Pharmaceutical Technology

APRIL 25, 2023

German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. The therapy candidate is currently under evaluation in the Phase l LuMIERE clinical trial.

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Velocity Clinical Research

AUGUST 18, 2023

She decided to focus on patient recruitment to promote diversity in clinical trial populations. Today, she’s Head of GP Engagement and Patient Recruitment for Velocity Clinical Research in the U.K. Through it all, her commitment to and belief in clinical research never wavered. Amira said, “ I have been in the U.K.

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Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Pharmaceutical Technology

JULY 28, 2022

According to the deal, Cidara will continue to oversee the international Phase III ReSPECT prophylaxis clinical trial underway. By leveraging our expansive commercial infrastructure, we will provide the resources needed to optimise the commercialisation of rezafungin and ensure patient access to this life-saving medicine in the US. “We

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Rethinking Clinical Trials

JULY 6, 2023

Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.

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pharmaphorum

APRIL 22, 2021

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. The poll of 114 triallists by clinical data specialist ERT found 82% of them found organisations aery using “virtual trial” approaches.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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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. The post Potentially game-changing schizophrenia drug enters Phase I trials appeared first on Drug Discovery World (DDW).

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Pharmaceutical Technology

JUNE 23, 2022

It was discovered by Incyte and licensed to Novartis in 2009. The latest development comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion in April this year. According to the trial data, a confirmed overall response rate (ORR) of 51.6%

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Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

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Pharmaceutical Technology

AUGUST 25, 2022

The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 23, 2023

With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.

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XTalks

FEBRUARY 19, 2024

In a recent study published by Weill Cornell Medicine in the Journal of Infectious Diseases , researchers have reported the potential of Moderna’s experimental mRNA vaccine in protecting adults against CMV, which could potentially also stop the transmission of the virus from mothers to their infants during pregnancy.

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Pharmaceutical Technology

MARCH 29, 2023

The partnership pursues an innovative approach to discovering and developing new medicines, using many of the modality-agnostic precision medicine platforms of Evotec. This programme has now proceeded into a Phase I clinical trial. Its eight-year extension is aimed at further deepening the strategic alliance.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2023

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

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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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Worldwide Clinical Trials

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In trials, Casgevy was shown to help prevent episodes of debilitating pain, known as vaso-occlusive crises, that often plague patients affected by sickle cell disease.

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pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license.

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Pharmaceutical Technology

APRIL 27, 2023

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. However, the reform has its share of critics. Applications will now be digitised.

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pharmaphorum

MARCH 24, 2022

There’s a rich history of finding useful medicines from fungi, from the antibiotic penicillin to immune suppressant cyclosporine and cholesterol drug lovastatin. The post GSK partners LifeMine on fungi-derived medicines appeared first on. Image by jggrz from Pixabay .

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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Scienmag

SEPTEMBER 14, 2020

Launching a dual-pronged attack on tumours using a combination of two innovative precision medicines could treat patients with multiple common cancers, a new clinical trial shows.

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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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Drug Discovery World

JULY 12, 2024

AB-1005 has also been awarded the innovative medicine designation, the Innovation Passport by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of Parkinson’s disease.

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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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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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STAT News

MARCH 24, 2023

The revision of the EU pharmaceutical legislation will set up a framework for the use of human medicines, from production, to clinical trials, to marketing authorization.

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Drug Discovery World

NOVEMBER 16, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the world’s first gene therapy for sickle-cell disease (SCD) and transfusion-dependent β-thalassemia (TDT). Trial results for Casgevy The authorisation is based on positive clinical trial data.

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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. Source link.

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Pharmaceutical Technology

APRIL 12, 2023

The latest move is a result of the cancellation of a licensing agreement between Cancer Prevention Pharmaceuticals (CPP) and One-Two Therapeutics Assets. Panbela will lead the global trial protocol design and submit it to the US Federal Drug Administration (FDA) and European Medicines Agency (EMA) for agreement on the registration pathway.

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Pharmaceutical Technology

DECEMBER 28, 2022

Gilead Sciences and Jounce Therapeutics have amended their current license agreement for first-in-class immunotherapy, GS-1811 (formerly JTX-1811). The initial license agreement was signed in 2020. It is currently being evaluated in Phase I clinical trial for the treatment of solid tumours.

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Pharmaceutical Technology

APRIL 25, 2023

In July 2022, Cidara gave Melinta US licensing rights for rezafungin following submission to the FDA. Cidara’s submitted marketing authorisation application to the European Medicines Agency has been accepted and is undergoing review. In 2019, Mundipharma acquired the rights to commercialise rezafungin outside the US.

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness.

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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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Pharmaceutical Technology

MARCH 31, 2023

Ibrexafungerp is currently being evaluated in Phase III clinical trials to treat invasive candidiasis (IC), a life-threatening fungal infection. Brexafemme is a novel, approved anti-fungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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Pharmaceutical Technology

DECEMBER 15, 2022

The EC approval is based on findings from two Phase III clinical trials, PRIME and PRIME2. The double-blind, placebo-controlled trials assessed the safety and efficacy of Dupixent versus placebo in adult uncontrolled prurigo nodularis patients.

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