President Biden sought yesterday to revive his massive spending package lying dormant in the Senate by highlighting a popular component of the bill — prescription drug pricing reform. Source: Drug…
Democrats in the U.S. House of Representatives and eight advocacy groups are pressing Department of Health and Human Services (HHS) head Xavier Becerra to use either “march-in” or government use…
Seventy-eight Republicans have thrown down the gauntlet in front of the Centers for Medicare & Medicaid Services (CMS), charging that limiting payments for Biogen’s Aduhelm pressures people with Alzheimer’s disease…
The FDA has issued a warning letter to Innoveix Pharmaceuticals arising from an inspection of the company’s drug compounding facility in Addison, Texas, last May in which an agency official…
The European Medicines Agency (EMA) has announced a new center that will deliver a network of real-world data (RWD) sources across the EU for use in drug reviews. Source: Drug…
Opdivo, Bristol Myers Squibb’s checkpoint inhibitor, increased survival time in patients with inoperable advanced esophageal cancer, both alone and in combination with the company’s T-cell booster Yervoy (ipilimumab). Source: Drug…
To try to avoid a government shutdown, the House has voted to extend the continuing resolution that’s funding the government through March 11. Source: Drug Industry Daily
After hundreds of hours with a court-appointed mediator, the Sackler family appears ready to contribute more than the $4.3 billion they previously pledged in their settlement over the opioid crisis…
Drug companies with a candidate nonopioid analgesic should consider applying for expedited review through FDA’s special approval pathways, according to new draft guidance released yesterday. Source: Drug Industry Daily
The FDA outlined clinical pharmacology considerations for developers of antibody-drug conjugates (ADCs) in a draft guidance released yesterday. Source: Drug Industry Daily