ORG – Page 30 – Talk Bio

CDER Employees Leave FDA in Droves Amid HHS Overhaul

2 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.

RFK Jr. Removes Top HHS Aides in Major Leadership Shakeup

2 months ago talkbio0Tagged Buckham, chief of, Hannah Anderson, Health, Heather Flick Melanson, Leadership, Policy, reshuffle, RFK Jr., Shakeup, Social Welfare, Staff, TMEM79 gene, Trump loyalists

RFK Jr.; Health and Human Services; leadership reshuffle; chief of staff; Matt Buckham; Heather Flick Melanson; Hannah Anderson; Trump loyalists; policy shakeup

J&J’s Stelara Revenue Plummets as Biosimilar Competition Intensifies in 2025

2 months ago talkbio0Tagged Autoimmune Diseases, Benefit, Biosimilars, drug price, formulary exclusion, Johnson & Johnson, manager, Pharmaceutical Services, Revenue Decline, Stelara, ustekinumab

Stelara; Johnson & Johnson; ustekinumab; biosimilars; revenue decline; Q2 2025; pharmacy benefit managers; formulary exclusion; drug pricing; autoimmune disease

Otsuka Inks $613M Deal for Cantargia’s Autoimmune Antibodies

2 months ago talkbio0Tagged Autoimmune Diseases, CAN10, Cantargia, global commercialization, Hidradenitis Suppurativa, IL1RAP antibodies, milestone payments, Otsuka Pharmaceutical, Systemic Scleroderma

Otsuka Pharmaceutical; Cantargia; autoimmune diseases; IL1RAP antibodies; CAN10; biotech deal; hidradenitis suppurativa; systemic sclerosis; milestone payments; global commercialization

Outsmarting Data Bottlenecks in Pharma: The Clinical Terminology Advantage

2 months ago talkbio0Tagged Aortic Valve Insufficiency, clinical terminology, data bottlenecks, Data Integration, Drug Industry, Interoperability, Pharma, Regulatory Compliance

data bottlenecks; clinical terminology; pharmaceutical industry; data integration; interoperability; regulatory compliance; AI in pharma; patient outcomes

Vertex, NHS England Finalize Reimbursement Deal for CF Drug Alyftrek

2 months ago talkbio0Tagged ALYFTREK, Cystic Fibrosis, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation, Health care facility, NHS England, Nitroglycerin/Sodium Citrate/Ethanol Solution, Reimbursement, triple therapy, UK

Vertex; NHS England; Alyftrek; cystic fibrosis; reimbursement agreement; triple therapy; CFTR gene mutation; NICE; UK healthcare

Sino Biopharm Acquires Merck’s PD-1xVEGF Bispecific Partner LaNova for up to $951M

2 months ago talkbio0Tagged Acquisition, Antibodies, Bispecific, Biopharm, Cancer Therapeutic Procedure, isononanoyl oxybenzene sulfonate, LaNova Medicines, Merck, PD-1xVEGF

Sino Biopharm; LaNova Medicines; acquisition; Merck; PD-1xVEGF bispecific antibody; cancer therapy; Chinese pharma; $951 million deal

FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return

2 months ago talkbio0Tagged Advisory Committees, Blenrep, Drug Approval, Eye, Eye safety, Multiple Myeloma, relapsed/refractory multiple myeloma, SmithKline Beecham, Toxicity aspects, United States, United States Food and Drug Administration

GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma