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The FDA cited MasterPharm following an inspection of its South Richmond Hill, N.Y. plant that revealed numerous violations of current good manufacturing practices. 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
Bayer will pay up to $4 billion to acquire North Carolina-based gene therapy company Asklepios BioPharmaceutical (AskBio) in a move that will extend the German pharma giant’s reach into regenerative therapies. 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
AstraZeneca’s COVID-19 vaccine candidate, AZD1222, elicited immune responses in older coronavirus patients similar to ones generated in younger adults, lending more promise to a vaccine that’s seen as one of the leading contenders in the race to become the first approved COVID-19 vaccine. 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
Walmart is suing the federal government seeking to block civil charges against the company over how it handled prescriptions for opioids that allegedly helped create the opioid epidemic. Read More
Generic drug titan Aurobindo Pharma announced that its Dayton, N.J., oral drug manufacturing facility has been hit with an FDA warning letter after being previously written up by the agency for a lengthy list of violations. Read More
Gilead Sciences said Friday that it had completed its $21 billion purchase of Immunomedics that will extend Gilead’s reach into oncology drugs. Read More