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A group representing the drug supply chain is strongly arguing that a proposed executive order to only supply drugs domestically could mean that Americans won’t have access to the drugs they need. Read More
Manufacturers need to provide two-week updates on any supply issues during the COVID-19 emergency and going forward, the FDA said in a new straight-to-final guidance. Read More
The FDA issued an emergency use authorization (EUA) for the anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate, clearing the way for HHS to distribute millions of doses for COVID-19 patients. Read More
In another blow to Genentech’s blockbuster cancer drug Herceptin, a federal appeals court upheld the U.S. Patent Trial and Appeals Board’s invalidation of two patents it holds on the drug. Read More
Mylan said it will waive its exclusive U.S. distribution rights for its copycat of AbbVie’s HIV antiviral Kaletra (lopinavir/ritonavir) to allow other suppliers to manufacture the potential COVID-19 treatment. Read More
President Trump signed a stimulus measure Friday that would help prevent drug shortages and change how the FDA deals with over-the-counter drugs. Read More
The FDA said it won’t object to outsourcing facilities using hydroxychloroquine sulfate or chloroquine phosphate for compounding during the COVID-19 pandemic. Read More
China’s National Medical Products Administration (NMPA) has banned the importation, sale and use of Bristol-Myers Squibb’s cancer blockbuster Abraxane (nanoparticle albumin-bound paclitaxel) following an inspection in the U.S. Read More