Disease Foundations Are Finding Their Way In New Research Relationships Disease foundations have realized that funding basic research is not enough to serve their patient groups, but forging those later-stage relationships can be tricky and all parties involved are developing new flexibilities, panelists at the BIO annual meeting said June 21 in Boston.
Biosimilar Interchangeability Stymied Mainly By Extrapolation Uncertainties, Amgen Says Amgen's R&D head Miletich tells the BIO International Convention that understanding, not detecting, minor structural differences between products is a key hurdle to creating interchangeable biologics. Also, designing trials which satisfy the statute's "any given patient" requirement is daunting.
Pfizer's Pain Eased By Another Lyrica Approval Pfizer gains another indication for its blockbuster pain drug Lyrica, even as it fights off generic competition from a variety of sources.
Humira Will Get Advisory Committee Review For Ulcerative Colitis FDA's Gastrointestinal Drugs Advisory Committee is scheduled to review Abbott's sNDA for the TNF blocker Humira Aug. 28.
Increased FDA China Inspections Backed By House Panel, While Purse Strings Pulled Still Tighter Funds for the Reagan-Udall Foundation must come from the FDA commissioner's office account, under successful amendment from Rep. DeLauro.
Ophthalmic Advisory Committee To Consider Two New Fields For Drug Therapy Genentech's Lucentis (ranibizumab) for diabetic macular edema and ThromboGenics's Jetrea (ocriplasmin intravitreal injection) for symptomatic vitreomacular adhesions would both be the first pharmacologic intervention for those indications, replacing surgical standards of care.
Combination Products Coalition Zeroes In On Auto-Injectors And Personalized Medicine In a new strategy, the coalition has launched an effort to obtain regulatory clarity in two specific product areas. FDA guidances are on the horizon in both.
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