Bio Pharma Dive
MAY 17, 2023
Spun out of the lab of former UCSF researcher Nicole Paulk, the biotech is targeting brain and eye tumors with a new kind of treatment it has dubbed “immuno-gene therapy.
Pharmaceutical Technology
MAY 17, 2023
Chinook Therapeutics and Ionis Pharmaceuticals have entered a partnership to develop an antisense oligonucleotide (ASO) therapy to treat a rare, severe chronic kidney disease. The collaboration aims to discover, develop and commercialise an ASO therapy. It will use the precision medicine approach, as well as the deep expertise of Chinook Therapeutics in nephrology and knowledge of Ionis Pharmaceuticals in RNA-targeted therapeutics.
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Bio Pharma Dive
MAY 17, 2023
The company said its “reversible” BTK inhibitor, which trails competitors from Sanofi and Merck KGaA, succeeded in Phase 2 testing without raising new safety concerns.
Pharmaceutical Technology
MAY 17, 2023
The US Food and Drug Administration (FDA) has accepted and granted priority review to Takeda ’s biologics licence application (BLA) for its enzyme replacement therapy, TAK-755, to treat congenital thrombotic thrombocytopenic purpura (cTTP). By replacing the missing or deficient ADAMTS13 enzyme, TAK-755 offers targeted therapy for addressing an unmet medical need for thrombotic thrombocytopenic purpura patients.
Bio Pharma Dive
MAY 17, 2023
The biotech plans to discuss the study results with regulators to determine next steps toward an approval application for the rare disease treatment.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 17, 2023
American pharmaceutical company Eli Lilly announced last week that it had seen encouraging clinical trial results of its new Alzheimer’s medication. According to the company, their experimental drug, donanemab, was shown in a late-stage trial to slow cognitive decline by 35 percent.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 17, 2023
Precision oncology company Boundless Bio has raised $100m in a Series C financing round for advancing extrachromosomal DNA (ecDNA)-directed therapies for oncogene-amplified cancer patients. Co-led by Leaps by Bayer and RA Capital Management, the Series C round saw the participation from new investors Piper Heartland Healthcare Capital and Sectoral Asset Management.
Bio Pharma Dive
MAY 17, 2023
Dunn is joining the neurological drug developer less than three months after stepping down from his role leading an agency office responsible for several controversial regulatory reviews.
Rethinking Clinical Trials
MAY 17, 2023
In this Friday’s PCT Grand Rounds, Robert O’Toole of the University of Maryland will present “ Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture.” The Grand Rounds session will be held on Friday, May 19, 2023, at 1:00 pm eastern. Dr. O’Toole is the chief of Orthopaedics at the R. Adams Cowley Shock Trauma Center, head of the Division of Orthopaedic Trauma, and director of clinical research in the Department of Orthopaedics at the Univer
Pharmaceutical Technology
MAY 17, 2023
The Inflation Reduction Act, which became US law in August 2022, has invited its fair share of critics and supporters over its drug pricing provisions. At a lively panel at Financial Times US Pharma and Biotech Summit on May 16, panellists were at odds over whether the new legislation would improve treatment affordability or stifle pharma innovation.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 17, 2023
The Indian Institute of Science (IISc) has embarked on a multi-institutional study on dengue to prove that the virus causing the disease has evolved dramatically in India. The research was done going by the rising cases of the mosquito-borne viral disease predominantly in the South-East Asia.
Pharmaceutical Technology
MAY 17, 2023
The Pharmaceutical Technology Excellence Awards celebrate the greatest achievements and innovations in the industry. The programme provides a platform to recognize the people and companies that are driving change and is powered by the business intelligence of GlobalData. This means that our team of researchers and journalists along with Artificial Intelligence analyse 1 billion datasets during the year to recognise and endorse top-tier companies and their achievements in 200+ counties.
Bio Pharma Dive
MAY 17, 2023
Cindy Perettie, the former Foundation Medicine CEO who most recently ran Roche’s molecular lab division, will follow Christi Shaw in the role.
