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.
Trending Articles
246 
Can robots break the cell therapy bottleneck?
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.
Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA approves Teva Pharmaceuticals’ AUSTEDO XR for TD and HD chorea
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.
NABL launches comprehensive training programme to enhance competence in reference material production
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 29, 2024
Home Editorial Services Interview Q&A Chronicle Specials Pharma Mart ePharmail Archives Join Pharma | Login Home > TopNews you can get e-magazine links on WhatsApp.
Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies
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
May 29, 2024: INSPIRE Pragmatic Trial to Be Featured in This Week’s PCT Grand Rounds
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.
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
Something In Pomegranates May Help The Brain Stave Off Alzheimer’s
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.
Interview: Has Cybin hit the biggest breakthrough in 40 years to treat psychiatric disorders?
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.
May 28, 2024: Program Leadership Attends Annual Steering Committee Meeting to Tackle Challenges, Share Lessons From Pragmatic Trials
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.
CinCor’s ‘hub-and-spoke’ parent nabs new funding to build its next biotechs
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.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
FDA accepts Sanofi’s Sarclisa sBLA for priority review
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.
This Protein Could Help Us Unravel The Mystery of Alzheimer’s
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.
COVID-19 vaccinations now ‘alarmingly low’ in Europe
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.
May 30, 2024: Workshop Materials Now Available From ‘Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials’
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.
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
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.
A biotech working on a new approach to IVF raises $33M in fresh funding
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.
Verona prepares for anticipated US launch of ensifentrine for COPD in Q3 2024
Pharmaceutical Technology
MAY 29, 2024
Ensifentrine is a first-in-class dual phosphodiesterase 3/4 inhibitor to treat chronic obstructive pulmonary disease (COPD).
Scientists Think This Psychedelic Drug Could Help Treat Anorexia
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.
Tris Pharma Gets FDA Approval for Non-Stimulant ADHD Medication
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.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Takeda, amid restructuring campaign, plots 641 layoffs at two Massachusetts sites
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.
Immunovant changes up plans for closely watched autoimmune drugs
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.
QUT team receives US DoD funding for Parkinson’s treatment
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.
Healthcare ads emerge as most violative as ASCI releases Annual Complaints Report
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.
2022 Research: The Rapid Rise of Ocean Freight Visibility
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.
Who decides whether you get into a clinical trial?
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.
BioNTech, flush with $145M from CEPI, looks to expand mRNA vaccine production in Africa
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.
Agios cashes in on cancer drug again with $905M Royalty Pharma deal
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.
BMS stakes $80m on Prothena’s neurodegenerative candidate
Pharmaceutical Technology
MAY 29, 2024
Prothena plans to initiate a Phase I trial in an undisclosed indication by the end of 2024.
DoP launches portal and constitutes ICPMR for implementation of R&D policy
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 […]
BridgeBio Builds on Positive Phase III Data for Acoramidis in ATTR-CM
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.
Safeguarding Patients: A Day in the Life of a Pharmacovigilance Leader
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
Merck to buy eye drug developer for $1.3B
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.
The New Age of Decentralized Clinical Trials
Advertisement
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.
Let's personalize your content