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Three large European investors are teaming up to form a $750 million company to create biopharmaceuticals businesses in Africa aiming to broaden the range of therapeutics available in the underserved markets there. Read More
The FDA has not been fully transparent about its Emergency Use Authorizations (EUAs) for COVID-19 treatments as it “does not uniformly disclose” its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics,” the Government Accountability Office said in a new report to Congress. Read More
Eli Lilly and South Korea’s Samsung Biologics have forged a long-term partnership to expand the Indianapolis, Ind.-based drugmaker’s supply of COVID-19 neutralizing antibody treatments, amid concerns about shortages as coronavirus cases spike globally. Read More
A New York bankruptcy judge ruled Tuesday to allow Purdue Pharma’s owners to give up $225 million to the government as part of a larger settlement for the company’s role in the opioid crisis, though the rest of the controversial $8.3 billion agreement still needs to be approved by the court. Read More
The U.S. House of Representatives has passed a bipartisan bill that aims to stop drugmakers from using a loophole that has allowed them to hold exclusivity on an orphan drug well after the seven years established in the Orphan Drug Act of 1983. Read More
Both Moderna’s and Pfizer’s COVID-19 vaccine candidates could receive Emergency Use Authorization (EUA) in less than a month and be ready for rollout in a matter of weeks, HHS Secretary Alex Azar said Wednesday, giving hope that high-risk patients could receive a vaccine before the year ends. Read More
The FDA issued a complete response letter (CRL) to Sanofi for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with the rare autoimmune condition, cold agglutinin disease. Read More
Alkermes was slapped with a Complete Response Letter from the FDA regarding its new drug application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder. Read More