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January 12, 2022
The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).
January 07, 2022
FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine booster dose interval from six to five months.
BAT has launched KBio Holdings—a biotech focused on the acceleration of research, development, and production of novel medicines that leverage plant-based technology.
Intravacc is partnering with Leiden University Medical Center for the development and evaluation of a new intranasal coronavirus vaccine candidate in a clinical Phase I/II study.
Pharming Group, has been granted a positive opinion by EMA for its Paediatric Investigation Plan for leniolisib.
January 05, 2022
FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.
January 03, 2022
The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.
FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.
An obvious theme for 2021 has been COVID-19, but the next 12 months will see industry and its people experiencing further change.
January 02, 2022
Overall, 2021 proved to be another good year for drug approvals in Europe, albeit with a slight disappointment for Alzheimer’s patients, but what should industry be watching out for in 2022?