Bio Pharma Dive
APRIL 18, 2023
The acquisition gives GSK a competitor to a similar drug being developed by Merck for the condition, which the companies estimate affects millions of people in the U.S.
Pharmaceutical Technology
APRIL 18, 2023
IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. The approval was based on successful results from a bioequivalence study comparing Rizafilm to Merck and Co’s Maxalt-MTL and the European reference Maxalt-Lingua. Rizaport and Maxalt are different formulations of Rizatriptan benzoate.
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Bio Pharma Dive
APRIL 18, 2023
Revenue topped analyst forecasts on strong market performance from the pharma’s multiple myeloma treatments, as well as the last quarter of significant COVID-19 vaccine sales.
Rethinking Clinical Trials
APRIL 18, 2023
Speaker Kanecia Zimmerman, MD, PhD, MPH Associate Professor of Pediatrics Duke Clinical Research Institute Duke University School of Medicine Slides Keywords COVID-19, RECOVER, Clinical Trials Key Points Long COVID is a set of multiple conditions with diverse clinical manifestations that can affect every major organ/tissue system, reflecting varied potential underlying and co-existing causes.
Bio Pharma Dive
APRIL 18, 2023
The decision to cut another 80 or so employees follows a trial setback, a canceled partnership and a failed merger bid. The CFO has also stepped down.
Pharmaceutical Technology
APRIL 18, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: HIV peptides.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Mirror
APRIL 18, 2023
Dudley, UK, April 18th 2023: Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced that it has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The license allows Sterling to manufacture antibody-drug conjugates (ADCs) for clinical use in its current Good Manufacturing Practices (cGMP) compliant manufacturing facility in Deesid
Pharmaceutical Technology
APRIL 18, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Glycoside hydrolase-ba
NPR Health - Shots
APRIL 18, 2023
Boys born to mothers who got COVID-19 while pregnant seem to have a higher risk of subtle developmental delays, including those associated with autism spectrum disorder.
Pharmaceutical Technology
APRIL 18, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Lipase compositions.
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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
Medical Xpress
APRIL 18, 2023
Effective management of depression through psychological therapy is associated with a lower likelihood of heart disease and stroke, according to research published today in European Heart Journal.
Pharmaceutical Technology
APRIL 18, 2023
On 17 April, a US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in favour of the potential approval of Entasis Therapeutics’ sulbactam-durlobactam for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex.
NPR Health - Shots
APRIL 18, 2023
Anthony Comstock pushed Congress to crack down on what he saw as harmful vices, such as pornography and contraception. An 1873 law named for him has appeared in recent court battles over abortion.
Pharmaceutical Technology
APRIL 18, 2023
The US Food and Drug Administration (FDA) has granted approval for the expanded indication of AbbVie ’s Qulipta (atogepant) as a preventive treatment for chronic migraines in adult patients. Qulipta received approval to treat migraine across frequencies, including both episodic and chronic. The medication has become the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist to receive approval for preventing episodic and chronic migraine.
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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
NPR Health - Shots
APRIL 18, 2023
Maria Caprigno was one of the youngest people in the U.S. to get the surgery. As parents and doctors grapple with the obesity treatment for teens, Caprigno cites the long-term benefits.
Pharmaceutical Technology
APRIL 18, 2023
Three regulators in different jurisdictions have accepted Bristol Myers Squibb’s applications for Abecma (idecabtagene vicleucel) for earlier use to treat triple-class exposed relapsed and/or refractory multiple myeloma in adult patients. The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics licence application for Abecma.
Medical Xpress
APRIL 18, 2023
Amid headlines about artificial intelligence's implications for everything from education to the future of work itself, Abhinav Jha, an assistant professor of biomedical engineering at the McKelvey School of Engineering and of radiology at the School of Medicine, both at Washington University in St. Louis, and his collaborators developed and evaluated two methods to quantitatively determine the realism of synthetic, or computer-generated medical images.
