Wed.Aug 24, 2022

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Moderna follows Pfizer in asking FDA to approve updated COVID shot

Bio Pharma Dive

The companies are moving quickly to supply vaccines targeting currently circulating omicron variants in time for the Biden administration's planned fall vaccination campaign.

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August 24, 2022: Diuretic Comparison Project, a Point-of-Care Clinical Trial, to Be Featured in PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Dr. Areef Ishani of the University of Minnesota will present “The Diuretic Comparison Project: A Large Pragmatic Clinical Trial.” The Grand Rounds session will be held on Friday, August 26, 2022, at 1:00 pm eastern. The Diuretic Comparison Project is a large, national “point-of-care clinical trial” comparing the effects of 2 thiazide-type diuretics, hydrochlorothiazide and chlorthalidone, on cardiovascular outcomes in older veteran

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Ovid turns to gene therapy startup to restock drug pipeline

Bio Pharma Dive

The New York biotech will invest in and develop up to three drugs with Gensaic, an emerging startup aiming to use the viruses that infect bacteria to deliver genetic medicines.

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Lacerta partners with Prevail to develop AAV capsids for CNS diseases

Pharmaceutical Technology

Lacerta Therapeutics has entered a new licensing and research partnership agreement with Eli Lilly and Company subsidiary, Prevail Therapeutics, to discover and develop adeno-associated virus (AAV) capsids for treating central nervous system (CNS) diseases. . Under the collaboration, Prevail will obtain rights to use one of the new AAV capsids of Lacerta for selected CNS targets that are currently undisclosed. .

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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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Safety worries spur Novartis to suspend drug dosing in Huntington’s trial

Bio Pharma Dive

Researchers reported signs of nerve damage in patients treated with the drug branaplam, which is among the most advanced candidates now in testing.

Drugs 286
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Moderna seeks FDA EUA for Covid-19 booster vaccine

Pharmaceutical Technology

Mode rna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 Omicron-targeting bivalent booster vaccine for Covid-19. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above. mRNA-1273.222 acts on the SARS-CoV-2 virus’ initial strain and the Omicron’s subvariants BA.4/BA.5.

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GERTEIS® PACTOR® SERIES In-Line Ribbon-Strength Measurement System

Pharmaceutical Technology

Abstract. In roller compaction, the ribbon density, being the result of a specified force and gap, is a key driver for ribbon and granule quality. Therefore, GERTEIS ® offers their Density Control feature to monitor and control the at-gap density on their PACTOR ® line of roller compactors. To reduce batch-to-batch variations, the preferred control parameter is ribbon strength.

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Opinion: To improve children’s health in low-income countries, put pediatric surgery on par with preventing malaria or HIV

STAT News

The devastation caused by malnutrition, HIV, tuberculosis, and malaria in low income countries is well known in the U.S. and other high-income countries, due in part to masterful marketing that has elevated these diseases into the collective consciousness — and convinced many people to open their wallets. But this narrow focus on fundraising and aid limits the public good that comes from investing in child health.

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Why keeping girls in school is a good strategy to cope with climate change

NPR Health - Shots

Education for girls brings numerous benefits when it comes to addressing the climate crisis. Oh, and it works for boys, too!

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The FDA stands by as the vaping industry flouts its orders

STAT News

WASHINGTON — The Food and Drug Administration has spent more than four years trying to decide whether retailers should be able to sell products like cotton candy-flavored liquids, vapes made to look like fidget spinners, and disposables filled with more nicotine than 200 cigarettes. And so far, the agency has explicitly ordered hundreds of them off the market.

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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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Young adults are using marijuana and hallucinogens at the highest rates on record

NPR Health - Shots

The National Institutes of Health annually surveys substance abuse among young adults in its Monitoring the Future study.

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Merck chases Bayer/Ionis with fast track for Factor XI drug

pharmaphorum

The FDA has given a novel anticoagulant from Merck & Co a fast-track designation as a treatment for people with end-stage renal disease (ESRD) who need dialysis, firing a warning short over the bows of a rival programme in development at Ionis and Bayer. The anticoagulant – codenamed MK-2060 – is a monoclonal antibody designed to inhibit Factor XI and is currently in a phase 2b trial in ESRD patients on dialysis, who often need to be treated with anticoagulants to prevent blood clots.

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New York counties gear up to fight a polio outbreak among the unvaccinated

NPR Health - Shots

Polio is spreading in a few New York counties with low vaccination rates. Experts warn that other places in the U.S. could face the same challenge.

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Roche launches digital PCR system for ultra-rare and emerging diseases

Pharma Times

Using the system, the researchers are able to divide DNA and RNA from an already extracted clinical sample into as many as 100,000 microscopic individual reactions

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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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Psilocybin shows promise for treating alcohol addiction, new study finds

STAT News

Taking one recreational drug as treatment for over-dependence on another is hardly intuitive, but a new study found that psilocybin , the psychedelic compound in magic mushrooms, could be a promising treatment for alcohol use disorder. The research , published Wednesday in the Journal of the American Medical Association and conducted by scientists at New York University, found that those given psilocybin-assisted therapy reduced heavy drinking by 83%, compared with a 51% reduction among those wh

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AskBio subsidiary readies to start clinical trials for Huntington’s Disease gene therapy

BioPharma Reporter

BrainVectis, a subsidiary of AskBio, has received clearance from the French authorities to start a Phase 1-2 clinical trial for its novel Huntingtonâs Disease gene therapy, BV-101.

