Pharmaceutical Technology
FEBRUARY 28, 2024
AGTC-501 is in Phase II development for retinitis in the SKYLINE trial (NCT03316560) and addresses unmet needs within the retinitis space
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 28, 2024
It’s been over three years since scientists first found microplastics swimming in four different human placentas, and as it turns out, that was just the tip of the iceberg. A few years later, at the start of 2023, researchers announced they had found microscopic particles of plastic waste in no fewer than 17 different placentas.
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Pharmaceutical Technology
FEBRUARY 28, 2024
Pelage Pharmaceuticals has secured $16.75m in a Series A financing round to further the development of PP405 for hair loss.
Bio Pharma Dive
FEBRUARY 28, 2024
The acquisition of Proof Diagnostics, which was formed to develop a COVID-19 test, gives Ginkgo a library of novel enzymes that can be used to make genetic medicines.
Pharmaceutical Technology
FEBRUARY 28, 2024
Amneal has signed an agreement with Zambon Biotech for IPX203 for the treatment of Parkinson's disease (PD) in certain regions.
Bio Pharma Dive
FEBRUARY 28, 2024
Shares of the Australian biotech rocketed up about 55% after the company announced results from a mid-stage study in generalized anxiety disorder.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
FEBRUARY 28, 2024
In this Friday’s PCT Grand Rounds, Joseph Doyle of the Massachusetts Institute of Technology (MIT) will present “Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, March 1, 2024, at 1:00 pm eastern. Doyle is the Erwin H.
Pharmaceutical Technology
FEBRUARY 28, 2024
As post-approval boundaries disproportionately affect rare disease patients, communities are rallying behind alternative options.
Bio Pharma Dive
FEBRUARY 28, 2024
The deal gives Viatris access to a treatment for heart attacks as well as a drug for lupus, both of which are currently in Phase 3 testing.
Pharmaceutical Technology
FEBRUARY 28, 2024
Regulatory standards concerning raw material selection are particularly stringent when it comes to Regenerative Medicines.
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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
Bio Pharma Dive
FEBRUARY 28, 2024
Well-known scientist and biotech entrepreneur Robert Langer is helping Lindus Health address longstanding challenges in contract drug research.
Pharmaceutical Technology
FEBRUARY 28, 2024
The goal had been for 10,000 patients to be on Leqembi by the end of March 2024, but only 2,000 patients received the drug as of 26 January.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 28, 2024
A Parliamentary Panel has asked the Department of Pharmaceuticals (DoP) and the Bureau of Indian Standards (BIS) to expedite the process of setting up National Standards for all types of medical devices and use of a ‘National Mark’ for all medical devices that comply with BIS/IEC standards.
Pharmaceutical Technology
FEBRUARY 28, 2024
BeiGene has announced the BLA acceptance by the US FDA for TEVIMBRA to treat advanced gastric or gastroesophageal junction adenocarcinoma.
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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
Rethinking Clinical Trials
FEBRUARY 28, 2024
Speakers Adrian Hernandez, MD Executive Director, Duke Clinical Research Institute Vice Dean, Duke University School of Medicine Christopher J. Lindsell, PhD Professor and co-Chief of Biostatistics, Department of Biostatistics & Bioinformatics Director, Data Science and Biostatistics, Duke Clinical Research Institute Duke University School of Medicine Editor in Chief, Journal of Clinical and translational Science Slides Keywords Decentralized Clinical Trials, Virtual
Pharmaceutical Technology
FEBRUARY 28, 2024
Whilst Minerva deals with clinical deficiencies, eyes turn to Karuna’s PDUFA date and other key Phase III readouts later this year.
Bio Pharma Dive
FEBRUARY 28, 2024
The company is still attempting to “monetize” its most advanced drug, a treatment to aid pregnancy via in vitro fertilization.
Pharmaceutical Technology
FEBRUARY 28, 2024
In an interview with Pharmaceutical Technology, the company’s chief scientific officer detailed the company’s upcoming 2024 plans.
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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.
pharmaphorum
FEBRUARY 28, 2024
Discover how digital technology and strategic partnerships are revolutionising the pharmaceutical industry, enabling faster delivery of life-saving medicines to patients, while advancing humanity's fight against diseases.
Pharmaceutical Technology
FEBRUARY 28, 2024
AbbVie will pay $48m in upfront costs and up to $665m in milestone payments to license OSE’s monoclonal antibody OSE-230.
Pharma Times
FEBRUARY 28, 2024
Breast cancer is responsible for around 47,000 new cases in England every year
Pharmaceutical Technology
FEBRUARY 28, 2024
The US FDA has granted approval for Allecra Therapeutics’ EXBLIFEP to treat complicated urinary tract infections.
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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.
BioPharma Reporter
FEBRUARY 28, 2024
Mandziuk is vice president of real world solutions and tokenisation and says nothing could have prepared the health industry for the global impact the Covid pandemic has had.
Pharmaceutical Technology
FEBRUARY 28, 2024
Biotechs need to navigate US-China relations when pursuing collaborations and drug manufacturing partnerships.
pharmaphorum
FEBRUARY 28, 2024
AbbVie has made another bolt-on deal in the immunology and inflammation category, paying $48 million upfront for rights to an antibody in preclinical development at OSE Immunotherapeutics. There’s another $665 million in potential milestones and a royalty tied to the deal, which focuses on OSE-230, billed as a potentially first-in-class activator of ChemR23, a G-protein coupled receptor (GPCR) found on some white blood cells.
Pharmaceutical Technology
FEBRUARY 28, 2024
IRA regulations have changed how pharma is approaching innovation in cancer drug discovery and development.
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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.
pharmaphorum
FEBRUARY 28, 2024
Rare Disease Day is an opportunity to highlight the importance of enhancing clinical trial success in rare diseases for the benefit of patients.
BioPharma Reporter
FEBRUARY 28, 2024
OneChain Immunotherapeutics has received â1.9m from the Spanish Ministry of Science and Innovation to advance a âgroundbreakingâ CAR-T therapy for acute lymphoblastic leukemia type T into clinical development.
Outsourcing Pharma
FEBRUARY 28, 2024
In a seminal move coinciding with Rare Disease Day, Emmes Endpoints Solutions has taken a significant step forward in the realm of rare disease research.
Fierce Pharma
FEBRUARY 28, 2024
As Novavax emerges from its “transition year” in 2023, the vaccine maker is still raising concerns among Wall Street investors in early 2024. | As Novavax emerges from its “transition year” in 2023, the vaccine maker is still raising concerns among Wall Street investors in early 2024.
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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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