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NICE to update endometriosis guidelines to improve diagnosis and surgical management

Pharmaceutical Technology

This marks the first update to NICE’s endometriosis guidelines since 2017, representing a huge milestone for patients and practitioners alike. This delay in diagnosis ultimately leads to disease progression and associated complications, such as chronic pelvic pain and infertility, which greatly affects the patients’ quality of life.

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Tackling the complex development landscape of pain medicines

European Pharmaceutical Review

The current medications (opioid and non-opioid) often force the patients to make an unfortunate choice between efficacy and debilitating side effects, leading to a cycling through multiple different therapies and suboptimal treatment response. 2017; 6(S1):1–3. Neuropathic pain: The scope of the problem. Pain and Therapy. Internet] NIH.

Medicine 102
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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

Blank acknowledged that in many cases, an exclusively paediatric patient population could lead to difficulties with drawing consent for early phase trials. Since the first approval in 2017, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cell and gene therapies.

FDA 105
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Understanding a rare disease through the lens of real world and prevalence data

Clarivate

Degeneration of the retinal ganglion cells causes rapidly progressing vision loss, leading to permanent (non-painful) blindness within a year. 9; 9/2017; p447; DOI:10.1016/j.je.2017.02.001 9; 9/2017; p447; DOI:10.1016/j.je.2017.02.001 Frontiers in Pharmacology; 13:1089033; DOI: 10.3389/fphar.2022.1089033

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Advancing AOCs to transform the delivery of RNA therapeutics

European Pharmaceutical Review

Known linkers in the RNA field are used to bond together the two pharmacologically active molecular entities and can be applied to multiple oligonucleotide modalities. Research advances are also helping us learn more about how RNA is processed, potentially leading to new strategies to alter dysfunctional RNA. 2017; 376:86-88.

Safety 98
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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

20 Good manufacturing practice (GMP) Commission Directive (EU) 2017/1572 (which supplemented Directive 2001/83/EC) lays out the principles and guidelines of GMP in the EU. Prior to joining Fieldfisher, Taly spent four years working as in-house counsel for a leading tech company helping launch products across multiple EU markets.

Marketing 103
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Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Legacy MEDSearch

Early non-randomized European studies have suggested that this leads to reduced incidence of coronary microvascular obstruction (MVO) [3,4] and smaller infarct size, which are both strongly correlated to improvement in heart failure hospitalizations and reduced mortality following primary PCI [5]. About Miracor Medical.

Medical 52