Pharmaceutical Technology

APRIL 24, 2023

Traditional medicine refers to the knowledge, skills and practices that indigenous and different cultures use to maintain health, encompassing forms such as herbal medicine, Traditional Chinese Medicine (TCM) and acupuncture. While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with cert

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Bio Pharma Dive

APRIL 25, 2023

Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.

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STAT News

APRIL 24, 2023

A new book on the U.S. response to the Covid-19 pandemic paints a picture of a country ill-prepared to cope with a dangerous biological foe, riven by partisan politics, and led by people who saw little political gain in taking ownership of managing the crisis. It also describes a country that remains ill-equipped to battle the next pandemic or major disease threat, though it lays out changes that could strengthen the country’s position.

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Medical Xpress

APRIL 28, 2023

Neuroscientists have uncovered how exploratory actions enable animals to learn their spatial environment more efficiently. Their findings could help build better AI agents that can learn faster and require less experience.

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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

Clinical Research

Pharmaceutical Technology

APRIL 26, 2023

AstraZeneca , Teva Pharmaceuticals , and Novartis , and other companies, are expanding their reach in the asthma space by capitalizing on digital technologies to enhance the patient experience. But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

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Bio Pharma Dive

APRIL 28, 2023

Pfizer’s latest Prevnar shot covers 20 strains of the virus, more than the 13 covered by its previous version and the 15 by Merck’s Vaxneuvance.

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Vaccination Vaccine 325

Medical Xpress

APRIL 28, 2023

Northwestern Medicine scientists have discovered how octopamine, the major "fight-or-flight" neurotransmitter in invertebrates, communicates with other cells in mammalian brains to prevent cell death, according to a study published in the Proceedings of the National Academy of Sciences.

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. The company is studying EDT-301 in sickle cell disease in a Phase I/II RUBY study (NCT04853576), and is on track to provide a clinical update by mid-2023.

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Bio Pharma Dive

APRIL 26, 2023

Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.

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STAT News

APRIL 26, 2023

When Cecilia Sorensen was an emergency medicine resident practicing at Denver Health in Colorado a few years ago, summer was known as “trauma season.” Gunshot and motor vehicle accident victims, people with heart attacks and COPD would stream into the ER. Later, on a fellowship, she witnessed the health impacts of drought in Syria. The common driver, she realized, was climate change and its impact, both locally and globally.

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Medicine 128

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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

Clinical Trials

Medical Xpress

APRIL 26, 2023

A successful gene therapy trialed at Michigan State University in dogs with an inherited eye disease is ready to be developed for clinical use in human patients with a rare condition called retinitis pigmentosa.

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Clinical Development Gene Therapy Development Gene 133

Pharmaceutical Technology

APRIL 27, 2023

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Described as the largest reform in over 20 years, the proposed revision touches on multiple topics ranging from unequal access to innovative medicines across the EU to new environmental protections.

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Bio Pharma Dive

APRIL 26, 2023

Founded by Howard Chang, John Maraganore and others, the RNA-focused startup drew investment from a large group of blue-chip venture investment firms.

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RNA 319

STAT News

APRIL 27, 2023

In public, hospitals rave about artificial intelligence. They trumpet the technology in press releases, plaster its use on billboards, and sprinkle AI into speeches touting its ability to detect diseases earlier and make health care faster, better, and cheaper. But on the front lines, the hype is smashing into a starkly different reality.

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Medicine Research 124

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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.

Clinical Trials

Medical Xpress

APRIL 27, 2023

Research led by Maynooth University and published today in the journal Science Signaling has found that the protein MYC is essential for MAIT cell growth, proliferation, metabolism and function. The latest findings are of critical importance to the study of MAIT cells and the development of metabolic disease such as obesity.

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Regulation Protein Development Research 130

Pharmaceutical Technology

APRIL 27, 2023

Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults. Vowst is an orally administered microbiota-based therapeutic, previously known as SER-109, and is indicated for the prevention of recurrence of CDI in people aged 18 years and above following an antibacterial treatment for recurrent CDI (rCDI).

