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The PTO’s Patent Trial and Appeal Board rejected five Mylan challenges to patents held by UCB Pharma and Pfizer covering the overactive bladder treatment Toviaz. Read More
The FDA granted tentative approval for Merck’s Lusduna Nexvue (insulin glargine injection), as a follow-on basal insulin biologic, a product similar to Sanofi’s flagship Lantus treatment. Read More
The FDA published new product-specific draft guidances for establishing bioequivalence in 20 drugs and combinations. The agency also revised draft guidances for 12 more substances. Read More
Following the U.S. Supreme Court’s defining decision on the biosimilar “patent dance” and approval process, Sandoz has requested that an unresolved part of its case against Amgen return to a California federal district court. Read More
FDA Commissioner Scott Gottlieb updated lawmakers on the agency’s plan to help lower drug prices using its “untapped authority” to increase competition and streamline generic drug approvals. Read More
The House passed its version of the FDA user fee reauthorization package, which is expected to bring in $1.42 billion in fiscal 2018, by a voice vote. Read More
The FDA is planning to modernize its recruitment and hiring practices to fill the several hundred vacancies plaguing the agency and attract more scientific talent. Read More
At a meeting on opioids abuse, FDA Commissioner Scott Gottlieb announced that the agency will expand its REMS requirements for extended-release and long-acting opioids to the manufacturers of immediate-release formulations — which account for 90 percent of the opioid painkiller prescriptions written each year in the U.S. Read More
The Senate and House appropriations committees approved their respective bills that provide a total of $5.2 billion for the FDA in fiscal 2018, $491 million more than the current fiscal year. Read More
With just over two months left in the program, the FDA finalized a question-and-answer guidance for GDUFA I, covering ANDA reviews, inspections and self-identification of facilities. Read More
The FDA approved the most generic drugs during May and June since it began tallying approvals, according to the agency’s latest report on the generics program — helping Commissioner Scott Gottlieb make good on his early promises to speed generics to market in an effort to lower U.S. drug prices. Read More