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.

Licensing 130

Licensing Licensing Clinical Development Clinical Trials 130

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

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Biosimilars are increasingly becoming the standard of care and both have several licensed biosimilar drugs (e.g.

Clinical Trials 104

Clinical Trials Clinical Trials Production Trials 104

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinical trial that includes participants from China and Eastern European countries.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

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.

Pharmacy 188

Pharmacy Sales Licensing Licensing 188

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.

Marketing 264

Marketing Medicine Production Clinical Trials 264

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.

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

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 […]

Regulation 188

Regulation Drugs Licensing Licensing 188

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 .

Medicine 105

Medicine Genome Genomics Engineer 105

XTalks

DECEMBER 1, 2020

Over the past several years, personalized medicine has led the charge in medical innovation, leading drug development efforts as well as furthering the research community’s understanding of human disease states. With this has come an increase in the size of the global clinical trials market, with an estimated worth of around $46.8

Clinical Trials 96

Clinical Trials Clinical Trials Trials Clinical Research 96

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.

Licensing 72

Licensing Licensing Trials Clinical Trials 72

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.

Clinical Trials 130

Clinical Trials Clinical Trials Insulin Medicine 130

pharmaphorum

MAY 17, 2021

Experts from Vynamic discuss their vision for a future where patients are at the heart of medicine reimbursement in Europe – and provide actionable steps for achieving this. There are different models, medicines are evaluated in different ways and the timelines for approval vary widely. However, much more needs to, and can, be done.

Medicine 93

Medicine Life Science Marketing Clinical Trials 93

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.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

Worldwide Clinical Trials

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.

Gene Editing 189

Gene Editing Gene Gene Therapy In-Vivo 189

XTalks

DECEMBER 18, 2024

Related: Arrowhead Pharmas New Rare Disease Campaign for FCS Highlights Importance of Lowering Triglycerides The FDAs approval of Crenessity was based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. Crenessity marks the third approved drug for Neurocrine. billion in revenue by 2024.

Genetics 116

Genetics Hormones Trials Drugs 116

Pharmaceutical Technology

FEBRUARY 17, 2023

Under the multiyear deal, Zephyr AI will license M2Gen’s RWD and will, in return, provide M2Gen will AI and machine learning technologies to enhance its products and services. M2GEN and Zephyr AI will together discover new cancer treatments and expanded use cases for better identifying new targets and enhancing clinical trial design.

Bioinformatics 147

Bioinformatics Production Clinical Trials Clinical Trials 147

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.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks.

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

AUGUST 4, 2022

P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. The programmes include P-BCMA-ALLO1, an allogeneic CAR-T to treat multiple myeloma and P-CD19CD20-ALLO1, an allogeneic dual CAR-T to treat B-cell malignancies.

Development 147

Development Clinical Trials Clinical Trials Gene Therapy 147

WCG Clinical

JUNE 14, 2024

In this article, we will explore the significant value derived from conducting clinical trials sponsored by pharmaceutical companies for both physicians and hospital systems, with a specific focus on cancer care, and address potential counterarguments.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

Pharmaceutical Technology

NOVEMBER 17, 2022

The therapy was found to be well tolerated by patients in clinical trials. NICE medicines evaluation interim director Helen Knight said: “This is the first treatment approved by NICE that targets this specific gene mutation in people with advanced non-small-cell lung cancer.

Gene 130

Gene Clinical Trials Clinical Trials Licensing 130

Pharmaceutical Technology

FEBRUARY 22, 2023

Spanish pharmaceutical firm Ferrer and Swiss biotechnology firm Asceneuron have signed a licensing agreement for the latter’s O-GlcNAcase inhibitor, ASN90, to treat progressive supranuclear palsy (PSP). The company now intends to conduct a Phase II clinical trial for determining the optimal dose range and efficacy of ASN90.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

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.

Trials 100

Trials Clinical Trials Clinical Trials Licensing 100

XTalks

FEBRUARY 12, 2025

LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population.

Cardiology 59

Cardiology Trials Clinical Trials Clinical Trials 59

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.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Licensing 130

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.

Sales 130

Sales FDA Approval Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JANUARY 31, 2023

Daewoong Pharmaceutical has entered an exclusive licensing agreement with CS Pharmaceuticals (CSP) for Bersiporocin, a first-in-class PRS inhibitor, in the Greater China region for Idiopathic Pulmonary Fibrosis (IPF). The Korea Drug Development Fund is supporting the trial by providing funds.

Clinical Trials 130

Clinical Trials Clinical Trials Licensing Licensing 130

Pharmaceutical Technology

OCTOBER 18, 2022

Gilead holds an option for licensing MGD024 as a possible therapy to treat specific blood cancers, including myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes.

Antibody 130

Antibody Development Sales Clinical Trials 130

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.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

Pharmaceutical Technology

NOVEMBER 22, 2022

The US Food and Drug Administration (FDA) has accepted AbbVie ’s Biologics License Application (BLA) of epcoritamab (DuoBody-CD3xCD20) to treat adults with relapsed/refractory (r/r) large B-cell lymphoma (LBCL), for priority review. Epcoritamab is intended for usage in such patients following two or more lines of systemic therapy.

Clinical Trials 130

Clinical Trials Clinical Trials Licensing Licensing 130

Druggist

NOVEMBER 6, 2020

Patients commonly request over the counter medicines for a chesty cough. In today’s post, I will seek to find the best medicine for chesty cough by looking at over the counter and pharmacy-only products available in the UK. The best evidence for or against the effectiveness of medicines comes from well designed clinical trials.

Medicine 69

Medicine Containment Production Pharmacy 69

Pharmaceutical Technology

MAY 24, 2023

It is also licensed by Spain’s Centro de Investigación Biomédica en Red de Enfermedades Raras, the Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz and the Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas. The therapy has also received orphan drug and fast-track designations.

Gene Therapy 130

Gene Therapy Gene Licensing Licensing 130

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.

Development 130

Development Trials Clinical Trials Clinical Trials 130

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

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.

Trials 105

Trials Clinical Trials Clinical Trials Life Science 105