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Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

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Drug discovery quarterly review: Second quarter 2023  

Drug Discovery World

joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. Regulatory developments There were several noteworthy developments across Pfizer’s pipeline, which were covered by DDW. Chris Boshoff, M.D.,

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FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

The Pharma Data

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif., Outside the U.S.,

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ViiV Healthcare Announces Analysis Showing no Antiretroviral Therapy Interruptions Due to COVID-19 Across its Clinical Development Programme for Investigational, Long-Acting Cabotegravir and Rilpivirine

The Pharma Data

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK .

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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at [link] by calling 1-800-822-7967.

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Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

The Pharma Data

No serious adverse events related to the vaccine candidates studied were reported. The majority of adverse events were mild and transient. We are proud to be partnered with Clover in our endeavors to develop a safe and effective COVID-19 vaccine that will be readily accessible around the world to combat this ongoing pandemic.”.

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Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% Senior Vice President and Head of Global Clinical Development at Regeneron. There was a 1.08

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