Sanofi and GSK's next-generation COVID-19 booster vaccine VidPrevtyn® Beta approved by the European Commission
After the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn® Beta, the vaccine was approved by the European Commission, as a booster for the prevention of COVID-19 in adults 18 years of age and older.
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Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster for children 5 through 11 years of age in European Union
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 5/5 µg) has been recommended for marketing authorization by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for children 5 through 11 years of age.
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Bayer with continued strong performance
The Bayer Group maintained its strong business performance across all three divisions in the third quarter. "Despite rising inflation and global supply chain problems, we were again able to boost sales and earnings," said Werner Baumann, Chairman of the Board of Management, when presenting the company's quarterly statement on Tuesday.
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Salvat Laboratories announces submission of New Drug Application to the U.S. FDA for Clobetasol Nanoemulsion for treating inflammation and pain after ocular surgery
Salvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in post-ocular surgery patients.
This submission comes after two successful phase III clinical trials conducted between 2020 and 2021.
Pfizer and BioNTech announce positive early data from clinical trial of Omicron BA.4/BA.5-adapted bivalent booster in individuals 18 years and older
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced early data from a Phase 2/3 clinical trial (NCT05472038) evaluating the safety, tolerability, and immunogenicity of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)).
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Bayer signs grant agreement to advance innovation in non-hormonal contraception
Bayer announced that it has received a grant from the Bill & Melinda Gates Foundation. As part of the grant, Bayer and the Bill & Melinda Gates Foundation have each committed more than US$ 12 million over four years to co-fund pre-clinical research activities with the goal of providing women globally with an option for non-hormonal contraception.
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Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID‑19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19.
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