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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
The FDA announced that it is developing guidance on compounding drugs during the COVID-19 pandemic to protect patients from “unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients.” Read More
Like other parts of the FDA, the Center for Drug Evaluation and Research had to scramble last year to address COVID-19 while not losing sight of its other important tasks, according to its latest annual report on Drug Safety Priorities. Read More
In just over four months, drug manufacturers will experience a change in the FDA’s online adverse event report system to help the agency figure out what stage the product the adverse event is associated with has reached. Read More
New treatments for cancer, hereditary angioedema and spinal muscular atrophy may be available to European patients soon, as the European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA/CHMP) recommended that the agency approve six new drugs, including two biosimilars and one generic, at its four-day meeting last week. Read More
The Biden administration has secured 100,000 doses of Eli Lilly’s combination monoclonal antibody (mAB) treatment to be delivered through March 31, with an option to buy an additional 1.1 million doses through November of this year. But will hospitals and outpatient centers even use them? Read More
In a 219-212 vote along party lines on Saturday, the House of Representatives passed the massive $1.9 trillion COVID-19 relief bill that includes $500 million in extra funding for the FDA and the elimination of Medicaid drug pricing rebate caps starting in 2023. Read More