Alectos Therapeutics Inc.
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Europe needs better pricing systems for so-called value added medicines if the market for such products is to be sustainable or attractive, Warrick Smith, director general of the British Generic Manufacturers Association, the BGMA, told Scrip.
Menlo Park, California-based Corium, a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, has appointed Dr Joseph J Sarret to the newly created position of chief business officer. Reporting to Corium's president and CEO Peter D Staple, Dr Sarret will serve as a member of the company's executive leadership team with responsibility for developing and implementing Corium's business strategies, building new alliances and expanding existing ones, and pursuing new business initiatives that leverage Corium's advanced transdermal technologies and product candidates.
The European Medicines Agency has agreed a new guideline on the development of modified-release dosage forms, describing the studies that will be needed to demonstrate the efficacy, safety and pharmacokinetic properties of formulations such as prolonged, delayed and multiphasic-release formulations of medicines.
FDA’s first two warning letters since draft compounding guidances may be another way to encourage outsourcer registration.