Mon.Nov 27, 2023

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GSK cancer drug Blenrep gets surprise trial win

Bio Pharma Dive

One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.

Drugs 277
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FDA fast-tracks Genelux’s oncolytic virus-based ovarian cancer therapy

Pharmaceutical Technology

Olvi-Vec is currently being evaluated in a Phase III trial as a treatment for platinum- resistant/refractory ovarian cancer.

Trials 246
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The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment

Worldwide Clinical Trials

By: Amy Raymond, PMP, PhD, Senior Director, Therapeutic Strategy Lead, Cellular & Genetic Medicines On November 16, the British regulatory body, Medicines and Healthcare products Regulatory Agency (MHRA) approved exagamglogene autotemcel (exa-cel) to treat severe sickle cell disease for patients ages 12 and up, becoming the first gene editing treatment to receive regulatory approval.

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November 27, 2023: NIH Announces Funding Opportunity for Implementation Studies of Substance Use Treatment and Prevention in Populations That Experience Health Disparities

Rethinking Clinical Trials

The National Institutes of Health’s Office of Disease Prevention (ODP) issued a new funding opportunity to support implementation studies in treatment and prevention for alcohol, tobacco, and other drugs use and misuse in adult populations that experience health disparities. ODP and participating NIH Institutes and Centers are inviting applications for research projects that test innovative approaches to implementing screening, brief intervention, and referral to treatment or prevention fo

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The New Age of Decentralized Clinical Trials

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

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Regeneron, Sanofi to seek new Dupixent approval in US after COPD success

Bio Pharma Dive

Results from the second of two Phase 3 trials testing the blockbuster drug in the respiratory condition showed treatment could reduce attacks and improve lung function.

Trials 152
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How quality clinical monitoring oversight ensures the success of clinical trials

Pharmaceutical Technology

High-quality monitoring and trial oversight procedures are essential for avoiding the serious consequences that come protocol deviations, poor data quality, and regulatory issues.

More Trending

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FDA grants second orphan drug designation to Priothera’s mocravimod

Pharmaceutical Technology

Mocravimod is currently being investigated in a global Phase III study in AML patients undergoing haematopoietic stem cell transplantation.

Drugs 130
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Novo to expand French plant in GLP-1 production push

Bio Pharma Dive

The planned $2.3 billion investment follows an earlier $6 billion commitment to expand manufacturing for drugs like its in-demand medicine Wegovy.

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AbbVie’s epcoritamab gets one step closer to follicular lymphoma approval 

Pharmaceutical Technology

AbbVie epcoritamab: The monoclonal antibody, approved to treat certain B-cell lymphomas, received an FDA breakthrough therapy designation.

Antibody 130
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Legalized medical cannabis five years on - Releaf discusses how far the industry hasn't come

BioPharma Reporter

It is five years this month since a ground-breaking change in UK healthcare history happened â with doctors being able to prescribe cannabis-based medicines for the first time.

Doctors 123
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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NICE recommends use of Wolman disease therapy in babies

Pharmaceutical Technology

The UK NICE has recommended the usage of Alexion sebelipase alfa for the treatment of Wolman disease in infants and toddlers on the NHS.

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What’s a corneal epithelial defect?

Antidote

The cornea is the outermost layer of the human eye, serving both as a protective covering and allowing light into the retina. To perform this function, the cornea is made up of several layers, the outermost of which is known as the epithelium.

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Sanofi and Regeneron’s Dupixent scores second win in Phase III COPD trial

Pharmaceutical Technology

Sanofi and Regeneron plan to submit the supplemental data from the two Phase III trials of Dupixent to the US FDA by the end of 2023.

Trials 130
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BMS Expands Cardio Partnership with Avidity in Potential $2.3B Deal

BioSpace

Building on a previous 2021 collaboration, Bristol Myers Squibb is paying $100 million upfront for the development of five cardiovascular targets utilizing Avidity Biosciences’ antibody oligonucleotide conjugates.

Antibody 117
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The New Age of Decentralized Clinical Trials

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.

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UK MHRA recalls batches of eye gels due to microbial contamination

Pharmaceutical Technology

The UK MHRA has issued a recall of batches of carbomer-containing lubricating eye gels due to potential microbial contamination.

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Novo Nordisk keeps GLP-1 expansion spree rolling with $2.3B manufacturing upgrade in France

Fierce Pharma

After plotting $6 billion in production upgrades earlier this month, Novo Nordisk’s CEO Lars Fruergaard Jørgensen suggested the expansion outlay was just the start. | After plotting $6 billion in production upgrades earlier this month, Novo Nordisk’s CEO Lars Fruergaard Jørgensen suggested the expansion outlay was just the start. Now, some three weeks later, he’s putting his company’s money where his mouth is.

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Novartis recalls Sandimmune oral solution over crystallisation issues

Pharmaceutical Technology

Novartis has announced a voluntary recall of two lots of its 100mg/mL Sandimmune Oral Solution over crystallisation issues.

