The Federal Trade Commission (FTC) has approved certain modifications to Bristol Meyers Squibb’s (BMS) divestiture agreements as part of the company’s 2019 acquisition of Celgene. Source: Drug Industry Daily
A federal judge in Pennsylvania is allowing a trial to proceed against Merck alleging the company’s Zostavax shingles vaccine induced the disease instead of preventing it. Source: Drug Industry Daily
When the FDA gets tough on clinical trial transparency, the industry listens. The problem is the FDA doesn’t get tough with enough regularity. Source: Drug Industry Daily
The UK’s National Institute for Health and Care Excellence (NICE) has recommended that the National Health Service (NHS) not offer BioMarin Pharmaceutical’s Vimizim (elosulfase alfa) for treating mucopolysaccharidosis type 4A…
Faced with defending its COVID-19 vaccine in the face of troubling side effects, Moderna held a conference call late last week to discuss the risk of heart inflammation in young…
Three days before the clock was set to run out on the legality of Janet Woodcock serving as acting commissioner of the FDA, President Biden has announced that he will…
The European Medicines Agency’s (EMA) human medicines committee recommended approving 11 new therapies during its monthly meeting last week. Source: Drug Industry Daily
Johnson & Johnson (J&J) plans to spin off its over-the-counter consumer products unit from its more lucrative prescription drugs and medical devices division, splitting itself into two publicly traded companies…
Sponsors seeking accelerated approval from the FDA should know that a required postapproval confirmatory trial takes about seven months longer than the typical phase 3 trial, leading some researchers to…
In order to be cost-effective relative to standard Alzheimer’s care, Aduhelm — the newly approved Alzheimer’s antibody — would have to cost no more than $3,000 per year, rather than…