ViiV Healthcare Initiates Rolling Submission of New Drug Application with US FDA for Long-Acting Cabotegravir for Prevention of HIV

ViiV Healthcare Initiates Rolling Submission of New Drug Application with US FDA for Long-Acting Cabotegravir for Prevention of HIV

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Global specialist HIV company ViiV Healthcare has begun a rolling submission of a new drug application (NDA) with the US FDA for carbotegravir, an investigational, long-acting, injectable drug to prevent HIV. Submissions of regulatory files will begin at the end of this year, focusing initially on countries where clinical trials were conducted. The company will […]

WHO Welcomes Sweden’s Announcement to Share COVID-19 Vaccine Doses with COVAX

WHO Welcomes Sweden’s Announcement to Share COVID-19 Vaccine Doses with COVAX

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Sweden has announced a donation of 1 million doses of the AstraZeneca vaccine to COVAX in order to support supplies in low-income countries and ensure populations are able to receive second doses. WHO and its partners are advocating for countries to make similar contributions, and Director-General Dr. Tedros Adhanom Ghebreyesus welcomed the announcement, stating that […]

WHO Lists Additional COVID-19 Vaccine for Emergency Use and Issues Interim Policy Recommendation

WHO Lists Additional COVID-19 Vaccine for Emergency Use and Issues Interim Policy Recommendation

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The Sinopharm COVID-19 vaccine, produced by Beijing Bio-Institute of Biological Products Co Ltd, has been listed for global emergency use. “The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccineaccess for countries seeking to protect health workers and populations at risk,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Health […]

Bharat Biotech and ICMR Announce Interim Results from Phase 3 trials of COVAXIN®; Demonstrates overall Interim Clinical Efficacy of 78% and 100% efficacy against Severe COVID-19 disease

Bharat Biotech and ICMR Announce Interim Results from Phase 3 trials of COVAXIN®; Demonstrates overall Interim Clinical Efficacy of 78% and 100% efficacy against Severe COVID-19 disease

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Globally recognized biotechnology innovator and distributor, Bharat Biotech, along with CMR, has announced promising Phase 3 trial Interim Results for COVAXIN®. Analysis based on a study that enrolled 25,800 participants between the ages of 18 and 98, of which 10% were over the age of 60, showed 78% Interim Clinical Efficacy. 100% efficacy was recorded […]

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

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A rare and critical type of blood clot called cerebral venous sinus thrombosis (CVST) has been detected in combination with low levels of blood platelets (thrombocytopenia) in six women between the ages of 18 and 48, 6 to 13 days after they received doses of the Johnson & Johnson (Janssen) vaccine in the U.S. More […]

All Californians 16+ Now Eligible for COVID-19 Vaccines

All Californians 16+ Now Eligible for COVID-19 Vaccines

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Following major milestones in its vaccination program, with almost half its population aged 16 and up and 73.9% of seniors over 65 have received one dose, all residents of the state of California ages 16 and above have become eligible for COVID-19 vaccinations as of April 15 th. This decision meets President Biden’s nationwide deadline […]

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