Bio Pharma Dive
OCTOBER 11, 2023
Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 8, 2023
The World Health Organization has approved a new vaccine that scientists argue will be a game-changer in the fight against malaria, which kills half a million people in Africa every year.
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Imperical Blog
OCTOBER 9, 2023
Clinical trial recruitment and patient engagement practices have evolved and so has clinical trial technology. What does the future look like? I recently spoke with Matthew Stumm, founder and president of the Boston-based patient recruitment agency Stark / Raving Health. I’ve known Matt for many… The post The Future of Clinical Trials, Patient Engagement, and Technology appeared first on Imperial Clinical Research Services Blog.
Outsourcing Pharma
OCTOBER 10, 2023
Complete clinical trials solution company, Hawthorne Effect, announced today (October 10) announced it had successfully recruited more than 1,000 patients in 48 states plus Hawaii for a study to qualify the prevalence of valvular heart disease (VHD).
Drug Patent Watch
OCTOBER 10, 2023
A strong patent portfolio is at the core of branded pharmaceutical firms. Accordingly, one way to assess the relative strength of pharmaceutical firms is to compare their patent-counts. This chart… The post Which pharmaceutical companies have the largest patent portfolios? appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
OCTOBER 11, 2023
From Statera Biopharma and Sorrento Therapeutics to Aceragen and Infinity Pharmaceuticals, 2023 has seen a record high 28 bankruptcies in the biotech space so far. Here’s why.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 11, 2023
Biomarin and CSL Behring’s haemophilia gene therapies have boosted innovation in the field, but assessing their cost effectiveness is less than straightforward.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 9, 2023
Getting up at least 50 steps a day is associated with a more than 20 percent cut in the risk of cardiovascular disease, new research shows – so you may only need to climb five flights of stairs per day to significantly boost your heart health.
Rethinking Clinical Trials
OCTOBER 12, 2023
In a new article published this week in Contemporary Clinical Trials Communications, the GRACE Demonstration Project team recommends that suicidality should be monitored in pragmatic clinical trials that measure depression as an outcome. The work builds on their experience conducting research involving patients with sickle cell disease and on previous work from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core.
Bio Pharma Dive
OCTOBER 10, 2023
There have been few bigger-ticket acquisitions recently. But a string of deals announced in early October may affirm the forecasts of analysts who expect M&A to tick up in the coming months.
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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
Pharmaceutical Technology
OCTOBER 13, 2023
The dose-selection Phase I trials for evaluating PepGen’s peptide-conjugated antisense oligonucleotide have been cleared to begin in the US.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 10, 2023
It wasn’t that long ago that some people speculated that long COVID was all in the mind – a psychosomatic illness. Thankfully, that period of speculation is now behind us. We have compelling evidence that long COVID is very real and can affect major organs in people who were previously hospitalised with the disease.
Rethinking Clinical Trials
OCTOBER 9, 2023
The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 16th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health
Bio Pharma Dive
OCTOBER 10, 2023
The pharma plans for the new Berkeley facility to produce clinical, and potentially commercial, supplies of a Parkinson’s disease cell therapy being tested by its subsidiary BlueRock.
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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.
Pharmaceutical Technology
OCTOBER 10, 2023
In a two-part column, F. Randy Vogenberg delves into why it is important to address emerging challenges in the employer-based US commercial insurance landscape.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 12, 2023
An elderly woman in Russia’s Far East was revealed on Wednesday to have lived for 80 years with an inch-long needle in her brain, after doctors made the unexpected discovery during a CT scan.
Rethinking Clinical Trials
OCTOBER 11, 2023
Keith Marsolo, PhD In this Friday’s PCT Grand Rounds, Keith Marsolo of Duke University will present “Incorporating Social Determinants of Health Into PCORnet.” The Grand Rounds session will be held on Friday, October 13, 2023, at 1:00 pm eastern. Marsolo is an associate professor of population health sciences at Duke University and a cochair of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records Core Working Group.
Bio Pharma Dive
OCTOBER 11, 2023
The finding from the study of its diabetes drug, which Novo didn’t detail, could help the company in its competition with rival drugmaker Eli Lilly.
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.
Pharmaceutical Technology
OCTOBER 9, 2023
GSK and Chongqing Zhifei have signed an exclusive agreement for co-promoting the former’s shingles vaccine, Shingrix, in China.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 11, 2023
Deep sleep could be key to forestalling slow declines in brain health that may one day lead to Alzheimer’s disease, the most common form of dementia.
Rethinking Clinical Trials
OCTOBER 10, 2023
Ethics and regulatory onboarding documentation for the NIH Pragmatic Trials Collaboratory’s newest Demonstration Projects are now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE studies. The consultations took place by video conference and included representation from the studies’ principal investigators, members of the NIH Coll
Bio Pharma Dive
OCTOBER 13, 2023
The awards, to biotechs Gritstone, Codagenix and CastleVax, are part of the program’s plan to develop vaccines with broader or longer-lasting benefits.
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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
Pharmaceutical Technology
OCTOBER 13, 2023
The Phase IIb SurVaxM vaccine study will enrol 265 patients and has an estimated completion date in Q2 2024.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 10, 2023
The Multi Disciplinary Committee (MDC) of Experts of the National Pharmaceutical Pricing Authority (NPPA) has recommended exemption of Cadila Pharmaceuticals’ dietary supplement Vitamin D3 Injection (cholecalciferol aqueous injection 6,00,000 IU/2ml) from the drug price control for certain period as it is covered under the scope of patent granted by the Patent Office.
Fierce Pharma
OCTOBER 9, 2023
Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers. | Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers.
Bio Pharma Dive
OCTOBER 13, 2023
Employers face a difficult decision over whether to cover the popular weight loss therapies, which cost between $900 and $1,400 for a typical month’s supply at list price.
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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.
Pharmaceutical Technology
OCTOBER 13, 2023
Amneal adds Prolia and Xgeva biosimilars to its oncology portfolio which already has three biosimilars products launched in the US.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 12, 2023
A Parliamentary Panel that looked into the implementation of Pradhan Mantri TB Mukt Bharat Abhiyan (PMTBMBA) has advised the Centre to use latest technologies such as drones, data integration systems and mobile apps to strengthen surveillance in order to test, control and eradicate tuberculosis from the country.
BioSpace
OCTOBER 11, 2023
Following the recommendations of an independent Data Monitoring Committee, Novo Nordisk has halted a Phase III kidney outcomes study of semaglutide ahead of schedule due to strong efficacy signals.
Bio Pharma Dive
OCTOBER 9, 2023
The purchase agreement with Chongqing Zhifei Biological Products is part of GSK’s plan to double sales of the shingles vaccine by 2026.
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