Bio Pharma Dive
SEPTEMBER 30, 2022
The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.
Pharmaceutical Technology
SEPTEMBER 30, 2022
After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
SEPTEMBER 30, 2022
The application comes a year earlier than previously had been expected, as company says drug reviewers are open to accelerated review based on data from early-stage trials.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 30, 2022
We spend a third of our lives asleep. And a quarter of our time asleep is spent dreaming. So, for the average person alive in 2022, with a life expectancy of around 73, that clocks in at just over six years of dreaming. Yet, given the central role that dreaming plays in our lives, we […].
Advertisement
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
Bio Pharma Dive
SEPTEMBER 30, 2022
The biotechnology startup will part with its lead drug candidate, an anti-inflammatory small molecule, in Novo Nordisk’s bet on inflammasome treatments.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 30, 2022
The Department of Commerce (DoC) has approved setting up a separate Export Promotion Council (EPC) for the medical devices sector under the administrative control of the Department of Pharmaceuticals to help exporters in promoting their products in international markets. The medical devices industry welcomed the move and the strategic step will go a long way […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 30, 2022
InflaRx has submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its lead candidate, vilobelimab, to treat Covid-19 patients who are critically ill. The latest development comes after the company had encouraging discussions with the agency at a Type B meeting. In addition, vilobelimab received Fast Track designation from the FDA to treat critically ill, mechanically ventilated, intubated patients with the infection.
Bio Pharma Dive
SEPTEMBER 30, 2022
Run by the hospital’s Healey Center, the platform trial is designed to evaluate several prospective treatments simultaneously and get answers on their potential more quickly.
Pharmaceutical Technology
SEPTEMBER 30, 2022
Pheon Therapeutics has announced its launch to progress new antibody-drug conjugates (ADCs) for treating solid tumours. The launch comes after the company raised $68m in a series A financing round led by Brandon Capital, Forbion and Atlas Venture. Seed investor Research Corporation Technologies (RCT) also took part in the funding round. The latest financing will aid the company in progressing its lead ADC programme to clinical proof-of-concept (PoC) and validate the new ADC pipeline. .
Rethinking Clinical Trials
SEPTEMBER 30, 2022
The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2023 Annual Conference until October 7, 2022. The conference will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
SEPTEMBER 30, 2022
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Verismo Therapeutics’ SynKIR-110 to treat mesothelin-expressing mesothelioma patients. A next generation cell therapy approach, SynKIR-110 acts on solid tumours. It is said to be the first product to leverage the new KIR-CAR platform, a modified NK-like receptor for boosting efficacy and persistence against aggressive solid tumours.
NPR Health - Shots
SEPTEMBER 30, 2022
California Rep. Ami Bera was bitten by a rabid fox on Capitol Hill in April. He's OK, but now, he wants to make sure the cost of the lifesaving treatment isn't a burden for those who need it.
STAT News
SEPTEMBER 30, 2022
Every day, pregnant people across the United States get the news that the futures they imagined for their babies are at risk due to a fetal condition. It may be something relatively minor, like a small benign growth on a lung, or something major, like a life-threatening heart or developmental problem. Some of these problems can be mediated by maternal-fetal surgery.
Rethinking Clinical Trials
SEPTEMBER 30, 2022
. Speakers. Margaret McConnell, PhD. Associate Professor. Department of Global Health and Population. Harvard T.H. Chan School of Public Health. Slides. Keywords. Randomized controlled trial. Key Points. This trial took place in South Carolina at a time when Medicare was thinking about how to improve outcomes and if expanding home nursing services could improve health outcomes.
Advertisement
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
SEPTEMBER 30, 2022
We live in a time where the rate of medical and superlative scientific advances is accelerating — by more than 1,300% since 1985, according to one recent estimate. With so many “unprecedented,” “transformative” breakthroughs happening, forecasting which one will be awarded top research honors isn’t getting any easier.
NPR Health - Shots
SEPTEMBER 30, 2022
Tua Tagovailoa sustained a major hit in a Sept. 25 game that the team called a back injury that raised questions. Now, he's being treated for a possible concussion after a Thursday game.
