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.
The collection, use and submission of patient experience data (PED) still requires significantly more FDA guidance, clarification and support, big-name sponsors told the agency in response to a request for information and comments on the subject. Read More
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
This week, three medical devices used for cardiac issues were deemed class I by the FDA, the most serious type of recall, as use of the device may cause serious injury or death. 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
Recommendations for study design to facilitate innovation in development of devices, such as deep brain, transcranial magnetic and spinal cord stimulations, intended to treat opioid use disorder (OUD) are the subject of a draft guidance issued July 27. Read More
AdvaMed and Deloitte have updated their 2017 report on assessing the value of diagnostic technologies by incorporating a look at how the shift of risk from payer to provider will affect the adoption of new medtech innovations — while at the same time, reducing cost, improving patient experience, outcomes and satisfaction. Read More