorder, Phase 3 trial, Precision Medicine, Subgroup A Nepoviruses, Valiltramiprosate

Alzheimer’s disease , ALZ-801 , Valiltramiprosate , APOE4 genotype , Mild cognitive impairment (MCI) , Amyloid-targeting therapy , Phase 3 trial results , Cognitive decline , Subgroup analysis , Precision medicine