Licensing and Research Laboratories - Drug Discovery Digest

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

The Pharma Data

JULY 2, 2025

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. The product was developed under a licensing agreement with Bristol Myers Squibb. Despite existing therapies, many PAH patients remain at substantial risk.

Trials

Trials FDA Licensing Licensing

Collaboration with the LIBD to Develop Centrally Acting COMT Inhibitors

The Pharma Data

MARCH 16, 2021

In partnering with the Lieber Institute, Boehringer Ingelheim has in-licensed preclinical pipeline candidates, representing a first-in-class approach for targets in neuropsychiatric disorders. The potential of centrally acting COMT inhibitors has not yet been evaluated in the clinic due to the unavailability of such compounds.

Licensing

Licensing Licensing Research Laboratories Pharmaceutical Companies

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

The Pharma Data

JULY 12, 2021

“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 in collaboration with Ridgeback Biotherapeutics.

Clinical Trials

Clinical Trials Laboratories Research Laboratories Hospitals

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

The Pharma Data

MARCH 8, 2021

“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

Trials Virus RNA Research Laboratories

ELRIG Announces USA Forum on Neuroimmunology in Drug Discovery

Elrig

APRIL 29, 2025

She serves as the Director of Business DevelopmentSearch and Evaluation at AstraZeneca, focusing on licensing and collaboration opportunities for drug candidates targeting respiratory and immunology indications.

Drugs

Drugs Science Clinical Trials Doctors

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.

Vaccine

Vaccine Immune Response Disease Clinical Trials

A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. In seeking to justify regulation of LDTs, FDA emphasizes that many of these tests are novel. [6] By their very nature, these tests are less likely to be exempt from FDA review.

FDA

FDA Laboratories Regulations Production

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

The Pharma Data

NOVEMBER 22, 2020

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. It holds the rights for the drug in the rest of the world. Revance Therapeutics’ DAXI to Treat Frown Lines.

FDA

FDA Licensing Licensing Treatment

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

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. Nature Neuroscience. Read You love to see it!

DNA

DNA RNA Engineering Licensing

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

The Pharma Data

AUGUST 10, 2021

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.

FDA

FDA Therapies Treatment Clinical Research

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

The Pharma Data

NOVEMBER 5, 2021

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.

Licensing

Licensing Licensing Vaccine Laboratories

Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3.

The Pharma Data

SEPTEMBER 1, 2021

Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Wayne and Wendy Holman and Merck. If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities.”. in collaboration with Ridgeback Biotherapeutics.

Laboratories

Laboratories Clinical Trials Virus Trials

Making the Micropipette

Codon

JANUARY 2, 2024

Credit: National Institutes of Health A 1915 survey of 57 research laboratories found that 40 percent of workplace-related infections were directly linked to mouth pipetting. Army researchers penned an article entitled, “ Hazards of Mouth Pipetting.” But mouth pipettes were fragile, inaccurate, and dangerous.

Laboratories

Laboratories DNA Licensing Licensing

The First Patented G.M.O.

Codon

JUNE 30, 2024

Chakrabarty was working at the Research & Development Center at General Electric Company in Schenectady, New York when he engineered a Pseudomonas strain to eat oil in 1972, but his interest in these microbes began nearly half a decade earlier while a postdoctoral fellow at the University of Illinois. Credit: Matt H.

DNA

DNA Engineering Laboratories Production

Lilly’s Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19

The Pharma Data

NOVEMBER 9, 2020

Lilly’s chief scientific officer and president of Lilly Research Laboratories. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA). The authorization is temporary and does not replace the formal review and approval process.

Treatment

Treatment FDA Hospitals Long-Term Care Facilities

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

The Pharma Data

APRIL 16, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS). “With the growing prevalence of variants in the U.S.

Treatment

Treatment Hospitals Long-Term Care Facilities Virus

Merck and Ridgeback Announce New Data For Investigational LAGEVRIO™ (molnupiravir) From Phase 3 MOVe-OUT Study

The Pharma Data

JUNE 7, 2022

Li, president, Merck Research Laboratories. Since licensed by Ridgeback, all funds used for the development of LAGEVRIO have been provided by Merck and Ridgeback. Any profits from the collaboration will be split between the partners equally. About Ridgeback Biotherapeutics.

Hospitals

Hospitals Research Laboratories Treatment Disease

Lilly’s bebtelovimab receives Emergency Use Authorization for the treatment of mild-to-moderate COVID-19

The Pharma Data

FEBRUARY 12, 2022

Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. Lilly has licensed and developed bebtelovimab after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.

Treatment

Treatment Hospitals FDA Clinical Trials

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science (IMCAS). have reached record highs.

Hospitals

Hospitals Treatment Trials Long-Term Care Facilities

Merck and Ridgeback Announce Initiation of a Rolling Review by the European Medicines Agency for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of COVID-19 in Adults

The Pharma Data

OCTOBER 26, 2021

Li, administrative vice chairman and chairman, Merck Research Laboratories. “ Food and Drug Administration (FDA), and is laboriously working to submit operations to other nonsupervisory agencies worldwide. This operation to the EMA is another step in our sweats to bring molnupiravir forward to cases encyclopedically,” saidDr.

Treatment

Treatment Government Vaccine Research Laboratories

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

The Pharma Data

MARCH 11, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

Hospitals

Hospitals Trials Long-Term Care Facilities Treatment

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. In 2012, Merck licensed islatravir (4’-ethynyl-2-fluoro-2’-deoxyadenosine or EFdA) from the Yamasa Corporation based in Choshi, Japan. Merck’s Commitment to HIV.

Trials

Trials Clinical Trials International Production

Drug Discovery Digest

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

Collaboration with the LIBD to Develop Centrally Acting COMT Inhibitors

Trending Sources

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

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

ELRIG Announces USA Forum on Neuroimmunology in Drug Discovery

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

A Final LDT Rule in April!? Will FDA be prepared?

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

Codon Digest: Injected Gene Editors

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

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

Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3.

Making the Micropipette

The First Patented G.M.O.

Lilly’s Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

Merck and Ridgeback Announce New Data For Investigational LAGEVRIO™ (molnupiravir) From Phase 3 MOVe-OUT Study

Lilly’s bebtelovimab receives Emergency Use Authorization for the treatment of mild-to-moderate COVID-19

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

Merck and Ridgeback Announce Initiation of a Rolling Review by the European Medicines Agency for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of COVID-19 in Adults

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

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