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 24, 2023

Submission of the application comes weeks after rivals Vertex and CRISPR filed their gene editing medicine for the disease with the agency.

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Gene Editing Gene Gene Therapy FDA Approval 256

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The National Institute for Health and Care Excellence (NICE) has published a final draft guidance recommending the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. The draft guidance is open for feedback from consultees after which the document and its recommendations will be used to establish the organization’s guidance on the use of this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 24, 2023

The divestment of Baqsimi to Amphastar could net Lilly more than $1 billion if sales goals are met.

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Sales Drugs 261

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Clinical Supply

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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Pharmacy Doctors Doctor Manufacturing 237

Rethinking Clinical Trials

APRIL 24, 2023

An upcoming webinar in the NIH HEAL Initiative’s HEAL Headliners series will highlight the experiences of 2 projects in meaningfully engaging patients and community partners throughout the research process to ensure that the findings have the greatest public health impact. The webinar will be held on Friday, May 5, 2023, at 2:00 pm eastern. Rosemarie Martin of Brown University and Linda Hurley of CODAC Behavioral Heathcare will report on a study of a systems-change approach for increasing

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Clinical Trials Clinical Trials Trials Research 246

Pharmaceutical Technology

APRIL 24, 2023

Vallon Pharmaceuticals has concluded the previously announced merger of its operations with biotechnology firm GRI Bio. With work on the agreement, announced in December 2022 , now complete, the combined entity will operate under the brand of GRI Bio. It will support the further development of GRI Bio’s natural killer T (NKT) cell modulators pipeline, to treat inflammatory, fibrotic and autoimmune diseases.

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Bio Pharma Dive

APRIL 24, 2023

The FDA has approved the pharma, which has had difficulty producing radiopharmaceutical drugs, to make its treatment Pluvicto at a New Jersey site.

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Drugs 171

Pharmaceutical Technology

APRIL 24, 2023

The UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of AbbVie and Johnson & Johnson’s Imbruvica as part of a combination therapy with venetoclax in previously untreated chronic lymphocytic leukaemia (CLL), based on final draft guidance published on 21 April. The British institute that oversees a therapy’s cost-effectiveness opted for the recommendation based on clinical data from the Phase II CAPTIVATE and the Phase III GLOW studies.

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Sales Trials Marketing Drugs 130

Bio Pharma Dive

APRIL 24, 2023

A second-generation treatment called eplontersen halted nerve damage and improved quality of life in a late-stage study the companies are using to seek U.S. approval.

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Drugs 148

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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

Pharmaceutical Technology

APRIL 24, 2023

Swiss company RetinAI Medical has collaborated with German pharmaceutical firm Boehringer Ingelheim to leverage artificial intelligence (AI) to advance novel treatments for geographic atrophy (GA) patients. The companies aim to improve GA patients’ outcomes by combining RetinAl’s Discovery platform and AI tools with the retinal diseases research of Boehringer Ingelheim.

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Development Clinical Trials Clinical Trials Research 130

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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Pharmaceutical Technology

APRIL 24, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to XORTX Therapeutics’ oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD) patients. The ODD comes after XORTX submitted an application to the FDA along with a comprehensive package including an analysis of ADPKD patients and descriptions of those expected to benefit from the therapy.

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Drugs Packaging Packaging Marketing 130

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

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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 24, 2023

Apellis Pharmaceuticals has received validation of its four marketing applications for intravitreal pegcetacoplan by regulatory authorities in Switzerland, the UK, Canada and Australia. Pegcetacoplan is an investigational targeted C3 therapy intended to treat geographic atrophy (GA) which is secondary to age-related macular degeneration (AMD). It targets excessive activation of the complement cascade, which is part of the body’s immune system.

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Rethinking Clinical Trials

APRIL 24, 2023

This podcast continues the discussion with Drs. Russell Rothman and Erin Holve as they discuss a decade of research in PCORnet®. Click on the recording below to listen to the podcast. NIH Pragmatic Trials Collaboratory · Podcast 45: From Observational Studies to Pragmatic Clinical Trials: Research in PCORnet® NIH Pragmatic Trials Collaboratory · Podcast 44: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials NIH Pragmatic Trials Collaboratory · Podcast 43: Ethical Considera

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Clinical Trials Clinical Trials Trials Research 100

Pharmaceutical Technology

APRIL 24, 2023

China’s National Medical Products Administration (NMPA) has accepted LianBio’s new drug application (NDA) for mavacamten, intended to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults, for priority review. Mavacamten’s safety and efficacy in symptomatic oHCM patients were assessed against a placebo in the global pivotal Phase III EXPLORER-HCM trial, and this data forms the basis of the NDA.

