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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Drug Discovery World

JULY 1, 2024

To address this bottleneck, Formation Bio (launched in 2016 as TrialSpark) has built technology platforms, processes, and capabilities with the aim of accelerating drug development and clinical trials.

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Drug Discovery World

JANUARY 8, 2024

The partners plan to take a MERS vaccine from early development through Phase II clinical trials. If the Phase II clinical trials are successful, an investigational ready reserve of 100,000 doses will be developed to quickly enter clinical trials in the event of a substantial outbreak.

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Vaccine Clinical Trials Licensing Licensing 148

Drug Discovery World

JULY 12, 2024

Earlier this year, AskBio presented the 18-month Phase Ib clinical trial results for AB-1005 , which met its primary objective of evaluating the safety of a one-time bilateral delivery of AB-1005 directly to the putamen.

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Drug Discovery World

AUGUST 21, 2024

Adcendo and Multitude Therapeutics have signed a licensing agreement for the development of a novel, highly differentiated antibody-drug conjugate (ADC) targeting Tissue Factor (TF) with the development code ADCE-T02.

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Drug Discovery World

DECEMBER 14, 2023

Dr Amrolia is Professor of Transplantation Immunology at the UCL Great Ormond Street Institute of Child Health and an international leader in CAR T-cell therapy for paediatric ALL, and ViroCell Biologics is a specialist viral vector CDMO for cell and gene therapy (CGT) clinical trials. The study is expected to initiate in Q2 2024.

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Drug Discovery World

NOVEMBER 16, 2023

Casgevy (exagamglogene autotemcel, or exa-cel) is the first medicine to be licensed that uses gene editing tool CRISPR, for which its inventors were awarded the Nobel Prize in 2020. Trial results for Casgevy The authorisation is based on positive clinical trial data.

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Therapies Clinical Trials Trials Treatment 278

BioPharma Drive: Drug Pricing

AUGUST 20, 2024

In addition to new stock offerings, this week saw Merck license an antibody drug conjugate and BARDA further work trying to innovate remote clinical trials.

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Clinical Trials Licensing Licensing Trials 57

Drug Discovery World

AUGUST 25, 2023

The headline news this week reflects the high level of interest and investment in neuroscience drug discovery, particularly neurodegenerative diseases like Alzheimer’s; including positive clinical trial results for new immunotherapy and biotherapeutic candidates, and hopes that existing medications could slow the progression of dementia.

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Drug Discovery World

DECEMBER 7, 2023

A potential schizophrenia treatment, discovered at Vanderbilt University in Tennessee in the US, has been cleared by the US Food and Drug Administration for use in Phase I clinical trials.

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Drug Discovery World

AUGUST 24, 2022

The medicine was licensed earlier this year by the Medicines and Healthcare products Regulatory Agency (MHRA). Whilst it is being used to treat patients with severe complications of monkeypox, there have been no clinical trials to confirm whether the drug can speed up recovery times. . PLATINUM will provide that evidence.”

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Clinical Trials Treatment Trials Small Molecule 52

The Pharma Data

AUGUST 5, 2020

AstraZeneca has signed a licensing deal with UK-based biotech company Redx Pharma for its fibrotic disease candidate RXC006. Following the out licensing agreement, AZ will take RXC006 into clinical development, and will focus on evaluating the asset in a number of fibrotic disease including IPF.

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Licensing Licensing Clinical Trials Clinical Development 52

Drug Discovery World

OCTOBER 3, 2023

Phase III trial data The WHO recommendation was based on pre-clinical and clinical trial data which showed good safety and high efficacy in four countries, making it the world’s second-ever WHO recommended vaccine for preventing malaria in children.

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Vaccine Clinical Trials Licensing Licensing 148

Drug Discovery World

JANUARY 25, 2024

This follows another BIA report in January 2024, which showed that the UK is a global leader in cell and gene therapy (CGT), with significant investment and the highest number of clinical trials in Europe. Major licensing and M&A deals demonstrate the ongoing quality and attractiveness of UK science.

