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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Clinical Trials Clinical Trials Trials Clinical Development 130

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 328

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 290

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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Drugs Marketing 278

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

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 241

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 173

Pharma Times

DECEMBER 5, 2023

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

Drug Delivery 137

Drug Delivery Drugs 137

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.

Gene Editing 173

Gene Editing Gene Medicine Drugs 173

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Clinical Supply

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

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 173

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

Pharma Times

DECEMBER 5, 2023

Millions of people in the UK are set to benefit from the second wave of funding - News - PharmaTimes

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129

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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

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

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 124

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

pharmaphorum

DECEMBER 5, 2023

Reinvigorating the Cancer Moonshot with empowered patients Mike.

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119

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Clinical Supply

XTalks

DECEMBER 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), marking a significant milestone for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC). Augtyro, a tyrosine kinase inhibitor (TKI), is available as oral capsules, each containing 40 mg of repotrectinib.

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Protein FDA Approval Medicine Trials 115

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 116

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 111

pharmaphorum

DECEMBER 5, 2023

BMS chases MSD/Seagen with first-line bladder cancer filing Phil.

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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

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 108

pharmaphorum

DECEMBER 5, 2023

Roche bounces back in PIK3 with inavolisib data Phil.

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Drug Patent Watch

DECEMBER 5, 2023

This chart shows the pharmaceutical companies with the most implant dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most implant dosed drugs… The post Which pharmaceutical companies have the most implant dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 105

Drugs 105

XTalks

DECEMBER 5, 2023

A central lab is a specialized facility that offers centralized services including laboratory tests and analyses for clinical studies and clinical care. These labs play a crucial role in ensuring standardization, accuracy and reliability of data across multiple study sites. Central labs ensure consistency in test methodologies, equipment and reporting standards, which is vital for the integrity of clinical trials.

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Clinical Trials Clinical Trials Trials Laboratory Information Management System 105

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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

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 105

pharmaphorum

DECEMBER 5, 2023

The pharma industry and the UK government may have reached an accord on the voluntary scheme of rebates used to limit rises in medicines spending in the UK, but the alternative statutory scheme remains a prickly subject.

Medicine 105

Medicine 105

Fierce Pharma

DECEMBER 5, 2023

As antibody-drug conjugates (ADCs) grow their importance in the oncology treatment space, efforts are underway to combine them with other agents. Enter Seagen. | Seagen unveiled detailed data showing its Tukysa could offer additional tumor progression benefit on top of Roche’s ADC Kadcyla. But with a negative early trend in overall survival, Seagen seems not ready to knock on the FDA’s door.

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Antibody Drugs 103

pharmaphorum

DECEMBER 5, 2023

Alto hits a high note with AI-driven depression therapy Phil.

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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