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Sci-B-Vac was shown more effective at fewer doses than Engerix-B in a Phase III study. VBI Vaccines sees its hepatitis B vaccine hitting potential markets by 2021.
US Supreme Court says judges, not juries, should decide if FDA would have rejected additional label warning; Merck appears to have the support of three justices who note FDA's position that it decided not to require a change to Fosamax labeling.
Inadequate control of contamination – in people, processes and places – was the dominant problem found in the 45 drug GMP warning letters that FDA issued in FY 2014. More than half went to compounding pharmacies.
Actavis is relaunching its version of the oral contraceptive after the Federal Circuit reverses a lower court and finds Bayer’s patent is invalid due to obviousness; the appeals court also finds that Biogen Idec’s Rituxan patent does not block GSK’s Arzerra.
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