We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
FDA Commissioner Scott Gottlieb told lawmakers the agency will work to break the stigma associated with medication-assisted treatments for opioid dependence and addiction. Read More
The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay, and how to request reconsiderations of user fee assessments. Read More
The PTO’s Patent Trial and Appeal Board issued a final rule clarifying when attorney-client privilege is recognized during the inter partes review process — as well as which communications are protected when seeking patents at the PTO or at foreign intellectual property offices. Read More
Senate Republicans released a competing tax reform plan that — in comparison to the House side’s proposed repeal — merely shrinks the size of the orphan drug research tax credit. Read More
The PTO’s Patent Trial and Appeal Board ruled against a Purdue Pharma patent on OxyContin, agreeing with Amneal Pharmaceuticals on the patent’s obviousness. Read More
Allergan drew bipartisan fire from U.S. House members considering issues raised by the company’s innovative scheme to shield its patents on the blockbuster dry-eye drug Restasis from challenges before the Patent Trial and Appeal Board. Read More
Without the credit’s lowering of development costs over the past 30 years, the number of orphan drugs produced in the U.S. would have dropped by one-third. Read More
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