Sept. 05, 2024 -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to certepetide for the treatment of cholangiocarcinoma. “Cholangiocarcinoma is a rare and aggressive form of cancer that presents a significant challenge for patie

9月5日，阿斯利康（AstraZeneca）中国宣布与江苏海莱新创医疗科技有限公司（下称：海莱新创）达成临床研究合作协议。根据协议，双方将结合临床前研究结果，共同开展阿斯利康免疫检查点抑制剂联合海莱新创的电场治疗，在以胆道恶性肿瘤为代表的消化道肿瘤等实体瘤中应用的临床研究。 胆道恶性肿瘤作为一种侵袭性极强的消化系统恶性肿瘤，更因其发病隐匿、进展迅速且综合治疗手段有限 ，在临床中面临巨大挑战。在这一疾病领域，阿斯利康目前在中国已为胆道癌、胃癌等患者提供多个创新疗法，覆盖免疫治疗、ADC等领域，同时也在致力于加速引进更多创新药品，推动防治关口前移，为患者带来获益。 此次阿斯利康中国与海莱新创的研究合作，有望为消化道肿瘤治疗带来新的治疗方案。肿瘤电场治疗是一种创新的肿瘤物理治疗模态，已在中国获批用于胶质母细胞瘤治疗 。 阿斯利康新闻稿指出，对于消化道肿瘤这类复杂疾病，单一疗法往往难以实现最佳治疗目标，随着创新技术手段和药物的涌现，联合治疗被认为是肿瘤临床治疗的未来发展趋势之一。 公开信息显示，阿斯利康在中国已经与多家企业达成联合治疗临床研究的合作协议，探索创新治疗方案。这些联合方案中

Topline results from NORSE EIGHT expected in Q4 CY2024 Sept. 04, 2024 -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the completion of enrollment for its NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patie

Sept. 04, 2024 -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced an update for its New Drug Application for Ketamine from the U.S. Food and Drug Administration (the “FDA”) with an assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. On September 3, 2024, the FDA communicated with the Company that the review is ongoing and no additional information is needed, but is s

Sept. 05, 2024 -- NRG Therapeutics, Ltd., an innovative neuroscience company targeting mitochondrial dysfunction, is pleased to announce that it has been awarded a non-dilutive grant from Target ALS Foundation. It is one of five recipients of the 2024 In Vivo Target Validation grants in collaboration with Biospective. The funding will be used to support its discovery programme for a treatment for Amyotrophic Lateral Sclerosis (ALS) (also known as Lou Gehrig’s disease or Motor Nuerone Disease)

2024年9月2日，先声药业发布公告，先声再明与深圳市塔吉瑞生物医药有限公司（下称塔吉瑞）就临床阶段抗肿瘤候选药物ALK/ROS1双重受体酪氨酸激酶抑制剂TGRX-326订立合作协议。 根据协议条款，先声再明将获得TGRX-326在中国大陆的独家商业化权益（包括但不限于对TGRX-326进行推广、相关策略的制订、调整及获得与此相关利益的权利等）。塔吉瑞将获得逾2000万美元首付款，并将向先声再明支付推广服务费。 TGRX-326是由塔吉瑞自主研发的第三代间变性淋巴瘤激酶（ALK）抑制剂，是一种强效、高选择性的ALK和c-ROS原癌基因1（ROS1）双重受体酪氨酸激酶（RTK）小分子抑制剂，对于ALK/ROS1融合基因阳性，以及包括 G1202R 在内的多种 ALK 耐药突变的非小细胞肺癌患者均具有极高的潜在治疗价值。 TGRX-326目前处于三期临床阶段。 先声再明是先声药业集团旗下专注于抗肿瘤创新药研发、生产和商业化的生物医药公司，2023年起独立运营，致力于以突破性治疗手段, 解决中国乃至全球肿瘤领域巨大的未满足临床需求。再明着力打造高价值创新研发管线，已上市产品组合包含科赛

Sept. 04, 2024 -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced it has successfully completed enrollment in its SEISMiC Extension Phase 2b study of istaroxime in early cardiogenic shock caused by heart failure. The study is evaluating the ability of istaroxime to improve heart function and low blood pressure in the setting of

Data presented at SSIEM 2024 Annual Symposium Twice-daily oral treatment with JNT-517 at 150mg dose delivered highly statistically significant mean blood phenylalanine reduction of 60% versus baseline in individuals with PKU JNT-517 was safe and well tolerated with no serious adverse events observed JNT-517 has been granted Orphan Drug Designation by the U.S. FDA for the treatment of PKU, as well as Orphan Designation by the European Commission and eligibility Sept. 04, 2024 -- Jnana Therapeuti

Sept. 03, 2024 -- 7 Hills Pharma Inc. (“7 Hills” or “7HP”), a clinical-stage pharma company advancing first-in-class integrin activators designed to safely enhance cancer immunotherapies, announced today that their first cancer patient has been safely dosed with alintegimod, an integrin-targeted agonist that may augment T cell activation and trafficking in patients who are resistant to immune checkpoint inhibitors. This multicenter Phase 1b/2a study (NCT06362369) is supported by a $13.4 millio

On-going Phase 2b clinical trial (ELPIS II) deemed pivotal and, if positive, acceptable for Biological License Application (BLA) submission for potential full traditional approval Alignment with FDA on ELPIS II primary and secondary endpoints Alignment with FDA on CMC and Potency Assay plan and requirements Sept. 03, 2024 -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related co