Wed.Feb 21, 2024

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NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

Bio Pharma Dive

The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drug developers must solve first.

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Would You Recognize a Seizure? Here’s How to Help as a Bystander.

AuroBlog - Aurous Healthcare Clinical Trials blog

Approximately 1 in 26 people develop epilepsy, a condition in which someone experiences recurring and unprovoked seizures. But experiencing a seizure does not always mean a person has epilepsy. Seizures can be provoked by acute head injuries, alcohol withdrawal and high blood sugar, among other things.

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Behind the new kind of cell therapy that just won FDA approval

Bio Pharma Dive

One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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United Therapeutics, in unusual step, sues FDA over rival’s drug application

Bio Pharma Dive

The biotech alleges that the agency is letting competitor Liquidia sidestep the rules by accepting an amendment to an application that’s involved in a patent dispute.

Drugs 177
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Will smart tech revolutionise drug delivery for ulcerative colitis patients?

Pharmaceutical Technology

Biora’s new smart pill represents a new treatment modality that may increase the efficacy of therapeutics for ulcerative colitis

More Trending

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Indian hospitals keen to navigate roadblocks to cancer patient recovery with regular annual screening

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian hospitals are keen to navigate roadblocks to cancer patient recovery with regular annual screening. While India excels in initial treatment and interventions, several challenges in post-treatment care hinder optimal recovery and long-term well-being. India has made significant strides in its medical care, showcasing technology, skilled professionals, and infrastructure.

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February 21, 2024: In This Week’s PCT Grand Rounds, Virtual Monitoring in Decentralized Clinical Trials

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern. Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice dean in the Duke University School of Medicine.

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Bavarian Nordic terminates cancer vaccine work

Bio Pharma Dive

The Danish company scrapped a vaccine in Phase 1 testing and will exit oncology altogether, focusing instead on infectious disease research.

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FDA approves new dose regimen for J&J multiple myeloma treatment

Pharmaceutical Technology

The US FDA has approved Johnson & Johnson’s (J&J) reduced dosing frequency of TECVAYLI for relapsed or refractory multiple myeloma.

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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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Clinical research is about trial and error

pharmaphorum

Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.

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BMS’ KRAZATI sNDA to treat colorectal cancer gains priority review

Pharmaceutical Technology

Bristol Myers Squibb (BMS) reported FDA acceptance of the sNDA for KRAZATI plus cetuximab to treat colorectal cancer for priority review.

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The evolution of clinical research: embracing new delivery models in the UK

pharmaphorum

Explore the evolution of clinical research in the UK, including the role of NIHR and Direct Delivery Teams in embracing new delivery models. Join our informative webinar to learn more.

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Genezen to license CSL’s lentiviral vector production system

Pharmaceutical Technology

Contract development and manufacturing organisation Genezen has announced plans to license CSL’s Cytegrity lentivirus production system.

Licensing 130
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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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Novavax dodges COVID vaccine refund by settling Gavi arbitration for up to $400M

Fierce Pharma

On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.

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PepGen earns FDA fast track designation for myotonic dystrophy type 1 candidate

Pharmaceutical Technology

A Phase I trial studying the therapy is underway after an FDA clinical hold was lifted last year, with initial data expected in 2024.

Trials 130
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Novo Nordisk, Eli Lilly lead industrywide sales surge in Q4

Fierce Pharma

In a year that started with more than two-thirds of biopharma companies posting | While Novo Nordisk and Eli Lilly continued to be the biopharma industry growth leaders in the fourth quarter of 2023, many other drugmakers also delivered big gains, including Daiichi Sankyo, Amgen, Teva, GSK and Novartis.

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WuXi ATU gains approval for Amtagvi manufacturing at US site

Pharmaceutical Technology

WuXi ATU received FDA approval to commence the analytical examination and production of Iovance’s Amtagvi at its Philadelphia site.

