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Janssen Pharmaceuticals is joining forces with HHS to develop a vaccine candidate for COVID-19 and the Johnson and Johnson subsidiary is prepared to produce it on a large scale. Read More
Amgen is calling for a jury trial for Hospira in the U.S. District Court for the District of Delaware, alleging that the Pfizer subsidiary’s proposed Neulasta (pegfilgrastim) biosimilar infringed on its patents for the anti-infection drug. Read More
HHS Secretary Alex Azar defended the administration’s proposed fiscal 2021 budget before the Senate Finance Committee yesterday and noted that the budget “supports quick congressional action” to lower the cost of prescription drugs. Read More
The FDA cited a combination drug-device product manufacturer in China for serious testing failures and other violations uncovered in an inspection of its facility northwest of Shanghai. Read More
Mallinckrodt is facing another class-action suit over the price of its H.P. Acthar Gel (repository corticotropin), this time from the city of Marietta, Georgia. Read More
CDER has launched a Controlled Substances Program (CSP) to help develop new policies and programs to encourage “appropriate access” to scheduled drugs. Read More
Former FDA Commissioner Scott Gottlieb warned a Senate committee yesterday of the potential for “unprecedented supply chain disruptions” as the COVID-19 outbreak threatens China’s production of starting materials. Read More