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.
Takeda’s patent for its multiple myeloma drug Velcade was restored and extended for five more years after a federal appeals court overturned a district court ruling. Read More
The PTO’s Patent Trial and Appeal Board once again ruled that a patent for AbbVie’s Humira was invalid and unpatentable, responding to additional challenges by Boehringer Ingelheim. Read More
The European Commission issued a Statement of Objections to Teva over its 2005 “pay-for-delay” deal with Cephalon in which Teva agreed not to market a cheaper generic for Cephalon’s sleep disorder drug Provigil (modafinil). Read More
A Pennsylvania federal court ruled that 11 generic manufacturers, including several subsidiaries of Teva Pharmaceuticals, must answer to a class-action lawsuit claiming they violated state consumer protection and unfair trade practice laws by inflating their prices. Read More
An FDA advisory panel unanimously recommended that the agency approve two biosimilars for the cancer treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Read More
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