AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 30, 2023
One of the challenges in treating cancer is stopping it from metastasizing, and a new study reveals one of the fundamental mechanisms through which this happens. Now we know about this mechanism, perhaps we can stop it. Key to this newly discovered process is GRP78, and it’s what’s known as a chaperone protein.
Pharmaceutical Technology
JULY 30, 2023
Pelabresib is a small molecule commercialized by MorphoSys, with a leading Phase III program in Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF).
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AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 30, 2023
Even as the Centre has listed the New Drugs, Medical Devices and Cosmetics Bill, 2023 to be tabled in Parliament during the current session, industry members are apprehensive that the new bill may mean centralisation of licensing and other powers to the Central drug regulatory authority and it may also have provisions which may harm […]
Pharmaceutical Technology
JULY 30, 2023
Pelabresib is a small molecule commercialized by MorphoSys, with a leading Phase III program in Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF).
BioSpace
JULY 30, 2023
Ulotaront failed to meet primary endpoints in two studies. The companies said high COVID-19 placebo effect “may have masked molecule’s therapeutic effect” and plan to discuss next steps with the FDA.
Pharmaceutical Technology
JULY 30, 2023
Gedeptin is a gene therapy commercialized by GeoVax Labs, with a leading Phase II program in Recurrent Head And Neck Cancer Squamous Cell Carcinoma.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 30, 2023
Gedeptin is a gene therapy commercialized by GeoVax Labs, with a leading Phase II program in Recurrent Head And Neck Cancer Squamous Cell Carcinoma.
BioSpace
JULY 30, 2023
Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space, experts told BioSpace.
Pharmaceutical Technology
JULY 30, 2023
Vamorolone is a small molecule commercialized by Catalyst Pharmaceuticals, with a leading Pre-Registration program in Duchenne Muscular Dystrophy.
BioSpace
JULY 30, 2023
The FDA has three upcoming action dates in the next two weeks, including a highly anticipated decision regarding Biogen and Sage’s depression drug zuranolone.
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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
JULY 30, 2023
Nirogacestat hydrobromide is a small molecule commercialized by SpringWorks Therapeutics, with a leading Pre-Registration program in Benign Tumor.
BioSpace
JULY 30, 2023
Syfovre has been linked to rare cases of eye inflammation that could lead to blinding, though Apellis’ review so far has found no connection between the treatment and the complications.
Pharmaceutical Technology
JULY 30, 2023
Vamorolone is a small molecule commercialized by Catalyst Pharmaceuticals, with a leading Pre-Registration program in Duchenne Muscular Dystrophy.
JAMA Internal Medicine
JULY 30, 2023
This case report presents the electrocardiogram findings of a patient in their 50s with intermittent compression-like pain in the chest and a history of hypertension and diabetes.
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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
JULY 30, 2023
Nirogacestat hydrobromide is a small molecule commercialized by SpringWorks Therapeutics, with a leading Pre-Registration program in Benign Tumor.
JAMA Internal Medicine
JULY 30, 2023
This Viewpoint explores whether there are benefits to drugs targeting β-amyloid protein in treating Alzheimer disease.
Pharmaceutical Technology
JULY 30, 2023
FPI-1434 is a monoclonal antibody conjugated commercialized by Fusion Pharmaceuticals, with a leading Phase II program in Endometrial Cancer.
Drug Patent Watch
JULY 30, 2023
Annual Drug Patent Expirations for QTERNMET+XR Qternmet Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are seven patents protecting this drug. Drug patent… The post New patent expiration for Astrazeneca Ab drug QTERNMET XR appeared first on DrugPatentWatch - Make Better Decisions.
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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
JULY 30, 2023
PF-06480605 is a monoclonal antibody commercialized by Pfizer, with a leading Phase II program in Crohn's Disease (Regional Enteritis).
Drug Patent Watch
JULY 30, 2023
Annual Drug Patent Expirations for ONGLYZA Onglyza is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There are two patents… The post New patent expiration for Astrazeneca Ab drug ONGLYZA appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JULY 30, 2023
PF-06480605 is a monoclonal antibody commercialized by Pfizer, with a leading Phase II program in Crohn's Disease (Regional Enteritis).
Drug Patent Watch
JULY 30, 2023
Obeticholic acid is the generic ingredient in one branded drug marketed by Intercept Pharms Inc and is included in one NDA. There are ten patents protecting this compound. Drug patent… The post New tentative approval for Optimus Pharma drug obeticholic acid appeared first on DrugPatentWatch - Make Better Decisions.
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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
JULY 30, 2023
CAP-1002 is a cell therapy commercialized by Nippon Shinyaku, with a leading Phase III program in Duchenne Muscular Dystrophy.
Drug Patent Watch
JULY 30, 2023
Annual Drug Patent Expirations for KOMBIGLYZE+XR Kombiglyze Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are three… The post New patent expiration for Astrazeneca Ab drug KOMBIGLYZE XR appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JULY 30, 2023
CAP-1002 is a cell therapy commercialized by Nippon Shinyaku, with a leading Phase III program in Duchenne Muscular Dystrophy.
Drug Patent Watch
JULY 30, 2023
Annual Drug Patent Expirations for QTERN Qtern is a drug marketed by Astrazeneca Ab and is included in two NDAs. It is available from one supplier. There are nine patents… The post New patent expiration for Astrazeneca Ab drug QTERN appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Pharmaceutical Technology
JULY 30, 2023
BNT-321 is a monoclonal antibody commercialized by BioNTech, with a leading Phase II program in Metastatic Colorectal Cancer.
Drug Patent Watch
JULY 30, 2023
DEXILANT SOLUTAB (dexlansoprazole) Takeda pharms usa Patent: 6,664,276 Expiration: Jul 30, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact… The post Drug Patent Expirations for the Week of July 30, 2023 appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JULY 30, 2023
BNT-321 is a monoclonal antibody commercialized by BioNTech, with a leading Phase II program in Metastatic Colorectal Cancer.
BioSpace
JULY 30, 2023
With its hypoimmune technology, the company looks to reshape the future of cell and gene therapy.
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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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