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The Drug Enforcement Administration is proposing to lower its annual manufacturing limits on certain controlled substances for 2018 — which would cut back production of several classes of opioid painkillers and other scheduled pharmaceuticals, some between 10 and 25 percent. Read More
The FDA outlined plans coordinating CDER and the Office of Regulatory Affairs in inspecting manufacturing facilities seeking approval for new pharmaceuticals. Read More
Tasked with thinking beyond the agency’s current policy proposals, the FDA created a new working group of senior staff members to develop ways to boost generic competition, according to Commissioner Scott Gottlieb. Read More
President Trump signed a package of legislation reauthorizing the FDA’s user fee agreements for the next five fiscal years — the culmination of over two years of work and negotiations between the federal government and private industry. Read More
Eli Lilly & Co. settled with several generic companies to resolve pending litigation over a unit dose patent for Cialis (tadalafil), delaying potential ANDA competition. Read More
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