BioSpace
OCTOBER 23, 2022
BioMed X and Sanofi have inked an R&D collaboration to use digital data and artificial intelligence to predict the efficacy of first-in-class drug candidates using virtual patient populations.
NPR Health - Shots
OCTOBER 23, 2022
NPR's Ayesha Rascoe speaks to Alexandra White of the National Institute of Environmental Health Sciences about the link between chemical hair straighteners and uterine cancer.
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BioSpace
OCTOBER 23, 2022
Top-line data from Tricida's VALOR-CKD trial showed veverimer failed to meet its primary endpoint and does not slow progression in patients with metabolic acidosis and CKD.
STAT News
OCTOBER 23, 2022
The U.S. is less than three weeks from the 2022 midterm elections, which will decide which issues are prioritized — and then passed or defeated — in local, state, and federal governments. Medical professionals generally understand how election results can affect their personal freedoms, the health of the communities they serve and live in, and even how they practice medicine.
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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
BioSpace
OCTOBER 23, 2022
PhaseBio plans to file Chapter 11 bankruptcy and sell off its bentracimab assets under a stalking horse arrangement with an unnamed “large pharmaceutical company.
JAMA Internal Medicine
OCTOBER 23, 2022
This Viewpoint discusses the benefits of streamlined point-of-care trial designs in clinical research, using lessons learned from the UK RECOVERY study of dexamethasone dosing for patients with COVID-19 and hypoxia.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
OCTOBER 23, 2022
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Drug Patent Watch
OCTOBER 23, 2022
Annual Drug Patent Expirations for ABILIFY Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from one supplier.…. The post New patent expiration for Otsuka drug ABILIFY appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
OCTOBER 23, 2022
The FDA greenlit AstraZeneca's tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma.
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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
Drug Patent Watch
OCTOBER 23, 2022
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BioSpace
OCTOBER 23, 2022
In a Phase III trial comparing Novartis’ experimental iptacopan against AstraZeneca's Soliris and Ultomiris in paroxysmal nocturnal hemoglobinuria, iptacopan demonstrated superiority.
Drug Patent Watch
OCTOBER 23, 2022
Annual Drug Patent Expirations for SINGULAIR Singulair is a drug marketed by Organon and is included in three NDAs. There is one patent protecting this drug and two Paragraph IV…. The post New patent expiration for Organon drug SINGULAIR appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
OCTOBER 23, 2022
Shares of Immunic stock have plunged more than 70% in premarket trading after an early peek at its Phase Ib psoriasis drug candidate has so far failed to distinguish itself from placebo.
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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.
Drug Patent Watch
OCTOBER 23, 2022
This chart shows the patent expirations for injectable dosed drugs over the next decade. The term of drug patents varies. The basic term for a patent is 20 years from…. The post Injectable dosed drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
OCTOBER 23, 2022
Alpine Immune Sciences has voluntarily terminated enrollment in two clinical trials of its immuno-oncology asset, davoceticept, after a second patient death.
Pharmaceutical Technology
OCTOBER 23, 2022
In January 2022, the United Kingdom adopted ISO 10993-7:2008 / Amd 1:2019 as BS EN ISO 10993-7:2008 / A1:2022 without modification. Prior to the implementation of the revised standard, no obvious consideration was given to patient age when setting the appropriate limits for ethylene oxide residues in medical devices. Arbitrary limits given as milligrams of exposure to residues per device were simply prescribed based on the physical contact time allowed for each category of device.
Pharmaceutical Technology
OCTOBER 23, 2022
The Japanese Ministry of Health, Labour and Welfare (MHLW) has agreed to review GSK ’s new drug application (NDA) for its respiratory syncytial virus (RSV) vaccine candidate for use in older adults. The proposed indication is for preventing RSV-caused lower respiratory tract diseases (LRTD) in adults aged 60 years and above. GSK made the submission based on the positive interim assessment findings from the multi-country, placebo-controlled, randomised, observer-blind Phase III AReSVi-006 clinica
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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.
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