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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
FDA Commissioner Scott Gottlieb outlined an action plan to remove barriers to generic competition, saying agency regulations have been “gamed” by brand-name manufacturers to delay generic drug approvals even after patents and exclusivity periods lapse. Read More
In a decision that reshapes the patent dance between biosimilar applicants and reference holders — and could affect the course of billions of dollars in the pharmaceutical industry — the U.S. Supreme Court ruled biosimilar manufacturers do not have to wait for FDA approval before beginning a six-month delay on commercial marketing. Read More
The FDA implemented a new policy to expedite generic drug reviews in areas of limited competition, and published a list of off-patent branded drugs with no approved alternatives, as the first steps in the agency’s action plan to help lower the costs of prescription drugs. Read More
CBER added several topics to its guidance agenda for 2017 in its mid-year update, including blood donor requalification and the use of certain serum tests in reducing infection transmission. Read More
An industry-funded group has petitioned the FDA to fully transition to opioid painkillers with abuse-deterrent labeling, and to require manufacturers to convert their non-deterrent products. Read More
Years of legal wrangling came to a close with Allergan agreeing to a $13 million settlement for claims the company illegally promoted eye drugs by providing consulting and other services to doctors. Read More