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July 28, 2015
FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.
July 27, 2015
The deal to acquire Allergan’s generic-drug business is valued at $40.5 billion.
FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.
July 21, 2015
A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.
July 20, 2015
Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.
July 17, 2015
A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.
July 10, 2015
The 21st Century Cures Act took a giant step forward with a 344-77 approval in the House; the Senate debate is still ahead.
July 07, 2015
A large health system will use the biosimilar version of infliximab from Hospira after the company offered a discount of 45%.
The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.
June 30, 2015
GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.