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FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

The Pharma Data

and Canada, has announced a significant regulatory milestone for its pulmonary arterial hypertension (PAH) treatment, WINREVAIR™ (sotatercept-csrk). Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) and granted it priority review status, seeking to update the U.S.

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

The Pharma Data

At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS. About Molnupiravir.

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Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19.

The Pharma Data

It continues to be critically important to advance potential antiviral treatments to address the devastating impact of COVID-19 globally,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “If View the full release here: [link]. “It

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Collaboration with the LIBD to Develop Centrally Acting COMT Inhibitors

The Pharma Data

Head of Department CNS Diseases Research at Boehringer Ingelheim. “By By combining our expertise, we hope to make significant steps forward to finding solutions for patients for which there currently is no treatment.”. Hugh Marston, Ph.D., The Lieber Institute for Brain Development.

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FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

The Pharma Data

The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments. It holds the rights for the drug in the rest of the world.

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FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) as Single Agent for Certain Patients With MSI-H/dMMR Advanced Endometrial Carcinoma

The Pharma Data

The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. Source link: [link].

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Codon Digest: Injected Gene Editors

Codon

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. When delivered using AAV9 in mice, the treatment significantly improved motor function and extended average lifespan. Nature Neuroscience. Read You love to see it!

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