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Emergent, amid gung-ho COVID-19 production push, eyes upgrade to Canadian vaccine plant: report

Mar 16, 2021 9:15am Novavax is one of the few COVID-19 vaccine players to pledge production capacity in Canada so far. (Simon Lehmann/iStock/Getty Images Plus) Emergent BioSolutions quickly positioned itself as one of the manufacturers to beat in the U.S. fight against COVID-19. Now, the company s laying out plans to upgrade a vaccine facility in Winnipeg with the help of the Canadian government. Emergent is in talks with Ottawa to fund an expansion of that plant, The Globe and Mail reports. The facility, which employs around 350, is equipped to handle the final manufacturing stages for mRNA, mammalian and microbial drugs including mRNA-based COVID-19 vaccines like those sold by Pfizer and Moderna.

Pfizer s COVID-19 vaccine faced EMA manufacturing concerns ahead of emergency nod: report

Mar 15, 2021 11:12am European regulators raised flags about the mRNA stability of Pfizer and BioNTech s COVID-19 vaccine about a month ahead of its EU authorization. Pfizer said the move was part of the normal regulatory review process. (SolStock) About a month before Pfizer and BioNTech won an emergency nod for their COVID-19 vaccine in Europe, regulators raised flags about lower-than-expected levels of intact mRNA in commercial batches, the BMJ reports. The European Medicines Agency outlined “a significant difference in the RNA in clinical batches and the proposed commercial batches, according to information leaked from an EMA cyberattack in December, which the BMJ subsequently reviewed. 

Fierce Pharma Asia—Takeda s Maverick buyout; Brii COVID antibodies trial halt; Dr Reddy s generic Lipitor recall

Takeda, Brii Biosciences and Dr. Reddy s Laboratories made our news this week. (Google) Takeda is buying its partner Maverick Therapeutics for its T-cell engager platform. The NIH has ended a clinical study testing Brii Biosciences anti-coronavirus antibody cocktail in hospitalized patients. Dr. Reddy s Laboratories is pulling a large volume of its generic Lipitor off U.S. pharmacy shelves due to impurities. And more. Takeda exercised an option to buy out Maverick Therapeutics as part of a collaboration deal penned in early 2017. For up to $525 million upfront, Takeda’s getting full control of Maverick’s COBRA T-cell engager platform and the cancer pipeline built around it. These assets include lead candidate MVC-101, now known as TAK-186, which is in a phase 1/2 study in solid tumors that express EGFR.

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