Search Results for “EU” – Page 28 – media

FUTURE-SUPER study was published in The Lancet Oncology, China’s pharmaceutical innovation helps advanced TNBC to move towards precision treatment

Recently, the FUTURE series of studies has brought good news again. The results of the FUTURE-SUPER clinical trial led by the team of Prof. Zhimin Shao and Prof. Zhonghua Wang from the Affiliated Cancer Hospital of Fudan University have been announced, which fully confirmed the effectiveness and safety of the first-line precision treatment based on the “Fudan typing”, and is about to change the clinical practice of the treatment of TNBC. The results of the study will be announced in 2023. The results of the study were first announced at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023, which attracted the attention of scholars around the world, and on January 9, 2024, the study was published in The Lancet Oncology, the top international oncology journal, with an impact factor as high as 51.1 under a fast-track system. The clinical study is also another landmark achievement of the ...
- Source: drugdu
- 164
- January 13, 2024
New Blood Test Identifies Neuroendocrine Subtype of Advanced Prostate Cancer

Roughly 10-15% of individuals with metastatic castration-resistant prostate cancer (CRPC) eventually develop neuroendocrine prostate cancer (NEPC), a challenging cancer subtype. This transformation is marked by a change from androgen-dependent cancer cells to those that no longer respond to androgens. Diagnosing NEPC typically involves a biopsy from a metastatic tumor, but this can be uncertain due to timing issues and the heterogeneous nature of metastatic tumors. Now, researchers have developed a blood test that can reliably detect NEPC and differentiate it from CRPC-adenocarcinoma (CRPC-adeno). In previous research, an international team of researchers from Dana-Farber Cancer Institute (Boston, MA, USA and the University of Trento (Trento, Italy) examined biopsy tissue samples to identify genetic and epigenetic shifts accompanying this shift from cancer cells that are dependent on hormones called androgens to cancer cells that no longer even recognize androgens. They discovered distinctive genome-wide epigenetic alterations, particularly in DNA methylation, that differentiate CRPC-adeno ...
- Source: drugdu
- 99
- January 13, 2024
FDA Fast Tracks SELLAS Life Sciences’ CDK9 Inhibitor for Acute Myeloid Leukemia

Pharmaceutical Executive Editorial Staff SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia. The FDA has granted Fast Track Designation to SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). The regulatory action was based on safety and efficacy data for the drug, which is being evaluated in an ongoing Phase I/II study (NCT04588922) in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for patients with AML. “Receiving fast track designation for SLS009 for relapsed or refractory AML, following the recent orphan drug designation for the same indication, underscores the potential for SLS009 and highlights the critical unmet need for patients with AML who face a poor prognosis due to the progressive nature of the disease,” ...
- Source: drugdu
- 161
- January 12, 2024
A Detailed Guide to EU API WC Certification

Navigating the export of Active Pharmaceutical Ingredients (APIs) to the European Union involves a critical component: obtaining the WC (Written Confirmation) certification. This certification is essential to assure that your product aligns with the EU's stringent quality and safety standards prior to market entry. In the competitive landscape of global pharmaceuticals, understanding the intricacies of WC certification is key to ensuring a seamless export process to the EU. Here, Drugdu.com, a specialized cross-border medical trade B2B platform, offers an in-depth interpretation of the EU API WC certification process, aimed at providing a clear understanding of its requirements, application procedure, and necessary documentation.
- Source: drugdu
- 182
- January 12, 2024
Pfizer PARP inhibitor Talzenna nabs EU combo nod

• Pfizer’s PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas’ Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release. The European Commission approved Pfizer’s application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi. Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC. • In another regulatory win for Pfizer, the FDA is reviewing the company’s full approval application on Genmab-partnered Tivdak. Under its priority review timeline, the FDA is assessing whether to convert Tivdak’s accelerated approval into a full nod to treat ...
- Source: drugdu
- 124
- January 11, 2024
Owkin and Evotec partner to accelerate therapeutics in oncology and I&I

The companies will aim to select targets, discover and develop new therapeutics Owkin and Evotec have entered into an artificial intelligence (AI)-powered strategic partnership in oncology, immunology and inflammation (I&I). Both companies will collaborate to accurately select targets, discover and develop new therapeutics. As part of the agreement, the French-American techbio company, Owkin, will identify indication-relevant targets and subgroups using AI applied to multimodel patient data with its cutting-edge target discovery engine. Evotec will utilise its shared research and development (R&D) platform to accelerate and de-risk the validation of targets, the identification of drug candidates and the successful completion of pre-clinical development activities up to an investigational new drug application (IND). In addition, an Owkin-Evotec joint research strategy team will steer the collaboration to design fully tailored strategic programme plans from target selection to IND, as well as ensuring the delivery of the programmes. Evotec will receive R&D funding from ...
- Source: drugdu
- 87
- January 9, 2024
China’s first self-developed! Hengrui Pharmaceuticals’ New Sugar-Lowering Compound Drug Henggrexin Metformin Extended-Release Tablets (I)(II) Approved for Marketing