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Medical Information and Pharmacovigilance: How Can You Create a Fusion of Innovation and Safety?

XTalks

The intersection of patient safety, technology and innovation in the pharmaceutical industry has given rise to substantial changes in medical information and pharmacovigilance. This dynamic landscape is marked by the integration of patient-centric approaches, real-world evidence and cutting-edge technologies. Pharmaceutical companies are navigating the challenges and opportunities presented by AI-driven analytics, wearable devices and patient-generated data, redefining how adverse events are det

Pharmacy 111
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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Everest Medicines gains NMPA approval in China for IgAN therapy

Pharmaceutical Technology

Everest Medicines has received approval from China's NMPA for its Nefecon to treat primary IgAN in adult patients.

Medicine 130
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Pharma's Q3 growth rankings: GLP-1 drugs from Eli Lilly, Novo Nordisk were once again the big story

Fierce Pharma

Eli Lilly’s fortunes have turned quickly. | It was the second straight quarter where the overwhelming success of blood sugar regulating treatments were the dominant story in the biopharma industry. Eli Lilly and Novo Nordisk delivered the highest revenue gains, at 38% and 29%, respectively.

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Signal: British biopharma applies for BLA for T-cell cancer therapy

Pharmaceutical Technology

Autolus Theraputics is forging ahead with its T-cell cancer therapy, obe-cel, aimed at treating persistant adult ALL.

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Scottish stem cell pro RoslinCT inks deal to produce Vertex and CRISPR's Casgevy

Fierce Pharma

Following the historic approval of the world’s first CRISPR-based gene-editing therapy in the United Kingdom this month, Vertex Pharmaceuticals has tapped its long-time manufacturing partner Roslin | RoslinCT, the CDMO arm of the Roslin Institute, is set to manufacture Vertex and CRISPR Therapeutics’ exa-cel “across the world” as part of Vertex’s global production network.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Amicus’ Pombiliti and Opfolda Is a New Therapy for Pompe Disease

XTalks

Amicus Therapeutics has recently received approval from the US Food and Drug Administration (FDA) for its drugs Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) for adults living with late-onset Pompe disease (LOPD) who are not improving on their current enzyme replacement therapy (ERT). “FDA approval of Pombiliti and Opfolda is a testament to the power of science, medicine and our passionate determination to improve the lives of people living with Pompe disease.

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EVERSANA brings genAI to medical content approvals

pharmaphorum

EVERSANA’s alliance with Amazon Web Services (AWS) on the application of generative artificial intelligence (genAI) to the pharma sector has borne its first fruit – a new tool to tackle the time-consuming and error-prone task of getting medical and regulatory content approvals.

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Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act

FDA Law Blog

By Riëtte van Laack & Anne K. Walsh — Although the Consumer Product Safety Act (CPSA) has been around for over 50 years to “protect the public against unreasonable risks of injury associated with consumer products,” it was not until 2008 that the statute was amended to authorize the Consumer Product Safety Commission (“CPSC”) to impose criminal liability against individual directors, officers, or agents of a corporation for violating the CPSA.

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MHRA launches online eligibility checker tool via the IRP

Pharma Times

The IRP will bring life-saving medicines to UK patients from 1 January 2024 - News - PharmaTimes

Medicine 134
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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What Does it Take to Change the Way We Manage Pain?

XTalks

Solving the opioid epidemic long-term requires bringing new, safe and better treatments to market to replace the reliance on opioids in the clinical setting. The development of a non-addictive, non-opioid treatment or an adjunct treatment that could reduce the needed opioid dosage would revolutionize how we treat pain. However, the industry is facing significant challenges in developing these therapies, including the weak ability of preclinical data to predict clinical success and insufficient f

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Biden admin urges Supreme Court to nix mifepristone restrictions

Fierce Pharma

Following similar campaigns mounted by industry players and biopharma trade groups, the United States' Solicitor General has joined a chorus of voices calling on the Supreme Court to overturn an ap | Following similar campaigns mounted by industry players and biopharma trade groups, the United States' Solicitor General has joined a chorus of voices calling on the Supreme Court to overturn an appeals court’s August ruling on the abortion pill mifepristone.

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SpringWorks Wins First FDA Approval for Non-Cancerous Desmoid Tumors

BioSpace

The Ogsiveo tablets are the first approval therapy for the rare subtype of soft tissue sarcomas, which can lead to severe pain and disability and previously were treated primarily through surgery.

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Paying it Forward Through a Passion Project

Intouch Solutions

Attending college, choosing a major, and then finding a career that aligns with your education and evokes passion can be much more difficult than it seems. Many students may find their passion while in college but are unsure how that degree translates in the real world post-graduation. Simi Krishnan, Senior Vice President, Analytics, has worked in analytics for nearly 20 years and has grown her career in the field, starting as an analyst through data science and now in a leadership role.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.