Pharmaceutical Technology

AUGUST 28, 2022

The latest development comes after Moderna sought emergency use authorization from the US Food and Drug Administration for its BA.4/BA.5 Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. 5 Omicron-targeting bivalent booster vaccine for Covid-19, mRNA-1273.222.

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Pharmaceutical Technology

SEPTEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) for bivalent formulations of Moderna and Pfizer -BioNTech’s Covid-19 vaccines as boosters. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. 5 lineage of the Omicron variant.

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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 companies have also commenced rolling submission for conditional marketing authorization from the European Medicines Agency (EMA) for this Omicron BA.4/BA.5-adapted

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Pharmaceutical Technology

OCTOBER 10, 2022

The data from the trial will be provided to the authorities in the coming months. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. A clinical trial of the vaccine is currently underway in individuals aged 12 years and above. 5-adapted bivalent vaccine in children aged five to 11 years for review.

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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. 5 subvariants of Omicron.

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Pharmaceutical Technology

AUGUST 30, 2022

Moderna chief commercial officer Arpa Garay said: “We are delighted to receive authorization from Swissmedic for our next-generation bivalent vaccine, mRNA-1273.214. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

NOVEMBER 7, 2022

In September, the European Medicines Agency (EMA) accepted the company’s submission seeking Conditional Marketing Authorization (CMA) variation for mRNA-1273.222 for use in individuals aged 12 years and above. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

OCTOBER 18, 2022

In August, the company sought emergency use authorization (EUA) from the US Food and Drug Administration for mRNA-1273.222, its BA.4/BA.5 Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. 5 Omicron-targeting bivalent booster vaccine for Covid-19.

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Pharmaceutical Technology

NOVEMBER 22, 2022

The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. 326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). With the world watching, the biopharmaceutical community got to work.

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Pharmaceutical Technology

AUGUST 24, 2022

Mode rna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. 5 Omicron-targeting bivalent booster vaccine for Covid-19.

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Pharmaceutical Technology

DECEMBER 20, 2022

Joseph McCall, article co-author and director, QA technical service, ADMA Biologics, explains why forming the group made sense both for the companies involved and for the industry: “We’ve found great advantage in sharing information and best practices so that you don’t have to make a mistake in order to learn from it. “The

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Pharmaceutical Technology

NOVEMBER 9, 2022

While experts interviewed by Pharmaceutical Technology found the cost-effectiveness estimates valid, the durability of gene therapies in haemophilia remains unclear, particularly in the case of Roctavian, which has faced similar queries from regulatory authorities. Topic sponsors are not involved in the creation of editorial content.

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ISPE

SEPTEMBER 11, 2023

49 However, regardless of the quality built into a product by enhanced understanding of product CQA and critical processes and the material parameters that impact those CQAs, a significant amount of data generated by manufacturing and testing must be submitted by sponsors to gain health authority approvals.

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