Sat.Feb 03, 2024 - Fri.Feb 09, 2024

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Operationalising diversity through site and patient engagement

pharmaphorum

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.

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Medable's enhanced electronic consent making patients feel more human and less like study subjects

Outsourcing Pharma

Results from a new research project have been announced by technology provider Medable on the enhanced electronic informed consent (elC) in clinical trials.

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Guidance on Standardizing Terminology and Collection: Another Step in FDA’s Path to Increasing Diversity and Inclusion in Clinical Trials

FDA Law Blog

By Deborah L. Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.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.

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February 7, 2024: Pragmatic Recruitment of Underrepresented Groups, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

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.

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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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NABL announces transitional changes in lab accreditation procedures

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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Data science in healthcare

pharmaphorum

Data science in healthcare is transforming the industry, from drug discovery to patient care. Learn about the role of data, artificial intelligence (AI), and the impact of initiatives like the NHS Datastore in revolutionising healthcare outcomes.

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Eisai falls behind on Leqembi patient goal

Bio Pharma Dive

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.

Drugs 177
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A clearer harmony and attractiveness for EU Clinical Trials Regulation

pharmaphorum

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.

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Alternative therapies are needed to combat the impending threat of AMR

Pharmaceutical Technology

The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.

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Cystic fibrosis patients ask DPIIT to allow local manufacturing of CFTR modulators to bring down price

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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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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Venture firm Scion Life Sciences launches with $310M to back new biotechs

Bio Pharma Dive

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.

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February 8, 2024: HCSRN Nears Early-Bird Registration Deadline, Announces Opening Plenary Speaker

Rethinking Clinical Trials

The Health Care Systems Research Network (HCSRN) continued early-bird registration and announced the opening plenary speaker for its 2024 Annual Conference , which be held from April 9 to 11 in Milwaukee, Wisconsin. This year's opening plenary session will feature keynote speaker David Kent, director of the Tufts Predictive Analytics and Comparative Effectiveness Center and a professor of medicine, neurology, and clinical and translational science at Tufts Medical Center and Tufts University Sch

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RegenxBio advances two candidates to make waves in the CNS space

Pharmaceutical Technology

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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You May Not Need to Lose as Much Weight as You Think, Expert Reveals

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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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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J&J says top drug prospect works across autoimmune disorders

Bio Pharma Dive

The pharma disclosed positive results from two studies testing its antibody drug nipocalimab in generalized myasthenia gravis or Sjögren's disease.

Drugs 312
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PBMs take bulk of blame as senators question BMS, J&J and Merck CEOs on high drug prices in US

Fierce Pharma

Thursday, when senators questioned three Big Pharma CEOs about the high price of drugs in the U.S., Health, Education, Labor and Pensions (HELP) committee chairman Bernie Sanders, I-Vermont, put th | CEOs from Bristol Myers Squibb, Johnson & Johnson and Merck faced tough questions from senators on why prices for drugs in the U.S. exceed those in other countries.

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US Senate committee interrogates big pharma on “outrageously high” drug prices

Pharmaceutical Technology

Pharma CEOs defended their high prescription drug costs, stating that the current prices are necessary for continued innovation.

Drugs 282
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Bipolar Disorder Linked to a Higher Risk of Early Death Than Smoking

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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BioNTech partners with Autolus to boost cell therapy manufacturing

Bio Pharma Dive

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.

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Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines

FDA Law Blog

By John A. Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. As stated in the press release , this was the fourth largest civil penalty settlement under the CSA and, ironically, did not involve the sale or distribution of any contr

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AstraZeneca posts 81% rise in FY 2023 profit after tax

Pharmaceutical Technology

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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Antifungal Creams Could Be Triggering a Wave of Superfungal Skin Infections

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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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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Novo Holdings to buy contract drugmaker Catalent for $16.5B

Bio Pharma Dive

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.

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AstraZeneca brings its cell therapy ambitions to Maryland with $300M plant investment, 150 planned hires

Fierce Pharma

Following a slew of cell therapy biotech team-ups, AstraZeneca is taking manufacturing into its own hands. | AstraZeneca is plugging $300 million into a new facility in Rockville, Maryland, to launch its cell therapy platforms in the United States for cancer trials and future commercial supply. In turn, AZ will create more than 150 new jobs.

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Medicines access: Unlocking the immense potential in cell and gene therapy  

Pharmaceutical Technology

Despite several ground-breaking developments, pharmaceutical and biotech companies are often reluctant to invest in cell and gene therapy.

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US Woman Receives Revolutionary Brain Implant For OCD And Epilepsy

AuroBlog - Aurous Healthcare Clinical Trials blog

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).

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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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Kyverna IPO adds to biotech momentum with $319M fundraise

Bio Pharma Dive

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.

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Inside the NCVR evolution in the UK

pharmaphorum

Explore the commercial research landscape in the UK and the evolution of the National Institute for Health Research (NIHR) through an informative webinar.

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Boehringer and CBmed partner to develop cancer therapies

Pharmaceutical Technology

Boehringer has entered a strategic collaboration with CBmed to expedite the translation of cancer treatment approaches into new therapies.

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Healthcare sector hails interim budget, calls for GST rationalization & increased investments

AuroBlog - Aurous Healthcare Clinical Trials blog

The healthcare industry has welcomed the interim budget presented by Union Finance Minister Nirmala Sitharaman, while adding that the government needs to prioritise spending towards healthcare sector and long standing demands like rationalisation of Goods and Services Tax (GST) and increased investments in the healthcare sector are yet to be addressed.

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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.