Search Results for “EU” – Page 27 – media

Hai Zheng Pharmaceutical and Sinopharm Signed Strategic Cooperation Agreement on Retail Project

Hai Zheng Pharmaceutical (hereinafter referred to as “Hai Zheng Pharmaceutical”) signed a strategic cooperation agreement on retail project with Sinopharm Holdings Corporation (hereinafter referred to as “Sinopharm”) in Shanghai. (hereinafter referred to as “Sinopharm”) signed a strategic cooperation agreement on retail project in Shanghai, both parties will carry out in-depth cooperation in healthcare and retail channels, through the integration of the advantageous resources of both parties to maximize the synergistic effect, and to bring more personalized, convenient and efficient drug purchasing experience for the majority of patients to improve the level of service. At the meeting, HANHUI Pharmaceutical and Guozhong Quanzai introduced the company profiles and project plans of the two sides respectively, and launched in-depth exchanges and discussions on the strategic cooperation of the two sides’ retail projects. Chairman Shen Xinghu and his entourage also visited the corporate showroom in Sinopharm Building to understand the development history, business innovation ...
- Source: drugdu
- 73
- January 23, 2024
FDA Fast Tracks Nurix Therapeutics, Inc’s Novel BTK Inhibitor for CLL, SLL

Pharmaceutical Executive Editorial Staff NX-5948 is under evaluation for for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor. The FDA has granted Fast Track Designation to Nurix Therapeutics, Inc’s investigational Bruton’s tyrosine kinase (BTK) inhibitor NX-5948 for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.1 NX-5948 has previously demonstrated that it is highly potent across a range of tumor cell lines with BTK inhibitor–resistance, which is an important treatment consideration for heavily pretreated patients with CLL and SLL, according to Nurix. “Fast Track designation for NX-5948 is an important recognition of the unmet patient need in CLL, particularly in the growing number of patients whose cancer has progressed ...
- Source: drugdu
- 121
- January 22, 2024
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 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
- 119
- January 22, 2024
Blood Test to Track Gene Expression in the Brain Could Help Prevent Neurological Diseases

Encased within a complex network of specialized blood vessels, the brain remains the body’s most protected organ. This intricate structure, while protective against external threats, poses significant challenges for researchers seeking to understand gene expression dynamics and their link to diseases. Addressing this challenge, scientists have now introduced a noninvasive method to track gene expression in the brain, potentially transforming research in brain development, cognitive function, and neurological disorders. The team of scientists at Rice University (Houston, TX, USA) has developed a groundbreaking class of molecules named released markers of activity (RMAs). These RMAs offer a noninvasive solution to measure gene expression in the brain via a simple blood test. Traditionally, assessing gene expression in the brain has been limited to post-mortem analysis or less sensitive and specific modern neuroimaging techniques. The RMA platform, however, introduces a synthetic gene expression reporter into the brain, which synthesizes a protein capable of ...
- Source: drugdu
- 110
- January 18, 2024
Announcement of Zhejiang Hai Zheng Pharmaceutical Co., Ltd. on the Passing of Consistency Evaluation of Generic Drugs for Cycloserine Capsules of the Company

Zhejiang Hai Zheng Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company” or “Haizheng Pharmaceuticals”) has received a Notice of Approval of Supplementary Application for Cycloserine Capsule from the State Drug Administration (hereinafter referred to as the “State Drug Administration”), and the Company’s drug Cycloserine Capsule has passed the generic drug consistency evaluation. (hereinafter referred to as “the State Drug Administration”) issued the “Drug Supplement Application Approval Notice” for Cycloserine Capsule, and the Company’s drug Cycloserine Capsule has passed the consistency evaluation of the quality and efficacy of generic drugs. Cycloserine Capsule is suitable for the treatment of active pulmonary tuberculosis and extrapulmonary tuberculosis (including renal tuberculosis) caused by tuberculosis bacteria that are sensitive to the drug and have been poorly treated with first-line anti-tuberculosis drugs (e.g., streptomycin, isoniazid, rifampicin and ethanol). Cycloserine capsules were developed by Eli Lilly and Company in the United States, and were launched in the ...
- Source: drugdu
- 85
- January 17, 2024
CAR-T drug launches pay-per-therapeutic-value program with up to 600,000 yuan drug rebate

