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Two-thirds of the way through fiscal year 2017, the FDA has received at least 877 ANDAs, passing fiscal 2016’s total of 852 and beating fiscal 2015’s total by more than 330 applications. Read More
The World Health Organization published its biennial update to its list of essential medicines, adding therapies for hepatitis C, HIV and leukemia, as well as new advice on combating antimicrobial drug resistance. Read More
The PTO’s Patent Trial and Appeal Board said it will review patents covering the blockbuster erectile dysfunction drug Cialis and a widely used pneumonia vaccine, Prevnar 13, granting petitions from Mylan and Merck Sharp & Dohme Corp. Read More
The PTO invalidated two more AbbVie patents on dosing regimens for Humira after continuing challenges from Coherus, which plans to submit its biosimilar version of the blockbuster drug for FDA approval later this year. Read More
The Congressional Budget Office officially scored the Senate bill reauthorizing the FDA’s user fee agreements, saying it would add $740 million to the budget and a negligible amount to the deficit over its five-year life. Read More
The House Energy and Commerce Committee voted unanimously to advance the FDA’s five-year user fee reauthorization package to the floor of the House — following a lengthy debate more on the rising cost of prescription drugs, than on the fee programs at the heart of the bill. Read More
The Senate Health, Education, Labor and Pensions Committee sought to answer basic questions on what is driving drug prices sky high, in a hearing ostensibly dedicated to the pharmaceutical industry — though it was frequently derailed by Democrats’ concerns over Republican efforts to repeal and replace the Affordable Care Act. Read More
In a case that may change how drug companies deal with patent infringement cases, the U.S. Supreme Court agreed to consider the constitutionality of the PTO’s inter partes review process, which allows the validity of patents to be challenged based on whether their claims are considered obvious at the time they are awarded. Read More
Pfizer and its generic injectables arm, Hospira, received a complete response letter for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited in a February FDA warning. Read More
A pharmacy chain brought class action suits against 16 generics manufacturers — including Mylan, Sandoz, and Teva — claiming they conspired to raise prices of seven drugs, including blood pressure medications, antidepressants and corticosteroids. Read More
The FDA surpassed many of its performance goals for generic drug applications through 2016, but the agency needs a plan for the user fees collected but not spent in the same year, according to the GAO. Read More