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The U.S. is bearing the brunt of pharmaceutical research costs because of “free-riding” by foreign countries in the past 15 years, the White House Council of Economic Advisers (CEA) claimed in a new report released yesterday. Read More
The sharp increase in FDA warning letters to Indian facilities last year will lead to a significant delay in U.S. generic launches by Indian drugmakers, according to CRISIL, an Indian research firm. Read More
The FDA issued a final rule amending the definition of “biological product” to include chemically synthesized polypeptides, a category of products that includes all insulins currently on the market. Read More
Unit-level tracking “is likely more fit” for investigations of substandard and illicit drug products, cargo theft and diversion, the WHO said. Read More
The FDA details how sponsors of nonclinical safety evaluations of new drugs and therapeutic proteins should consider their impact on the immune system, in a draft guidance released yesterday. Read More
A coalition of unions and patient advocacy groups has urged the Federal Trade Commission to strengthen its requirements for AbbVie and Allergan’s planned $63 billion merger. Read More
The Attorneys General of a dozen states and the U.S. Chamber of Commerce have urged a federal appeals court to dissolve the novel “negotiating class” in the multidistrict opioid litigation, arguing that Judge Dan Polster of the U.S. District Court for the Northern District of Ohio lacked the legal authority to create it. Read More
A federal judge in Massachusetts ruled that seven former Insys Therapeutics executives must pay nearly $57 million in restitution for their role in the company’s scheme to boost prescriptions of its sublingual fentanyl spray Subsys. Read More