Rethinking Clinical Trials

JANUARY 3, 2024

In this Friday's PCT Grand Rounds, Rui Wang of Harvard Medical School will offer the final session in our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with "Methods for Handling Missing Data in Cluster Randomized Trials." The session will be held on Friday, January 5, at 1:00 pm eastern. Wang is an associate professor of population medicine and the director of the Division of Biostatistics in the Department of Population Medicine at Harvard Medical School and

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Trials Clinical Trials Clinical Trials Medicine 286

Pharmaceutical Technology

JANUARY 3, 2024

A new report from Novotech delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.

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Clinical Trials Clinical Trials Trials Research 295

Bio Pharma Dive

JANUARY 3, 2024

The $650 million fund exceeded Goldman’s target and comes amid cautious optimism that biotech could rebound from a lengthy downturn.

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Pharmaceutical Technology

JANUARY 3, 2024

This collaboration comes six years after the German company Boehringer signed two agreements to develop treatments for NASH.

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Development 245

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Clinical Supply

Bio Pharma Dive

JANUARY 3, 2024

The hemophilia B therapy, which Pfizer will sell in Canada as Beqvez, is also under review in the U.S., where the FDA expects to make a decision by the second quarter.

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Gene Therapy Gene 171

Pharmaceutical Technology

JANUARY 3, 2024

Novartis will pay Voyager $100m upfront and up to $1.2bn in milestone-based payments and royalties on net sales.

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Gene Therapy Gene Development Sales 246

Pharmaceutical Technology

JANUARY 3, 2024

The first of a two-part series on therapies that receive an FDA priority review designation dives into how these vouchers incentivise innovation for low-commercial value-diseases.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 3, 2024

Do you hate salad? It’s OK if you do, there are plenty of foods in the world, and lots of different ways to prepare them.

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Clinical Trials Clinical Trials Clinical Research Trials 166

Pharmaceutical Technology

JANUARY 3, 2024

Oragenics has concluded the announced acquisition of assets focusing on neurological drug therapies and technologies from Odyssey Health.

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Drugs 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 3, 2024

Navigating regulatory affairs in the biopharma industry requires a skilled talent pool, according to Benjamin James, HR Leader, Asia-Pacific, Cytiva Lifesciences – a global life sciences (biopharma) company. He cited Cytiva’s Global Biopharma Resilience Index (GBRI), which reveals a decline in overall talent pool resilience, with the score dropping from 6.27 in 2021 to 5.

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HR Life Science Clinical Trials Clinical Trials 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

JANUARY 3, 2024

A US court has granted the FTC's request to halt the acquisition due to concerns that it will promote anticompetitive practices.

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ACRP blog

JANUARY 3, 2024

Historically, patient recruitment and retention have been pressing issues within the clinical trial space. Eighty-five percent of trials fail to recruit enough patients, while 80% are delayed due to other factors like participant dropouts. These high rates are influenced by financial, emotional, and logistical barriers to participation, such as geographic location and travel-related costs, which prevent patients from enrolling in trials and accessing life-changing medicine.

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Clinical Trials Clinical Trials Trials Medicine 122

Pharmaceutical Technology

JANUARY 3, 2024

The EMA has validated the marketing authorisation application of Bristol Myers Squibb (BMS) for repotrectinib to treat solid tumours.

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Marketing 130

BioPharma Reporter

JANUARY 3, 2024

Gilda DâIncerti is CEO and founder of PQE Group, a life science consulting company, and she likes her company to work like a small English village where everyone knows each other.

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Life Science Regulation Marketing 119

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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

JANUARY 3, 2024

The immuno-oncology company has also completed enrolment in a Phase I trial investigating its dendritic cell vaccine DOC1021.

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Vaccination Vaccine Drugs Trials 130

Fierce Pharma

JANUARY 3, 2024

As the J.P. | As the J.P. Morgan Healthcare Conference rolled on in San Francisco, BioNTech, Alnylam and many other companies updated investors on their strategies heading into 2024.

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Sales Vaccination Vaccine 115

Pharmaceutical Technology

JANUARY 3, 2024

MediLink Therapeutics has signed a global partnership and licence deal with Roche to develop YL211 for solid tumours.

