Remove Licensing Remove Research Laboratories Remove Trials
article thumbnail

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

The Pharma Data

We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Molnupiravir.

Trials 69
article thumbnail

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

The Pharma Data

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. About Molnupiravir.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3.

The Pharma Data

Study Now Enrolling Participants Who Live in the Same Household as Someone With Symptomatic, Laboratory-Confirmed COVID-19. The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms.

article thumbnail

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

The Pharma Data

The company has an exclusive collaboration and license deal with CStone Pharmaceuticals for development and commercialization of pralsetinib and specific other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Patent Trial and Appeal Board (PTAB) had instituted inter partes review (IPR) against U.S.

FDA 52
article thumbnail

Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives First Authorization in the World

The Pharma Data

Li, administrative vice chairman and chairman, Merck Research Laboratories. “ Voluntary licenses As part of its commitment to wide global access, Merck preliminarily blazoned that it has entered into a licensing agreement with the Medicines Patent Pool to increase broad access for molnupiravir in low-and middle- income countries.

article thumbnail

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 application is based on overall response data from Cohorts D and K of the KEYNOTE-158 trial, which will be presented for the first time at the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract #795P). Continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.

FDA 52
article thumbnail

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. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. ” Clinical trials are underway. The Lancet HIV.

DNA 52