Breckenridge Pharmaceutical, Inc., -the U.S. subsidiary of Towa International that markets, distributes, and sells generic pharmaceuticals in the United States, – announced today that the Food and Drug Administration (FDA) has granted final approval of Everolimus Tablets for Oral Suspension (TFOS), 2mg, 3mg and 5mg, a generic version of AFINITOR DISPERZ® by Novartis Pharmaceuticals Corporation. The ANDA is held by its partner Natco Pharma Limited, India and Breckenridge plans to launch immediately. Everolimus TFOS is a kinase inhibitor indicated in adult and pediatric patients aged one year and older with tuberous sclerosis complex („TSC“) for the treatment of subependymal giant cell astrocytoma („SEGA“) that requires therapeutic intervention but cannot be curatively resected.

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, and Paragon 28, Inc. (NYSE: FNA), a leading medical device company focused exclusively on the foot and ankle orthopedic segment, today announced they have entered into a definitive agreement for Zimmer Biomet to acquire all outstanding shares of common stock of Paragon 28 for an upfront payment of $13.00 per share in cash, corresponding to an equity value of approximately $1.1 billion and an enterprise value of approximately $1.2 billion. Paragon 28 shareholders will also receive a non-tradeable contingent value right (CVR) entitling the holder to receive up to $1.00 per share in cash if certain revenue milestones are achieved. The CVR will be payable in whole or in part if net sales exceed $346 million up to $361 million (with the CVR payments calculated linearly between… 

Stryker (NYSE:SYK), a global leader in medical technologies, announced today a definitive agreement to sell its U.S. spinal implants business to Viscogliosi Brothers, LLC, a family-owned investment firm specializing in the neuro-musculoskeletal space, to create a newly formed company called VB Spine, LLC. After closing, VB Spine will become a strategic partner to Stryker with exclusive access to Mako Spine and Copilot for use with VB Spine’s implants in spine procedures. The transaction will enhance the focus of both Stryker and VB Spine to meet the needs of customers and their patients and is expected to achieve faster growth and deliver greater value for all stakeholders. The definitive agreement also includes a binding offer to acquire Stryker’s spinal implants business in France, subject to required consultations with employees and/or employee representatives. The sale of Stryker’s spinal implants business in other… 

The Global Health Innovative Technology (GHIT) Fund announced today a total investment of approximately JPY 2 billion (USD 12.7 million1) in eight projects for the development of new diagnostics and drugs for neglected tropical diseases (NTDs) and malaria.2 JPY 670 Million (USD 4.2 Million1) Investment in a Critical Diagnostic Tool to Combat Leishmaniasis. In addition, the GHIT Fund will invest in the following five screening projects for a total amount of approximately JPY 83 million (USD 0.5 million1): 1) Screening project against malaria by MMV and Daiichi Sankyo Co., Ltd. 2) Screening project against dengue and Zika by Eisai and Drugs for Neglected Diseases initiative (DNDi) 3) Screening project against Lassa fever by MMV and RIKEN 4) Screening project against Rift Valley fever by MMV and RIKEN 5) Screening project against Ebola and Marburg by MMV and RIKEN

Eine aktuelle europäische Studie unter Leitung der Veterinärmedizinischen Universität Wien (Vetmeduni) weist erstmals ein neues, bislang unbekanntes Zeckenvirus nach. Gefunden wurde der neue Flavivirus-Subtyp in erkrankten Gämsen und anhaftenden Zecken aus Österreich und Italien. An der Studie waren zahlreiche Forschungseinrichtungen aus Österreich, Italien, der Tschechischen Republik und den Vereinigten Arabischen Emiraten beteiligt. Welche Folgen das […] FSME & Co.: Wissenschaftler entdecken in den Alpen ein neues Zeckenvirus

Roche announced today that the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the United States Food and Drug Administration (FDA). This will be the first 510(k) cleared test of its kind available in the U.S. measuring lipoprotein (a), or Lp(a), in nanomoles per liter (nmol/L). The National Lipid Association (NLA) recommends all adults measure their Lp(a) – often referred to as L-P-Little-A – at least once in a lifetime to help assess cardiovascular risk. Due to its unique properties, Lp(a) can vary in size and has no single, defined molecular weight. For this reason, there is a consensus in the scientific community that Lp(a) levels should be measured in terms of the number of particles per liter of blood (nmol/L), rather than mass units (mg/dL), and that any conversion between mass and molar units, is generally… 

Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has approved BLINCYTO® (blinatumomab) monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). The Phase 3 E1910 clinical trial led by ECOG-ACRIN Cancer Research Group studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses. Study results demonstrated that BLINCYTO added to multiphase consolidation chemotherapy showed superior overall survival (OS) versus chemotherapy alone. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO plus chemotherapy arm (n=112) and 62.5% in the chemotherapy arm (n=112). The E1910 study was designed and conducted independently from industry. ECOG-ACRIN led the trial with public funding and sponsorship provided by the National Cancer Institute (NCI),… 

Obwohl Titandioxid (TiO2) im Verdacht steht, beim Einatmen krebserregend zu sein, wurden TiO2(Nano)-Partikel in synthetischen Textilfasern von Gesichtsmasken für die Allgemeinheit nachgewiesen. Das berichtete das Fachblatt NATURE bereits im Jahr 2022 – trotzdem ignorierten Bund und Länder die Gefahr. Bis heute. Bei der STEM-EDX-Analyse von Abschnitten einer Vielzahl von Einweg- und wiederverwendbaren Gesichtsmasken wurden agglomerierte, nahezu kugelförmige TiO2-Partikel in Vliesstoffen, Polyester-, Polyamid- und Zweikomponentenfasern sichtbar gemacht. Die mittlere Größe der Partikel reichte von 89 bis 184 nm, was auf einen großen Anteil von Partikeln im Nanobereich (< 100 nm) schließen lässt. Die mittels ICP-OES ermittelte Gesamtmasse des TiO2 reichte von 791 bis 152.345 µg pro Maske. Die geschätzte TiO2-Masse an der Faseroberfläche reichte von 17 bis 4394 µg und überstieg systematisch den zulässigen Grenzwert für die inhalative TiO2-Exposition (3,6 µg), der auf der Grundlage eines Szenarios mit intensivem Tragen von… 

Die Privatklinik Friedenweiler hat als erste Klinik in Deutschland eine EMDR-Zertifizierung (Eye Movement Desensitization and Reprocessing) von EMDRIA Deutschland e.V. erhalten, dem wissenschaftlichen Fachverband für Anwenderinnen und Anwender der psychotherapeutischen Methode EMDR. Die Therapie kommt insbesondere bei der Behandlung von Posttraumatischen Belastungsstörung (PTBS) zum Einsatz. Die EMDR-Therapie beruht auf einer gesteuerten Augenbewegung. Ziel der Therapie ist es, belastende Erinnerungen von den damit verknüpften Emotionen zu trennen und neu zu interpretieren, damit diese erträglich werden. Während die Patientin oder der Patient sich auf eine Erinnerung oder Situation konzentriert, die das Trauma hervorgerufen hat, folgt sie oder er mit den Augen dem Finger der Therapeutin oder des Therapeuten. Die Augenbewegung unterstützt die Integration und die Neubewertung. „Die Therapeutinnen und Therapeuten der Privatklinik Friedenweiler sind speziell in dem Verfahren EMDR ausgebildet und nehmen regelmäßig an Fortbildungen teil. Das Verfahren wird indikationsübergreifend eingesetzt und…