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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
June 07, 2021
FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.
June 02, 2021
Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.
June 01, 2021
FDA has issued an emergency use authorization for sotrovimab, an investigational monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19.
In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally.
May 27, 2021
EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).
EMA has recommended EU marketing authorization for Bylvay (odevixibat) as a treatment of progressive familial intrahepatic cholestasis (PFIC).
May 26, 2021
CMA has launched an anti-competition investigation into AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals.
FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.
May 25, 2021
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
The guidance addresses implementation of amendments made by the FDA Reauthorization Act of 2017.