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.” Among the panel participants included representatives from Teva, Blue Rock Therapeutics, and BMS.

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Rethinking Clinical Trials

DECEMBER 5, 2023

Health Data Research Network (HDRN) Canada is now accepting applications for its Pragmatic Trials Training Program. This 2-year, virtual, pan-Canadian program will provide training to advanced learners across 3 streams: (1) future trial leaders (faculty-level trainees), (2) postdoctoral fellows, and (3) highly qualified personnel employed in the public and private sectors.

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Trials Clinical Trials Clinical Trials Research 320

Bio Pharma Dive

DECEMBER 5, 2023

The announcement ends a lengthy setback that began when the company and partner Valneva accused a clinical trial site operator of study misconduct.

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Trials Clinical Trials Clinical Trials Vaccination 273

Pharmaceutical Technology

DECEMBER 5, 2023

Professor Timothy Mackey talks about the recent reports of fraudulent Ozempic pens and the challenges in chasing drug counterfeiters.

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Clinical Supply

Bio Pharma Dive

DECEMBER 5, 2023

Under the new model, CVS’ pharmacy network will price drugs based on the amount the company paid for them, plus a defined markup and additional pharmacist fee.

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Pharmacy Drugs 233

Pharmaceutical Technology

DECEMBER 5, 2023

Oxford Biomedica has signed an agreement to acquire CDMO ABL Europe from Institut Mérieux subsidiary TSGH SAS in a deal worth €15m ($16.27m).

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Pharmaceutical Technology

DECEMBER 5, 2023

The US FDA has accepted the NDA filed by Vanda Pharmaceuticals for its drug tradipitant to treat gastroparesis symptoms.

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Drugs 147

Bio Pharma Dive

DECEMBER 5, 2023

The company expects its pharmaceutical division to deliver 20 new medicines through the end of the decade, including several it believes could earn peak annual sales of more than $5 billion.

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Sales Medicine Drugs 156

Pharmaceutical Technology

DECEMBER 5, 2023

In a Type C meeting, the FDA requested additional data to support Travere’s Filspari approval for treating focal segmental glomerulosclerosis.

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Bio Pharma Dive

DECEMBER 5, 2023

The gene editing biotech is shelving two of its most advanced cancer drugs, and joining a growing group of companies exploring cell-based medicines for inflammatory diseases like lupus.

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Gene Editing Gene Medicine Drugs 156

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Pharmaceutical Technology

DECEMBER 5, 2023

Merck has signed an agreement for the commercialisation of products that include Abbisko Therapeutics’ pimicotinib for all indications.

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Production 130

Bio Pharma Dive

DECEMBER 5, 2023

Launched from BrainChild founder Michael Jensen’s lab at the Washington-area hospital, the company is focusing first on pediatric brain tumors.

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Development Drugs 156

Pharmaceutical Technology

DECEMBER 5, 2023

Discussions at the 10th CTO Europe conference reflected old and new challenges that add pressure on companies running oncology trials.

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Trials 130

Drug Discovery World

DECEMBER 5, 2023

Cancer Research UK (CRUK), Cancer Research Horizons, and precision oncology company Guardant Health have launched a collaboration to advance cancer treatment. The agreement will enable the parties to discuss opportunities for collaboration to support the charity’s research and clinical development activities, focusing primarily on its clinical trials run by its Centre for Drug Development.

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Drugs Research Trials Clinical Trials 114

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

Pharmaceutical Technology

DECEMBER 5, 2023

TCR-T Library is under clinical development by Alaunos Therapeutics and currently in Phase II for Squamous Cell Carcinoma.

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Clinical Development Development 130

BioSpace

DECEMBER 5, 2023

The Swiss pharma’s Fabhalta, a Factor B inhibitor, is the first FDA-approved oral monotherapy for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria.

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FDA Approval 113

Pharmaceutical Technology

DECEMBER 5, 2023

Seismic Therapeutic has secured $121m in a Series B funding round to advance the development of its immunology pipeline.

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Development 130

BioPharma Reporter

DECEMBER 5, 2023

We sat down with Cary Claiborne, CEO and president of Adial Pharma, to discuss the challenges of treating alcohol abuse and company's solution â a serotonin-3 receptor antagonist that could affect neurotransmitters like dopamine and modulate the behavioural effects of alcohol.

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Development Clinical Development 111

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

Pharmaceutical Technology

DECEMBER 5, 2023

Pacmilimab is under clinical development by CytomX Therapeutics and currently in Phase II for Mycosis Fungoides.

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Clinical Development Development 130

Fierce Pharma

DECEMBER 5, 2023

As Johnson & Johnson places a magnifying glass on its pharmaceutical business, the focus for the remainder of the decade rests on the shoulders of some 25 new and upcoming drugs.

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Sales Drugs 108

Pharmaceutical Technology

DECEMBER 5, 2023

Pacmilimab is under clinical development by CytomX Therapeutics and currently in Phase II for Thymic Carcinoma.

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Clinical Development Development 130

Pharma Times

DECEMBER 5, 2023

The platform safely and effectively replicates the electric signalling process compounds - News - PharmaTimes

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Drug Delivery Drugs 130

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply

Pharmaceutical Technology

DECEMBER 5, 2023

Access and buy GlobalData’s databook on the latest filings and grants activity for iNtRON Biotechnology here.

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pharmaphorum

DECEMBER 5, 2023

In a new episode of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Ari Tulla, CEO and co-founder of Elo Health, about his ‘big vision’ to transform food – changing it from a leading cause of disease to the medicine it can be.

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Medicine 104

Pharmaceutical Technology

DECEMBER 5, 2023

Dazukibart is under clinical development by Pfizer and currently in Phase II for Chronic Cutaneous Lupus Erythematosus (CCLE) / Discoid Lupus Erythematosus (DLE).

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Clinical Development Development 100

BioSpace

DECEMBER 5, 2023

Fueled partly by increasing lifespans and cancer incidence, the area’s worth is projected to soar to 13.67 billion by 2032, Precedence Research reports.

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Marketing Research 109

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

Pharmaceutical Technology

DECEMBER 5, 2023

Cosibelimab is under clinical development by Checkpoint Therapeutics and currently in Phase I for Metastatic Transitional (Urothelial) Tract Cancer.

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Clinical Development Development 100

Fierce Pharma

DECEMBER 5, 2023

Travere Therapeutics will reduce its workforce by 20%, with the jo | Travere Therapeutics will reduce its workforce by 20%, with the job cuts focused on “non-field-based employees,” the company said on Tuesday. The layoffs are part of a shake-up of the San Diego-based company as it focuses on its launch of kidney drug Filspari and develops pegtibatinase as a potential treatment for the metabolic disorder homocystinuria (HCU).

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Development Drugs 99

Pharmaceutical Technology

DECEMBER 5, 2023

Access and buy GlobalData’s databook on the latest filings and grants activity for 4D Molecular Therapeutics here.

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Outsourcing Pharma

DECEMBER 5, 2023

Merck has entered into a $70 million licensing agreement with Abbisko Therapeutics for pimicotinib, which is currently being evaluated in a phase 3 study for the treatment of tenosynovial giant cell tumor (TGCT).

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Licensing Licensing Drugs Regulation 98

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Clinical Supply