FDA grants RMAT status for BlueRock’s Parkinson’s therapy
Pharmaceutical Technology
MAY 31, 2024
The US FDA has granted RMAT designation for BlueRock Therapeutics' cell therapy, bemdaneprocel (BRT-DA01), for Parkinson's disease.
Pharmaceutical Technology
MAY 31, 2024
The US FDA has granted RMAT designation for BlueRock Therapeutics' cell therapy, bemdaneprocel (BRT-DA01), for Parkinson's disease.
Bio Pharma Dive
MAY 29, 2024
A partnership between cell therapy delivery specialist Portal Biotechnologies and precision robotics maker Multiply Labs could address manufacturing hurdles, the CEOs said.
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Pharmaceutical Technology
MAY 30, 2024
The US FDA approved Teva Pharmaceuticals’ AUSTEDO XR as a once-daily treatment option for tardive dyskinesia and Huntington’s disease chorea.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 29, 2024
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Worldwide Clinical Trials
MAY 30, 2024
Authors: Rich Worldwide Clinical Trials Exec. Director, Therapeutic Strategy Lead, Neuroscience & Lucie Undus, MD PhD, Exec. Director, Therapeutic Area Medical Lead. In the quest to shift ALS from terminal to treatable, we still have a long way to go. Since marketing authorization for the first breakthrough treatment in 1994, the steady increase in clinical trials reflects the community’s commitment to finding effective ALS treatments despite the numerous hurdles associated with clinic
Rethinking Clinical Trials
MAY 29, 2024
Dr. Shruti Gohil In this Friday’s PCT Grand Rounds, Shruti Gohil of the University of California, Irvine, will present “The INSPIRE Abdominal and Skin/Soft Tissue Infection Trials: Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients.” The Grand Rounds session will be held on Friday, May 31, 2024, at 1:00 pm eastern.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 29, 2024
A substance found in foods like pomegranates, strawberries, and walnuts restored the ability to detect and remove damaged cells in mice modeling Alzheimer’s disease, scientists report in a new paper. The same research team previously found a form of vitamin B3 called nicotinamide riboside (NR) helps remove damaged mitochondria from the brain.
Outsourcing Pharma
MAY 30, 2024
In an intriguing interview with Cybinâs CEO, Doug Drysdale, OSP senior editor, Liza Laws found out how second-generation psychedelics could be the biggest breakthrough in psychiatry in 40 years.
Rethinking Clinical Trials
MAY 28, 2024
Drs. Kevin Weinfurt, Lesley Curtis, and Adrian Hernandez, co–principal investigators of the Coordinating Center Leaders of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, on May 9 and 10 for the program’s 2024 Annual Steering Committee Meeting—an opportunity to network and hold rich discussions on key issues related to pragmatic research.
Bio Pharma Dive
MAY 30, 2024
The $73 million round for CinRx Pharma, which created a startup AstraZeneca bought last year, will help fund subsidiaries making drugs for obesity, irritable bowel syndrome and gastroparesis.
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Pharmaceutical Technology
MAY 28, 2024
The US FDA has accepted for priority review Sanofi's sBLA for Sarclisa regimen for transplant-ineligible newly diagnosed multiple myeloma.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 28, 2024
There are a lot of connected, moving biological parts in our brains, which makes the study of brain diseases particularly challenging. Now new research has shed light on a key brain process potentially involved in Alzheimer’s disease.
pharmaphorum
MAY 30, 2024
COVID-19 vaccination rates have fallen precipitously in Europe and should be ramped up this autumn so they are at least in line with influenza vaccine uptake.
Rethinking Clinical Trials
MAY 30, 2024
Complete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials.” The 1-day workshop, held on May 19 at the 45th annual Society for Clinical Trials meeting in Boston, introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems.
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Bio Pharma Dive
MAY 29, 2024
The Series B funding from Two Sigma Ventures, RA Capital and others will help Gameto develop technology it says could replace hormonal injections and shorten the IVF process.
Pharmaceutical Technology
MAY 29, 2024
Ensifentrine is a first-in-class dual phosphodiesterase 3/4 inhibitor to treat chronic obstructive pulmonary disease (COPD).
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 27, 2024
The psychedelic drug psilocybin (as found in ‘magic’ mushrooms) has promising potential as a treatment for the eating disorder anorexia nervosa, according to new research that looked at its effects on an animal model of the condition.
Antidote
MAY 30, 2024
One may choose to participate in a clinical trial for many reasons. Volunteering often has multiple benefits, from advancing medical research to gaining access to cutting-edge medical care. However, deciding to enroll in a clinical trial is only one part of the process.
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.
BioSpace
MAY 29, 2024
Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients.
Bio Pharma Dive
MAY 30, 2024
The company is prioritizing development of an earlier so-called FcRn inhibitor, a type of medicine that’s shown promise treating multiple inflammatory conditions.
Pharmaceutical Technology
MAY 28, 2024
Scientists of QUT have secured A$4m ($2.65m) grant from the US DoD for developing new treatments for Parkinson's disease.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 27, 2024
The Advertising Standards Council of India (ASCI) has released its Annual Complaints Report, which offers a comprehensive analysis of advertisements that were considered objectionable in the fiscal year 2023–24. ASCI examined 10,093 complaints and investigated 8,299 advertisements.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Fierce Pharma
MAY 28, 2024
A recently announced $900 million restructuring drive is already making waves at Takeda, wi | From early July to March 2025, the Japanese drugmaker will cut 495 staffers at its Cambridge location and 146 in Lexington, Massachusetts. Takeda is the largest life sciences employer in the state.
BioSpace
MAY 29, 2024
Additional analyses from BridgeBio Pharma’s late-stage study show the oral drug candidate’s improved clinical outcomes in transthyretin amyloid cardiomyopathy patients.
Bio Pharma Dive
MAY 28, 2024
The deal involves royalties for a brain cancer drug Agios previously sold off and that Royalty Pharma thinks could generate more than $1 billion in U.S. sales.
Pharmaceutical Technology
MAY 29, 2024
Prothena plans to initiate a Phase I trial in an undisclosed indication by the end of 2024.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 30, 2024
The Department of Pharmaceuticals (DoP) has said that it has developed a portal for monitoring the implementation of the research and development (R&D) policy and has constituted the Indian Council for Pharmaceuticals and Medtech Research and Development (ICPMR), as envisaged in the National Policy on Research and Development and Innovation in the Pharma-Medtech Sector in […]
Fierce Pharma
MAY 30, 2024
As various efforts to produce next-generation vaccines in Africa are being carried forward by the likes of the World Health Organization (WHO) and the Bill & Melinda Gates Foundation, BioNTech | Under an expansion of the partners’ existing deal, the Coalition for Epidemic Preparedness Innovations (CEPI) is committing up to $145 million to bolster BioNTech’s efforts to establish vaccine R&D and manufacturing capabilities at the German company’s facility in Kigali, Rwanda.
XTalks
MAY 30, 2024
Pharmacovigilance, particularly within cancer therapeutics, is more than just a profession for Ashish Jain, Senior Director of Clinical Safety and Pharmacovigilance at Curis. Driven by a deep-rooted passion for patient safety, Ashish provides a personal glimpse into his everyday responsibilities and the evolving landscape of his field. From Pharmacy School to Pharmacovigilance Ashish’s journey into pharmacovigilance began during his pharmacy school days, where an internship first exposed him to
Bio Pharma Dive
MAY 29, 2024
An acquisition of EyeBio will hand Merck a treatment for diabetic macular edema and age-related macular degeneration that’s ready for pivotal testing.
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