Pharmaceutical Technology
APRIL 18, 2023
Pipeline Therapeutics and Janssen Pharmaceutical have signed a global licence and development agreement for PIPE-307 to treat disorders of the nervous system. An oral, selective, muscarinic M1 receptor antagonist, PIPE-307, has been designed to drive oligodendrocyte precursor cells’ mutations into oligodendrocytes that produce myelin. PIPE-307 has already been evaluated in two Phase I clinical trials in healthy patients, and has also received Food and Drug Administration (FDA) clearance as
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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.
NPR Health - Shots
APRIL 18, 2023
Blacklegged ticks, the arachnids that carry Lyme disease, are out and about for more of the year thanks to warming temperatures across much of the country. Here's how to stay safe.
Medical Xpress
APRIL 18, 2023
Cancer survivors may be at long term heightened risk of subsequent cardiovascular disease, irrespective of traditional underlying risk factors, suggest the findings of a large UK Biobank study, published online in the journal Heart. Those with previous breast or blood cancers may be at greatest risk, the findings indicate.
STAT News
APRIL 18, 2023
BRISTOL, Tenn. — Zoe Poplin cupped her hands around her 17-month-old’s head, as if her palms over his ears could protect him. “I’m worried about him,” she said. She stroked baby Ezra’s back. “Because when they’re little, you know, their little cells are splitting real fast, and he’s growing and all it takes is one misreading, and he could end up with childhood cancer.
Medical Xpress
APRIL 18, 2023
Chronic wounds are a major health problem for diabetic patients and the elderly—in extreme cases they can even lead to amputation. Using electric stimulation, researchers in a project at Chalmers University of Technology, Sweden, and the University of Freiburg, Germany, have developed a method that speeds up the healing process, making wounds heal three times faster.
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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.
STAT News
APRIL 18, 2023
Over the past five years, digital mental health has risen from a niche topic to a global health priority. Patients, researchers, regulators, and investors alike are thrilled by the potential of ubiquitous mobile technology like smartphones to help diagnose problems, monitor health, and even deliver evidence-based therapies. Two companies that came to embody this potential were Mindstrong for smartphone monitoring of mental health and Pear Therapeutics for FDA-approved apps and digital interventi
Medical Xpress
APRIL 18, 2023
An innovative three-step ablation approach including ethanol infusion of the vein of Marshall improves freedom from arrhythmias in patients with persistent atrial fibrillation compared to pulmonary vein isolation (PVI) alone, according to late breaking science presented at EHRA 2023. Preliminary results at 10 months are presented, with follow up ongoing until 12 months.
NPR Health - Shots
APRIL 18, 2023
We spoke to Dr. Ghazali Babiker, country director for Médecins Sans Frontières in Sudan, who is in Khartoum. He offered a grim assessment of the impact of fighting on the ability to give health care.
Medical Xpress
APRIL 18, 2023
A score based on four readily available clinical and imaging parameters identifies the heart failure patients who benefit most from atrial fibrillation ablation, according to late breaking science presented at EHRA 2023, a scientific congress of the European Society of Cardiology (ESC).
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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.
STAT News
APRIL 18, 2023
People ages 65 and older and those who are immunocompromised will be allowed to receive an additional dose of Covid-19 vaccine this spring if they wish, the Food and Drug Administration announced Tuesday. In authorizing another dose for people in these demographics, the agency is following in the footsteps of Canada and the United Kingdom, which earlier announced that older adults, adults who live in care facilities, and people who are immunocompromised would have access to an additional booster
Medical Xpress
APRIL 18, 2023
Young teen smokers who also vape may be at heightened risk of persistent and heavier smoking in their late teens, reveal the combined findings of two nationally representative UK and U.S. studies, published online in the journal Tobacco Control.
STAT News
APRIL 18, 2023
A hospital in Idaho recently announced it will shutter its labor and delivery services due to doctors’ unwillingness to practice medicine in the face of the state’s restrictive and punitive laws surrounding reproductive health care. This comes on the heels of a hospital in rural Washington state closing its labor and delivery services due to concerns over the cost of these services.
Medical Xpress
APRIL 18, 2023
New research from University of East Anglia reveals why some children may be slower to learn words than others.
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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.
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