We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The European Council — which represents the heads of state or the governments of EU members — must also adopt the proposed legislation for it to become law. Read More
The FDA has reached an agreement on draft commitments to the biosimilars industry for the upcoming iteration of the biosimilar user fee program, BsUFA III, which will cover fiscal 2023 through 2027. Read More
President Biden is taking aim at the pharma industry, directing his administration to issue a comprehensive drug pricing plan within 45 days and to implement a Trump-era proposal to import cheaper prescription drugs from Canada. Read More
Fourteen of the world’s largest drug companies spend millions of dollars more on stock buybacks and executive compensation than they do on research and development, a new congressional report has concluded. Read More
Acting FDA Commissioner Janet Woodcock is calling for a wide-ranging federal investigation into her own agency’s actions during the drug approval process with Biogen over its newly approved Alzheimer’s disease drug Aduhelm (aducanumab). Read More
The FDA shot down each of the requests in the petition, except a requested revision to draft guidance to clarify the definition of what are known as “free” and “bound” paclitaxel or albumin. Read More
The findings showed that the risk of mortality for patients treated with an interleukin-6 receptor antagonist plus a corticosteroid was reduced by 13 percent vs. standard of care. Read More
The European Parliament has voted to expand the European Medicines Agency’s (EMA) authority to monitor the supply chain for drugs and medical devices. Read More
Biogen and FDA have narrowed the treatment indications for Aduhelm (aducanumab), now recommending the antiamyloid antibody only for patients with mild cognitive impairment (MCI) and early Alzheimer’s disease (AD). Read More
OxyContin maker Purdue Pharma filed a restructuring plan that includes its owners, the Sackler family, paying $4.2 billion toward the settlement of opioids lawsuits, dissolves Purdue following its bankruptcy, and has the Sackler family and Purdue agreeing to disclose about 30 million internal documents related to the company and the family’s roles in igniting and fueling the opioid crisis over the past 20 years. Read More