Worldwide Clinical Trials

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials.

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Clinical Research Trials Research Clinical Trials 173

XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research. Integrating DHTs Across Drug Development Phases Dr.

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Clinical Development Development Clinical Trials Clinical Trials 116

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”

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Clinical Development Development Clinical Trials Clinical Trials 110

XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

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Clinical Trials Clinical Trials Trials Production 64

Worldwide Clinical Trials

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.”

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Clinical Trials Clinical Trials Trials Clinical Development 130

Pharmaceutical Technology

AUGUST 25, 2022

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

Pharmaceutical Technology

OCTOBER 21, 2022

Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinical development through Phase Ib for HB-700 to treat KRAS-mutated cancers.

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Development Production Licensing Licensing 278

XTalks

JANUARY 22, 2025

The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. Importantly, the vaccine was well tolerated, with no safety concerns identified during the trial. Valneva is also advancing its investigational Lyme disease vaccine candidate, VLA15, currently in Phase II clinical development.

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Immune Response Vaccination Vaccine Trials 59

Pharmaceutical Technology

NOVEMBER 30, 2022

While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options. However, the current MS pipeline offers new hope for PPMS patients, with three late-stage agents currently in development.

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Development Clinical Trials Clinical Trials Trials 246

Pharmaceutical Technology

NOVEMBER 28, 2022

Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD). This includes an upfront payment of $2m from AstraZeneca. This includes an upfront payment of $2m from AstraZeneca.

Development 264

Development Gene Expression Licensing Licensing 264

Pharmaceutical Technology

JULY 18, 2022

There have recently, however, been some notable developments towards improving the care of bronchiectasis patients. These include the ongoing clinical development of AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’ icenticaftor (QBW251).

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Marketing Trials Development Protein 147

Pharmaceutical Technology

JUNE 12, 2023

Six cannabinoids have recently completed or are undergoing Phase II trials. In 2022, Pfizer acquired the drug, with the promise of accelerating clinical development via new, differentiated, and best-in-class approaches, enhancing optimism for further drug development.

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Drugs Development Clinical Development Sales 358

Worldwide Clinical Trials

JUNE 13, 2024

The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinical trials. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

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Trials Clinical Trials Clinical Trials Clinical Development 130

Worldwide Clinical Trials

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” Umbrella Trial: Examines numerous drugs administered as individual drugs or combinations in a single tumor type.

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Trials Clinical Trials Clinical Trials Drugs 208

pharmaphorum

MAY 7, 2021

It’s illegal in most countries including the US and UK but Small Pharma is convinced of its potential as a therapeutic medicine for depression and has already begun clinical development. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.

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Drug Trials Trials Marketing Drugs 98

Pharmaceutical Technology

AUGUST 9, 2022

The filing also comprised the safety analysis carried out during the course of these studies as well as their open-label extensions and is accompanied by a long-term open-label Phase III C021 safety trial. In the clinical development programme, 1,944 epilepsy patients received cenobamate treatment.

Life Science 246

Life Science Clinical Development Trials Marketing 246

Pharmaceutical Technology

AUGUST 18, 2022

The latest approval is based on findings from the Phase III clinical trials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?0/?0 0 genotypes.

Gene Therapy 246

Gene Therapy Gene Genotype In-Vivo 246

pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Gaining patient input on marketing and recruitment materials. How the NIHR’s Patient Engagement in Clinical Development service can help.

Clinical Trials 116

Clinical Trials Clinical Trials Trials Life Science 116

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

Antibody 98

Antibody Trials Licensing Licensing 98

XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

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Clinical Trials Clinical Trials Trials Clinical Research 97

pharmaphorum

JANUARY 6, 2022

Roche’s idiopathic pulmonary fibrosis (IPF) therapy Esbriet is already being squeezed by its main rival in the market, and could come under renewed pressure if another competitor from PureTech Health gets approved. The first clinical data on the drug in healthy older adults seems to back up that hypothesis. Ofev made $2.34

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Trials Marketing FDA Approval Development 106

Cloudbyz

NOVEMBER 22, 2024

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

pharmaphorum

MARCH 15, 2022

Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinical trials of a new formulation of Sarclisa for blood cancer multiple myeloma, accelerating its development. Sanofi has partnered with drug delivery specialist Enable Injections to develop the subcutaneous formulation.

