EFPIA Files Complaint Against French Law Promoting Off-Label Avastin Use

Earlier this week, EFPIA, Europe's pharmaceutical industry association, announced it had filed a complaint with the European Commission against the French “RTU Regime.” promoting the use of Roche's cancer drug Avastin for the off-label treatment of wet age-related macular degeneration (AMD). The decree allows the French medicines regulator (ANSM) to issue a temporary authorization for use of a product in an unauthorized indication, purely for economic purposes, notwithstanding the existence of an authorized alternative treatment. This development is troubling and contravenes European Community law and jurisprudence, writes EFPIA, along with EUCOPE and EuopaBio. “The regime allows [ANSM] to issue a temporary authorisation for use of a product in an unauthorised indication, also for economic purposes, notwithstanding the existence of an authorised alternative treatment,” the trade groups wrote in their recent press release. “This development is troubling and contravenes European Union law and jurisprudence.” View the trade groups' Press Release here.  While Roche's Avastin is not approved by health regulators as a treatment for AMD, it works in a similar way to the treatments currently authorized for AMD, such as Lucentis, marketed by Novartis and Roche, and Eylea, from Bayer and Regeneron. France has argued that encouraging the use of Avastin, which costs around 30 times less than those rival treatments, could result...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs

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In this study, AT1-AAs were detected in the sera of patients with peripheral arterial disease (PAD) and the positive rate was 44.44% vs. 17.46% in non-PAD volunteers. In addition, analysis showed that AT1-AAs level was positively correlated with PAD. To reveal the causal relationship between AT1-AAs and vascular aging, an AT1-AAs-positive rat model was established by active immunization. The carotid pulse wave velocity was higher, and the aortic endothelium-dependent vasodilatation was attenuated significantly in the immunized rats. Morphological staining showed thickening of the aortic wall. Histological examination showe...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
FromConsumer Reports:GlaucomaMore than 2 million Americans have glaucoma, but 50% know it. Glaucoma often goes undiagnosed because it causes no symptoms until vision declines, at which point treatment no longer helps.People aged 40-60 should be examined by an optometrist every 3-5 years; those older than 60 need an eye exam every 1-2 years.Many eye doctors screen for glaucoma with tonometry (measures eye pressure) but that ’s not enough. Relying only on intraocular pressure (IOP) when screening for glaucoma could miss up to 50% of all cases. Theexam should also include an ophthalmoscopy, which involves examining your...
Source: Clinical Cases and Images - Blog - Category: Universities & Medical Training Tags: Ophthalmology Source Type: blogs
Publication date: 1 October 2019Source: Cell Reports, Volume 29, Issue 1Author(s): Paulina M. Wojnarowicz, Raquel Lima e Silva, Masayuki Ohnaka, Sang Bae Lee, Yvette Chin, Anita Kulukian, Sung-Hee Chang, Bina Desai, Marta Garcia Escolano, Riddhi Shah, Marta Garcia-Cao, Sijia Xu, Rashmi Kadam, Yehuda Goldgur, Meredith A. Miller, Ouathek Ouerfelli, Guangli Yang, Tsutomu Arakawa, Steven K. Albanese, William A. GarlandSummaryId helix-loop-helix (HLH) proteins (Id1–4) bind E protein bHLH transcription factors, preventing them from forming active transcription complexes that drive changes in cell states. Id proteins are pr...
Source: Cell Reports - Category: Cytology Source Type: research
We examined human lung tissue from COPD patients and normal control subjects, and found a substantial increase in p16-expressing alveolar cells in COPD patients. Using a transgenic mouse deficient for p16, we demonstrated that lungs of mice lacking p16 were structurally and functionally resistant to CS-induced emphysema due to activation of IGF1/Akt regenerative and protective signaling. Fat Tissue Surrounds Skeletal Muscle to Accelerate Atrophy in Aging and Obesity https://www.fightaging.org/archives/2019/09/fat-tissue-surrounds-skeletal-muscle-to-accelerate-atrophy-in-aging-and-obesity/ Researchers her...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
This popular science piece on the development of senolytic therapies capable of clearing harmful senescent cells from aging tissues is a cut above the average. It is important to see more publicity for this line of work. Not because it will aid the industry, but because the more attention that is given to the field, the faster that existing senolytic treatments such as the dasatinib and quercetin combination will become available through off-label prescription and physician networks. Tens of millions of patients with inflammatory age-related diseases caused in part by senescent cells, and the many cancer survivors with hig...
Source: Fight Aging! - Category: Research Authors: Tags: Daily News Source Type: blogs
Publication date: Available online 29 August 2019Source: Progress in Retinal and Eye ResearchAuthor(s): Ali A. Hussain, Yunhee Lee, John MarshallAbstractExtracellular matrices (ECMs) are maintained by tightly coupled processes of continuous synthesis and degradation. The degradative arm is mediated by a family of proteolytic enzymes called the matrix metalloproteinases (MMPs). These enzymes are released as latent proteins (pro-MMPs) and on activation are capable of degrading most components of an ECM. Activity of these enzymes is checked by the presence of tissue inhibitors of MMPs (TIMPs) and current opinion holds that th...
Source: Progress in Retinal and Eye Research - Category: Opthalmology Source Type: research
It’s no secret that air pollution isn’t good for your health. In particular, exposure to the byproducts of burning the fuel that powers most of our motor vehicles has been linked to higher risk of lung cancer, respiratory infections, stroke and heart disease, as well as an increased risk of death from these conditions. A new study now adds another worrisome pollution-related risk: eye disease. Dr. Suh-Hang Hank Juo, from the center for myopia and eye disease at China Medical University in Taiwan, and his colleagues documented for the first time in a large population that exposure to two common air pollutants&md...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized health macular degeneration Pollution Source Type: news
To the Editor We recently reported a phase I dose-escalation study of the oral tyrosine kinase inhibitor vorolanib (previously known as X-82 [Tyrogenex]), which was used as a treatment for neovascular age-related macular degeneration (AMD). We have since been made aware of a 2008 report detailing 2 cases of neovascular AMD treated with oral sorafenib, which deserves mention. Like vorolanib, sorafenib is a multikinase inhibitor that has been used to treat cancer. It has theoretical utility as a treatment for wet AMD because it downregulates the production of vascular endothelial growth factor and platelet-derived growth factor.
Source: JAMA Ophthalmology - Category: Opthalmology Source Type: research
Conclusions- Our findings reveal that PVR involving intussusception and splitting of extravascular columns, endothelial proliferation, vesiculation, fenestration, and thickening is induced before neovascularization, suggesting that identifying and targeting these processes may prevent development of advanced neovascular disease in the future. Visual Overview- An online visual overview is available for this article. PMID: 31242036 [PubMed - in process]
Source: Arteriosclerosis, Thrombosis and Vascular Biology - Category: Cardiology Authors: Tags: Arterioscler Thromb Vasc Biol Source Type: research
CONCLUSION: Thyroid disorders and eye diseases are interrelated through several mechanisms thus, awareness of this relation is of a great impact on early diagnosis and treatment. PMID: 31237221 [PubMed - as supplied by publisher]
Source: Endocrine, Metabolic and Immune Disorders Drug Targets - Category: Drugs & Pharmacology Tags: Endocr Metab Immune Disord Drug Targets Source Type: research
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