Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China. 1 Kratz et al.,

Licensing 52

Licensing Licensing Pharmaceutical Companies Treatment 52

The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. TOKYO and CAMBRIDGE, England , Dec.

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

Drug Target Review

JULY 6, 2023

1 Ethical concerns surrounding the use of animal studies is increasing, especially considering 90 percent of drug candidates fail in clinical trials. 2 Therefore, the scientific community is researching and developing efficient ways to test compounds without the use of animals, to avoid unsuccessful outcomes in clinical trials.

Animal Testing 105

Animal Testing Drugs Clinical Trials Clinical Research 105

The Pharma Data

DECEMBER 30, 2020

Long-term safety profile consistent with previously completed controlled trials. Treatment with AXS-07, rapidly, substantially, and durably relieved migraine pain and associated symptoms in this trial. The study enrolled patients who had completed the previous pivotal studies of AXS-07: the MOMENTUM and INTERCEPT trials.

Trials 52

Trials Treatment Clinical Trials Therapies 52

The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

NOVEMBER 5, 2020

There was a handful of positive clinical trial news reported today. The Janssen Pharmaceutical Companies of Johnson & Johnson announced two Phase III trials, DISCOVER-1 and 2 demonstrated Tremfya (guselkumab) improved fatigue in adults with active psoriatic arthritis (PsA). Here’s a look. Janssen’s Tremfya. Pfizer’s Xeljanz.

Clinical Trials 40

Clinical Trials Trials Hospitals Pharmaceutical Companies 40

The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. BioInvent International AB (publ).

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

DECEMBER 1, 2020

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the open-label Phase 2 COMET-TRD trial of AXS-05 in patients with treatment resistant depression (TRD). AXS-05 was well tolerated in the COMET trial.

Treatment 52

Treatment Trials Clinical Trials Therapies 52

The Pharma Data

DECEMBER 13, 2020

To access the live call, please dial 1 (833) 540-1168 (domestic) or 1 (929) 517-0359 (international) and refer to conference ID 8792127. RLY-1971 is currently being evaluated in a first-in-human trial designed to treat patients with advanced or metastatic solid tumors. ET to discuss the collaboration. About Relay Therapeutics.

Licensing 40

Licensing Licensing Clinical Trials Small Molecule 40

The Pharma Data

APRIL 29, 2022

SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data.

Clinical Trials 52

Clinical Trials Vaccine Licensing Licensing 52

The Pharma Data

DECEMBER 20, 2020

“This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. Philippe Archinard , PhD, Chairman and CEO of Transgene, said: “We are pleased that we have received a first approval to initiate the Phase l/lla trial of BT-001. LUND, Sweden and STRASBOURG, France , Dec.

Virus 40

Virus Trials Clinical Trials Clinical Development 40

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — The members of the Nomination Committee for BioInvent International AB :s (publ) (“BioInvent) Annual General Meeting in 2021 have now been appointed. Proposals to the Nomination Committee can be sent to Stefan Ericsson , by mail: BioInvent International AB (publ).), BioInvent International AB (publ).

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

New Drug Approvals

DECEMBER 24, 2023

1] Society and culture Names Eplontersen is the international nonproprietary name. [9] 1] Society and culture Names Eplontersen is the international nonproprietary name. [9] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85” WHO Drug Information. 22 December 2023.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. ” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Protalix has licensed to Pfizer Inc. CARMIEL, Israel and BOSTON , Dec.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

NOVEMBER 23, 2020

“In the last months, Ultimovacs has strengthened its corporate and clinical development position having launched multiple mid-stage clinical trials and established a solid financial runway. Mr. Berkien is currently a board member of the Nordic Pharma Licensing Group.

Clinical Trials 52

Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. Wainberg, M.D., .

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

JANUARY 19, 2021

BioInvent’s management team will also give an update on the ongoing Phase I/IIa trial of BI-1206 in combination with rituximab and BioInvent’s partner CASI Pharmaceuticals (NASDAQ: CASI) will provide an update on the development plan and potential for BI-1206 in China. BioInvent International AB (publ) Co.

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

The Pharma Data

NOVEMBER 18, 2020

. “Based upon our anti-Globo H targeted approaches in cancers of high unmet needs, OBI Pharma is proud to have presentations on the progress of our trial presented at ESMO-Asia 2020 for our novel therapeutic cancer vaccine, OBI-833.” Title: A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients.

Vaccine 52

Vaccine Small Molecule Immune Response Hospitals 52

The Pharma Data

JANUARY 21, 2021

.–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. Eur J Neurol. 2020;27(S1).

