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A 5,000 percent price hike for the only drug indicated for treating a specific type of parasitic infection – and one that is critical for patients with lowered immune systems – is drawing howls from the public. Read More
Antibiotics developer Cempra said Friday the FDA granted a qualified infectious disease product designation for its investigational candidate Taksta to treat acute bacterial skin and skin structure infections. Read More
The FDA granted fast track designation to a drug from Mapp Biopharmaceutical to treat the Ebola virus and to Dimension Therapeutics to treat patients with hemophilia B. Read More
Amgen is acquiring Dutch biotechnology company Dezima Pharma for $300 million plus up to $1.25 billion in milestone payments, the companies announced Wednesday. Read More
Amneal Pharmaceuticals can begin marketing its generics version of Allergan’s Alzheimer’s extended-release drug Namenda XR on Jan. 31, 2020, pending FDA approval, under an agreement reached by the two firms. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif. manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More