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.”

Clinical Trials 130

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

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

XTalks

NOVEMBER 26, 2024

The trial demonstrated a 42 percent reduction in combined cardiovascular death and recurrent hospitalizations at Month 30, with cardiovascular-related hospitalizations reduced by half. A Marketing Authorization Application has been submitted to the European Medicines Agency (EMA), with a decision anticipated in 2025.

Genetic Disease 105

Genetic Disease Genetics Protein Clinical Development 105

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

XTalks

NOVEMBER 21, 2024

Additionally, over a 176-week period, weekly injections of tirzepatide (marketed as Zepbound and Mounjaro) using pooled doses of 5 mg, 10 mg and 15 mg, significantly reduced the risk of disease progression to type 2 diabetes by 94 percent compared with placebo in adult prediabetes patients who were obese or overweight.

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Sales Insulin Drugs Trials 105

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.

Trials 130

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.

Trials 208

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

MAY 27, 2021

Sheila Rocchio highlights four key areas life sciences must improve on as an industry to drive real change in how clinical trials are conducted. AI models can be used to monitor trial processes and automate tasks associated with data collection, review and analysis. Next generation of decentralised trials.

Clinical Trials 119

Clinical Trials Clinical Trials Trials Life Science 119

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.

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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

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 105

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.”

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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.

Trials 97

Trials Sales Drug Delivery Antibody 97

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

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

World of DTC Marketing

NOVEMBER 19, 2021

government has provided Moderna with nearly $10 billion in taxpayer money for research and development and the purchase of 500 million doses of this mRNA COVID-19 vaccine. This includes almost the entire cost of clinical development. SUMMARY: The U.S. Additionally, Moderna used patents and non-exclusive rights that the U.S.

Vaccine 44

Vaccine Vaccination Allergies Production 44

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.

Gene Therapy 102

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.

Bacteria 147

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.

Clinical Trials 98

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.

Vaccine 299

Vaccine Vaccination Bacteria Protein 299

pharmaphorum

JANUARY 31, 2022

Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinical trial of its mRNA-based candidate DS-5670 that focuses on its use as a booster dose. The post Daiichi makes play for share of Japan’s COVID booster market appeared first on.

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Marketing Vaccine Vaccination Antibody 96

XTalks

JULY 29, 2024

Participant recruitment is challenging, especially in those indications in which there are competing clinical trials necessitating a comprehensive understanding of the disease research ‘landscape’ and targeted outreach and stakeholder collaboration. Sharing patient experiences is also important for gathering real-world insights.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Research 105

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

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