Regulation or Law

US Government Shutdown Threatens to Stress an Already Depleted FDA

4 weeks ago talkbio0Tagged delays, Drug Approval, federal funding, Government Shutdown, public health medicine (field), regulatory, Staff, Surgical aspects, United States Food and Drug Administration, user fees

Government shutdown; FDA operations; drug approval delays; FDA staff cuts; user fees; public health; federal funding; regulatory delays

Glenmark Pharma Signs $1.1 Billion Deal with Hengrui for HER2-Targeted Antibody-Drug Conjugate

1 month ago talkbio0Tagged Cancer Therapeutic Procedure, Glenmark, Hengrui Pharma, HER2-targeting antibody drug conjugate, License, milestone payments, Neoplasms, royalties, Trastuzumab Rezetecan

Glenmark; Hengrui Pharma; Trastuzumab Rezetecan; HER2-targeting antibody drug conjugate; oncology; exclusive license; $1.1 billion deal; cancer therapy; milestone payments; royalties

Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

1 month ago talkbio0Tagged Biogen, Candidiasis, Chronic Mucocutaneous, Complete, controls, High dose, Manufacturing, New Drug Application, nusinersen, regulatory, Response Letter, resubmission, Science of Chemistry, Spinal Muscular Atrophy, Spinraza, United States Food and Drug Administration

Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission

ICER Draft Report: High-Cost GLP-1 Obesity Drugs Deemed Cost-Effective—Affordability Still a Concern

2 months ago talkbio0Tagged Affordability, cardiovascular benefits, Cost-Effectiveness, CREM gene, Glucagon-Like Peptide 1, Health Policy, Obesity, semaglutide, tirzepatide, value-based pricing

ICER; GLP-1; semaglutide; tirzepatide; obesity drugs; cost-effectiveness; health policy; affordability; value-based pricing; cardiovascular benefits

Fosun Licenses Immunology Asset FXS6837 to Sitala in $670M Deal

2 months ago talkbio0Tagged Autoimmune Diseases, Fosun Pharma, FXS6837, Immunology, License, Sitala

Fosun Pharma; Sitala; FXS6837; immunology; license agreement; autoimmune diseases; biotech; pharmaceuticals; $670 million

After CDC shooting, employees and public health leaders urge RFK Jr. to change his rhetoric

3 months ago talkbio0Tagged campus, CDC, Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Leadership, Officer David Rose, public health leaders, RFK Jr. rhetoric, Security Measures, Shooting sensation quality, vaccine misinformation, workplace safety

CDC shooting; RFK Jr. rhetoric; vaccine misinformation; CDC employee reactions; public health leaders; security measures; Atlanta CDC campus; Officer David Rose; HHS leadership; workplace safety

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

3 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

Trump Gives Pharma CEOs 60-Day Ultimatum for ‘Most Favored Nation’ Drug Pricing

3 months ago talkbio0Tagged Drug Industry, Drug Prescriptions, drug price, executive order, Health Policy, Medicaid, nation policy, Transplant Registry Unified Management Program

Trump; pharmaceutical industry; drug pricing; most favored nation policy; executive order; prescription drugs; healthcare policy; Medicaid; tariffs

Novartis Bets on Covalent Chemistry in $1B Matchpoint Therapeutics Deal

3 months ago talkbio0Tagged Advanced phase, biotechnology partnerships, covalent chemistry, Covalent Interaction, Drug Development, Inflammatory disorder, License, Matchpoint Therapeutics, Novartis, oral inhibitors

Novartis; Matchpoint Therapeutics; covalent chemistry; exclusive option and license agreement; inflammatory diseases; oral inhibitors; Advanced Covalent Exploration platform; drug development; biotechnology partnerships

CDER Employees Leave FDA in Droves Amid HHS Overhaul

3 months ago talkbio0Tagged CDER, Employee, Health Policy, HHS Overhaul, Jr., layoffs, resignations, restructuring, Robert F. Kennedy, United States Food and Drug Administration

CDER; FDA; HHS overhaul; employee resignations; layoffs; health policy; restructuring; Robert F. Kennedy Jr.