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With the price of opioid rescue drug naloxone nearly quadrupling in Baltimore last year, Baltimore City Health Commissioner Leana Wen called for a federal investigation into the drug, which holds a spot on the World Health Organization’s List of Essential Medicines. Read More
The FDA has blessed a new treatment for the bleeding disorder von Willebrand disease. The FDA disclosed Tuesday that it has approved California drugmaker Baxalta’s Vonvendi (recombinant von Willebrand factor) for on-demand treatment of adult patients with the inherited disorder. Read More
The FDA approved Alexion Pharmaceuticals’enzyme replacement drug Kanuma for an ultra rare disorder known as lysosomal acid lipase deficiency in pediatric and adult patients. Read More
The Secretary’s Advisory Committee on Human Research Protections is asking for more data on how proposed changes to the Common Rule requiring the use of a single IRB across a multisite trial could affect workflow. Read More
A law firm that represents drugmakers is urging the FDA to rethink its stance on granting meetings with senior FDA officials, saying the agency’s policy can imperil drug research. Read More
Par Pharmaceutical’s efforts to litigate its way to a generic version of Adderall XR ended with a whimper Nov. 24, after a federal judge barred the company from challenging Shire’s patents. Read More
A recent report suggests the advisory committees that the FDA relies upon to ensure medical products are safe and effective can be wildly inconsistent in their recommended approval rates. Read More