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Opinion: The FDA is at a crossroads for reducing tobacco-related disease and death

STAT News

The U.S. is at a crossroads for tobacco use, the country’s leading cause of preventable death , at nearly half a million deaths a year. Since the onset of Covid-19, which has been universally labeled as a pandemic, more Americans have died from tobacco use than from Covid.

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Abbott’s Proclaim Plus Spinal Cord Stimulation System Clenches FDA Approval

XTalks

The first clinical use of spinal cord stimulation was in 1967 for chronic pain management in cancer patients. A spinal cord stimulator consists of electrodes and a generator which looks like a small battery pack. The electrodes are placed between the vertebrae and the spinal cord (the epidural space), while the generator is positioned under the skin.

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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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Amazon to shut down telehealth venture Amazon Care by end of year

STAT News

Amazon announced Wednesday it will shut down its medical venture Amazon Care at the end of the year, a surprising move less than a month after the tech giant’s blockbuster announcement that it plans to acquire One Medical. In a memo to staff, Amazon Health Services leader Neil Lindsay said that the ambitious effort to stand up a nationwide primary care service to offer employers “was not a complete enough offering for the large enterprise customers we have been targeting, and wasn&

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New patent for Alkermes Inc drug ARISTADA

Drug Patent Watch

Annual Drug Patent Expirations for ARISTADA Aristada is a drug marketed by Alkermes Inc and is included in two NDAs. It is available from one supplier. There are sixteen patents…. The post New patent for Alkermes Inc drug ARISTADA appeared first on DrugPatentWatch - Make Better Decisions.

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What Fauci’s exit tells us about the ongoing fight against Covid

STAT News

There was a time when Anthony Fauci thought he would retire when the Covid-19 pandemic was over. He told himself he’d spend a year as President Biden’s top medical adviser and that Covid-19 would be settled by then. That, he admits now, may never happen. But this December, he announced this week , will have to be good enough.

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Covid researchers launch Monkeypox study  

Drug Discovery World

A new study investigating a potential treatment for people who have been diagnosed with monkeypox has been launched by the same team who helped develop Covid-19 treatments. . Led by the University of Oxford, the PLATINUM study will investigate the use of Tecovirimat to see if it can help speed up the recovery of Monkeypox patients. . The trial will see participants receive either a 14-day course of 600 mg tecovirimat twice daily or a matched placebo treatment.

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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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STAT+: How a long-overlooked protein could remake neuroscience drug discovery — or plunge the FDA into controversy

STAT News

So, imagine you get punched in the head. Not once, but a bunch of times. The next day, you’d of course feel dizzy, wary of loud children, and incapable of thoughtful discussion. But under an MRI, the changes to your neural architecture would likely be subtle, difficult to discern. And after a couple of days, any doctor examining your blood or spinal fluid would have trouble uncovering signs of trauma.

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Idiopathic pulmonary fibrosis research round-up

Antidote

Though idiopathic pulmonary fibrosis (IPF) is the most common type of pulmonary fibrosis , it still has no known cause and no known cure. Because it causes scarring of the lungs, IPF can make it difficult to breathe and gets worse over time — meaning researchers are continually searching for breakthroughs that allow for a better understanding of the condition and how best to treat it.

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STAT+: Pharmalittle: AstraZeneca may exit the vaccine business; Bavarian Nordic looks at expired monkeypox vax doses to boost supplies

STAT News

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is the refreshing chocolate raspberry.

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Amgen’s Soliris biosimilar clears phase 3, but won’t launch until 2025

pharmaphorum

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion’s blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The biotech has confirmed it will not launch the biosimilar until March 2025 however, honouring the terms of its 2020 agreement with Alexion that resolved litigation over the validity of patents covering Soliris (eculizumab) in the US.

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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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Could air conditioning help prevent extreme violence in prisons? Research suggests so

NPR Health - Shots

New research documents what many have long believed: that heat can lead to extreme violence in prisons. Some now want cooling zones or air conditioning installed to help staff and those incarcerated.

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Trial results for Pfizer and BioNTech’s COVID-19 vaccine for children released

Pharma Times

The phase 2/3 trial results showed that the vaccine was effective in protecting children

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WHO recommends two mAbs in fight against Ebola

BioPharma Reporter

The World Health Organization (WHO) has published its first guidelines for Ebola virus disease therapeutics, issuing âstrong recommendationsâ for the use of two monoclonal antibodies.

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New patent for Teva Branded drug QVAR 80

Drug Patent Watch

Annual Drug Patent Expirations for QVAR+80 Qvar 80 is a drug marketed by Teva Branded Pharm and is included in one NDA. There are seven patents protecting this drug. This…. The post New patent for Teva Branded drug QVAR 80 appeared first on DrugPatentWatch - Make Better Decisions.

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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.