Ketamine News: PharmaTher Begins FDA Filing For KETARX Application, Stella Acquires Field Trip Assets
Ketamine News: PharmaTher Begins FDA Filing For KETARX Application, Stella Acquires Field Trip Assets
Specialty biotech company PharmaTher Holdings Ltd. (OTCQB:PHRRF) has filed a pre-submission facility correspondence in advance of its Abbreviated New Drug Application (ANDA) for its novel racemic ketamine KETARX to the FDA.
專業生物技術公司PharmaTher Holdings Ltd.(OTCQB：PHRRF)已在其簡明新藥申請(ANDA)因為它的新型外消旋****凱塔克斯給食品和藥物管理局。
The filing of the pre-submission correspondence is expected to help achieve an expedited review of the company's ANDA, compared to the standard approval times.
與標準審批時間相比，提交前函件的提交預計將有助於加快對公司ANDA的審查。
PharmaTher anticipates KETARX approval to come sometime within 2024's first quarter and U.S. commercial launch in the second quarter, closely followed by the pursuit of international approvals to support ketamine's growing global demand for anesthesia and analgesia, as well as the treatment of mental health disorders including depression, anxiety and suicidal ideation.
PharmaTher預計KETARX將在2024年的第一季度內獲得批准，第二季度在美國上市，緊隨其後的是尋求國際批准，以支持****對麻醉和止痛以及治療包括抑鬱、焦慮和自殺意念在內的精神健康疾病日益增長的全球需求。
The company's stated priority is to commercialize KETARX in the U.S. under ketamine's FDA-approved label through its new partnership with generic pharma company Vitruvias Therapeutics Inc., offering various dosage forms with the option to increase concentration and ready-to-administer applications.
該公司宣稱的優先事項是通過與仿製藥公司Vitruvias Treateutics Inc.建立新的合作夥伴關係，將KETARX在美國以經FDA批准的****標籤進行商業化，提供各種劑型，並可選擇增加濃度和隨時給藥。
PharmaTher is also commercializing its microneedle PharmaPatch through several partnerships with psychedelics-developing companies.
PharmaTher還通過與迷幻藥物開發公司的幾個合作夥伴關係，將其微針PharmaPatch商業化。
Stella Expands Trauma Care Offering With Field Trip Assets' Buy
Stella通過購買野外旅行資產擴展創傷護理服務
Mental healthcare treatment provider Stella has acquired ketamine company Field Trip's (OTC:FTHWF) U.S. assets -see Reunion Neuroscience's recent take-private transaction announcement- toward broadening its treatments offering and becoming "a comprehensive provider of holistic, effective biological and psychological treatments."
精神保健治療提供商Stella收購了****公司field Trip(場外交易代碼：FTHWF)的美國資產-參見留尼汪神經科學公司最近的私有化交易公告-以擴大其治療產品，並成為“一家全面、有效的生物和心理治療的綜合提供商”。
The announcement follows a May-dated $7 million funding round toward further clinical research and expanding Stella's clinic model from a network-based approach to operating its own facilities.
在宣佈這一消息之前，Stella在5月份進行了一輪700萬美元的融資，用於進一步的臨床研究，並擴大Stella的臨床模式，從基於網路的方法運營自己的設施。
To date, Stella's therapies are offered across 35 U.S. locations, as well as in Israel and Australia.
到目前為止，Stella的療法在美國35個地點以及以色列和澳大利亞提供。
The company's Dual Sympathetic Reset (DSR) protocol is an advanced Stellate Ganglion Block (SGB) procedure designed specifically to treat Post Traumatic Stress Injury (PTSI) and was first introduced by its CMO Dr. Eugene Lipov in 2006.
該公司的雙交感神經重置(DSR)方案是一種高級星狀神經節阻滯(SGB)程式，專為治療創傷後應激損傷(PTSI)而設計，最初由其CMO推出尤金·利波夫博士在2006年。
Stella currently offers ketamine protocols through treatments such as its Special Operation Forces Protocol combining ketamine with DSR for the treatment of high-risk brain injury.
Stella目前通過其特別行動部隊協定等治療提供****方案，將****與DSR相結合，用於治療高危腦損傷。
The acquisition will have Stella assume operations of Field Trip clinics in New York and Washington D.C., expanding the geographical reach of the DSR protocol.
此次收購將使Stella承擔紐約和華盛頓特區的field Trip診所的業務，擴大DSR協定的地理覆蓋範圍。
Additionally, the company is opening a new treatment clinic in Irvine, California which is joining the also new one in Chicago, Illinois.
此外，該公司還將在加利福尼亞州的爾文開設一家新的治療診所，加入伊利諾伊州芝加哥的新診所的行列。
Incoming Field Trip advanced outcome data, research, technology stack and clinics will help Stella offer cutting-edge digital psychedelic therapies offerings along with its existing services.
即將到來的野外旅行高級結果數據、研究、技術堆棧和診所將幫助Stella在其現有服務的基礎上提供尖端的數位迷幻療法產品。
Former Field Trip's founder and president Mujeeb Jafferi and CTO Amardeep Manhas will join Stella's leadership team as president and clinics operation officer and chief technology officer respectively.
前野外旅行創始人兼總裁、穆傑布·賈弗裡和首席技術官阿瑪迪普·曼哈斯將加入斯特拉的領導團隊，分別擔任總裁和診所運營官和首席技術官。
Photo: Benzinga edit with photo by PopTika and luchschenF on Shutterstock.
照片：Benzinga編輯與PopTika和LuchschenF在Shutterstock上的照片。
譯文內容由第三人軟體翻譯。