Bio Pharma Dive
JUNE 29, 2023
After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.
Pharmaceutical Technology
JUNE 30, 2023
Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 28, 2023
Golden staph are ubiquitous bacteria, living harmlessly on the skin or inside the nose of nearly one in three people worldwide. Yet they are duplicitous, too. In some situations, golden staph (Staphylococcus aureus) can become monsters, causing dangerous infections in the skin, blood, bones, or elsewhere.
Rethinking Clinical Trials
JUNE 29, 2023
Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster. ” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.
Bio Pharma Dive
JUNE 26, 2023
By the end of September, the FDA will hold two anticipated advisory meetings and issue important decisions on drugs for Alzheimer’s, depression and a type of vision loss.
Pharmaceutical Technology
JUNE 26, 2023
After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
JUNE 29, 2023
In the latest episode of the NIH Collaboratory Grand Rounds podcast , Dr. Joshua Denny continues his discussion about All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine. The full May 5 Grand Rounds webinar with Dr. Denny is also available. The post June 29, 2023: Grand Rounds Podcast with Dr.
Bio Pharma Dive
JUNE 30, 2023
The agency granted a long-awaited clearance on Thursday, but unexpected aspects of the hemophilia treatment’s label had some investors worried about its commercial prospects.
Pharmaceutical Technology
JUNE 29, 2023
Genprex has announced that the FDA has granted fast-track designation for Reqorsa, its small cell lung cancer (SCLC) therapy.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 25, 2023
Regular, short snoozes keep our brains young by preserving volume, a quality linked with healthy cognitive functions and a lower risk of dementia and other diseases.
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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
Rethinking Clinical Trials
JUNE 29, 2023
Rosa Gonzalez-Guarda and Cherise Harrington In an interview during the Annual Steering Committee Meeting, Drs. Rosa Gonzalez-Guarda and Cherise Harrington, cochairs of the Health Equity Core Working Group , shared insights and next steps for health equity in the NIH Pragmatic Trials Collaboratory. One question discussed at the meeting was how to embed health equity in pragmatic clinical trials.
Bio Pharma Dive
JUNE 30, 2023
The life sciences investor spoke with BioPharma Dive about emerging life sciences markets around the globe and why the firm invests in first-time biotech founders.
Pharmaceutical Technology
JUNE 28, 2023
Research has shown that GLP-1RAs may have the potential to treat chronic metabolic diseases such as non-alcoholic steatohepatitis (NASH).
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 27, 2023
Research Checks interrogate newly published studies and how they’re reported in the media. The analysis is undertaken by one or more academics not involved with the study, and reviewed by another, to make sure it’s accurate. Don’t we all want to do what we can to reduce the impact of age-related decline on our memory?
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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.
Pharma Mirror
JUNE 29, 2023
A bright smile is said to be the best compliment one can hear from others, and the heart of preserving and sweetening those smiles lies in a dentist’s hand. Dentistry, the art, and science of oral health, confines a diverse range of practices and professionals committed to maintaining the well-being of your teeth, gums, and overall oral health.
Bio Pharma Dive
JUNE 29, 2023
Sigilon Therapeutics, a biotech that’s been collaborating with Lilly since 2018, has agreed to be bought for up to $310 million in the pharma’s second announced buyout this month.
Pharmaceutical Technology
JUNE 27, 2023
Vertex and Lonza have entered a partnership to establish a facility in Portsmouth, US, to manufacture cell therapies for type 1 diabetes.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 29, 2023
There’s one animal that ruins summer evenings: the mosquito. While mosquitoes don’t carry any diseases in the UK, their itchy bites are far from fun. Everyone has a friend who gets covered in mosquito bites and a friend who doesn’t get a single one.
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.
Fierce Pharma
JUNE 29, 2023
After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. | After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.
Bio Pharma Dive
JUNE 27, 2023
A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.
Pharmaceutical Technology
JUNE 28, 2023
GSK has received a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine from the US Food and Drug Administration.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 28, 2023
The National Accreditation Board for Testing and Calibration Laboratories (NABL) now accepts the “Limited Liability Partnership” as a legal entity of Conformity Assessment Body (CAB) under the Limited Liability Partnership Act 2008.
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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
Fierce Pharma
JUNE 30, 2023
A former statistician at Pfizer and his associate have been charged (PDF) with insider trading, using advance inform | A former statistician at Pfizer and his associate have been charged with insider trading, using advance information to make more than $350,000 from stock purchases that they executed one day before the company made trial results public for COVID-19 blockbuster Paxlovid.
Bio Pharma Dive
JUNE 30, 2023
An agreement to divest the dry eye disease treatment Xiidra and a few other medicines adds to the Swiss pharma's yearslong push to slim down from the healthcare conglomerate it once was.
Pharmaceutical Technology
JUNE 29, 2023
The FDA has announced that Lantidra, a cellular therapy for type 1 diabetes, has become the first treatment of its kind to be approved.
ACRP blog
JUNE 30, 2023
Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. Incorrect billing can result in federal and state violations as well as financial penalties. “To ensure billing compliance, research professionals should inspect their program, measure risks, and assemble the team members who can make billing compliance better,” said Kelly Willenber
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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.
Fierce Pharma
JUNE 27, 2023
AbbVie recently filed a patent infring | AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert.
Bio Pharma Dive
JUNE 27, 2023
The treatment could become Pfizer’s first marketed gene therapy, an area the pharma has poured significant resources into in recent years.
Pharmaceutical Technology
JUNE 30, 2023
BioMed X has announced that it has begun a joint research project with Sanofi on artificial intelligence (AI) driven drug development.
Outsourcing Pharma
JUNE 29, 2023
Anebulo Pharmaceuticals is currently developing a new, first-of-its-kind drug, ANEB-001, intended to rapidly reverse the negative effects of ACI within one hour of administration. The treatment is a cannabinoid receptor antagonist, which blocks THC, the substance which gives cannabis its psychotropic effects, from binding in a personâs CB1 receptor.
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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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