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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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The killer instinct: Using investigational natural killer therapy to treat Alzheimer’s

Drug Discovery World

DDW Editor Reece Armstrong speaks to Dr Paul Song , MD, NKGen and Dr Vince DeOrchis , clinician, to find out more about the investigational natural killer therapy SNK01 and the benefit of using a patient’s own cells to treat Alzheimer’s. In October 2023, pharmaceutical company NKGen Biotech released data from its Phase I clinical trial on the use of its investigational natural killer therapy, SNK01, to treat patients with Alzheimer’s disease.

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Polpharma looks to challenge Takeda’s Entyvio in IBD

Pharmaceutical Technology

Polpharma’s biosimilar candidate PB106 showed non-inferiority to the reference therapy Takeda’s Entyvo in a Phase III trial.

Trials 130
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Novo, Novartis, BMS and J&J win judge's blessing to combine arguments in upcoming IRA hearing

Fierce Pharma

Four major drugmakers are joining forces as they prepare to battle certain aspects of the Inflation Reduction Act (IRA) in court next month. | A federal judge in New Jersey agreed to let Bristol Myers Squibb, Novo Nordisk, Novartis and J&J present oral arguments together in their bid to challenge the government's new Medicare negotiations framework.

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Bavarian Nordic’s revenue soars post-mpox outbreaks

Pharmaceutical Technology

Bavarian Nordic reported a preliminary revenue of $1bn for 2023, driven by sales of JYNNEOS, its moneypox/smallpox vaccine.

Sales 130
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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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Joseph Papa, after leaving Bausch, begins another turnaround project as CEO of Emergent BioSolutions

Fierce Pharma

Joseph Papa has reemerged nearly a year after stepping down as head honcho of Bausch + Lomb. | Joseph Papa has re-emerged nearly a year after stepping down as head honcho of Bausch + Lomb. The former Valeant helmsman is now tasked with turning around Emergent BioSolutions as its new CEO.

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MHRA bans OTC sale of codeine after recreational abuse reports

Pharmaceutical Technology

Codeine linctus has been reclassified from a pharmacy-only medicine to a prescription-only medicine in the UK.

Sales 130
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Long-Acting Injectable Cabenuva Found More Effective Than Daily ART at Suppressing HIV in Patients With Adherence Challenges

Pharmaceutical Commerce

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

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Sarilumab by Regeneron Pharmaceuticals for Polyarticular Juvenile Idiopathic Arthritis (PJIA): Likelihood of Approval

Pharmaceutical Technology

Sarilumab is under clinical development by Regeneron Pharmaceuticals and currently in Pre-Registration for Polyarticular Juvenile Idiopathic Arthritis (PJIA).

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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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Mobile ADHD awareness game launches in Germany

pharmaphorum

Attention-deficit hyperactivity disorder (ADHD) in adults is not well understood and highly underdiagnosed, but the developers of a mobile game designed to raise awareness hope to shine a light on the struggles of people struggling with the condition.

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Squaric acid dibutyl ester by Squarex Pharmaceutical for Herpes Labialis (Oral Herpes): Likelihood of Approval

Pharmaceutical Technology

Squaric acid dibutyl ester is under clinical development by Squarex Pharmaceutical and currently in Phase I for Herpes Labialis (Oral Herpes).

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PhRMA, navigating turbulence, taps Gilead CEO to helm board of directors

Fierce Pharma

Following the exodus of several prominent drugmakers and some surprising drug pricing setbacks in Washington, the influential industry lobbying group PhRMA has been busy navigating new challen | PhRMA revealed that Gilead CEO Daniel O’Day has donned the mantle as chair of the board of directors, replacing Novartis chief Vas Narasimhan, who held the position for much of 2023.

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Biologics Development in Immunology and Inflammation — Featuring Amir Reichman, CEO of Scinai Immunotherapeutics – Xtalks Life Science Podcast Ep. 147

XTalks

This episode features an interview with Amir Reichman, CEO of Scinai Immunotherapeutics , a biopharma company focused on developing cutting-edge biological treatments within the inflammation and immunology (I&I) sector, with a primary focus on addressing autoimmune and infectious diseases. Scinai Immunotherapeutics is working on developing nanosized antibodies from alpacas, known as VHH-antibodies or NanoAbs, which show promise as improved biological therapies for various illnesses.

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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.