It's a Design Problem: Women and Clinical Trials
BioSpace
APRIL 11, 2024
While women’s clinical trial participation has increased, clinical trials still largely are not designed for women.
Sat.Apr 06, 2024 - Fri.Apr 12, 2024
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Fixing clinical trial data management
pharmaphorum
APRIL 11, 2024
It’s 2024 and in most clinical trials, data is still being moved from the EHR to the EDC manually – with employees reading data from one screen and typing it onto another. How did we get here? And how do we get past it? On today’s pharmaphorum podcast, host Jonah Comstock speaks with Iddo Peleg, CEO of Yonalink, about these very questions.
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Women want to participate in clinical trials. Lack of flexibility is still a problem.
Bio Pharma Dive
APRIL 8, 2024
Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.
“This Is The First Time”: Drug Shows Signs of Slowing Parkinson’s Disease
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 7, 2024
A drug used to treat diabetes slowed the progression of motor issues associated with Parkinson’s disease, a study published in the New England Journal of Medicine said Wednesday. Parkinson’s is a devastating nervous system disorder affecting 10 million people worldwide, with no current cure.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
How Efficient Logistics Can Change the Lives of Rare Disease Patients
Pharmaceutical Commerce
APRIL 10, 2024
If manufacturers cannot ensure safe, cost-effective delivery of treatments for rare diseases, access will remain a challenges for many patients living with these conditions.
Scientists Accidentally Made a Mouse Grow Legs in Place of Genitals
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 8, 2024
Turning off a gene early in mouse development led researchers to end up with an accidental six-legged embryonic mammal. This strange result took the spinal cord research of developmental biologists Anastasiia Lozovska and Moisés Mallo and their colleagues at Portugal’s Gulbenkian Science Institute in a new direction.
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FDA accepts Shorla’s oral liquid leukaemia drug NDA
Pharmaceutical Technology
APRIL 8, 2024
The FDA has approved the NDA for SH-201, an oral liquid drug that slows or stops the growth of certain types of leukaemia.
April 10, 2024: Primary Results of PRIM-ER Trial to Be Featured in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
APRIL 10, 2024
Dr. Corita Grudzen, principal investigator of PRIM-ER In this Friday’s PCT Grand Rounds, Corita Grudzen of the Memorial Sloan Kettering Cancer Center will present “Primary Palliative Care for Emergency Medicine, a Cluster Randomized Stepped-Wedge Trial Across 33 Emergency Departments,” including the results of the PRIM-ER trial. The Grand Rounds session will be held on Friday, April 12, 2024, at 1:00 pm eastern.
Alzheimer’s Is More Common in Women, And This May Help Explain Why
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 9, 2024
In the US, roughly two out of every three people with Alzheimer’s is a woman, a statistic that could be partially explained by the fact women typically live longer than men. Yet researchers have suspected there could be more to the story.
New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.
Bio Pharma Dive
APRIL 10, 2024
The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.
The New Age of Decentralized Clinical Trials
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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
Moderna pauses plans to build mRNA facility in Kenya
Pharmaceutical Technology
APRIL 12, 2024
Moderna has announced the halt of its project to build a messenger ribonucleic acid (mRNA) manufacturing facility in Kenya.
Enhancing Sponsor Outcomes: The Power of In-House Clinical Assessment Support
Worldwide Clinical Trials
APRIL 8, 2024
By Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies In the intricate world of clinical trials, the precision and reliability of clinical assessments stand as pivotal factors in determining a trial’s success. Expertly managed clinical assessments by a team with fastidious attention to detail optimizes precision and reliability and helps you successfully navigate the complex terrain of clinical research.
Export of Ayush and herbal products registers 1.65% growth in first 10 months
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 9, 2024
Exports of Ayush (Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy) drugs and herbal products from the country have reported 1.65 per cent growth during the first ten months of the current fiscal year. The growth in the month of January stood at 14.
Novartis pauses some trials of cancer drug Kisqali to fix manufacturing
Bio Pharma Dive
APRIL 10, 2024
The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.
