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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
The company aims to “be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021,” said CEO Stéphane Bancel. 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
FDA Commissioner Stephen Hahn pledged yesterday that the agency will publicly post detailed explanations of all Emergency Use Authorization (EUA) decisions, including all COVID-19 vaccine candidates now in the pipeline. Read More
The European Medicines Agency (EMA) has launched a rolling review of Moderna’s vaccine candidate mRNA-1273, on the heels of the Cambridge, Mass., drugmaker’s announcement that the vaccine demonstrated 94.5 percent efficacy in early results from a phase 3 trial. Read More
The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
As Pfizer and Moderna prepare to file for Emergency Use Authorization for their promising COVID-19 vaccines in the coming weeks, they will face unprecedented distribution challenges – in Pfizer’s case the need to hold the doses at super-cold temperatures. Read More
Pfizer announced that it has launched a delivery and distribution pilot program for its COVID-19 vaccine in four U.S. states to determine how to handle challenges posed by the candidate’s ultra-low temperature requirements. Read More
The FDA has updated its final guidance on the use of convalescent plasma in COVID-19 treatment and clinical trials, extending its enforcement to Feb. 28, 2021. Read More