Regulation or Law

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

17 hours 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

1 week 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.

RFK Jr. Reshuffles Top HHS Leadership, Replacing Chief of Staff and Deputy Chief

1 week ago talkbio0Tagged Buckham, Changing, CHARGE Syndrome, chief of, federal, Hannah Anderson, Health Policy, Heather Flick Melanson, Leadership, RFK Jr., Shakeup, Staff, TMEM79 gene

RFK Jr.; HHS; leadership shakeup; chief of staff; Heather Flick Melanson; Hannah Anderson; Matt Buckham; staff changes; federal health policy

RFK Jr. Fires Top HHS Leadership in Major Department Shakeup

1 week ago talkbio0Tagged Buckham, CHARGE Syndrome, Hannah Anderson, Health Policy, Heather Flick Melanson, Leadership, RFK Jr., Shakeup, Staff, TMEM79 gene, White House liaison

RFK Jr.; HHS; leadership shakeup; chief of staff replaced; Heather Flick Melanson; Hannah Anderson; Matt Buckham; health policy; White House liaison

RFK Jr. Cancels USPSTF Meeting Amid Healthcare Groups’ Integrity Concerns

2 weeks ago talkbio0Tagged CHARGE Syndrome, Congress (U.S. Legislature), expert, Health Policy, meeting cancellation, Preventive Care, RFK Jr., USPSTF

RFK Jr.; USPSTF; meeting cancellation; preventive care; health policy; HHS; Congress; expert panel integrity

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

1 month ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

FDA Acting CDER Head Jacqueline Corrigan-Curay to Retire Amid Leadership Turnover

1 month ago talkbio0Tagged agency departures, CDER, Drug Regulations, Jacqueline Corrigan-Curay, Leadership, Personnel Turnover, Retirement, United States Food and Drug Administration

FDA; Jacqueline Corrigan-Curay; CDER; retirement; leadership turnover; drug regulation; agency departures

Trump Administration Considers Limits on Direct-to-Consumer Drug Advertising

1 month ago talkbio0Tagged Ditiocarb, drug price, executive order, Health Policy, Pharma, pharmaceutical regulation, Transplant Registry Unified Management Program

Trump administration; DTC drug advertising; pharmaceutical regulation; drug pricing; executive order; health policy; pharma marketing

New Rules and Regulatory Trends in Biopharma Manufacturing in 2025

1 month ago talkbio0Tagged Biopharma, country-of-origin labeling, digital quality systems, forced labor compliance, green manufacturing, import rules, Manufacturing, regulatory, Serialization, Trump administration tariffs, United States Food and Drug Administration

biopharma manufacturing; 2025 regulations; FDA; digital quality systems; green manufacturing; import rules; Trump administration tariffs; country-of-origin labeling; forced labor compliance; serialization

Trump Taps Dr. Oz as Lead Negotiator for ‘Most Favored Nation’ Drug Pricing Policy

2 months ago talkbio0Tagged Dr., Drug Costs, drug price, Health Policy, Myasthenic Syndromes, Congenital, Nation, ounce, pharmaceutical negotiations, Transplant Registry Unified Management Program

Trump; Dr. Mehmet Oz; Most Favored Nation; drug pricing; CMS; pharmaceutical negotiations; healthcare policy; drug costs