Pramipexole Dihydrochloride

11月份是集采项目井喷的月份，也是新版医保目录公布的月份 11月26日，我们来聊聊相关话题 ↓↓↓↓↓↓ 文：子非鱼 11月19日，四川一家三甲医院---巴中市中心医院发出《关于接收2024年新药申报资料的公告》，该公告显示，根据临床诊疗工作的实际需求，医院将开始2024年新药遴选申报资料接收工作，共有113个药品纳入《巴中市中心医院待引进新药目录》。（以下下简称《目录》，目录附文后），要求于2024年11月19日至12月4日前申报，逾期不再受理。 根据公开信息，巴中市中心医院始建于1943年，是一所集医疗、教学、科研、预防、保健、康养为一体的三级甲等综合医院，是巴中市医保定点医院，该院有南池院区、南坝院区、感染病院区三个院区，南池院区位于四川省巴中市巴州区南池河街1号，南坝院区及感染病院区位于四川省巴中市巴州区将军大道七支道。 该院此次引进药品要求是在《目录》内的品种，且在四川省平台上挂网，此外，除外标注为急抢救药品、专科治疗用药或开展新技术新项目临床必需的药品，申报药品不能是四川省平台价格红区药品。 根据《公告》显示，此次引进的药品只能是上述《目录》内的113个，包括102个化学药，11个中成药，《目录》对引进的部分品种做出了特殊要求，比如，阿瑞匹坦注射液（18ml∶130mg）有三个条件，分别对质量、转换比及包材做出要求：1.国产药品需要通过一致性评价；2.转换比为1；3.中硼硅玻璃管制注射剂瓶、注射液用局部覆聚四氟乙烯膜溴化丁基橡胶塞与抗生素瓶用铝塑组合盖包装。 又比如，聚多卡醇注射液（2ml:20mg（1.0%））、盐酸普拉克索片等品种，“需要同时使用原研、进口药品及国产药品”；而对于屈螺酮炔雌醇片(Ⅱ)、雌二醇凝胶、地屈孕酮片、雌二醇片/雌二醇地屈孕酮片复合包装、甲氨蝶呤注射液、酒石酸唑吡坦片等品种，则均明确“需要原研、进口药品，无需国产药”。 厂家申报需要按《新药申报资料目录及要求》办理，需要填报《2024年新药申报资料信息表》、质量保证、廉洁准入、新药申报承诺书、厂家委托等材料。 此外，厂家必须从该院药品供应合同的配送公司中，按各个院区的合同关系，分别为该院南池院区、南坝院区、经开区院区指定配送公司，否则视为申报资料不合格，新药形式审查不予通过（集采中标药品除外）。 ps.这也为业界学习了解医院的配送商构成提供了一个真实的案例，从下表可以看出，四川省内医药商业的碎片化现状。 图源：巴中市中心医院 《关于接收2024年新药申报资料的公告》附件2 11月份是集采项目井喷的月份，也是新版医保目录公布的月份 11月26日，我们来聊聊相关话题 ↓↓↓↓↓↓ 四川引入新药的文章，可点击下方标题进入内容页： 川大华西医院成办分院引入34个品种、停用1个公示（附名单） 华西医院某下辖医院，引入45个药品，停用4个在院药品（附名单） 华西医院终于进药了！61个品种，含5个中成药（附清单） 中成药终于可以进华西医院了，但要国谈或1类新药...... 中成药及辅助用药，无一进入华西医院（附最新引进清单） 华西医院否认拒绝中成药：不是一竿子打死，在用中药试剂就有100多种！

Nov. 11, 2024 -- Pharma Two B Ltd. (“Pharma Two B”), a late-clinical stage company that is developing P2B001, an innovative combination product candidate for the treatment of Parkinson’s Disease (“PD”) and Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) (“Hepion”), a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today jointly announced that the U.S. Securities and Exchange Commission ("SEC") has declared effective the registration statement on Form F-4 (as amended, the "Registration Statement") filed with the SEC related to Pharma Two B’s merger transaction with Hepion as previously announced on July 22, 2024 (the “Proposed Transaction”). The Proposed Transaction, which has been approved by the respective boards of directors of Pharma Two B and Hepion, is expected to close in the fourth quarter of 2024 and remains subject to approval by both Pharma Two B and Hepion’s respective stockholders, regulatory approval, listing of Pharma Two B’s ordinary shares on Nasdaq under the ticker symbol “PHTB” and other customary closing conditions. Upon the anticipated closing of the Proposed Transaction, the combined company will operate under the “Pharma Two B” name. Hepion also announced that a special meeting (the “Special Meeting”) of its stockholders will be held on December 12, 2024 to approve the Proposed Transaction. The Special Meeting will be held at 9:00 a.m. Eastern Time via live webcast at www.virtualshareholdermeeting.com/HEPA2024SM. Hepion stockholders of record at the close of business on the record date of November 6, 2024 are entitled to vote at the Special Meeting. Hepion filed its definitive proxy statement/prospectus relating to the Proposed Transaction with the SEC and will mail it to stockholders on or about November 8, 2024. More details about the Proposed Transaction and the resolutions to be voted upon at the Special Meeting can be found in the definitive proxy statement/prospectus, available at http://www.sec.gov. Hepion stockholders who need assistance in completing the proxy card, need additional copies of the proxy statement/prospectus, or have questions regarding the Special meeting may contact Hepion’s proxy solicitor, Campaign Management, by calling 1-855-422-1042 or emailing info@campaign-mgmt.com. A.G.P./Alliance Global Partners is serving as financial advisor to Hepion and Sheppard, Mullin, Richter & Hampton LLP is acting as U.S. legal advisor to Hepion and Lipa Meir & Co.is acting as Israeli legal advisor to Hepion. Sullivan & Worcester LLP is serving as legal advisor to A.G.P. Laidlaw & Company (UK) Ltd. is acting as financial advisor to Pharma Two B. and Meitar Law Offices and Goodwin Procter LLP are acting as legal advisors to Pharma Two B. Pharma Two B is a private, late-stage pharmaceutical company. Pharma Two B’s mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders, with a clear unmet need, that are based on previously approved oral drugs and that may offer meaningful clinical benefits, as well as improved safety and enhanced convenience. Pharma Two B’s lead product candidate is P2B001. For more information, please visit: www.pharma2b.com. P2B001 is an investigational, novel, fixed-dose, extended-release combination of pramipexole and rasagiline (0.6 mg/0.75 mg), both at low doses that are not commercially available. Marketed pramipexole and rasagiline are currently indicated for the treatment of PD (as monotherapy and adjunct therapy for early and more advanced patients). P2B001 is being developed for potential use as a first-line therapy for people with PD. Extended release rasagiline is a new and proprietary formulation of rasagiline developed by Pharma Two B. In a Phase 3 clinical trial, P2B001 demonstrated that it provides benefits comparable with commercially used doses of marketed pramipexole-ER (PramiER) while minimizing associated daytime sleep-related and dopaminergic side effects. Pharma Two B owns worldwide-granted patents for both pharmaceutical composition and method of treatment with P2B001. Hepion is a biopharmaceutical company headquartered in Edison, New Jersey, previously focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and shows potential for the treatment of hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Hepion’s cyclophilin inhibitor, rencofilstat, was being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease. In December 2023, Hepion’s board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. Additionally, Hepion initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. On April 19, 2024, Hepion announced that it has begun wind-down activities in its ASCEND- NASH clinical trial which wind-down activities have since been completed and the trial has been closed. Hepion is continuing efforts, to the extent that cash is available, to provide any value derived from rencofilstat to its shareholders. The content above comes from the network. if any infringement, please contact us to modify.