pharmaphorum
FEBRUARY 8, 2024
Discover effective strategies for operationalising diversity in clinical trials through site and patient engagement. Learn how to promote DEI (Diversity, Equity, and Inclusion) and enhance representation for a more inclusive and impactful research environment.
Pharmaceutical Technology
FEBRUARY 7, 2024
When consent management processes are disconnected or poorly managed, it can have a detrimental impact on patient experiences.
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Outsourcing Pharma
FEBRUARY 6, 2024
Results from a new research project have been announced by technology provider Medable on the enhanced electronic informed consent (elC) in clinical trials.
FDA Law Blog
FEBRUARY 5, 2024
By Deborah L. Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. As we described in our blog post here , the Food and Drug Omnibus Reform Act (FDORA) enacted at the end of 2022 adds new statutory obligations related to the development of diversity action plans by sponsors of certain device and drug clinical trials, and requires FDA to issue guidance.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Rethinking Clinical Trials
FEBRUARY 7, 2024
In this Friday’s PCT Grand Rounds, Cynthia Hau of the VA Boston Health Care System will present “Pragmatic Recruitment of Underrepresented Groups: Experience From the Diuretic Comparison Project.” The Grand Rounds session will be held on Friday, February 9, 2024, at 1:00 pm eastern. Hau is a statistician for the VA Cooperative Studies Program Coordinating Center in the VA Boston Health Care System.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 5, 2024
In order to ensure the seamless transition of accredited laboratories, the National Accreditation Board for Laboratories (NABL) has announced an extension of the transition period for accredited laboratories from the initial deadline of December 31, 2023 to the revised date of August 31, 2024.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 7, 2024
Stay updated on the latest clinical trials happening from January 15th to January 19th, 2024. Explore trials by ExeVir, NurixTx, Synendos Therapeutics, and Oxford BioTx.
Bio Pharma Dive
FEBRUARY 6, 2024
The Alzheimer’s drug was administered to a total of 2,000 U.S. patients as of Jan. 26, signaling to analysts that an earlier goal of 10,000 may take longer than expected to hit.
pharmaphorum
FEBRUARY 6, 2024
For the latest episode of the pharmaphorum podcast, web editor Nicole Raleigh sat down with Chris Bamford, director of clinical trial regulatory management at IQVIA, and Shirley Rutter, associate director and strategic quality lead of global quality management at IQVIA Biotech.
Pharmaceutical Technology
FEBRUARY 6, 2024
The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 8, 2024
A report by the US Centers for Disease Control and Prevention claims antifungal creams and combinations of antifungal treatments with corticosteroids are likely to be contributing to the rise and spread of severe skin, scalp, and nail fungal infections.
Bio Pharma Dive
FEBRUARY 7, 2024
The new firm intends to carefully select its startups and fund them for the long haul. “We're not a company formation factory,” said Aaron Kantoff, the firm’s co-founder.
Pharma Times
FEBRUARY 9, 2024
The rare neurodevelopmental condition CDKL5 is characterised by early-onset epilepsy
Pharmaceutical Technology
FEBRUARY 9, 2024
Pharma CEOs defended their high prescription drug costs, stating that the current prices are necessary for continued innovation.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 7, 2024
People with bipolar disorder are four to six times more likely to die prematurely than those without the condition, according to a study that compared data on thousands of people with and without the disorder.
Bio Pharma Dive
FEBRUARY 5, 2024
The pharma disclosed positive results from two studies testing its antibody drug nipocalimab in generalized myasthenia gravis or Sjögren's disease.
Pharma Times
FEBRUARY 5, 2024
The aggressive brain cancer is responsible for over 3,000 cases in the UK every year
Pharmaceutical Technology
FEBRUARY 8, 2024
AFFINITY data has spurred RegenxBio towards a pivotal study for DMD while pivotal CAMPSIITE data has the company moving towards an FDA BLA.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 6, 2024
Patients of cystic fibrosis (CF) and their relatives have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to take steps to provide CF drugs at an affordable cost using the provisions of the Patents Act, 1970, considering that the drugs at present cost anywhere from Rs. 21 lakh to Rs. 2.66 crore.
Bio Pharma Dive
FEBRUARY 8, 2024
The German biotech will invest $200 million in Autolus — funds that, along with a $50 million fee, will give it licensing opportunities and access to supply infrastructure.
Pharma Times
FEBRUARY 7, 2024
The HTA reported that Brainomix 360 improved access to treatment for stroke patients
Pharmaceutical Technology
FEBRUARY 9, 2024
AstraZeneca has reported a significant 81% rise in profit after tax, reaching $5.96bn for FY 2023 from $3.29bn in the previous year.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 6, 2024
American Amber Pearson used to wash her hands until they bled, terrified by the idea of contamination from everyday items, a debilitating result of her obsessive compulsive disorder (OCD).
Bio Pharma Dive
FEBRUARY 5, 2024
In a related deal, Novo Holdings subsidiary Novo Nordisk will buy three major Catalent factories for $11 billion as it works to keep pace with demand for its obesity and diabetes medicines.
Pharma Times
FEBRUARY 8, 2024
The committee has advised that the vaccine should be given to those at the highest risk
Pharmaceutical Technology
FEBRUARY 7, 2024
Gilead Sciences has announced a 22.9% increase in net income of $5.61bn for FY23 as against $4.56bn in FY22.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 5, 2024
If you’re one of the one in three people whose New Year’s resolution involved losing weight, it’s likely you’re now contemplating what weight-loss goal you should actually be working towards. But type “setting a weight loss goal” into any online search engine and you’ll likely be left with more questions than answers.
Bio Pharma Dive
FEBRUARY 7, 2024
The company, a leading developer of cell therapies for autoimmune diseases, is the fifth drug startup to go public in 2024. All of them raised at least $100 million.
Pharma Times
FEBRUARY 9, 2024
OART is increasingly emerging to assess and adapt treatment for cancer patients
Pharmaceutical Technology
FEBRUARY 6, 2024
Health Canada has approved Chiesi Global Rare Diseases’ MYALEPTA as a treatment for individuals with lipodystrophy, an ultra-rare condition.
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