Recently, Hengrui Pharmaceuticals’ subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Certificate of Drug Registration approved for issuance by the State Drug Administration, approving the company’s self-developed Hengrui Pharmaceuticals Metformin Extended-Release Tablets (I) (II) (Ruicinda®) for marketing, which, together with dietary control and exercise, is applicable to adult patients with type 2 diabetes mellitus (T2DM) who are suitable for receiving treatment with Hengrui Pharmaceuticals and Metformin, in order to improve the glycemic control of such patients. This marks the successful launch of China’s first self-developed sodium-glucose cotransporter protein 2 inhibitor (SGLT2i) combined with metformin in a fixed-complex, extended-release formulation, which will bring more convenience to T2DM patients in China. Diabetes mellitus has become the third chronic disease that seriously endangers human health after tumor and cardiovascular disease. At present, China has become the first country with diabetes, in which patients with type 2 diabetes mellitus (T2DM) have a progressive decline ...
- Source: drugdu
- 85
- January 9, 2024
Invivyd Seeks EUA for Monoclonal Antibody Designed to Prevent COVID-19 in Immunocompromised Individuals

Pharmaceutical Executive Editorial Staff VYD222 is a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents. Invivyd, Inc. has filed a request with the FDA for emergency use authorization (EUA) for VYD222, a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents. The EUA submission was based on positive initial findings from the pivotal Phase III CANOPY clinical trial for VYD222 and data for ongoing in vitro neutralization activity against relevant COVID-19 variants. VYD222 was found to demonstrate a potent response against multiple SARS-CoV-2 variants currently circulating, including the fastest growing variant in the United States, JN.1, as well as HV.1, BA.2.86, XBB.1.5.10/EG.5, and HK.3. “We are tremendously pleased by the fact that VYD222 continues to demonstrate in vitro neutralization activity against the latest dominant variant, JN1, as well as other prevalent SARS-CoV-2 strains,” said Dave ...
- Source: drugdu
- 112
- January 8, 2024
First in China! Hengrui Pharmaceuticals’ Abiraterone Acetate Nanocrystal Formulation Approved for Marketing, Bringing New Treatment Options for Prostate Cancer Patients

Recently, Hengrui Pharmaceuticals’ subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has received the Certificate of Drug Registration approved by the State Drug Administration, which authorizes the company’s self-developed Abiraterone Acetate Tablets (II) (Trademark: Eragon®) to be listed on the market. This is the first Abiraterone Acetate nanocrystalline preparation approved for marketing in China, and also the second new chemical drug of Class 2 approved for marketing by Hengrui Pharmaceuticals. Abiraterone Acetate Tablets (II) innovatively introduces nanocrystal technology, which can significantly improve drug bioavailability and reduce the degree of food influence, thus improving patients’ drug adherence, and will bring new and better therapeutic choices for metastatic prostate cancer patients in China. Prostate cancer is the most common malignant tumor of the urinary male reproductive system. In China, the incidence rate and mortality rate of prostate cancer account for the sixth and tenth of male malignant tumors, respectively. The 5-year survival rate of ...
- Source: drugdu
- 167
- January 7, 2024
Treatment of Orthopedic Postoperative Pain, Hengrui Pharmaceuticals’ New Drug Application for Tegretol Fumarate Injection Accepted

Postoperative pain is acute pain that occurs immediately after surgery. Inadequate management of postoperative pain may lead to a variety of psychological and physiological negative effects, such as persistent pain and the possibility of turning into a chronic state. Opioids are the most commonly used drugs for the treatment of moderate to severe acute and chronic pain. Classical μ-opioid receptor (MOR) agonists, including morphine and fentanyl, are among the more potent analgesic classes of opioids and can activate both the G protein-coupled pathway and the β-arrestin2 signaling pathway.Activation of the G protein-coupled pathway is conducive to a potent central analgesic effect, whereas activation of the β-arrestin2 signaling pathway causes gastrointestinal side effects, such as gastrointestinal dysphoria. Side effects. Currently, there are no biased MOR agonists with good analgesic effects and low incidence of adverse effects on the market in China, and there is an unmet clinical need. In December 2023, ...
- Source: drugdu
- 90
- January 7, 2024

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