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A coalition of cystic fibrosis patients, family members and supporters appealed in an open letter to Vertex Pharmaceuticals to expand access to the company’s drugs to treat the disease. Read More
Members of the Sackler family did in fact pressure Purdue Pharma executives to grow its market share of OxyContin and other opioids, according to allegations made in a hefty package of internal documents released by the House Committee on Oversight and Reform. Read More
Sanofi and GlaxoSmithKline (GSK) have signed an agreement with Gavi, the Vaccine Alliance pledging to provide 200 million doses of their COVID-19 vaccine to the COVAX initiative should the vaccine clear regulatory hurdles. Read More
No private vendors have stepped up so far to bid on Florida’s $30 million contract to devise a Canadian drug importation program aimed at lowering prescription drug prices in the state. Read More
The FDA unveiled a final guidance yesterday on referencing approved drug products in Abbreviated New Drug Application (ANDA) submissions that seeks to clear up confusion commenters expressed about draft guidance the agency issued Jan. 17, 2017. Read More
The FDA will not make COVID-19 vaccine developers go through pre-approval inspections for an Emergency Use Authorization (EUA), but companies will have to submit detailed manufacturing data and meet certain other requirements, said a senior official in the Center for Biologics Evaluation and Research (CBER). Read More
A study by the world body found no clinical benefit or improvement in survival outcomes for COVID-19 patients in a review of multiple trials. Read More
The FDA announced that a memorandum of understanding (MOU) between the agency and states for regulating traditional compounding pharmacies that distribute their products to other states is now available for signature by state health agencies. Read More
The FDA has had to push back its review of Spectrum Pharmaceuticals’ biologics license application (BLA) for Rolontis (eflapegrastim) due to COVID-19 travel restrictions. Read More
The UK’s Institute of Cancer Research said it is “deeply disappointed” by a decision by the National Institute of Health and Care Excellence (NICE) to recommend Merck’s Keytruda (pembrolizumab) as a first-line treatment for certain head and neck cancer patients but not in combination with chemotherapy. Read More