pharmaphorum

AUGUST 21, 2022

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

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Med Ed 101

AUGUST 21, 2022

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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Impact Pharmaceutical Services

AUGUST 21, 2022

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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Documentation Pharmaceutical Companies Pharmaceutical Companies 40

Pharmaceutical Technology

AUGUST 21, 2022

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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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.