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Bio Pharma Dive

APRIL 26, 2023

The drug is the first microbiota-based pill to win U.S. approval. Like a rival therapy approved in December, it’s for difficult-to-treat C. diff infections.

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FDA Approval Drugs 300

STAT News

APRIL 23, 2023

At age 93, struggling with the effects of a stroke, heart failure and recurrent cancer, Teri Sheridan was ready to end her life using New Jersey’s law that allows medically assisted suicide — but she was bedbound, too sick to travel. So last Nov. 17, surrounded by three of her children, Sheridan drank a lethal dose of drugs prescribed by a doctor she had never met in person, only online.

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Doctors Doctor Drugs 119

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.

Clinical Research

Medical Xpress

APRIL 24, 2023

In a new study, Harvard researchers took a granular approach to measuring the duration and frequency of suicidal thinking. With the help of a smartphone app, they were able to monitor participants multiple times a day over several weeks. These assessments revealed that suicidal thinking changes rapidly—with far shorter timescales than previously thought.

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Research 129

Pharmaceutical Technology

APRIL 24, 2023

The National Institute for Health and Care Excellence (NICE) has published a final draft guidance recommending the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. The draft guidance is open for feedback from consultees after which the document and its recommendations will be used to establish the organization’s guidance on the use of this combination regimen for patients in the UK’s National Health Services.

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Drugs 246

Bio Pharma Dive

APRIL 27, 2023

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

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FDA Approval Drugs Trials 312

STAT News

APRIL 24, 2023

Marburg could soon become the second virus in the past year to have experimental vaccine candidates ready for testing under an emergency use listing. Until this point, no licensed vaccines or treatments are available for Marburg. That was also the case with the Sudan strain of Ebola, which caused an outbreak in Uganda with 164 cases and more than 55 deaths in the last quarter of 2022.

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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.

Clinical Supply

Medical Xpress

APRIL 26, 2023

A new study by investigators from the Smidt Heart Institute at Cedars-Sinai suggests long COVID-19 might be caused by a dysfunction of the immune system.

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Immune Response 139

Pharmaceutical Technology

APRIL 24, 2023

The Covid-19 pandemic pushed the healthcare industry toward rapid digitalisation, with the rise of telehealth, telepresence systems, remote diagnostics, predictive AI, and wearable technology now changing the way healthcare is delivered and improving patient outcomes. Emerging technologies such as AR and VR are becoming increasingly routine for professional training, surgical assistance, and treatment for psychological and neurological disorders.

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Bio Pharma Dive

APRIL 28, 2023

While Humira sales declined, the drop was mostly due to price concessions AbbVie made to secure equal insurer access in the face of copycat competition.

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Fierce Pharma

APRIL 26, 2023

Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval aliu Wed, 04/26/2023 - 22:30

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Trials Drugs 133

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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.

Clinical Trials

Medical Xpress

APRIL 28, 2023

Gone are the days of dictatorial leaders in sport, screaming from the side-lines and insulting their players, and instead we are seeing an era of emotionally intelligent leaders who demonstrate an understanding of other people while getting effective results.

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Research 128

FDA Law Blog

APRIL 25, 2023

By Philip Won & Jeffrey K. Shapiro — Does your firm manufacture a “cyber device”? A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” If a device uses software that connects to the internet, it is most likely a cyber device and subject to new section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.

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Bio Pharma Dive

APRIL 27, 2023

The cell and gene therapy developer will also cut back on manufacturing and certain research in California as it redirects resources to three priority programs.

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Gene Therapy Gene Manufacturing Development 268

STAT News

APRIL 25, 2023

This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about  The Obesity Revolution. S hira Rosenbluth went on her first diet at 10 years old. It was her own idea: She’d learned that a neighbor was doing some sort of junior WeightWatchers program, and her parents encouraged her to stick with it even after Rosenbluth changed her mind.

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Development Drugs 105

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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.

Clinical Trials