PharmaFocus Today – Page 180 – media

Synendos set to study endocannabinoid inhibitor for neuropsychiatric conditions

Swiss company Synendos therapeutics has been given the go-ahead from the European Medicines Agency (EMA) to advance its lead candidate, SYT-510, into a Phase I clinical trial to treat neuropsychiatric disorders. The first-in-class inhibitor targets endocannabinoids—naturally occurring, lipid-based neurotransmitters that help to maintain homeostasis. SYT-510 is said to inhibit endocannabinoid reuptake, which raises the amount of those neurotransmitters available in the synaptic cleft and increases neurotransmission. In the upcoming planned Phase I first-in-human trial, the focus will be on assessing the safety, tolerability and pharmacokinetics in healthy patients receiving increasing single doses of SYT-510. Basel headquartered-Synendos was spun out of the University of Bern in 2019, raising $27.8m in two Series A funding rounds in 2020 and 2021, co-led by Kurma Partners, Sunstone Life Science Ventures, and Ysios Capital. The company secured a two-year Eurostars grant in 2021, a European Union (EU) funding scheme, named the EndoCARE programme, to propel ...
- Source: drugdu
- 86
- January 22, 2024
Announcement of Tonghua Dongbao on the Achievement of Primary Endpoint in Phase IIa Clinical Trial of URAT1 Inhibitor (THDBH130 Tablets)

Tonghua Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd (“Dongbao Zixing”), a wholly-owned subsidiary of Tonghua Dongbao Pharmaceuticals Co., Ltd. (“Tonghua Dongbao”), has completed a pivotal Phase IIa clinical trial and obtained the summary report of the trial. The results of the study showed that the primary endpoints were achieved. The relevant information is announced as follows: I. Basic information of the drug 1、Name: THDBH130 Tablets 2、Indications：Hyperuricemia and gout 3、Dosage form: Tablet 4、Specification：2.5mg、20mg 5、Registration Classification: Chemical 1 6、Applicant: Dongbao Zixing (Hangzhou) Biomedical Co. 7, drug clinical trial approval: State Drug Administration approved the issuance of drug clinical trial approval notice (2021LP02020). The State Drug Administration approved the issuance of a notice of approval for clinical trial of the drug (2021LP02022; 2021LP02023), agreeing to carry out clinical trials. II. R&D Investment As at the date of this announcement, the Company has invested approximately RMB79.39 million in research and development in the Project. III. ...
- Source: drugdu
- 110
- January 22, 2024
Announcement of Hengrui Pharmaceuticals on the Notification of Approval for Clinical Trial of Drugs by Subsidiary Company

Shanghai Shengdi Pharmaceuticals Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Company Limited (hereinafter referred to as the “Company”), has received the Notice of Approval for Clinical Trial of Adebenosumab Injection approved by the State Drug Administration (hereinafter referred to as the “State Drug Administration”). Ltd. has received the “Notice of Approval for Clinical Trial” from the State Drug Administration (hereinafter referred to as “SDA”) for Adebenosumab Injection, which will be launched in the near future. The relevant information is announced as follows: I. Basic information of the drug Drug Name: Adebelizumab Injection Formulation: Injection Application: Clinical Trial Acceptance No.: CXSL2300746 Conclusion of Approval: According to the Drug Administration Law of the People’s Republic of China and relevant regulations, after examination, the application for clinical trial of Adebelizumab Injection accepted on October 31, 2023 complies with the relevant requirements for drug registration, and approval is granted for the product to ...
- Source: drugdu
- 117
- January 22, 2024
Announcement of Tasly Bioharma on the Notification of Approval of Drug Clinical Trial

Tasly Bioharma (hereinafter referred to as the “Company”) has received a Notice of Approval for Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the “SDA”) for the project of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as the “B2278 Injection”), agreeing to carry out the project of Coronary Artery Bypass Grafting (Coronary Artery Bypass Grafting). The Company has received a Notice of Approval for Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as “B2278 Injection”) from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing to carry out a clinical trial on chronic heart failure caused by chronic ischemic cardiomyopathy with indications of Coronary artery bypass graft (“CABG”). The relevant information is announced as follows: I. Basic information of the drug Drug name: human umbilical cord mesenchymal stem cell injection Dosage form: Injection Specification: 5×107 cells/1 ...
- Source: drugdu
- 110
- January 22, 2024
China Biopharm Launches Phase III Clinical Study of Semaglutide Injection

On January 16, China Biopharmaceutical announced that the Group has initiated a Phase III clinical study of Semaglutide Injection in China for the indication of type 2 diabetes mellitus. Semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) analog with 94% sequence homology to human GLP-1, a peptide secreted by small intestinal L-cells, which is known for its ability to increase insulin synthesis and secretion, inhibit appetite, and delay gastric emptying. Semaglutide reduces blood glucose by stimulating insulin secretion and decreasing glucagon secretion. Semaglutide is the first weekly GLP-1 formulation in China with both hypoglycemic and cardiovascular indications, and its effects in lowering blood glucose, reducing body weight, and cardiovascular protection in diabetes have been well proven. Compared with the previous generation of glucose-lowering drugs, Semaglutide’s outstanding advantage is its longer half-life, which allows it to be administered once a week, greatly improving patient compliance. Currently, Semaglutide has become one of the ...
- Source: drugdu
- 89
- January 21, 2024
Merck’s Keytruda again bags industry-first cervical cancer nod—with limitation