STAT News
SEPTEMBER 30, 2022
Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the fourth quarter: Arrowhead Pharmaceuticals and partner Takeda Pharmaceuticals are nearing the completion of a mid-stage, placebo-controlled clinical trial of an RNA-based drug called fazirsiran in patients with alpha-1 antitrypsin deficiency, or AATD, an inherited disease that causes severe liver and lung damage.
pharmaphorum
SEPTEMBER 30, 2022
Dr. Houda Hachad is vice president of clinical operations at AccessDx Laboratory, where she focuses on expanding the use of pharmacogenomic testing, a major piece of the puzzle for precision medicine. Genetic testing has become vastly more accessible in the last 20 years and has opened all kinds of doors in medicine, from pharmacogenetics and better understanding drug interactions and adverse events to tremendous advances in oncology: understanding the underlying genetics of cancer cells has all
Advertisement
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.
STAT News
SEPTEMBER 30, 2022
SAN DIEGO — After a steep drop in its stock price and with mounting competition from rivals, genomics giant Illumina on Thursday launched a new line of high-powered DNA sequencers, ratcheting up the race to read genetic information accurately and cheaply. The new instruments, dubbed the NovaSeq X Series, can churn out up to 20,000 human genomes in a year, 2.5 times the max output of the company’s current machines, executives announced.
Antidote
SEPTEMBER 30, 2022
Since 1999, October has been recognized as Health Literacy Month. The goal, as defined by the Institute for Healthcare Advancement , is to raise awareness about the importance of understandable health information — but what is health literacy and why is it important?
STAT News
SEPTEMBER 30, 2022
The climate crisis — the greatest threat to human health in history — is often framed “in ways that pay little attention to its health dimensions,” as the authors of The Lancet’s annual “Countdown: Tracking Progress on Health and Climate Change” report were forced to remind us. This tragic reality was on display in Health Affairs , JAMA , Kaiser Health News , and The Lancet itself, among others, when they limited their reporting on the recently pa
XTalks
SEPTEMBER 30, 2022
Each year, National Coffee Day falls on September 29 in the US and Canada. Not to be confused with International Coffee Day, which happens just two days later on October 1, National Coffee Day 2022 also takes place on the same day as National Starbucks Day. Here’s everything you need to know about the history of coffee, the significance of the holiday and deals to expect from coffee chains.
Advertisement
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.
STAT News
SEPTEMBER 30, 2022
WASHINGTON — A Juul executive fiercely criticized the Food and Drug Administration’s approach toward regulating vaping companies during a tobacco industry conference Thursday. Joe Murillo, the company’s chief regulatory officer, came armed with a number of criticisms of the agency, including its alleged inability to withstand political pressure.
pharmaphorum
SEPTEMBER 30, 2022
Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The approval makes Relyvrio (sodium phenylbutyrate and taurursodiol) the first new therapy option for ALS – also known as motor neuron disease (MND) – since Mitsubishi Tanabe Pharma’s intravenous Radicava (edaravone) was cleared by the FDA in 2017.
STAT News
SEPTEMBER 30, 2022
The Food and Drug Administration approved a new medicine for ALS from Amylyx Pharmaceuticals on Thursday, providing a desperately-needed new treatment option for a devastating disease. The medicine, to be sold as Relyvrio, is not a cure for ALS but proved to moderately slow the progression of the neurological disease, which causes the destruction of neurons in the brain and spinal cord, resulting in weakened muscles, paralysis, and death.
pharmaphorum
SEPTEMBER 30, 2022
Part I. Novel oncologic drugs continue to command premium pricing, driven by a combination of unmet needs, and delivering often-iterative, sometimes-significant improvements in survival or maintenance of a progression-free state. The stable of PD-1/PD-L1 checkpoint inhibitors, led by Keytruda (pembrolizumab), represents the current generation of high value, high price drugs to tackle a variety of cancers in mono- or combination therapy.
Advertisement
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
SEPTEMBER 30, 2022
For companies that have spent years developing interactive technologies to help treat disease, the tricky question inevitably comes: How far are you willing to go to prove it works? Some test their products, sometimes called digital therapeutics, in the most rigorous, and expensive, way. They run a randomized trial with a sham control that mimics everything about a product, except the piece that’s supposed to have therapeutic effect.
NPR Health - Shots
SEPTEMBER 30, 2022
After a car accident, Frankie Cook went to the ER to make sure she didn't have a concussion. She walked out of the hospital in the clear. Then came the bill.
STAT News
SEPTEMBER 30, 2022
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday.
Pharma Times
SEPTEMBER 30, 2022
New formulation may be suitable for large-scale trials and commercial supply in the future
Advertisement
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.
Expert insights. Personalized for you.
364 
Let's personalize your content