Dickinson, who has been a staff attorney since 1994, takes the helm from Ralph Tyler on an interim basis. read more
Gilead's deal with the Medicines Patent Pool limits the developing countries that have access to generics and requires that the drugs be manufactured in India. read more
BLAs for Seattle Genetics' antibody-drug conjugate to treat two rare lymphomas are based on single-arm trials, and the company has begun a confirmatory study for only one indication. read more
As the agency struggles to adapt to globalization of the pharmaceutical supply chain, exact harmonization of regulatory standards may not be a goal worth pursuing. read more
Draft document addresses how FDA expects drugs and devices to be developed contemporaneously and how those products will be reviewed simultaneously by the relevant regulatory centers at FDA with collaboration across divisions. read more
Morgan Stanley analysts poured cold water on investor hopes in Hong Kong by downgrading pharma and distribution sectors in a July 7 research note. read more
Approved last year for pseudobulbar affect and gradually gaining sales and formulary adoption, Nuedexta will be studied in additional CNS indications. read more
Distribution of the new 6 mg/mL oral solution concentration will begin this month, but 12 mg/mL concentration products can still be used until they expire, FDA says. read more
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