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US gives EUA J&J’s COVID-19 vaccine
expresspharma
March 01, 2021
In J&J’s 44,000-person global trial, the vaccine was found to be 66 per cent effective at preventing moderate-to-severe COVID-19 four weeks after inoculation.
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Ocugen, Bharat Biotech announce agreement for commercialisation of Covaxin in US market
expresspharma
February 03, 2021
Ocugen is also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN to support its US immunisation programme.
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US approval for MSD’s heart failure med Verquvo
pharmatimes
January 22, 2021
The Food and Drug Administration (FDA) in the US has approved MSD’s (known as Merck in the US and Canada) heart failure treatment Verquvo (vericiguat).
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US could purchase over 1.5 million doses of Regeneron’s COVID-19 antibody cocktail
europeanpharmaceuticalreview
January 19, 2021
The additional doses of casirivimab and imdevimab, two monoclonal antibodies, will be used in non-hospitalised COVID-19 patients.
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Leukocare Starts Operations in the US
contractpharma
January 12, 2021
Leukocare AG, a German biotechnology company specialized in formulation development for biologics, viral vectors and vaccines, has opened its development laboratories and offices in Milford, MA.
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Fujifilm to Invest $2B in US Manufacturing Site
contractpharma
January 08, 2021
Fujifilm Corporation is investing more than $2 billion to establish a new large-scale cell culture production site in the U.S. to accelerate the growth of its biopharmaceutical contract development and manufacturing business.
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US priority review for Forxiga in chronic kidney disease
pharmatimes
January 07, 2021
The US Food and Drug Administration (FDA) has granted AstraZeneca’s Forxiga (dapagliflozin) a priority review for the treatment of new or worsening chronic kidney disease (CKD).
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US may halve doses of Moderna vaccine to speed rollout: Moncef Slaoui
expresspharma
January 05, 2021
Moncef Slaoui, Head of Operation Warp Speed, said that officials were in talks with Moderna and the Food and Drug Administration about the idea.
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Merck announces supply agreement with US for initial doses of investigational biological therapy to treat Covid-19
pharmaceutical-business-review
December 29, 2020
Merck acquired MK-7110 through the acquisition of OncoImmune, a privately held, clinical-stage biopharmaceutical company.
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Biocon launches Tacrolimus capsules in US
expresspharma
December 29, 2020
It is an immunosuppressant used in the treatment of organ transplant patients, which reduces the body’s ability to reject a transplanted organ.