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Latest From Review Pathway
However, the month may be losing its influence over the US FDA's annual submission total.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Highlights of year-end application submissions including candidates from AstraZeneca, BioMarin, Lilly, MorphoSys, and Seattle Genetics.
New FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination product agreement meeting with regulators to get clarification. The guidance outlines what is expected of both sides in such meetings.
Financial ties between companies and healthcare bodies distort the production and use of evidence, claims a paper co-authored by researchers, clinicians and decision makers, including a representative of Germany’s HTA body, IQWiG.
Richard Pazdur, FDA's oncology chief, reiterates the breakthrough therapy designation is for agency-sponsor communication and not an investor tool.
CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.
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