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.
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 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.
Pharmaceutical Technology
APRIL 26, 2023
Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinical development. Lighthouse Capital and Life Venture Partners served as financial advisors to the company. Led by Eight Roads Ventures, the financing round saw participation from strategic investors, including the Trinity Innovation Fund, ABio-X, Delta Capital and F-Prime Capital.
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.
Rethinking Clinical Trials
APRIL 26, 2023
In this Friday’s PCT Grand Rounds, Matthew Semler of Vanderbilt University will present “Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-Crossover Trial.” The Grand Rounds session will be held on Friday, April 28, 2023, at 1:00 pm eastern. Dr. Semler is an assistant professor of medicine and bioinformatics and the medical director of the Center for Learning Healthcare in the Vanderbilt Center for Clinical and Translation
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
APRIL 26, 2023
MiNA Therapeutics has entered into a research collaboration and option licensing agreement with BioMarin Pharmaceutical to speed up the development of therapeutic ribonucleic acid activation (RNAa) candidates to treat rare genetic diseases. The option licensing agreement is based on early-stage clinical results. Both firms will be involved in the discovery, potential development and commercialisation of the RNAa therapeutic candidates.
Bio Pharma Dive
APRIL 26, 2023
One year after its market debut, the company’s AMD drug Vabysmo is on track for blockbuster sales as Regeneron’s rival treatment faces new threats.
Pharmaceutical Technology
APRIL 26, 2023
The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). This marks the first-ever designation for genetically modified gamma-delta T cell therapies. INB-400, an autologous, genetically engineered gamma-delta T cell therapy, is the company’s DeltEx chemotherapy-resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology.
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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
APRIL 26, 2023
Vedanta Biosciences has raised $106.5m in financing to advance a pipeline of defined bacterial consortia therapies. Co-led by new investors the AMR Action Fund and AXA IM Alts, the investment syndicate also included existing investors Reimagined Ventures, the Bill & Melinda Gates Foundation, Atlantic Neptune, Fiscus Ventures, PEAK6 and Skyviews Life Science.
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.
Pharmaceutical Technology
APRIL 26, 2023
Click Therapeutics announced the initiation of a fully remote trial investigating the potential of digital therapeutics to reduce migraine occurrences in adults diagnosed with episodic migraines. The ReMMi-D Phase III trial is expected to enroll approximately 558 participants in the US. Patients will receive the digital therapy through their mobile phone applications over a 12-week period, and its efficacy will be evaluated based on the difference in the number of monthly migraine days. in Decem
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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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
Pharmaceutical Technology
APRIL 26, 2023
The US Food and Drug Administration (FDA) has granted accelerated approval for Biogen ’s Qalsody (tofersen) 100mg/15mL injection to treat adult amyotrophic lateral sclerosis (ALS) patients with a mutation in the superoxide dismutase 1 (SOD1) gene. Qalsody is an antisense oligonucleotide (ASO) that has been designed for binding to SOD1 mRNA to reduce the production of SOD1 protein.
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
Pharmaceutical Technology
APRIL 26, 2023
Akebia Therapeutics has received marketing authorisation from the European Commission (EC) for its Vafseo (vadadustat) to treat symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients on chronic maintenance dialysis. It is applicable to all 27 European Union member states, along with Liechtenstein, Norway and Iceland. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that has been designed to imitate the physiologic effect of altitude
Medical Xpress
APRIL 26, 2023
Inhaling low concentrations of ethanol vapor can disable the influenza A virus in mice, without harmful side effects, says a new study by scientists at the Okinawa Institute of Science and Technology (OIST). The scientists believe it may also treat similar viruses such as the one that causes COVID-19.
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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.
Antidote
APRIL 26, 2023
For individuals and companies that write health-focused blogs, continually finding topics to cover can be a challenge at times. Whether you’re a health influencer, patient advocacy organization, or another player in the clinical trial industry, finding unique topics to differentiate a blog is not always easy. However, through the below ideas and a unique voice, it is possible to write a plethora of clinical trial blogs that stick out from the rest.
Medical Xpress
APRIL 26, 2023
Months after COVID-19, previously infected people with persistent neuropsychiatric symptoms had abnormal brain activity during memory tests, with less activity in brain regions normally used for memory tasks, but more activity in other areas of the brain, according to new research published in the April 26, 2023, online issue of Neurology.
Fierce Pharma
APRIL 26, 2023
FDA approves first oral microbiome therapy Vowst. Will Nestlé be around to help Seres with the launch?
Medical Xpress
APRIL 26, 2023
New research has revealed children's physical activity in the UK has largely returned to pre-pandemic levels—but children are still more sedentary during the week.
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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.
BioSpace
APRIL 26, 2023
Will Biogen’s Qalsody Be a Catalyst for Gene-Specific ALS Research?
Medical Xpress
APRIL 26, 2023
Scientists are unraveling the complex mystery underlying how the immune system mounts a potent defense against one of the world's most relentless killers—the deadly parasites that cause the worst form of malaria.
Fierce Pharma
APRIL 26, 2023
UPDATED: Gearing up for key approvals, GSK projects 'Shingrix-like' sales for its RSV vaccine fkansteiner Wed, 04/26/2023 - 09:52
Medical Xpress
APRIL 26, 2023
Researchers from Children's Hospital of Philadelphia (CHOP) and Princeton University have discovered a novel genetic disorder associated with neurodevelopmental differences. The discovery identified the disorder in 21 families from all over the world. The study "Abrogation of MAP4K4 protein function causes congenital anomalies in humans and zebrafish" is published in Science Advances today, April 26.
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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.
Cloudbyz
APRIL 26, 2023
The biotechnology industry has experienced rapid growth over the past few years, with numerous start-ups emerging to develop innovative therapies, diagnostics, and solutions for a wide range of diseases and conditions. One of the critical factors determining the success of these start-ups is the speed at which they can bring their products to market.
Medical Xpress
APRIL 26, 2023
Blood clot researchers could benefit from a new device that mimics a human vein, replacing the need for animals for some studies.
Fierce Pharma
APRIL 26, 2023
Bristol Myers' Giovanni Caforio to hand CEO baton to commercial chief Chris Boerner esagonowsky Wed, 04/26/2023 - 16:44
Medical Xpress
APRIL 26, 2023
At least 3,700 out-of-state mental health providers utilized New Jersey's COVID-19 Temporary Emergency Reciprocity Licensure program to provide mental health services to more than 30,000 New Jersey patients during the first year of the pandemic, according to a Rutgers study.
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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.
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