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More than 10 percent of drugs marketed with an Accelerated Approval (AA) failed to include mention of the AA on the label, a new study has found. Read More
The FDA and the Federal Trade Commission (FTC) have launched a campaign against false or misleading information about biosimilars that “may constitute unfair or deceptive practices” leading to decreased confidence in biosimilars. Read More
Intercept Pharmaceuticals has resolved patent litigation against Apotex Pharmaceuticals and MSN Laboratories over their alleged infringement on Intercept’s intellectual property protections for its liver disease drug Ocaliva (obeticholic acid). Read More
The bill would enable the FDA to immediately approve drugs instead of waiting out the normal 30-month approval stay if the only barrier to approval is a REMS patent. Read More
A new draft guidance from the FDA offers drug sponsors recommendations for developing potency assays for every stage of the lifecycle of monoclonal antibodies (mAbs) that directly target viral proteins. Read More
The FDA has denied a citizen petition to grant a breakthrough therapy designation for Cassava Science’s investigational Alzheimer’s therapy, simufilam, because the petition was submitted by an individual rather than the company. Read More
Novo Nordisk and Sanofi, the two largest makers of insulin in the U.S., seem unlikely to budge on pricing despite competitor Eli Lilly’s announcement of price cuts and subsequent letters from Sen. Bernie Sanders (I-Vt.) calling on the two companies to follow suit. Read More