topic regulatory-filings-and-submissions 
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.
FDA Law Blog: Biosimilars
APRIL 21, 2024
5,196,404 covering ANGIOMAX (bivalirudin) after the company’s patent counsel untimely filed for a PTE 62 days after the ANGIOMAX NDA 020873 approval at 5:18 PM on Friday, December 15, 2000 (see our summary and “coda” posts here and here ). which brings us to the topic of this post. Patent and Trademark Office (“PTO”) for U.S.
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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
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.
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.
Pharma in Brief
JANUARY 9, 2022
In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. As a result of these amendments, Health Canada will now approve a COVID-19 drug by issuing a notice of compliance ( NOC ) after examining a new drug submission ( NDS ) or supplement to a new drug submission ( SNDS ).
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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