The Centers for Medicare and Medicaid Services reduced the amount Medicare Part B will pay hospitals for purchasing drugs through the 340B discount program — cutting reimbursements down to the…
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, a high-ranking agency official told an FDAnews regulatory conference. Source: Drug Industry…
The FDA updated its guidance on communications with generics manufacturers to reflect the timelines agreed to in the second generation of the GDUFA program, which took effect Oct. 1. Source:…
The European Medicines Agency revised its 2009 guideline on developing treatments for axial spondyloarthritis, accounting for changes in clinical practice. Source: Drug Industry Daily
A multistate price-fixing lawsuit against generic drugmakers should be dramatically expanded to target more drugs, more companies and, for the first time, individual company executives, the attorneys general who filed…
The U.K.’s National Institute for Health and Care Excellence published guidances for three drugs in four indications, recommending their use by the NHS as long as the sponsors comply with…
FDA advisory committee members recommended approval for some versions of Braeburn’s modified-release reformulation of buprenorphine but balked at endorsing higher dosages of the medication, which is indicated for weekly or…
The number of “pay-for-delay” patent settlements agreed to by pharmaceutical companies in fiscal 2015 declined from the year before, according to a report from the Federal Trade Commission. Source: Drug…
Gilead is defending a suite of patents for its profitable hepatitis C antivirals from challenges by a non-profit group petitioning the PTO’s Patent Trial and Appeal Board. Source: Drug Industry…
The PTO’s Patent Trials and Appeals Board reversed course last week, granting inter partes review of a Herceptin patent that it previously refused, following challenges from Hospira. Source: Drug Industry…