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The attorneys general also seek to add Mylan President Rajiv Malik and Emcure CEO Satish Mehta as individually-named defendants in the civil antitrust cased. Read More
House Republicans’ $1.51 trillion tax reform bill released Thursday would repeal the orphan drug tax credit, which currently allows drug manufacturers to claim a credit equal to 50 percent of the costs of any human clinical testing done for a product in a rare disease, as defined by the FD&C Act. Read More
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 average sales price minus 22.5 percent, rather than the previous ASP plus 6 percent — for the 2018 calendar year. Read More
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 litigation told a federal court. Read More
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 patient access programs and agreed-upon discounts. Read More
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. Read More
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. Read More
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. Read More
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in previously untreated patients. Read More
The FDA is looking for creative approaches to the opioid crisis, including new requirements for product packaging, as ways to reduce overall exposure to the painkillers. Read More