The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

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The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. LOS ANGELES , Jan.

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Drug Target Review

NOVEMBER 25, 2024

I saw an opportunity which others didn’t, to develop a small molecule targeting a well-known cancer pathway, a master switch of cancer Afterwards, I moved to Germany to work for Merck KGaA, where I headed up the licensing and business development team. I would also advise anyone, young women and men included, to always believe in themselves.

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The Pharma Data

OCTOBER 19, 2020

In addition to its manufacturing efforts, the Company has also made progress in its clinical trial preparations. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc.

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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.

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The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

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Drug Target Review

FEBRUARY 9, 2024

What are the current challenges and limitations surrounding stem cell therapy in preclinical studies, and how are these issues addressed to ensure the safety and efficacy of potential treatments before advancing to clinical trials? Despite their potential, ADSC therapy faces several challenges in preclinical studies.

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The Pharma Data

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders.

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The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

JANUARY 13, 2021

Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

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Drug Target Review

MARCH 4, 2025

The MyPhenome test has already gained traction among obesity specialists, particularly in Chicago and Florida, and Phenomix has formed strategic partnerships with multiple pharmaceutical companies to support clinical trials and further analyse obesity-related data.

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Drug Hunter

APRIL 20, 2023

The molecule was the first allosteric TYK2 inhibitor to enter clinical trials, is the first JAK-family kinase inhibitor approved for psoriasis, and is also the first approved drug targeting a pseudokinase domain. MRTX1133 is currently in Ph I/II trials as an oral agent. #3: For more coverage, visit December 2022’s MOTM.

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

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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.

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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.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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The Pharma Data

OCTOBER 22, 2020

Additional details on the INTERLINK-1 clinical trial can be found here. Including the $50 million payment triggered by dosing the first patient in the Phase 3 INTERLINK-1 clinical trial, Innate Pharma has received $400 million to date. . MARSEILLE, France, Oct. About Innate Pharma: Innate Pharma S.A.

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The Pharma Data

AUGUST 17, 2020

In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. Dragonfly received U.S. Food and Drug Administration clearance in May 2020 for its investigational new drug application to develop DF6002.

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The Pharma Data

DECEMBER 13, 2020

RLY-1971 is currently being evaluated in a first-in-human trial designed to treat patients with advanced or metastatic solid tumors. To learn more about the first-in-human clinical trial of RLY-1971, please visit here. About Relay Therapeutics.

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The Pharma Data

MARCH 30, 2021

In particular, our expectations regarding the FAP targeting agents, including FAPI-46 and FAPI-74,could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global (..)

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Predictive Oncology

MARCH 17, 2023

Cancer Research Horizons to incorporate PEDAL into future drug discovery processes to enable drug development on a global scale 11 marketed drugs 2nd largest oncology out-licensor globally 150+ active licenses 160+ new drugs into early-phase clinical trials $647 million revenue from royalties & IP $2.8

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Drug Target Review

DECEMBER 11, 2024

Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials. An approach grounded in GLP, coupled with advanced analytical techniques, is essential for effectively mitigating matrix effects.

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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.

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The Pharma Data

NOVEMBER 25, 2020

Under the agreement, which may generate revenue for BioInvent of up to SEK 30 million , BioInvent will provide process development, scale-up, supply of material for toxicological studies and clinical grade material in 1000L scale for use in phase I and II clinical trials. The Company’s validated, proprietary F.I.R.S.T

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Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec.

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The Pharma Data

AUGUST 11, 2020

Researchers at University College London conducted the two year clinical trial which showed that the progression of the disease could be halted for over two years. Researchers want to investigate this drug further and are hoping to collaborate with AstraZeneca on a larger clinical trial.

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New Drug Approvals

APRIL 2, 2025

3] History Vertex Pharmaceuticals announced in January 2024 that suzetrigine had successfully met several endpoints in its Phase III clinical trials. [5] 3] History Vertex Pharmaceuticals announced in January 2024 that suzetrigine had successfully met several endpoints in its Phase III clinical trials. [5] 85 (1): 1119.

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The Pharma Data

JANUARY 3, 2021

The company expects to dose the first patient for the global PBGM01 clinical trial program in the first quarter of 2021. FDA clearance of our IND represents a significant milestone that supports the transition of Passage Bio to a clinical-stage company,” said Bruce Goldsmith, Ph.D., About PBGM01.

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LifeSciVC

JULY 17, 2024

In parallel, we’re developing our own complementary correctors to enable combination therapies, with multiple candidates targeting different regions of the CFTR protein, including one that is currently in an ongoing Phase 1 clinical trial.

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The Pharma Data

AUGUST 4, 2020

UK-based Oxford Biomedica has signed a new development, manufacture and license agreement with Beam Therapeutics for next-generation CAR-T therapeutics. The agreement grants Beam a non-exclusive license to Oxford Biomedica’s LentiVector platform, for tis application in next-generation CAR-T programmes in oncology.

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Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. The post The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment appeared first on Worldwide Clinical Trials. In June 2023, the U.S.

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New Drug Approvals

DECEMBER 24, 2023

Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85” WHO Drug Information. hdl : 10665/340684.

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Advarra

AUGUST 2, 2022

The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. Could our Trial Lend Itself Well to a DCT Model? Clinical trials are slow and costly, built around the research centers studying local participants.

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