LAW – Talk Bio

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

3 weeks 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

2 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

4 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

4 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

4 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

5 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

Tempest Seeks Strategic Partners to Launch Phase 3 Liver Cancer Trial Amid Funding Challenges

5 months ago talkbio0Tagged altretamine/cisplatin/cyclophosphamide protocol, amezalpat, Avastin, biotech, Clearance, Clinical Oncology, Liver and Intrahepatic Biliary Tract Carcinoma, partnerships, Peroxisome Proliferator-Activated Receptors, Phase 3 trial, strategic, Tecentriq, United States Food and Drug Administration

Tempest Therapeutics , Amezalpat , Phase 3 Trial , Liver Cancer (HCC) , Strategic Partnerships , Biotech Funding , PPAR⍺ Antagonist , Clinical Oncology , FDA Clearance , Tecentriq and Avastin Combination Therapy

Annexon Advances Guillain-Barré Syndrome Awareness and Introduces Groundbreaking Targeted Therapy

5 months ago talkbio0Tagged Annexon, ANX005, Approved, GBS, Guillain-Barré syndrome, Move GBS Forward™, Phase 3, Phase 3 trial, Tanruprubart, Targeted Therapy, United States Food and Drug Administration

Guillain-Barré Syndrome (GBS) , Annexon , Tanruprubart (ANX005) , Targeted therapy , GBS education campaign , Move GBS Forward™ , Phase 3 trial results , FDA approval

Rallybio Halts Development of Lead FNAIT Program Following Phase 2 Failure

5 months ago talkbio0Tagged Alloimmune thrombocytopenia, Biotech pipeline shift, Fetal and neonatal alloimmune thrombocytopenia, Fetus, immune disorder therapy, Infant, Newborn, Mother (person), Phase 2 clinical trial, Rallybio RLYB212

Rallybio RLYB212, Fetal and neonatal alloimmune thrombocytopenia (FNAIT), Phase 2 clinical trial, Maternal immune disorder therapy, Biotech pipeline shift

Wave Life Sciences’ WVE-N531 Shows Promise in Duchenne Muscular Dystrophy Treatment

5 months ago talkbio0Tagged Approved, Dystrophin, Gene Expression, Health Improvement, Muscle Tissue, Muscular Dystrophy, Duchenne, Phase 2 Clinical Trials, skipping, United States Food and Drug Administration, WVE-N531

Duchenne muscular dystrophy (DMD), WVE-N531, exon 53 skipping, Phase II trial, dystrophin expression, muscle health improvement, FDA approval