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The FDA has laid out its plan to modernize the way it interacts with data to inform regulatory decisions like drug reviews, unveiling a three-component Data Modernization Action Plan (DMAP) on Wednesday that will begin bringing its data strategies up to date. Read More
AstraZeneca (AZ) has won a patent lawsuit in a federal court against Mylan Pharmaceuticals and Kindeva Drug Delivery, which were planning to make generic versions of AZ’s blockbuster asthma drug Symbicort (budesonide/formoterol). Read More
In March 2020, the FDA controversially granted hydroxychloroquine and chloroquine an Emergency Use Authorization (EUA), before later withdrawing the EUA. Read More
Over-the-counter drug major Perrigo said this week it is selling its generic prescription drug business to Altaris Capital Partners for $1.55 billion. The purchaser is paying $1.5 billion in cash and taking on more than $50 million in potential R&D milestone payments and contingent purchase obligations with third-party prescription partners. Read More
GlaxoSmithKline (GSK) should not be allowed to add an allergy indication to its European Medicines Agency (EMA) marketing authorization for Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol), the agency’s Committee for Medicinal Products for Human Use (CHMP) decided last week. Read More
The FDA has suddenly decided to call for an advisory committee meeting to discuss San Francisco biotech FibroGen’s investigational anemia pill, roxadustat, late in its review process, a development that was not anticipated. Read More
To speed the rollout of COVID-19 vaccine doses, the European Commission (EC) is considering an emergency approval mechanism in lieu of its more time-consuming and stringent conditional marketing authorization process. Read More
Because of the way expensive, single-dose drugs are priced and paid for in the U.S., extra doses in discarded vials can’t be used to recoup costs, according to a congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine. Read More
Medicare Part B may be unintentionally creating perverse incentives for hospitals to use certain drugs based on what the program reimburses for them, rather than medical necessity, a new Government Accountability Office (GAO) report finds. Read More
As U.S. vaccinations against COVID-19 gain momentum, health officials are using new tools to gather postmarket safety data, including a new early warning system called V-Safe. Read More