Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Zai Lab is leading clinical development in its territory. “We Read on for this week’s.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

The Pharma Data

MARCH 16, 2021

While peripherally acting COMT inhibitors are currently used as an adjunctive therapy in the treatment of neurological conditions, including Parkinson’s disease, this new collaboration is investigating centrally acting COMT inhibitors in neuropsychiatric disorders. Our mission is to create breakthrough therapies that change lives.

Licensing 52

Licensing Licensing Research Laboratories Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 23, 2020

At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In Ton Berkien joins Ultimovacs with over 15 years of experience in strategic business development and corporate finance in the biopharmaceutical industry.

Clinical Trials 52

Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

The Pharma Data

NOVEMBER 8, 2020

The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy. The NDA was resubmitted on May 2020.

FDA 52

FDA Trials Pharmaceuticals Pharmacokinetics 52

The Pharma Data

AUGUST 1, 2021

AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. 2,3 TULIP-2 demonstrated superiority across multiple efficacy endpoints versus placebo with both arms receiving standard therapy.

Trials 52

Trials Therapies Disease Treatment 52

The Pharma Data

NOVEMBER 18, 2020

The cholesterol-lowering activity of SEFA-1024 was additive to the lowering obtained with statin treatment, suggesting that SEFA-1024 could be used in combination with these important standard-of-care cardiovascular therapies. A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH. 1 [link].

Trials 40

Trials Engineering Pharmacokinetics Therapies 40

The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co.

Clinical Trials 40

Clinical Trials Clinical Development Production Trials 40

The Pharma Data

JANUARY 18, 2021

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. for the treatment of post-herpetic neuralgia.

Small Molecule 40

Small Molecule Clinical Trials Trials Therapies 40

The Pharma Data

OCTOBER 26, 2020

2019. billion related to certain license and collaboration agreements, and certain other items. Merck presented long-term findings from the EORTC1325/KEYNOTE-054 trial evaluating KEYTRUDA as adjuvant therapy in resected, high-risk stage III melanoma at the ESMO Virtual Congress 2020. .

Vaccine 40

Vaccine Trials Licensing Licensing 40

The Pharma Data

OCTOBER 26, 2020

Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. SAN JOSE, Calif. , AR-301 (VAP). AR-101 (HAP).

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Clinical Trials 52

The Pharma Data

NOVEMBER 5, 2020

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. Prior to joining Imperative Care in 2019, Davis served as chief commercial officer and president of North America at Penumbra, Inc.,

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

The Pharma Data

APRIL 27, 2021

the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

JANUARY 7, 2021

NST) is a Dutch biotech company focused on developing structurally engineered fatty acids (‘SEFAs’) for the treatment of inflammatory, metabolic, and liver diseases. A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH. 8, 2021 08:00 UTC.

Engineering 40

Engineering Treatment Licensing Licensing 40

The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. AUTHORIZED USE IN THE U.S.:

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

JANUARY 13, 2021

Dr. Lederman continued, “Despite the recognized promise of anti-CD40-ligand mAb therapy, first generation anti-CD40-ligand mAbs were limited because their crystallizable fragment (Fc) domain interacted with a cell surface receptor called Fc?RII, RII, which resulted in an increased risk of thrombosis. International Immunol. (11):1583

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. AUTHORIZED USE IN THE U.S.: IMPORTANT SAFETY INFORMATION FROM U.S.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 5, 2020

billion versus third quarter 2019 (4). billion versus third quarter 2019. billion versus third quarter 2019. Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.”

Production 52

Production FDA FDA Approval Trials 52

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. Ranibizumab and other anti-VEGF agents have had a dramatic impact on the development of therapies for these blinding disorders.

Science 40

Science Virus FDA Approval Treatment 40

The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., million as of December 31, 2019. Research and development expenses were $16.3

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Small Molecule 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer BioNTech COVID-19 Vaccine.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

Drugs 237

Drugs Licensing Licensing Regulations 237

The Pharma Data

NOVEMBER 29, 2020

Antiviral therapies are used to help control disease, but they are limited by toxicity and the emergence of viral resistance. Participants receive either pre-emptive or prophylactic antiviral therapy post-transplant and are followed for a 12-month observation period. 2019; 102: 900-931. 2019, vol 15, no 11, 2673-2683.

Vaccine 52

Vaccine Clinical Trials Disease Trials 52

The Pharma Data

NOVEMBER 11, 2020

Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a biologics license application (BLA) for a rare pediatric disease product application may be eligible for a voucher which can be redeemed to obtain priority review for a subsequent marketing application for a different product.

Clinical Trials 40

Clinical Trials Trials Disease FDA 40

The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. since Q4 2019.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

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 52

Vaccine Immune Response Disease Clinical Trials 52

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” and Roche will develop, manufacture and distribute it outside of the U.S.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. TARRYTOWN, N.Y. ,

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

SEPTEMBER 9, 2020

Both collaborators are committed to developing these novel vaccines with preclinical and clinical data at the forefront of all their decision making. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. ” About Ascentage Pharma.

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. Rare diseases is a high-growth therapy area with rapid innovation and significant unmet medical need.

Regulations 75

Regulations International Disease Small Molecule 75

The Pharma Data

DECEMBER 10, 2020

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

NOVEMBER 20, 2020

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Vaccine 52

Vaccine FDA Clinical Trials Trials 52

The Pharma Data

AUGUST 20, 2020

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

The Pharma Data

DECEMBER 5, 2020

” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.

Production 40

Production Trials Treatment Pharmaceuticals 40