All articles by Akosua Mireku

CMS mandates registry data for coverage of Alzheimer’s drugs

CMS announced that it will cover Eisai’s Leqembi, upon a traditional approval, if physicians enter patient data into registries.

FDA proposes new model for easy-to-understand prescription guides

The FDA proposes a revamped patient medication information guide to increase medication adherence and reduce patient harm.

Abiogen acquires EffRx to fortify bone disease portfolio

The Italian pharmaceutical company Abiogen Pharma acquired Effrx Pharmaceuticals, taking a step towards global expansion.

FDA awards full approval to Paxlovid amidst hazy coverage plans

A few weeks after Covid-19 emergency declaration ended, the FDA has approved Paxlovid for adults with Covid-19.

Illegal online pharmacies gain traction as regulators lag behind

As US drug prices increase, consumers are turning to illegal online pharmacies that allow unmoderated, cheaper access to drugs.

FDA delays Sarepta’s DMD gene therapy decision until June

After a positive AdCom recommendation, the FDA has moved the regulatory action date for Sarepta’s DMD gene therapy.

FDA approves breakthrough pneumonia therapy

The FDA approved Xacduro, developed by Entasis which is now a part of Innoviva, as the global challenge of bacterial resistance rises.

Centessa’s haemophilia therapy wins FDA fast track designation

UK takes measures to tackle Utrogestan hormone replacement shortage

Following a year of HRT shortages in 2022, the UK is issuing a serious shortage protocol for Utrogestan amidst new supply issues.

Research consortium picks eight rare diseases to advance gene therapies

The Accelerating Medicines Partnership Bespoke Gene Therapy Consortium plans to facilitate pre-IND work for gene therapies in the next year.