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Development Drugs 130

pharmaphorum

JANUARY 3, 2024

The race for obesity drug assets is becoming more intense as pharmaceutical companies strive to develop effective treatments for weight loss. This article explores the efficacy, potential sales, and market trends in the field of obesity drugs.

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Drugs Sales Marketing Development 114

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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

JANUARY 3, 2024

The UK MHRA has introduced the International Recognition procedure (IRP), a new pathway for medicine approvals.

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Medicine 130

pharmaphorum

JANUARY 3, 2024

The UK medicines regulator has launched its mutual recognition framework for authorising medicines in a move that it says will help to bring new drugs to patients in the UK more quickly.

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Regulation Medicine Drugs 112

Fierce Pharma

JANUARY 3, 2024

Gene therapies have been approved for certain patients with beta thalassemia. After a successful phase 3 readout, Agios hopes it can reach a unique subgroup and eventually all patients. | Gene therapies have been approved for certain patients with beta thalassemia. After a successful phase 3 readout, Agios hopes it can reach a unique subgroup and eventually all patients.

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Gene Therapy Gene Trials Drugs 110

XTalks

JANUARY 3, 2024

Leading global biopharma company AstraZeneca along with Ionis Pharmaceuticals, a pioneer in RNA-targeted therapy, received approval from the US Food and Drug Administration (FDA) for their innovative drug Wainua (eplontersen) for treating polyneuropathy associated with hereditary transthyretin-mediated amyloidosis in adults, commonly known as hATTR-PN or ATTRv-PN.

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FDA Approval Protein RNA Clinical Trials 105

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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

Fierce Pharma

JANUARY 3, 2024

As the J.P. Morgan Healthcare Conference moves into its third day, we're covering the latest developments here. | On Wednesday at the the J.P. Morgan Healthcare Conference, attendees will get a chance to hear from AbbVie, Amarin and several other pharmaceutical companies.

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Development 108

XTalks

JANUARY 3, 2024

As we step into 2024, the food industry is buzzing with the introduction of innovative new food products. From air fryer-ready chicken wings to cauliflower-based puffs, let’s dive into the list of exciting new offerings that are set to hit the shelves this year. 1. Perdue’s Revolution in Wings: Air Fryer Ready Crispy Wings Perdue Farms introduced a game-changer in the world of chicken wings: Perdue Air Fryer Ready Crispy Wings.

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Production Protein Hormones Packaging 103

Fierce Pharma

JANUARY 3, 2024

Booming demand for blood sugar-modulating diabetes and obesity drugs became the top trend in the biopharma industry in 2023, with two companies—Novo Nordisk and Eli Lilly—overwhelming the market wi | Booming demand for blood sugar-modulating diabetes and obesity drugs became the top trend in the biopharma industry in 2023, with two companies—Novo Nordisk and Eli Lilly—overwhelming the market with their dominance.

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Sales Drugs Marketing 106

pharmaphorum

JANUARY 3, 2024

UK report calls for the mothballed Rosalind Franklin Lab to be repurposed as a manufacturing unit to support clinical trials of bacteriophages as new antimicrobial agents

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Clinical Trials Clinical Trials Research Manufacturing 99

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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

Fierce Pharma

JANUARY 3, 2024

As the J.P. Morgan Healthcare Conference kicked off in San Francisco, EY released its annual report on the industry's dealmaking firepower. | As the J.P. Morgan Healthcare Conference kicked off in San Francisco, EY released its annual report on the industry's dealmaking firepower. Plus, Moderna, bluebird and other companies updated investors on their businesses heading into 2024.

Sales 105

Sales 105

Pharma Times

JANUARY 3, 2024

NaviCam ProScan is the first AI-assisted reading tool for gastrointestinal bleeding

Drugs 131

Drugs 131

Fierce Pharma

JANUARY 3, 2024

After a pair of high-profile approvals for sickle cell disease gene ther | After a pair of high-profile approvals for sickle cell disease gene therapies in the U.S. last month, Pfizer is ushering in the New Year with a regulatory endorsement for its hemophilia B gene therapy north of the border.

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Gene Therapy Gene 101

Pharma Times

JANUARY 3, 2024

The new hub will be located in the King’s Cross Knowledge Quarter, London

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Drugs Development Research 127

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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