Bio Pharma Dive
OCTOBER 11, 2023
Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.
Pharmaceutical Technology
OCTOBER 11, 2023
Biomarin and CSL Behring’s haemophilia gene therapies have boosted innovation in the field, but assessing their cost effectiveness is less than straightforward.
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Bio Pharma Dive
OCTOBER 11, 2023
The finding from the study of its diabetes drug, which Novo didn’t detail, could help the company in its competition with rival drugmaker Eli Lilly.
Pharmaceutical Technology
OCTOBER 11, 2023
GlobalData analyst Wafaa Hasan discusses key topics around cybersecurity for the pharmaceutical industry.
Bio Pharma Dive
OCTOBER 11, 2023
The once high-flying biotech is cutting staff for the second time in a year and delaying some research to save cash.
Pharmaceutical Technology
OCTOBER 11, 2023
Ozempic is approved in the US, Canada, EU, Japan, and Australia as a treatment for type 2 diabetes.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
OCTOBER 11, 2023
Keith Marsolo, PhD In this Friday’s PCT Grand Rounds, Keith Marsolo of Duke University will present “Incorporating Social Determinants of Health Into PCORnet.” The Grand Rounds session will be held on Friday, October 13, 2023, at 1:00 pm eastern. Marsolo is an associate professor of population health sciences at Duke University and a cochair of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records Core Working Group.
Bio Pharma Dive
OCTOBER 11, 2023
Some venture investors are putting more of their money into “inside rounds,” while others are exploring opportunities to combine portfolio companies.
Pharmaceutical Technology
OCTOBER 11, 2023
Microbiome mapping technology company Kanvas Biosciences has announced the acquisition of assets from California-based Federation Bio, bringing with it two active therapeutics programmes.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 11, 2023
The advancements in space technology have given hope to the healthcare industry. An amalgamation of the two can provide high-quality surgical care to patients around the world without any geographic barriers, eventually leading to easy access, said Dr.
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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
OCTOBER 11, 2023
SparX’s monoclonal antibody was used to develop the Claudin 18.2 tumour-specific antigen targeting CAR-iNKT cell therapy.
Rethinking Clinical Trials
OCTOBER 11, 2023
Speakers Speaker: David M. Murray, PhD NIH Associate Director for Prevention and Director, NIH Office of Disease Prevention Moderator: Jonathan C. Moyer, PhD Statistician, NIH Office of Disease Prevention Slides Keywords Implementation; Study design; Hybrid; Clustered; DECIPHeR Key Points People often contest that hybrid designs are not as rigorous as they should be.
Pharmaceutical Technology
OCTOBER 11, 2023
MinervaX is currently conducting Phase II trials of the prophylactic maternal vaccine against group B streptococcus bacterial infections.
BioSpace
OCTOBER 11, 2023
Following the recommendations of an independent Data Monitoring Committee, Novo Nordisk has halted a Phase III kidney outcomes study of semaglutide ahead of schedule due to strong efficacy signals.
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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
OCTOBER 11, 2023
Agomab Therapeutics has secured €94.9m ($100m) in its Series C funding round to advance the development of its fibrosis-focused pipeline.
Fierce Pharma
OCTOBER 11, 2023
For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate. | For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate.
Pharmaceutical Technology
OCTOBER 11, 2023
Cellipont Bioservices has signed an agreement with Diakonos Oncology to develop DOC1021, a cell therapy to treat glioblastoma multiforme.
BioSpace
OCTOBER 11, 2023
From Statera Biopharma and Sorrento Therapeutics to Aceragen and Infinity Pharmaceuticals, 2023 has seen a record high 28 bankruptcies in the biotech space so far. Here’s why.
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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.
Pharmaceutical Technology
OCTOBER 11, 2023
Gritgen Therapeutics has launched operations at its commercial GMP facility in Suzhou Industrial Park, China.
Pharma Times
OCTOBER 11, 2023
The deal gives Kyowa access to a therapy for early-onset metachromatic leukodystrophy - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 11, 2023
The collaboration aims to boost open innovation hub SakuLab-Tsukaba at Astellas’ Tsukuba Research Centre.
Fierce Pharma
OCTOBER 11, 2023
Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief m | Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine.
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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.
Pharmaceutical Technology
OCTOBER 11, 2023
BioMap has entered into a strategic alliance with Sanofi to co-develop AI modules and expedite drug discovery for biotherapeutics.
Outsourcing Pharma
OCTOBER 11, 2023
Technology company, Medable Inc., offering services for modern clincal trials has joined forces with Pluto Health, a smart care coordination services company offering a health coordination platform.
Pharmaceutical Technology
OCTOBER 11, 2023
Topline results from an ongoing Phase IIa study with SLS009 are expected by the end of the year.
Pharma Times
OCTOBER 11, 2023
Eligible patients in Scotland will now have access to Nubeqa and Stivarga - News - PharmaTimes
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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.
BioSpace
OCTOBER 11, 2023
The European Union is expected to order the gene sequencing giant to divest Grail in the coming days, according to multiple media reports citing unnamed sources familiar with the matter.
Outsourcing Pharma
OCTOBER 11, 2023
The heavy burden on immediate family members with neurodegenerative diseases and their caregivers, was the initial driving force to study pharmacy for Andrea Pfeifer.
Fierce Pharma
OCTOBER 11, 2023
Mallinckrodt has essentially walked back its promise to pay $1.7 billion in an opioid settlement thanks to the company's second bankruptcy in just two years. | Mallinckrodt has essentially walked back its promise to pay $1.7 billion in an opioid settlement thanks to the company's second bankruptcy in just two years.
Eye on FDA
OCTOBER 11, 2023
FDA has announced that the Office of Prescription Drug Promotion (OPDP) is planning a study to evaluate the influence that statements made in a promotional communication about patient adherence to a medication may have on the resulting preference for a medicine. OPDP regularly conducts research on a wide-ranging scale to help define the agency’s perspective on how various conditions might impact a target audience of a promotional communication.
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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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