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Trials Sales Drug Delivery Antibody 97

pharmaphorum

JUNE 1, 2022

Medical imaging specialist Median Technologies has launched a new business unit that will provide decision-making tools – underpinned by artificial intelligence – for sponsors of clinical trials in oncology. Bringing a new cancer drug to market costs an average of $2.8 Bringing a new cancer drug to market costs an average of $2.8

Trials 98

Trials Clinical Trials Clinical Trials FDA Approval 98

pharmaphorum

MAY 13, 2021

The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinical trial and part of 55 globally, across 15 countries.

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Gene Therapy Gene Trials Protein 102

Pharmaceutical Technology

SEPTEMBER 22, 2022

Under the deal, GSK will obtain an exclusive licence for the development and marketing of tebipenem pivoxil HBr in all countries. Since 2009, Meiji has marketed tebipenem HBr in Japan. Known as Orapenem, it is marketed for the treatment of paediatric infections limited to pneumonia, otitis media and sinusitis.

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Bacteria Marketing Trials Clinical Development 147

pharmaphorum

JANUARY 14, 2022

In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide Clinical Trials Early Phase Services, Keith Fern. Keith Fern joins Elligo with a decade of proven leadership in the CRO industry.

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Clinical Trials Clinical Trials Trials Development 98

pharmaphorum

MAY 3, 2022

Belsomra’s first-to-market advantage in the US hasn’t however translated into big annual sales, which have stayed planted just over the $300 million mark since 2019. The class as a whole is, however, trying to break into a low-cost generic market, and almost inevitably is facing pushback from payers.

Marketing 97

Marketing Drugs Sales Pharma Companies 97

XTalks

DECEMBER 5, 2024

Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. The trial included 465 participants who were either obese or overweight.

Trials 104

Trials Drugs Clinical Trials Clinical Trials 104

Pharmaceutical Technology

AUGUST 17, 2022

VLA15 is the only vaccine for Lyme disease in clinical development, according to GlobalData, the parent company of Pharmaceutical Technology. The Phase III trial announcement comes at a notable time, as the number of Lyme disease cases is growing over the long term in several countries, including the UK and the US. of Valneva.

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Vaccination Vaccine Bacteria Protein 299

Worldwide Clinical Trials

APRIL 15, 2024

Worldwide Clinical Trials recently conducted a comprehensive research study, where we included 140 key industry-decision makers from biotech and pharmaceutical companies of all sizes. The Advantages of Midsize CROs In contrast to large CROs, midsize CROs like Worldwide Clinical Trials offer a unique value proposition to the market.

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Clinical Trials Clinical Trials Clinical Development Clinical Research 130

pharmaphorum

NOVEMBER 16, 2021

Injectable antibodies targeting PCSK9 have failed to take off as expected in the cholesterol-lowering market, but Merck & Co hopes to do much better with an oral alternative. In another 14-day trial involving men and women, MK-0616 reduced LDL cholesterol by around 65% from baseline when it was added to background therapy with statins.

Trials 98

Trials Drugs Sales Clinical Trials 98

Pharmaceutical Technology

APRIL 17, 2023

The proposed merger is expected to realise at least $50m of net transaction cash proceeds, set to be used to finance the merged entity’s business as well as Phase II trials and operations through the second quarter of 2025. The merger is scheduled to be completed by the third quarter of 2023.

Gene Therapy 246

Gene Therapy Gene Clinical Development Development 246

Pharmaceutical Technology

JUNE 28, 2022

A PARP inhibitor, Lynparza is co-developed and co-marketed by Merck and AstraZeneca. The CHMP adopted a positive opinion based on findings from the global, parallel-group, placebo-controlled, double-blind Phase III OlympiA clinical trial.

Clinical Trials 162

Clinical Trials Clinical Trials Trials Medicine 162

XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.

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Clinical Trials Clinical Trials Trials Clinical Development 87

Pharmaceutical Technology

FEBRUARY 14, 2023

Under the deal, Corbus Pharmaceuticals will have exclusive rights to develop and commercialise CRB-701 in Canada, Australia, the UK, the EU (including the European Free Trade Area), and the US, while CSPC will retain SYS6002’s rights in the remaining markets. According to the agreement, CSPC will receive a $7.5m

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