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Drug Discovery World

JULY 26, 2023

A Cancer Research UK-funded clinical trial has shown, for the first time, that a new class of antibody could benefit cancer patients whose existing treatments have stopped working. The drug, MOv18 IgE, was developed by researchers at King’s College London.

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Drug Discovery World

JANUARY 3, 2023

A monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, has entered clinical trials less than 12 months after discovery. . The commencement of the trial triggers a $5 million milestone payment to RQ Bio and will enable the company to execute its four scientific programmes focused on viral diseases. .

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Drug Discovery World

AUGUST 2, 2022

Biotechnology company Calidi Biotherapeutics has announced that a Phase I US clinical trial will use the company’s licensed oncolytic virotherapy platform NeuroNova to deliver an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma. . Official comments .

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

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Clinical Trials Vaccine Trials Immune Response 52

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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Drug Discovery World

MARCH 7, 2024

A combined pipeline of therapeutic candidates Akari’s nomacopan is a bispecific recombinant inhibitor of complement C5 and leukotriene B4 (LTB4) being evaluated in a Phase III clinical trial for paediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).

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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 Discovery World

NOVEMBER 6, 2023

Approved projects will then be brought into the CDD for its experienced team to plan, sponsor and run an early phase clinical trial. Cancer Research Horizons will lead on any subsequent later-stage development which may include out-licensing to a suitable third party.

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Conversations in Drug Development Trends

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. That’s because psychedelic trials are logistically heavy, requiring special licensing for drug handling, training for staff in Schedule I drug requirements, and standardized facilities.

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Drug Discovery World

OCTOBER 2, 2023

INAQOVI, developed by Otsuka Pharmaceutical and Astex Pharmaceuticals, is the first oral hypomethylating agent to be licensed in the EEA in this patient population.

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Drug Discovery World

MARCH 27, 2024

These include the Gamaleya Federal Research Center of Epidemiology and Microbiology’s GamTBvac and the University of Zaragoza’s MTBVAC, both of which are currently in Phase III development and have demonstrated positive safety and efficacy results in clinical trials.

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Drug Discovery World

MARCH 20, 2024

Suitable projects will then be brought into the CDD post-approval for its experienced team to plan, sponsor and run an early-phase clinical trial. Cancer Research UK’s innovation unit, Cancer Research Horizons, will lead on any subsequent later-stage development which may include out-licensing to a suitable third party.

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Drugs Clinical Trials Licensing Licensing 130

Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor.

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Drug Discovery World

JULY 2, 2024

Current applications are primarily within clinical trials, but the growing body of evidence suggests that microbiome-based interventions may soon become a valuable component of cancer treatment strategies,” said Hedyeh Ebrahimi, City of Hope postdoctoral medical oncology fellow and first author of the study.

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Drug Discovery World

JULY 28, 2023

The top stories: Partnership could enhance antibody discovery for cancer research Cancer Research Horizons has signed a collaboration agreement to license the entire Twist Biopharma Solutions Library of Libraries. New eBook: Breakthroughs accelerating therapeutic antibodies The latest eBook by DDW is out now.

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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

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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Drug Discovery World

DECEMBER 20, 2022

The clinical development of etranacogene dezaparvovec was led by uniQure and sponsorship of the clinical trials transitioned to CSL after it licensed global rights to commercialise the treatment. . Thank you to all for the role you have played in helping us reach this regulatory milestone in Europe.” .

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Drug Discovery World

OCTOBER 27, 2023

A Phase I clinical trial to evaluate the safety and tolerability of HB‑400 in humans is ongoing. It is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead Sciences.

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Drug Discovery World

AUGUST 23, 2022

If approved, ASTX727 would be the first and only oral hypomethylating agent licensed in the European Economic Area (EEA) for the initial treatment of adults with AML who are ineligible for intensive chemotherapy, offering a potentially more convenient treatment regimen. .

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Drug Discovery World

MARCH 6, 2024

Earlier last year the biotech successfully led a second round of investment, taking the total up to £13.2m ($16.7m), which will take it up to the start of in-human clinical trials later this year. SynaptixBio has signed a worldwide exclusive license to intellectual property from CHOP, enabling commercialisation of a treatment​.

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