INGELHEIM, Germany & VIENNA -Tuesday 26 October 2021 [ AETOS Wire ]

    Boehringer Ingelheim will be commencing a new collaboration with Thoeris GmbH with the goal of advancing a first-in-class approach for the treatment of urea cycle disorders (UCDs) independent of the underlying monogenetic cause
    UCDs are genetic disorders with highly variable onset and severity, causing excess ammonia levels in the blood, which can lead to irreversible brain damage, coma and death
    This collaboration is part of Boehringer Ingelheim’s commitment to leveraging emerging science to deliver transformative treatment options for patients with high medical need.

(BUSINESS WIRE)-- Boehringer Ingelheim and Thoeris GmbH announce a collaboration and license agreement with the aim to investigate novel first-in-class therapies for patients with urea cycle disorders (UCDs). UCDs are rare diseases caused by genetic liver dy ... Read more »

• Gross Merchandise Value (GMV) growth of 29.7% to €163.9 million in Q1 FY22, compared to €126.4 million in Q1 FY21

• Top-line strength evident by two-year GMV growth of 65.3% in Q1 FY22 vs. Q1 FY20

• Strong gross profit margin of 49.0%, as compared to 46.4% in Q1 FY21

• Continued strong profitability with adjusted EBITDA of €14.0 million compared to €10.4 million in Q1 FY21, representing strong growth of 34.4%

• Increase of adjusted EBITDA margin to 8.9% from 8.3% in Q1 FY21 

MUNICH, Germany-Tuesday 16 November 2021 [ AETOS Wire ]

(BUSINESS WIRE)-- MYT Netherlands Parent B.V. (NYSE: MYTE) (“Mytheresa” or the “Company”), the parent company of Mytheresa Group GmbH, today announced financial results for its first quarter of fiscal year 2022 ended Sept ... Read more »

Scientist Grégoire Courtine demonstrated the effectiveness of ARC Therapy during his Presidential Special Lecture

EINDHOVEN, Netherlands & LAUSANNE, Switzerland-Tuesday 16 November 2021 [ AETOS Wire ]

(BUSINESS WIRE)-- ONWARD Medical N.V. (Euronext: ONWD), a medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today announced Grégoire Courtine, Ph.D., Professor of Neuroscience at the Swiss Federal Institute of Technology (EPFL) and co-Director of NeuroRestore, demonstrated the effectiveness of ONWARD’s ARC Therapy to stabilize blood pressure after spinal cord injury during his Presidential Special Lecture at NEUROSCIENCE 2021.

“Paralysis and loss of sensation are the more commonly known impacts of spinal cord injury, but a potentially more serious complication is orthostatic hypotension - low blood pressure tied to changes in body position,” said Profess ... Read more »

NEUCHATEL, Switzerland-Tuesday 16 November 2021 [ AETOS Wire ]

(BUSINESS WIRE)-- Masimo (NASDAQ: MASI) today announced the findings of a prospective study published in Frontiers in Neurology in which Dr. Na Xu and colleagues at Capital Medical University in Beijing investigated whether general anesthesia guided by Masimo SedLine® Brain Function Monitoring parameters on Root® could reduce the incidence of postoperative delirium (POD) in patients undergoing carotid endarterectomy (CEA). Using a combination of SedLine’s Patient State Index (PSi), an index based on processed electroencephalogram (EEG), and the Density Spectral Array (DSA), which represents the power of the EEG on both sides of the brain, to guide anesthesia during the procedure, the researchers found a significantly reduced risk of postoperative delirium, and concluded that patients “may benefit from the monitoring of multiple EEG parameters during surgery.”1

The researchers not ... Read more »

• The Theramex portfolio now includes a safe and effective non-hormonal option to treat menopause symptoms through the scientifically supported DT56a natural compound, recommended by gynaecologists worldwide. • Femarelle® products cover all menopause stages to improve symptoms and women's bone health and will be available in different countries from the 2nd quarter of 2022.

• The commercialisation agreement was reached with product developer Se-cure Pharmaceuticals Ltd.

LONDON-Tuesday 16 November 2021 [ AETOS Wire ]

(BUSINESS WIRE)-- Theramex, a company dedicated women’s health, recently acquired the Femarelle® product licence to treat menopause symptoms. Femarelle will be available in different markets from the 2nd quarter of 2022. This commercialisation agreement was reached with Se-cure Pharmaceuticals Ltd., the company that developed the product.

Femarelle® offers non-hormonal ther ... Read more »

ST. GALLEN, Switzerland -Friday 12 November 2021 [ AETOS Wire ]

    Committee for Medicinal Products for Human Use (CHMP) recommends approval of first orally administered therapy for the treatment of ANCA-associated vasculitis (GPA and MPA) in Europe
    European Commission decision for EU Marketing Authorization expected in Q1 2022

(BUSINESS WIRE)-- Regulatory News:

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of Tavneos® (avacopan) in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), the two main forms of ANCA-associated vasculitis. A positive opinion by the CHMP is a formal scientific recommendation supporting marketing authorization ... Read more »