Pharmaceutical Technology
MARCH 27, 2024
CROs are fundamental to the development of cancer treatments but face multiple challenges. We analyze the biggest trends in oncology and the technological solutions available to CROs to optimize efficiencies.
Bio Pharma Dive
MARCH 27, 2024
The failure of a medicine known as TUDCA is yet another disappointment for ALS patients, as it comes just after Amylyx’s therapy Relyvrio proved unsuccessful in confirmatory testing.
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Rethinking Clinical Trials
MARCH 27, 2024
Drs. Amit Garg and Stephanie Dixon In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine and Dentistry will present “Effect of a Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial.” The Grand Rounds session will be held on Friday, March 27, 2024, at 1:00 pm eastern.
Bio Pharma Dive
MARCH 27, 2024
An arm of the private equity firm pledged up to $750 million in funding for Moderna’s flu shot development, in exchange for milestones and royalties.
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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
MARCH 27, 2024
Cryopyrin-Associated Periodic Syndromes disease is an indication for drug development with over 10 pipeline drugs currently active according to GlobalData.
Bio Pharma Dive
MARCH 27, 2024
The startup’s performance will test investors’ appetite for early-stage drugmakers, as Boundless has only advanced as far as Phase 1 clinical trials.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MARCH 27, 2024
Brainomix's e-Lung AI can accurately identify idiopathic pulmonary fibrosis patients most likely to progress and could inform the clinical trial design for new therapies
Pharmaceutical Technology
MARCH 27, 2024
Avenzo Therapeutics has secured $150m in Series A-1 financing round to progress the development of its oncology pipeline.
pharmaphorum
MARCH 27, 2024
Incorporating the patient experience into observational studies can enhance the quality of real-world evidence gathered. Learn how patient-centred approaches can lead to stronger research outcomes.
Pharmaceutical Technology
MARCH 27, 2024
Johnson & Johnson (J&J) has obtained US FDA fast track status for nipocalimab to lower foetal and neonatal alloimmune thrombocytopenia risk.
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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
Fierce Pharma
MARCH 27, 2024
Akebia never lost confidence in its oral chronic kidney disease (CKD) anemia drug Vafseo, even after the FDA nixed its first approval bid two years ago with a complete response letter.
Pharmaceutical Technology
MARCH 27, 2024
Respiratory Tract Infections disease is an indication for drug development with over 120 pipeline drugs currently active according to GlobalData.
Fierce Pharma
MARCH 27, 2024
For various reasons, pharma firms often favor distribution pacts rather than relying on local subsidiaries to market their drugs. | As pharma firms increasingly favor distribution pacts rather than relying on local subsidiaries to market their drugs, French major Sanofi has enlisted local companies to enhance the profile of its medicines across South and East Asia.
Pharmaceutical Technology
MARCH 27, 2024
Labor And Delivery disease is an indication for drug development with over 10 pipeline drugs currently active according to GlobalData.
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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.
Antidote
MARCH 27, 2024
MS is a chronic disease that is estimated to impact over a million Americans. The condition causes damage to the body’s central nervous system, leading to numbness, memory problems, sight issues, and difficulties with coordination.
Pharmaceutical Technology
MARCH 27, 2024
Takeda has announced that the Japanese MHLW approved its ADZYNMA to treat congenital thrombotic thrombocytopenic purpura (cTTP).
BioSpace
MARCH 27, 2024
After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
Pharmaceutical Technology
MARCH 27, 2024
Pneumonia disease is an indication for drug development with over 230 pipeline drugs currently active according to GlobalData.
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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.
BioSpace
MARCH 27, 2024
Citing a JAMA study that found Ozempic could be profitably produced at under $5 per month, Senator Bernie Sanders on Wednesday called on Novo Nordisk to lower prices for the diabetes treatment and the weight-loss drug Wegovy.
Pharmaceutical Technology
MARCH 27, 2024
The US FDA has approved Merck's sotatercept-csrk (WINREVAIR) for the treatment of pulmonary arterial hypertension (PAH).
BioPharma Reporter
MARCH 27, 2024
From math hater to a leader in clinical data, itâs been a long journey for Jennifer Visser-Rogers, vice president for statistical research and consultancy at Phastar.
Pharmaceutical Technology
MARCH 27, 2024
Cough disease is an indication for drug development with over 40 pipeline drugs currently active according to GlobalData.
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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.
BioSpace
MARCH 27, 2024
Continuing 2024’s biotech initial public offering rally, Boundless Bio will debut Thursday on the Nasdaq with the proceeds used to advance its pipeline of extrachromosomal DNA cancer assets.
Pharmaceutical Technology
MARCH 27, 2024
The market for multiple sclerosis therapies is expected to be worth over $41bn by 2030, according to GlobalData.
pharmaphorum
MARCH 27, 2024
Astellas has become the first drugmaker to bring a claudin 18.2 (CLDN18.2) targeted therapy to regulatory approval, getting a green light in Japan for Vyloy as a treatment for stomach cancer. The Ministry of Health, Labour and Welfare (MHLW) has cleared Vyloy (zolbetuximab) for use in combination with chemotherapy for patients with HER2-negative CLDN18.2-positive advanced or recurrent gastric cancer that cannot be treated with surgery.
Pharmaceutical Technology
MARCH 27, 2024
Mixed Pain (Nociceptive Pain/Neuropathic Pain) disease is an indication for drug development with over 270 pipeline drugs currently active according to GlobalData.
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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.
Fierce Pharma
MARCH 27, 2024
At a recent skull session in a conference room at Bayer’s U.S. | Bayer is laying off 90 of its employees at its United States headquarters in Whippany, New Jersey, part of its ongoing restructure which CEO Bill Anderson has said will cost many their jobs.
Pharmaceutical Technology
MARCH 27, 2024
Hematopoietic Stem Cell Transplantation disease is an indication for drug development with over 10 pipeline drugs currently active according to GlobalData.
pharmaphorum
MARCH 27, 2024
More than half (52%) of people who participated in a major survey of the GB public were dissatisfied with the NHS, as staff shortages, strikes, and record waiting lists take their toll. The results from the annual British Social Attitudes (BSA) survey came from 3,000 people interviewed across England, Scotland, and Wales and showed that less than a quarter (24%) were satisfied with the health service, a 29 percentage drop in three years.
Pharmaceutical Technology
MARCH 27, 2024
Primary Mediastinal B-Cell Lymphoma disease is an indication for drug development with over 140 pipeline drugs currently active according to GlobalData.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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