Worldwide Clinical Trials

APRIL 25, 2024

Authors: Rolana Avrumson, MS, VP Clinical Projects, Clinical Assessment Technologies; Barry Dussault Executive Director, Project Management, Franchise Area Lead, Pain Upwards of 58% of patients experience moderate to severe post-surgical pain, while some research places that figure even higher at a staggering 80%. These data highlight both the prevalence of post-surgical pain and the critical need for comprehensive, non-opioid treatments aimed at alleviating it.

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Clinical Trials Clinical Trials Compliance Trials 130

Bio Pharma Dive

APRIL 25, 2024

The layoffs will impact some 2,200 employees, the company said, as it repositions its business ahead of looming patent expirations for top-selling products.

Drugs 293

Drugs Production 293

Pharmaceutical Technology

APRIL 25, 2024

Marking another chapter in the long-running saga, J&J has deprioritised the CD388 influenza programme allowing Cidara to buy it back.

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Bio Pharma Dive

APRIL 25, 2024

“With each passing year, we're more committed to becoming a serious player in the genetic medicine space,” a Regeneron executive said.

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Gene Editing Gene Genetics Medicine 294

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Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 25, 2024

Researchers have identified dysfunctions in two specific brain systems in people who have psychosis – systems that help us filter attention to important internal and external information and predict or anticipate rewards.

Scientist 202

Scientist Research Clinical Trials Clinical Trials 202

Bio Pharma Dive

APRIL 25, 2024

The cuts of four pipeline prospects come as BioMarin resets its priorities following the slow launch of its hemophilia gene therapy Roctavian.

Gene Therapy 284

Gene Therapy Gene Drugs 284

Bio Pharma Dive

APRIL 25, 2024

The British drugmaker has bolstered its business with nearly $5 billion in acquisitions as attention turns to its pipeline of experimental medicines.

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Medicine Drugs 171

Pharmaceutical Technology

APRIL 25, 2024

Merck has announced an investment of more than €300m ($320.8m) in a new Life Science Research Center at its global headquarters in Darmstadt, Germany.

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Life Science Research 147

BioSpace

APRIL 25, 2024

Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response.

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Gene Therapy Gene FDA Approval 117

Pharmaceutical Technology

APRIL 25, 2024

Biogen has reported net income of $393.4m for the first quarter (Q1) of 2024, an increase from $387.6m in the same period a year ago.

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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

XTalks

APRIL 25, 2024

Heart failure, affecting over 64 million people worldwide , remains a formidable challenge in the medical community despite advancements in pharmacotherapy over the past decade. The prognosis for heart failure patients is disheartening, with a mere half surviving beyond five years post-diagnosis. This stark reality highlights the urgent need for novel heart failure management options, particularly for advanced stages of the disease.

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Development Trials Clinical Trials Clinical Trials 111

Pharmaceutical Technology

APRIL 25, 2024

The first episode in Sterling's podcast series on digital dealmaking in life sciences puts a spotlight on corporate culture

Life Science 130

Life Science 130

Outsourcing Pharma

APRIL 25, 2024

Wuxi AppTec says recent allegations made by the US government that it has shared clients' data with Beijing without consent are âmisleadingâ and âinaccurateâ.

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Regulation Marketing 111

Pharmaceutical Technology

APRIL 25, 2024

Speakers discuss how SMEs can attract capital after a rise in investment activity in Q1 2024 compared to the last quarter of 2023.

Life Science 130

Life Science 130

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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

Pharma Times

APRIL 25, 2024

The tool will help people find out about clinical trials for myeloma, MGUS, SMM and AL amyloidosis

Clinical Trials 130

Clinical Trials Clinical Trials Trials 130

Pharmaceutical Technology

APRIL 25, 2024

Mundipharma is to acquire all assets and rights related to antifungal candidate Rezzayo (rezafungin) from Cidara Therapeutics.

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BioSpace

APRIL 25, 2024

With its lawsuit filed against Pfizer and BioNTech, the British multinational biopharma has joined the high-profile patent battle over mRNA technology used in COVID-19 vaccines.

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Vaccination Vaccine 99

Pharmaceutical Technology

APRIL 25, 2024

A Senate Committee is investigating the “outrageously high” US price tags of the blockbuster diabetes and obesity drugs.

Drugs 130

Drugs 130

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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

Outsourcing Pharma

APRIL 25, 2024

Last month, OSP was excited to write about One2Treat, a progressive startup specializing in digital health solutions, which has launched a forward-thinking approach aimed at tackling key challenges in the biopharma industry.

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Clinical Development Development 98

Pharmaceutical Technology

APRIL 25, 2024

The FDA has approved Utility Therapeutics’ Pivya tablets, a new treatment for female adults with UTIs.

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FDA Approval 130

BioPharma Reporter

APRIL 25, 2024

Back in 2014, AstraZeneca and Merck were the first to receive FDA approval for their PARP inhibitor Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients.

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FDA Approval Sales Marketing Gene 98

BioSpace

APRIL 25, 2024

The genetic engineering startup, recently honored by BioSpace readers for its work environment, is downsizing as it seeks to launch its first clinical trials.

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Genetic Engineering Engineer Clinical Trials Clinical Trials 104

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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

APRIL 25, 2024

After AstraZeneca’s recent acquisitions of various technologies across different therapeutic areas, some investors started to wonder if the British pharma is stretching too thin. | After AstraZeneca’s recent acquisitions of various technologies across different therapeutic areas, some investors started to wonder if the British pharma is stretching too thin.

Vaccination 97

Vaccination Vaccine 97

BioSpace

APRIL 25, 2024

Gilead on Thursday reported revenue growth in the first quarter of 2024, driven by the strong sales of its HIV, cancer and liver diseases franchises, while culling a number of candidates.

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Sales 98

Fierce Pharma

APRIL 25, 2024

Just a few months after laying into CEOs from Bristol Myers Squibb, Merck & Co., and Johnson & Johnson about the high costs of their drugs, Sen. | Just a few months after laying into CEOs from Bristol Myers Squibb, Merck & Co. and Johnson & Johnson about the high costs of their drugs, Sen. Bernie Sanders, I-Vermont, is taking Novo Nordisk to task for allegedly turning its blockbuster GLP-1s Ozempic and Wegovy into “luxury goods.

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Drugs 93

BioSpace

APRIL 25, 2024

Humira maintained its blockbuster status and market share dominance in the first quarter of 2024, but experienced a drop in sales as biosimilar competition heated up, AbbVie reported on Friday.

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Sales Marketing 92

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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

APRIL 25, 2024

Merck touted newly approved Winrevair and what the emergence of the potential blockbuster means for the company as it faces the LOE of Keytruda.

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Marketing 103

Pharma Times

APRIL 25, 2024

X-linked Charcot-Marie-Tooth is the second most common form of the rare peripheral neuropathy disease

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Research 115

Fierce Pharma

APRIL 25, 2024

For the first time in more than 20 years, the FDA has approved a | For the first time in more than 20 years, the FDA has approved a treatment for uncomplicated urinary tract infections. And the endorsement has come for an oral antibiotic that has been available in Europe for more than 40 years. It’s an odd set of circumstances and a dose of foresight by Utility Therapeutics that bring Pivya (pivmecillinam) to the market in the United States in the therapy’s golden years.

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Marketing 89

Pharmaceutical Commerce

APRIL 25, 2024

The deal further grows the Big Pharma company’s US production capabilities, especially when it comes to global parenteral products.

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Manufacturing Production 105

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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