Quality Systems

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

Articles

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 granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).

FDA Grants Oncolyze Orphan Drug Designation for Leukemia Treatment

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

FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.

FDA Accepts IND for Poseida Therapeutics’ Allogeneic CAR-T Cell Therapy Candidate

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. 

Here Come the COVID-19 Treatment Options

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Warp speed is amazoning pharma practices and protocols.

Industrious Pharmaceuticals

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

An obvious theme for 2021 has been COVID-19, but the next 12 months will see industry and its people experiencing further change.

Regulatory Oversight and Compliance