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

Pharmaceutical Technology

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

FDA 105
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Early diagnosis in Alzheimer’s disease: A first step towards better care

Clarivate

Personalized care relies on pharmacological and non-pharmacological interventions aimed at (temporarily) relieving cognitive and non-cognitive symptoms (Alzheimer’s Association, n.d.; FDA cleared the first CSF diagnostic test based on the detection of Aβ40/Aβ42 (U.S. FDA-Approved Treatments for Alzheimer’s. Emblad, S.

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Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Legacy MEDSearch

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical. Are you hiring?

Medical 52
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Can Hepatitis C drugs reduce symptoms of PTSD?

European Pharmaceutical Review

The researchers studied 254 VA patients who were diagnosed with PTSD and hepatitis C between October 1999 and September 2019. Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus. The findings are to be published in the American Journal of Epidemiology.

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2022 in review: Drug development milestones for tropical diseases

Pharmaceutical Technology

This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology. As per the WHO’s 2022 malaria report , 63,000 malaria deaths were attributed to Covid-19-caused disruptions to services from 2019–21.

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Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Medgadget

While for other patients the possible adverse side effects from medication may prevent them from finding pharmacological therapies effective. Throughout 2016 and until mid-2019 we conducted a deep technology due diligence, as well as market research, and met and spoke with dozens of mental healthcare providers.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.