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.
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.
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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By Deborah L. Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.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.
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.
pharmaphorum
FEBRUARY 5, 2024
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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.
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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
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.
Rethinking Clinical Trials
FEBRUARY 8, 2024
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
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.
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.
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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.
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.
FDA Law Blog
FEBRUARY 7, 2024
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
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.
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.
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.
Fierce Pharma
FEBRUARY 8, 2024
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.
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.
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).
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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
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.
Fierce Pharma
FEBRUARY 6, 2024
In a midstage trial, Eli Lilly’s star diabetes and weight-loss drug tirzepatide showed promise in fatty liver disease, a difficult-to-treat condition that doesn’t yet have an FDA-approved therapy.< | Eli Lilly's star diabetes and weight loss drug tirzepatide showed promise in fatty liver disease with a massive anti-MASH benefit accompanied by a "clinically meaningful" anti-fibrosis effect.
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.
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.
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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.
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.
Fierce Pharma
FEBRUARY 6, 2024
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.
Pharmaceutical Technology
FEBRUARY 8, 2024
Despite several ground-breaking developments, pharmaceutical and biotech companies are often reluctant to invest in cell and gene therapy.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 8, 2024
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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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.
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