On January 11, Fosun Kate and Chenshi Health, a health management and comprehensive patient service platform under Sinopharm Holdings, jointly launched the first lymphoma pay-per-therapeutic value plan for Ekeda in China. Eligible patients who fail to achieve complete remission (CR) after treatment with Ekeda, a CAR-T treatment that originally cost $1.2 million, will receive a rebate of up to RMB600,000. The program will be China’s first innovative payment model for lymphoma drugs paid by the value of efficacy, and Ekeda will be China’s first bioinnovative drug paid by the value of efficacy. “If the complete remission indicator is not reached at three months, even if there is efficacy but the efficacy is not as good as complete remission, half of their out-of-pocket drug purchase price will still be refunded under the program. If this patient’s medication is completely self-funded, then the maximum return is 600,000 RMB for the medication. If ...
- Source: drugdu
- 198
- January 16, 2024
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace

Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy uses mPNS to deliver a quick, painless and non-invasive treatment in sessions lasting just 13.5 minutes, according to Neuralace. Each session utilizes magnetic pulses to provide relief for a potential improvement in pain management. Neuralace said a recent trial of 71 patients demonstrated efficiency, plus significant improvements in subject outcomes. The company believes its therapy represents a paradigm shift in PDN treatment. Axon Therapy offers a non-pharmacological and non-invasive option that could reduce dependence on medications and their associated side effects. The company says FDA clearance paves the way for broader access to innovative pain ...
- Source: drugdu
- 149
- January 15, 2024
Hengrui Pharmaceuticals’ “Double Ai” Combination Study for Advanced Lung Adenocarcinoma Featured in The Lancet Supplement

Recently, the results of the prospective, multicenter, single-arm phase II clinical study of carilizumab in combination with apatinib and albumin paclitaxel in advanced lung adenocarcinoma (CAPAP-lung), led by Prof. Wu Lin of Hunan Cancer Hospital, have been published in The Lancet (IF=15.1) and eClinicalMedicine (IF=15.1), which is a subseries of The Lancet. eClinicalMedicine (IF=15.1).1 The results of the study showed that the first-line treatment of advanced lung adenocarcinoma negative for epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations with karelizumab in combination with apatinib (the “double-Ai” combination) and albumin paclitaxel demonstrated a clinically meaningful antitumor effect. Demonstrated clinically meaningful antitumor activity and a manageable safety profile with low hematological toxicity. This study is the first exploration of advanced non-small cell lung cancer (NSCLC) treated with platinum-free chemotherapy in combination with immunologic agents and anti-vascular drugs, and is expected to provide new options for first-line treatment of EGFR/ALK ...
- Source: drugdu
- 94
- January 15, 2024
European Commission greenlights Mirati’s Krazati in KRAS-mutated NSCLC

Mirati Therapeutics has received conditional marketing authorisation from the European Commission for Krazati (adagrasib), a targeted treatment for patients with KRASG12C-mutated advanced non-small cell lung cancer (NSCLC). Mirati filed a marketing authorisation application to the European Medicines Agency (EMA) for Krazati in this indication in May 2022. In November 2023, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorisation to the therapy. In October 2023, pharma-giant Bristol Myers Squibb acquired Mirati for a total value of $4.8bn. The deal is expected to close by the end of Q1 2024. Krazati was the company’s lead marketed drug and significant driver for potential revenues. According to GlobalData’s Pharma Intelligence Center, Krazati is forecast to generate $1.24bn in sales in 2029. Krazati is a small molecule RAS inhibitor which suppresses cancer cell signalling and prevents cell proliferation by inhibiting mutant KRAS, a signalling protein which acts as a molecular ...
- Source: drugdu
- 177
- January 13, 2024

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