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The FDA reported the first U.S. drug shortage linked to the novel coronavirus outbreak — but did not name the drug. It is likely pindolol, a beta blocker for treatment of blood pressure manufactured by Mylan and Sun Pharma. Read More
More drugmakers have unveiled plans for countermeasures against the coronavirus as experts forecast that the outbreak is almost certain to become a pandemic. Read More
Allergan has agreed to sell off its investigational drug brazikumab and its pancreatic enzyme drug Zenpep (pancrelipase) to clear the way for its proposed $63 billion acquisition by AbbVie. Read More
The Institute for Clinical and Economic Review (ICER) released a draft cost-benefit analysis comparing three sickle cell disease treatments — Novartis’ Adakveo, Global Blood Therapeutics’ Oxbryta and Emmaus Life Sciences’ Endari — predicting that the expected cost would exceed the benefit for all three products. Read More
“The ever-increasing expenses associated with the legal and regulatory compliance for this segment of drugs are simply not sustainable,” the company said. Read More
In a final guidance, the FDA outlined the new structure of the user fee program under the Biosimilar User Fee Act of 2017 (BSUFA II) which eliminated certain fees and extended the agency’s authority to collect fees through fiscal 2022. Read More