Disease, Licensing and Research Laboratories

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

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

The Pharma Data

MARCH 8, 2021

“We are very pleased to share our initial Phase 2 infectivity data at this important conference, which remains at the forefront for critical clinical scientific information in infectious diseases,” shared Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics. “At About Molnupiravir. About Ridgeback Biotherapeutics.

Trials

Trials Virus RNA Research Laboratories

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

The Pharma Data

JULY 12, 2021

The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). Since licensed by Ridgeback, all funds used for the development of EIDD-2801/MK-4482 have been provided by Wayne and Wendy Holman and Merck. About Ridgeback Biotherapeutics.

Clinical Trials

Clinical Trials Laboratories Research Laboratories RNA

Collaboration with the LIBD to Develop Centrally Acting COMT Inhibitors

The Pharma Data

MARCH 16, 2021

This collaboration with the Lieber Institute further expands our innovative neuropsychiatric research program, a key focus area at Boehringer Ingelheim, with a first-in-class mechanism that may have the potential to address these symptoms,” said Dr. Hugh Marston, Ph.D., Head of Department CNS Diseases Research at Boehringer Ingelheim. “By

Licensing

Licensing Licensing Research Laboratories Pharmaceutical Companies

ELRIG Announces USA Forum on Neuroimmunology in Drug Discovery

Elrig

APRIL 29, 2025

Understanding the role of neuroimmune interactions has become increasingly important in tackling complex neurological diseases. 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 Laboratories

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.

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. 24] These submissions all related to a single disease. In seeking to justify regulation of LDTs, FDA emphasizes that many of these tests are novel. [6] 68006, 68012 (Oct.

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. The drug also received Rare Pediatric Disease Designation for these indications. It was granted Priority Review.

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. In the U.S.,

FDA

FDA Therapies Treatment Clinical Research

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. Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Data from the study is expected in the second half of 2021.

Laboratories

Laboratories Clinical Trials Virus Trials

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. Prometheus Laboratories, Inc.,

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

. “The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” said Daniel Skovronsky, M.D., www.lilly.com?and?www.lilly.com/news.?P-LLY.

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 scientists rapidly developed the antibody in less than three months 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 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. Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to develop early-stage drug candidates for viral diseases of global concern, advanced molnupiravir through IND submission. Emory/DRIVE received some research funding from the U.S. to 51.7%]; 6.6%

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. About BLAZE-4.

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 scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. www.lilly.com?and?www.lilly.com/news.?P-LLY.

Hospitals

Hospitals Treatment Trials Long-Term Care Facilities

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 scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.

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. Forward-Looking Statement of Merck & Co.,

Trials

Trials Clinical Trials International Production

Drug Discovery Digest

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

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

Trending Sources

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

Collaboration with the LIBD to Develop Centrally Acting COMT Inhibitors

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 Biotherapeutics Announce Initiation of Pivotal Phase 3.

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

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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