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Friday, Biogen announced that it was planning to acquire Reata for approximately $7.3 billion, while Alexion, AstraZeneca’s rare disease subsidiary, announced that it had entered a purchase and license agreement for a portfolio of preclinical gene therapy programs and technologies from Pfizer. Read More
The Senate Finance Committee has advanced a bill seeking to reform pharmacy benefit managers (PBMs) by prohibiting them from deriving compensation for Medicare Part D-covered drugs based on the drug’s list price, among other proposals. Read More
HHS announced plans to issue several FDA-related proposed and final rules in the coming year in its semiannual inventory of rulemaking actions. Read More
Over the past week, the FDA issued final guidance for deoxyribonucleic acid (DNA) reactive impurities in pharmaceuticals, assessing biosimilar user fees, hydrogen peroxide-based contact lens products and CDER’s program for the recognition of voluntary consensus standards guidance on medical device development tools. The FDA 2024 user fees were also announced. Read More
While prescription drug user fees increased a hefty 19.9 percent and medical device fees a modest 8.7, fees for biosimilar applications dropped up to an eye-popping 373 percent. Read More
Teva has filed a motion in district court seeking a trial postponement while an interim appeal is ongoing, the latest in a back-and-forth with the Department of Justice (DOJ) which has accused the Israeli drugmaker of defrauding Medicare via a Copaxone (glatiramer) kickback scheme involving charitable foundations. Read More
Seven major pharmaceutical companies — AbbVie, Amgen, Gilead, Johnson & Johnson, Novartis, Roche and Takeda — have formed the INTREPID (International Readiness for Preventing Infectious Viral Disease) Alliance to accelerate progress in discovery and development of new antivirals for future pandemics. Read More
A vaccine for a common — but deadly — infection of newborns, a new cancer treatment, and more promising data on an Alzheimer’s drug are among the stories we cover this month. Read More
The FDA has issued a final guidance outlining a program that allows stakeholders to propose pharmaceutical quality standards for recognition by CDER, providing industry with additional resources for pharmaceutical development and manufacturing. Read More
The Institute for Clinical and Economic Review (ICER) will assess the comparative clinical effectiveness and economic value of Novartis’s drug iptacopan for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare genetic blood disease. Read More