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© 2022 MJH Life Sciences and BioPharm International. All rights reserved.
© 2022 MJH Life Sciences™ and BioPharm International. All rights reserved.
FDA is incentivizing drug manufacturers through higher data integrity requirements.
Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.
A structured assessment process can determine compliance for lifecycle process validation.
August 16, 2022
Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA.
The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain.
A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.
August 15, 2022
The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.
August 12, 2022
Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.
Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.
Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.
August 11, 2022
Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.
August 10, 2022
FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.
Democrats approve curbs for Medicare plans, but not for commercial drug coverage.