By Kate Rawson
The coming year will bring Food & Drug Administration approval of a first-ever cancer vaccine, the reintroduction of a withdrawn...
New Years' Resolutions
If a panel of analysts are correct, the coming year will bring the reintroduction of Biogen-Idec's Tysabri, approval of Merck's human papilloma virus vaccine Gardasil and a continued stalemate over generic biologics. We asked top pharmaceutical analysts to weigh in on the events they think will move the market in 2006.
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An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.
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An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.
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The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
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Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
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New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.
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The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.
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Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”