Trials 52

Trials Treatment Disease Therapies 52

The Pharma Data

JANUARY 27, 2021

Based on these results, we will now move to identify the recommended Phase II dose for the Phase IIa part of the trial and look forward to further evaluating the exciting potential of BI-1206 to bring much needed innovation to lymphoma patients,” said Martin Welschof, Ph.D, (Nasdaq: CASI), a U.S. CEO of BioInvent.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

LifeSciVC

JULY 6, 2023

After years of steady progress and tens of millions of dollars invested, Sanofi Genzyme corporate strategy shifted, and eventually a strategic decision was made to suspend the program, focus resources on immunology/immuno-oncology, and out license these assets. I hope that others in our industry maintain a similar focus on innovation.

Small Molecule 47

Small Molecule Licensing Licensing Science 47

The Pharma Data

NOVEMBER 26, 2020

an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Protalix has licensed to Pfizer Inc. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial.

Disease 52

Disease Treatment Clinical Trials FDA 52

The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program. ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan.

Licensing 40

Licensing Licensing Clinical Trials Disease 40

New Drug Approvals

SEPTEMBER 6, 2024

2 History Efficacy was evaluated in MARIPOSA (NCT04487080), a randomized, active-controlled, multicenter trial of 1074 participants with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic non-small cell lung cancer and no prior systemic therapy for advanced disease. [2] 20 August 2024.

FDA Approval 48

FDA Approval FDA International Treatment 48

The Pharma Data

NOVEMBER 29, 2020

C-Founder of Ascentage Pharma and Chairman of its Scientific Advisory Board, and Warner-Lambert/Parke-Davis Professor in Medicine, Professor of Internal Medicine, Pharmacology and Medicinal Chemistry, Director of Michigan Center for Therapeutic Innovation, University of Michigan , is a leading researcher in the field. Shaomeng Wang, Ph.D.,

Licensing 40

Licensing Licensing Small Molecule Clinical Trials 40

The Pharma Data

JANUARY 13, 2021

“This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. Tislelizumab is being investigated in a broad clinical program, including five Phase 3 trials in lung cancer indications.

Production 52

Production Trials Clinical Trials Treatment 52

The Pharma Data

NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — BioInvent International AB ‘s (publ) (“BioInvent”) (OMXS: BINV) Extraordinary General Meeting (the “EGM”) today resolved to approve the Board of Directors’ resolution on a directed issue of 29,395,311 new shares and 14,697,655 new warrants to CASI Pharmaceuticals Inc.

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

JANUARY 12, 2021

JTX-4014 demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor naïve patients, which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, JTX-4014 was shown to have an acceptable safety profile.

Clinical Trials 52

Clinical Trials Therapies Trials Science 52

The Pharma Data

AUGUST 15, 2021

VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease. Pfizer is collaborating with Vivet on the clinical supply of VTX-801 for the Phase 1/2 clinical trial.

Disease 52

Disease FDA Treatment Clinical Trials 52

Codon

SEPTEMBER 29, 2024

The average pass rate of phase I trials went up by 5 percent. At best, the corporations with the best models released weak versions to the public under non-commercial licenses. Internally, they had a simplified architecture. Existing preclinical studies were halted based on suggested toxicological concerns the model raised.

Engineering 137

Engineering Virus DNA Therapies 137

The Pharma Data

SEPTEMBER 7, 2021

Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. Our Clinical Trials and Research. Contributions to Research, Life-Sciences Industry.

Clinical Trials 52

Clinical Trials Vaccine Virus Trials 52

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related. Non-COVID-19-Related.

Long-Term Care Facilities 52

Long-Term Care Facilities Trials Virus Clinical Trials 52

The Pharma Data

APRIL 27, 2022

About Tislelizumab Novartis is evaluating tislelizumab, a uniquely designed anti-PD-1 monoclonal antibody, in a global clinical development program consisting of 14 pivotal clinical trials across a broad array of solid tumors, with more than 8,800 patients enrolled to date in 35 countries.

Treatment 52

Treatment Clinical Development Therapies Clinical Trials 52

The Pharma Data

JANUARY 31, 2021

This, along with our other partnerships and internal programs, reflects Gilead’s commitment to continuing innovation to discover a cure for HIV and bring about an end to the HIV epidemic.”. “We This press release features multimedia.

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

New Drug Approvals

SEPTEMBER 20, 2023

1] [2] Society and culture Names Motixafortide is the international nonproprietary name. [4] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82” WHO Drug Information. 1] Motixafortide is a hematopoietic stem cell mobilizer and a CXCR4 antagonist. [1] an autologous transplant).

FDA Approval 52

FDA Approval FDA International Clinical Trials 52