Bio Pharma Dive
JULY 31, 2023
According to the company, FDA officials have signaled openness to using a surrogate endpoint for assessing accelerated approval of a treatment for limb-girdle muscular dystrophy.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 3, 2023
An experimental vaccine that aims to slow down or prevent the progression of Alzheimer’s disease has been trialed in mice with promising early results. Mice engineered with genes that put them at greater risk of an Alzheimer’s-like disease had fewer amyloid plaques following the vaccine.
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Pharmaceutical Technology
AUGUST 4, 2023
Amid one of the worst dengue fever outbreaks in decades, Bangladesh has recorded the highest number of hospitalised cases of the disease in a day.
Rethinking Clinical Trials
AUGUST 4, 2023
Swimming with the Sharks: Translation of Pragmatic Trial Results Description Dr. Greg Simon discussing translating pragmatic clinical trial results. Biography Gregory Simon, MD, MPH Senior Investigator, Kaiser Permanente Washington Health Research Institute SPOT Demonstration Project PI Health Care Systems Interactions Core Chair Related View more content from the Disseminating, Implementing, and Sustaining Evidence-Based Practices into Clinical Care: NIH-Hosted Workshop.
Bio Pharma Dive
AUGUST 3, 2023
One patient received its Duchenne gene therapy, Elevidys, this week and a handful more could follow shortly, surprising some analysts and raising near-term sales expectations.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 1, 2023
As scientists continue to look for clues as to how dementia can be prevented and cured, they’ve found that the bodybuilding supplement beta-hydroxy beta-methylbutyrate (or HMB) protects against cognitive decline in mice.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
AUGUST 3, 2023
This year’s Annual Steering Committee Meeting for the NIH Pragmatic Trials Collaboratory featured implementation science as one of the topics of focus. In an interview after his keynote presentation, Dr. David Chambers, deputy director for implementation science at the National Cancer Institute, shared his thoughts on opportunities for implementation science in the context of pragmatic trials.
Bio Pharma Dive
AUGUST 4, 2023
The surprise rejection of a high-dose form of Eylea could be resolved earlier than anticipated. But some of the company’s pipeline projects have stumbled.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 30, 2023
One of the challenges in treating cancer is stopping it from metastasizing, and a new study reveals one of the fundamental mechanisms through which this happens. Now we know about this mechanism, perhaps we can stop it. Key to this newly discovered process is GRP78, and it’s what’s known as a chaperone protein.
Pharmaceutical Technology
AUGUST 2, 2023
Tyra Biosciences has received orphan drug designation (ODD) from the US FDA for TYRA-300 to treat achondroplasia, a common form of dwarfism.
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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
Rethinking Clinical Trials
AUGUST 2, 2023
Dr. Eric Perakslis In this Friday’s PCT Grand Rounds, Eric Perakslis of Duke University will present “AI & ML: Want to Play a Game?” The Grand Rounds session will be held on Friday, August 4, 2023, at 1:00 pm eastern. Bergstrom is a professor in population health sciences and the chief research technology strategist in the Duke University School of Medicine.
Bio Pharma Dive
AUGUST 2, 2023
Intergalactic, a developer of non-viral gene therapies built by ex-Biogen executive Michael Ehlers, is folding less than two years after its launch.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 2, 2023
The brains in mice benefit from an active and varied lifestyle by forming enhanced neural connections.Researchers in Germany compared the brain activity of mice raised in different environments and found those raised in an ‘enriched’ environment had more activity in their hippocampus, suggesting the presence of a more robust and connected neural network.
Pharmaceutical Technology
AUGUST 4, 2023
The US FDA has granted approval for an expanded indication of Merck’s Ebola vaccine, Ervebo, for usage in the paediatric population.
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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.
Rethinking Clinical Trials
AUGUST 1, 2023
From left: NIH Collaboratory Coordinating Center co–principal investigators Lesley Curtis, Adrian Hernandez, and Kevin Weinfurt With the NIH Pragmatic Trials Collaboratory entering its second decade, we are expanding our presence on the LinkedIn social media platform to promote research that advances the design, conduct, and dissemination of pragmatic clinical trials.
Bio Pharma Dive
AUGUST 3, 2023
The company disclosed the study result alongside second quarter earnings showing Lumakras sales were flat versus the same period one year prior.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 30, 2023
Even as the Centre has listed the New Drugs, Medical Devices and Cosmetics Bill, 2023 to be tabled in Parliament during the current session, industry members are apprehensive that the new bill may mean centralisation of licensing and other powers to the Central drug regulatory authority and it may also have provisions which may harm […]
Pharmaceutical Technology
JULY 31, 2023
While messenger ribonucleic acid (mRNA)-based cancer vaccines have been in development for decades, their development had languished.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharma Times
AUGUST 2, 2023
The University of Strathclyde, the NHS and New York University join forces to increase knowledge - News - PharmaTimes
Bio Pharma Dive
AUGUST 3, 2023
Sales of the company’s COVID-19 vaccine plummeted 94% year over year. But executives believe newer products can help revenue rebound.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 2, 2023
In a significant decision, the Department of Pharmaceuticals (DoP) has rejected a review petition filed by Zydus Healthcare against the National Pharmaceutical Pricing Authority (NPPA) for fixing the retail price of anti-diabetic combination formulation comprising sitagliptin and metformin, observing that while the NPPA has not acted strictly by the books, it protected the public interest.
Pharmaceutical Technology
JULY 31, 2023
Alexion has signed a definitive agreement for acquiring and licencing Pfizer’s early-stage gene therapy portfolio for rare diseases.
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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
XTalks
AUGUST 3, 2023
Johnson & Johnson’s latest bankruptcy attempt, tied to its proposed $8.9 billion settlement for talc litigations, has been shot down by the United States Bankruptcy Court for the District of New Jersey. Last week, Bankruptcy Court Judge Michael Kaplan decided that Johnson & Johnson’s subsidiary LTL Management didn’t meet certain requirements to qualify as a good faith bankruptcy attempt.
Bio Pharma Dive
AUGUST 2, 2023
Yosemite is one of a new class of biotech venture funds that also includes the recently launched Dimension and Cure Ventures.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 3, 2023
Researchers at the Indian Institute of Science (IISc) have found that picolinic acid, a natural compound produced by mammalian cells, can block several disease-causing viruses such as SARS-CoV-2 and influenza A viruses. The Institute is now looking for partners in pharma companies to pursue further clinical development of the findings.
Pharmaceutical Technology
AUGUST 2, 2023
Two lots of Lupin’s Tydemy have been recalled due to a decrease in ascorbic acid levels leading to reduced effectiveness.
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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.
Outsourcing Pharma
AUGUST 3, 2023
At-risk families of patients diagnosed with motor neurone disease (MND), better known in the US as amyotrophic lateral sclerosis (ALS) will now have access to genetic sequencing thanks to a financial award from Innovate UK.
Bio Pharma Dive
AUGUST 2, 2023
The biotech, which has struggled to grow sales of its medicine Xpovio, is laying off 20% of its staff and focusing on late-stage studies in endometrial cancer and myelofibrosis.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 1, 2023
India’s advanced wound care market is on the growth trajectory with faster healing & minimised scarring. This is where the positive acceptance of Negative Pressure Wound Therapy (NPWT) that uses a vacuum dressing to ensure healing in acute and chronic conditions in India is gaining popularity.
Pharmaceutical Technology
AUGUST 1, 2023
BioNTech has acquired all the remaining shares of technology company InstaDeep in a deal valued at €500m ($549m) in cash.
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