Pharmaceutical Technology
MAY 17, 2023
AGC Biologics has introduced the BravoAAV and ProntoLVV viral vector platforms that offer quick clinical and commercial production and release of good manufacturing practices (GMP). Both platforms use the company’s development, manufacturing and analytical capabilities in lentiviral vector (LVV) and adeno-associated viral vector (AAV). AGC Biologics’ proprietary procedure and capsid-based platform methods can speed up development timelines, thereby enabling the delivery of GMP products in nine m
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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
Medical Xpress
MAY 17, 2023
With scarce clinical resources unable to keep pace with elevated rates of mental illness, technological solutions could help decrease waitlists and disparities in access to therapy. Recent advances in artificial intelligence have fueled interest in the use of chatbots and virtual assistants for mental health treatment.
Pharmaceutical Technology
MAY 17, 2023
WuXi Biologics and InflaRx have entered a manufacturing partnership for advancing Gohibic (vilobelimab) to treat certain critically ill Covid-19 patients. Under the collaboration, WuXi Biologics will be responsible for providing cGMP manufacturing of Gohibic. The treatment is an investigational first-in-class monoclonal anti-human complement factor C5a antibody.
Medical Xpress
MAY 17, 2023
Soil-transmitted helminth infections are caused by different species of parasitic worms, including whipworms, hookworms and roundworms. Worldwide, more than 1.5 billion people are infected with at least one soil-transmitted helminth, with most of the infected population living in low- and middle-income countries.
Velocity Clinical Research
MAY 17, 2023
CUMBERLAND, MD – It's been smooth biking so far for the ACRP Ride4DEI team as they wrapped up day three yesterday (May 16) en route from Pittsburgh, PA to Washington, D.C. in an effort to raise money and awareness promoting diversity on all levels in clinical trials. But obstacles loom for the plucky bikers, says Sergio Armani, ACRP Ride4DEI Creator, and EVP, Business Development, Helios Clinical Research.
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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.
Medical Xpress
MAY 17, 2023
A new study of more than 50,000 US adolescents across the country indicates that vaping nicotine is strongly linked with an increased likelihood of high levels use of binge drinking and cannabis usage.
XTalks
MAY 17, 2023
New World Health Organization (WHO) guidance advises against the use of sugar substitutes for weight loss purposes. The WHO conducted a systematic review of available evidence and concluded that non-sugar sweeteners do not offer long-term benefits in reducing body fat in adults or children. While a mild reduction in body weight may occur in the short term, it is not sustainable over time.
Medical Xpress
MAY 17, 2023
Researchers at the University of Michigan Rogel Cancer Center have discovered a new nutrient source that pancreatic cancer cells use to grow. The molecule, uridine, offers insight into both biochemical processes and possible therapeutic pathways.
XTalks
MAY 17, 2023
The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio. Among them are three ocular, three neurological and two systemic rare conditions, which were chosen from a starting list of 62 nominated diseases.
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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.
Medical Xpress
MAY 17, 2023
Scientists say tonsil removal is both cost- and clinically effective for adults who get recurrent severe sore throats.
Fierce Pharma
MAY 17, 2023
Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type aliu Wed, 05/17/2023 - 09:41
Medical Xpress
MAY 17, 2023
The accuracy of detecting bowel cancer is increased to almost 100% by carrying out a common test twice rather than once, a new study published in the British Journal of Surgery shows.
Pharma Times
MAY 17, 2023
Dosing optimisation technology will be incorporated alongside anti-hypertensive drugs
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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.
Medical Xpress
MAY 17, 2023
After hearing firsthand from patients about how the disease impacted their lives, a team of researchers and graduate students at University of Western Ontario were inspired to investigate the symptoms associated with an understudied spine disease called diffuse idiopathic skeletal hyperostosis (DISH).
Pharma Times
MAY 17, 2023
Partnership will provide a healthcare boost across in low and middle-income countries
Medical Xpress
MAY 17, 2023
Researchers at National Jewish Health evaluating computerized tomography (CT) scans of emphysema progression in the COPDGene study showed that, during a span of 10 years, participants with pre-existing emphysema who continued smoking had the largest decline in adjusted lung density (ALD). The lung density decline was notably worse in current smokers compared with former smokers.
Fierce Pharma
MAY 17, 2023
Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29
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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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