After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type. But again, the achievement was not perfect for Merck. Thanks to a new FDA nod, Merck’s Keytruda is the first PD-1 drug to be approved in combination with chemoradiotherapy to treat patients with stage 3 to 4a cervical cancer, the New Jersey pharma giant said Friday. This marks Keytruda’s 39th indication in the U.S. The approval, however, was narrower than expected. It came on the back of results from the Keynote-A18 trial, which showed a tumor progression benefit for the Keytruda-chemoradiation regimen in a broader patient population with earlier-stage cervical cancer. Keynote-A18 tested the Keytruda combo in patients whose cancer was as early as stage 1b2. Among the entire trial population, adding Keytruda to chemoradiotherapy slashed the risk of ...
- Source: drugdu
- 90
- January 21, 2024
Across 25 industries, pharma staffers most satisfied with compensation

2023 was riddled with labor strikes across industries as workers lobbied for higher pay amid economic headwinds that shook up the global economy. As for the biopharma industry, employees are more content with their income compared with workers in other fields, a new report suggests. USA Today recently analyzed more than 3 million reviews on the employee review service Glassdoor, focusing on 500 large companies in 25 industries and seeking to identify the industries with the highest number of pay-related complaints. Employees in the pharma and biotechnology sector reported the fewest number of pay complaints, according to the report. On the flip side, the healthcare field took the second-highest position for pay frustration, second only to education. Some drugmakers in particular rose above their peers and others in terms of pay. Novartis, GSK, AstraZeneca and Genentech made the list of the top-10 companies overall where employees are most satisfied with ...
- Source: drugdu
- 94
- January 21, 2024
Emergent snares contract worth up to $236M to supply anthrax vaccine to Defense Department

Emergent BioSolutions was awarded a 5-year, $235.8 million contract with the U.S. Department of Defense to supply the anthrax vaccine BioThrax to the various branches of the military. Under the terms of the deal, Emergent is guaranteed a purchase minimum of $20.1 million, with future orders estimated to be worth at least $20 million for each following year. Beyond the initial 5-year term, the contract has a 5-year option that could extend the deal to 2033. In all, the procurement pact could be worth up to $235.8 million, the company said in a Jan. 11 release. “Emergent is proud to continue supporting and preparing our nation’s service members who have a high risk of exposure to anthrax bacteria by supplying BioThrax vaccine,” Paul Williams, senior vice president, products head at Emergent, said in the release. Founded in 1998, Emergent has been a long-time supplier of anthrax countermeasures to the U.S. ...
- Source: drugdu
- 80
- January 21, 2024
SinoCellTech Voluntarily Discloses Notice of Drug Clinical Trial Approval for SCTC21C, a Product of its Controlling Subsidiary

Important Note: Recently, Beijing Shenzhou Cell Biotechnology Group Co. (hereinafter referred to as the “Company”) has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing that the Company’s self-developed product, SCTC21C Injection, can be used for the treatment of CD38+. (the “Company”) received a Notice of Approval for Clinical Trial of Drugs from the State Drug Administration (the “SDA”), agreeing to carry out clinical trials for the treatment of CD38+ hematologic malignancies for the Company’s self-developed product SCTC21C Injection. As there are many unpredictable factors in the process of clinical trials of pharmaceutical products, the results and timing of clinical trials, review and approval are subject to certain uncertainties, investors are advised to make decisions with caution and take precautions against investment risks. The relevant information is announced as follows: I. Basic Product Information 1. Product name: SCTC21C ...
- Source: drugdu
- 93
- January 21, 2024
Zhengda Tianqing Etrazepam Ethanolamine Tablets (Tepsin) Approved for Market Listing

On January 16th, Zhengda Tianqing received the Certificate of Drug Registration approved by the State Drug Administration (NMPA), approving the registration and marketing of Eltrombopag olamine tablets (trade name: Tepsin) for the following indications: for use in patients with chronic immune thrombocytopenia (ITP) who have had a poor response to previous treatments of glucocorticosteroids and immunoglobulins, as well as in children aged 6 years and above. ) patients to raise platelet counts and reduce or prevent bleeding. This product is intended for use only in patients with ITP who are at increased risk of bleeding due to thrombocytopenia and clinical conditions. Eltrombopag olamine tablets are an oral, small-molecule, nonpeptide thrombopoietin receptor agonist (TPO-RA) that works by increasing platelet counts. In the Chinese Guidelines for the Diagnosis and Treatment of Primary Immune Thrombocytopenia in Adults (2020 Edition), Eltrombopag is the only drug with the highest level (1a) of evidence and A ...
- Source: drugdu
- 85
- January 21, 2024

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