How Machine Learning Drives Clinical Trial Efficiency
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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.
UK’s NICE recommends AbbVie’s Aquipta to treat migraines
Pharmaceutical Technology
APRIL 11, 2024
The oral drug, which gained UK approval in September 2023, is used for the prevention of both chronic and episodic migraines.
Pfizer accused of 'bringing discredit' on industry with 'unnecessary' vaccine tweet
BioPharma Reporter
APRIL 9, 2024
Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.
DTAB recommends prohibiting pain relief combination S(+) etodolac+paracetamol
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 11, 2024
The Drugs Technical Advisory Board (DTAB) of the Union health ministry has once again recommended prohibiting the manufacture, sale and distribution of pain relief drug combination S(+) etodolac+paracetamol, after considering a sub-committee report.
Vertex to buy kidney disease drugmaker Alpine for $4.9B
Bio Pharma Dive
APRIL 10, 2024
The deal, which company CEO Reshma Kewalramani described as “just the right fit,” is the largest acquistion in Vertex’s 35-year history.
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.
BMS and 2seventy bio’s Abecma gains approval for multiple myeloma
Pharmaceutical Technology
APRIL 8, 2024
Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma have received FDA approval for relapsed or refractory multiple myeloma (RRMM).
Number of ongoing US drug shortages reaches new high, pharmacist group says
Fierce Pharma
APRIL 11, 2024
As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.
Fasting-Style Diet Seems to Result in Dynamic Changes to Human Brain
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 10, 2024
Scientists looking to tackle our ongoing obesity crisis have made an important discovery: Intermittent calorie restriction leads to significant changes both in the gut and the brain, which may open up new options for maintaining a healthy weight.
Pfizer, with new study results, seeks to bring RSV shot to adults aged 18-59
Bio Pharma Dive
APRIL 9, 2024
The company plans to submit the trial data to regulators in a bid to win approval of its vaccine Abrysvo in adults as young as 18 years old.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
J&J and Legend’s Carvykti scores early line approval for MM by FDA
Pharmaceutical Technology
APRIL 8, 2024
J&J and Legend’s CAR-T cell therapy has been approved as a second-line therapy for patients with multiple myeloma (MM).
Has Pfizer brought discredit on the industry with misguided vaccine tweet? Industry weighs in
BioPharma Reporter
APRIL 9, 2024
Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.
Radical Vaccine Strategy Could Help Quash Parasite Afflicting Millions
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 11, 2024
Using viruses that infect bacteria to detect proteins sprouted by a notorious parasite, scientists have honed in on possible vaccine targets for schistosomiasis, a neglected tropical disease that currently affects an estimated 600 million people worldwide, causing 280,000 deaths per year.
Trial shows Wegovy can ease heart failure symptoms
Bio Pharma Dive
APRIL 8, 2024
The results were the second time Novo has shown its weight loss treatment can help with the condition, and may help it secure broader use of the drug.
The New Age of Decentralized Clinical Trials
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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.
UK charities condemn continued drug shortages
Pharmaceutical Technology
APRIL 12, 2024
As the UK tackles several drug shortages, UK charities and pharmacists called for urgent action to be taken.
AACR, Cancer Treatment and the Promise of Antibody-Drug Conjugates
BioSpace
APRIL 12, 2024
This week’s American Association for Cancer Research annual meeting drove home the importance of antibody-drug conjugates as an emerging class of potential anti-cancer therapeutics.
DTAB recommends various amendments in Medical Devices Rules, 2017
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 10, 2024
The Drugs Technical Advisory Board (DTAB) has recommended various amendments to the Medical Devices Rules (MDR), 2017, for inclusion of disinfectants under the definition and applicability clauses and to bring in changes for quality management rules in line with the updated ISO standards for the devices.
US sues Regeneron, alleging false price reporting on Eylea
Bio Pharma Dive
APRIL 11, 2024
The lawsuit claims the drugmaker didn’t disclose reimbursement to drug distributors for credit card fees, artificially inflating the reported price of the blockbuster eye drug.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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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