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Two drug companies are pushing back against proposed FDA guidance that would require drug sponsors to hold pre-trials to determine whether patients with a nasty form of esophageal swelling could benefit from an alternate therapy. Read More
British regulators will continue to issue EU-required Certificates of Pharmaceutical Product (CPPs) even if there is no formal Brexit agreement, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said on Monday. Read More
The House and Senate will each take a hard look at drug prices Tuesday, one in a mark-up that would require drugmakers to make public justifications for price increases or high launch prices, the other in a hearing that will gather executives from some of the nation’s largest pharmacy benefit managers. Read More
Three drugmakers have agreed to pay nearly $123 million to settle separate claims that they defrauded the government through an elaborate kickback scheme involving charitable foundations. Read More
Oklahoma Attorney General Mike Hunter has dismissed most of his state’s case against Johnson & Johnson and Teva, winnowing down a landmark opioids lawsuit to a public nuisance complaint. Read More
Ned Sharpless officially stepped into the position of FDA acting commissioner today, following former commissioner Scott Gottlieb’s resignation, effective last Friday. Read More