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Trials Drugs Production 130

Rethinking Clinical Trials

APRIL 24, 2023

In the latest episode of the NIH Collaboratory Grand Rounds podcast , Drs. Russell Rothman, Erin Holve and Lesley Curtis continue their discussion about PCORnet – From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet®. The full March 24 Grand Rounds webinar with Drs. Rothman and Holve is also available.

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Clinical Trials Clinical Trials Research Trials 100

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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

Bio Pharma Dive

APRIL 24, 2023

AI-derived data can range from insightful to useless. Learn how to get one and not the other.

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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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Vaccination Vaccine Licensing Licensing 111

Medical Xpress

APRIL 24, 2023

Sauna heat therapy reduces blood pressure in middle-aged people, according to researchers at Brigham Young University in Utah. The study also revealed that its specific sauna method lowered body core temperature more than methods used in prior heat studies. Researchers presented their work at the American Physiology Summit, held in Long Beach, California, April 20–23.

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Research 111

BioPharma Reporter

APRIL 24, 2023

Moderna will explore next generation technologies - including quantum computing and artificial intelligence - to advance and accelerate mRNA research via a new partnership with IBM.

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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 24, 2023

Researchers have developed a new method to distinguish between cancerous and healthy stem cells and progenitor cells from samples of patients with acute myeloid leukemia (AML), a disease driven by malignant blood stem cells that have historically been difficult to identify. The findings, published today in the journal Cell Stem Cell, pave the way for the development of new techniques to predict whether patients will respond to chemotherapy.

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Development Research 103

ACRP blog

APRIL 24, 2023

Dr. Courtney Burnett’s personal story, a brief history, and endless gratitude For patients and physicians alike, clinical research provides hope that ongoing innovation will offer new options to treat and even cure challenging illnesses. Indeed, most of modern medicine revolves around learnings from disruptive, successful clinical trials that investigated the safety and efficacy of promising therapeutic options.

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Clinical Trials Clinical Trials Trials Medicine 98

XTalks

APRIL 24, 2023

Dutch food and biotechnology company Corbion recently developed a new system to help bakers determine how long their products can stay mold-free naturally. The system involves testing against 11 different mold strains and comparing up to three different natural mold inhibitor formulations to determine which one works best for a particular product. The system takes into consideration various factors like the characteristics and formulation of the product to predict the number of days before mold

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Packaging Packaging Production Development 98

Medical Xpress

APRIL 24, 2023

Doctors are more extroverted, agreeable, and conscientious, but also more neurotic and less open than their patients, finds an analysis of responses to two nationally representative Australian surveys, published online in the open access journal BMJ Open.

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Doctors Doctor 98

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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

BioPharma Reporter

APRIL 24, 2023

BioMarin Pharmaceutical has opened the expansion of its manufacturing plant at Shanbally, Co. Cork: with the site now able to provide end-to-end manufacturing for a number of the companyâs commercial products.

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Manufacturing Production 98

Medical Xpress

APRIL 24, 2023

A new study, published in the Cochrane Database of Systematic Reviews and led by an Upstate Medical University professor, has found that compared with standard antibiotic treatment, stool transplantation can increase the number of people recovering from Clostridioides difficile (C. diff) infection, a condition that causes potentially life-threatening diarrhea.

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XTalks

APRIL 24, 2023

Rare diseases can often be progressive, chronic and fatal. Approximately 72 percent of rare diseases are genetic, and around 70 percent of rare genetic diseases emerge in childhood. Sadly, one-third of children with rare diseases die before their first birthday. Out of over 7,000 rare diseases, only 5 percent (or less) of rare diseases are thought to have approved treatment options, known as “orphan” therapies.

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Gene Therapy Gene Trials Clinical Trials 95

Medical Xpress

APRIL 24, 2023

Young children with common ear, nose, and throat (ENT) issues may be at subsequent risk of autism or high levels of demonstrable autism traits, suggests research published online in BMJ Open.

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Research 98

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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.

Clinical Supply