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According to the company, Lumykras (Sotorasib) is the first targeted therapy approved in the European Union for patients with the KRAS G12C mutation.

European Commission Approves Lumykras (Sotorasib) to Treat KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.

NICE Recommends Darzalex in Combination with Velcade to Treat Multiple Myeloma

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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).

Medicare Limits Aduhelm Coverage to Patients in Clinical Trials

FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine  booster dose interval from six to five months.

FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine

BAT has launched KBio Holdings—a biotech focused on the acceleration of research, development, and production of novel medicines that leverage plant-based technology.

BAT Launches Biotech Company to Accelerate the Development of Novel Medicines

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. 

Clinical Trial on Intranasal Coronavirus Vaccine Set to Start

Pharming Group, has been granted a positive opinion by EMA for its Paediatric Investigation Plan for leniolisib.

Pharming Gains Nod from EMA on PIP for Leniolisib

FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.

FDA Keeps New Drugs Coming

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 Expands Use of Pfizer-BioNTech COVID-19 Vaccine

FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible. 

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