Pharmaceutical Technology

SEPTEMBER 29, 2022

The European Medicines Agency (EMA) has accepted Moderna ’s submission seeking a variation to the Conditional Marketing Authorization (CMA) for assessing a 50µg dose of the Omicron-based bivalent Covid-19 booster candidate, mRNA-1273.222, for adults aged 12 years and above. The company is also seeking regulatory approvals across the globe.

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Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted The submission comes after the regulatory agency provided guidance to incorporate clinical findings of the bivalent Omicron BA.1-adapted

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Pharmaceutical Technology

AUGUST 24, 2022

The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above. Topic sponsors are not involved in the creation of editorial content. 1 subvariant.

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Clarivate

NOVEMBER 17, 2021

In this episode of Conversations in Healthcare , Carolyn Hynes from AstraZeneca discusses the importance of regulatory intelligence. Moreover, being compliant with today’s regulations is not necessarily sufficient because the regulatory environment itself keeps evolving. Mike Ward: Celine, what’s your take on this topic?

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Pharmaceutical Technology

APRIL 25, 2023

The BLA filing brings bluebird closer to its competitors CRISPR Therapeutics and Vertex Pharmaceuticals , which finished a rolling BLA for their CRISPR-based gene therapy exa-cel for the same condition earlier this month. The Somerville, Massachusetts-headquartered company has also requested a priority review.

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Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

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