Latest News & Analysis
Proposed rule will revisit controversial provisions in the January 340B final rule to address manufacturer concerns about the US discount program.
A new ATMP, two generics and a biosimilar got the thumbs up this week from the European Medicines Agency’s drug evaluation committee, the CHMP. The committee also recommended one product for conditional authorization and another for a pediatric use authorization, But it turned down a multiple myeloma product, and a sea squirt-based MS drug was withdrawn from the review process.
FDA says in a warning letter that Hangzhou Facecare Cosmetics's response to inspectors' findings following a June inspection was inadequate and the firm's imports in September were ordered detained without physical examination at all US ports.
Argentina’s patent office, INPI, has rejected an application for a key patent relating to Gilead’s hepatitis C drug Sovaldi (sofosbuvir).
Original new drugs and biologics recently approved by US FDA.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.
‘Outstanding Issues’ Clarified For Nine Products Nearing EU Review End – Including Neulasta Biosimilar
Ammtek, Pfizer, Portola and Roche are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are nearing the end of the review pathway. Questions are also in store for the sponsor of a biosimilar version of filgrastim.
US FDA also indicated plans to update definition of biologic product and propose a one-page Patient Medication Information in the latest Unified Agenda.
US Federal Circuit finds in Amgen v. Sandoz that the BPCIA preempts innovator companies from seeking penalties under state law against a biosimilar sponsor that does not engage in the 'patent dance.'
When FDA piloted the use of Section 706 authority to obtain records in advance of inspection, the US agency found the results included more inspection findings but not quicker inspections.
FDA’s expectation is that the most responsible individual at manufacturing sites be involved in inspections. The agency is increasingly talking about its “responsible corporate official” or Park Doctrine powers to hold top officials responsible for manufacturing issues and problems.
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