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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A new draft guidance from the FDA offers drug sponsors recommendations for developing potency assays for every stage of the lifecycle of monoclonal antibodies (mAbs) that directly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
An international group of university students devoted to advancing health equity and access to therapies has filed a citizen’s petition seeking heightened efforts to improve compliance with clinical trial reporting requirements — yet another call for the FDA to step up enforcement in this area. Read More
A bill that would prevent pharma companies from blocking generic competition by patenting their drugs’ Risk Evaluation and Mitigation Strategy (REMS) programs is making a return appearance in the 118th Congress. Read More
In its latest annual report on drug safety priorities, the FDA’s Center for Drug Evaluation and Research (CDER) highlighted the agency’s continued focus on COVID-19 products and its commitment to safety around opioids. Read More