Sun.Aug 21, 2022

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Axsome bounces back as FDA clears depression drug

pharmaphorum

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. The FDA has cleared Auvelity (dextromethorphan/bupropion) for the treatment of major depressive disorder (MDD) in adults, setting up a launch in the fourth quarter of this year. It is the first and only oral NMDA receptor antagonist to be approved for this use, and the first oral therapy with a new mechanism of action in around

FDA 98
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China NMPA grants IND clearance for Ascletis’ Covid-19 therapy

Pharmaceutical Technology

The China National Medical Products Administration (NMPA) has granted clearance for Ascletis Pharma’s Investigational New Drug (IND) application of its drug candidate, ASC10, for Covid-19. An RNA-dependent RNA polymerase (RdRp) inhibitor, ASC10 is an oral double prodrug. Compared to molnupiravir, a single prodrug, ASC10 has a varied chemical structure.

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COPD Case Review

Med Ed 101

KE is a 66-year-old male with a history of cigarette smoking (still currently smoking), COPD, atrial fibrillation, hypertension, osteoarthritis, and GERD. In this COPD case review, he reports that he is having a more difficult time breathing, in particular, he notes that he needs to rest after walking to the upstairs level of his house. […]. The post COPD Case Review appeared first on Med Ed 101.

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Case Study 1 – Establishment of a Long-Term Medical Writing Partnership

Impact Pharmaceutical Services

Download a PDF of this case study. Establishment of a Long-Term Medical Writing Partnership. In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a biologic agent for the treatment of Crohn’s disease. Following the successful completion of these 2 CSRs and the establishment of a highly positive collaborative relationship with the client, IMPACT was subsequently contracted over the

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven