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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

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine.

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Crescita Announces Licensing Agreement for Pliaglis; in China

The Pharma Data

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8

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Update on the safety of COVID-19 Vaccine AstraZeneca

The Pharma Data

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines.

Vaccine 52
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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

This product was developed by uniQure prior to being licensed to CSL Behring. This was despite the 6-month data also demonstrating clinical benefits in reduction of bleeding events and declines in the use of FIX replacement therapy.

Therapies 119
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Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. About Molnupiravir.

Trials 69
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COVID-19 nasal vaccine candidate effective at preventing disease transmission

The Pharma Data

That’s how easy it’s for SARS-CoV-2, the virus that causes COVID-19, to enter your nose. Anderson Professor of Chemical and Biomolecular Engineering, and his colleagues, are reporting in iScience the event of an intranasal subunit vaccine that gives durable local immunity against inhaled pathogens. Breathe in, exhale.

Vaccine 52
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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% There was a 1.08 REGN-COV2 was well tolerated in the trial. high dose, 1.6% low dose; 2.3%

Virus 40