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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Clinical Trials Trials Compliance FDA 40

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. at 16 weeks and 76.2% at 52 weeks). .”

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Trials Clinical Trials Treatment Licensing 130

Drug Discovery World

AUGUST 16, 2024

CAR-T therapy for nasopharyngeal cancer enters Phase II trials The US Food and Drug Administration (FDA) has approved a Phase II clinical trial for Biosyngen’s BRG01, an EBV-specific CAR-T cell therapy. First claudin 18.2 monoclonal antibody.

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Licensing Licensing Drugs Clinical Trials 147

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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Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. Chief Investigator Dr Bristi Basu, University of Cambridge, and Co-Chief Investigator Dr Debashis Sarker, King’s College London, are leading the trial.

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Trials Small Molecule Pharmacokinetics Clinical Trials 130

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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Trials Clinical Trials Regulations FDA 80

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. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

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Trials Clinical Trials Licensing Licensing 97

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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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 147

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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Therapies Clinical Trials FDA Clinical Development 147

Drug Discovery World

AUGUST 24, 2022

The trial will see participants receive either a 14-day course of 600 mg tecovirimat twice daily or a matched placebo treatment. As a community-based trial, participants will take the treatment or placebo in their own homes. The trial looks to include at least 500 participants in the UK. .

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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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Research Clinical Trials Licensing Licensing 130

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

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

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. February 2022.

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Vaccine Disease Trials Pharmaceutical Companies 130

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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Clinical Trials Vaccine Licensing Licensing 130

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

JULY 2, 2024

In a Phase I trial, patients with metastatic kidney cancer who took a live biotherapeutic product alongside immunotherapy and enzymatic tyrosine kinase inhibitors experienced improved health outcomes.

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Trials Treatment Clinical Trials Licensing 147

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 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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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

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

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.

Vaccine 147

Vaccine Clinical Trials Licensing Licensing 147

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 40

The Pharma Data

OCTOBER 19, 2020

. “We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner. We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S.

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Clinical Trials Trials Pharmaceuticals Treatment 52

Drug Discovery World

MARCH 24, 2023

This synergy was demonstrated by the AIPAC Phase IIb trial’s encouraging efficacy and safety, including a over 2.9-month Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA).

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Drug Discovery World

NOVEMBER 6, 2023

The CDD will sponsor and manage KWF-supported trials. Dr Stephen Nabarro, Interim Director of Cancer Research UK’s Centre for Drug Development, said: “We are delighted to join forces with KWF, who will be invaluable in helping us bring more of the most promising early phase clinical agents into first in human trials.

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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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Licensing Licensing Science Clinical Trials 130

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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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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Clinical Trials Licensing Licensing Clinical Development 147

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

DECEMBER 20, 2022

The positive opinion is based on findings from the pivotal HOPE-B trial, which showed that patients treated with etranacogene dezaparvovec demonstrated durable increases in mean Factor IX activity levels which led to an adjusted annualised bleed rate (ABR) reduction of 64%. . World’s most expensive drug.

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Therapies Clinical Trials Licensing Licensing 130

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

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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Treatment Pharmacokinetics Clinical Trials Licensing 130

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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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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Clinical Trials Trials Treatment FDA 52

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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