PharmaFocus Today – Page 221 – media

First to take 12 months of market exclusivity! Zhengda Tianqing Everolimus Tablets first generic listing

On December 26, Zhengda Tianqing received the Certificate of Drug Registration approved by the State Drug Administration, approving the registration and listing of Everolimus Tablets (trade name: Chingvishi). Evervimox Tablet is not only the first generic in China, but also the first product that has been granted 12 months of market exclusivity due to “first generic approval + first successful patent challenge” since the implementation of the mechanism for early resolution of drug patent disputes (Drug Patent Linkage System) in China. The approved indications of Zhengda Tianqing Everolimus Tablets are: (1) Adult patients with advanced renal cell carcinoma who have failed prior treatment with sunitinib or sorafenib. (2) Adult patients with unresectable, locally advanced or metastatic, well-differentiated (moderately differentiated or highly differentiated) progressive pancreatic neuroendocrine tumors. (3) Adult patients with unresectable, locally advanced or metastatic, well-differentiated, progressive non-functional gastrointestinal or lung-derived neuroendocrine tumors (NET). (4) Adult and pediatric patients with ...
- Source: drugdu
- 205
- January 7, 2024
New Drug Application Accepted for Garsorasib (D-1553, KRAS G12C Inhibitor)

On December 29, 2023, China’s National Drug Administration (NMPA) has formally accepted the New Drug Application (NDA) for Garsorasib tablets (D-1553 tablets, KRAS G12C inhibitor) for the treatment of locally advanced or metastatic non-small-cell lung cancer with disease progression or intolerable disease after prior first-line systemic therapy, and with the presence of a KRAS G12C mutation confirmed by testing. metastatic non-small cell lung cancer. This NDA acceptance is primarily based on the results of a Phase II single-arm registrational clinical study (Study D1553-102, CDE Registry No. CTR20220745) conducted in China with Professor Lu Shun of Shanghai Chest Hospital as the principal investigator. Previously, the results of the Phase I clinical study of D-1553 in KRAS G12C mutation-positive non-small cell lung cancer were selected for an oral presentation at the World Conference on Lung Cancer (WCLC) in August 2022 and published in April 2023 in the Journal of Thoracic Oncology1 . ...
- Source: drugdu
- 206
- January 7, 2024
Hengrui’s Innovative Drugs Piratinib and Dalsili Breast Cancer Indications Both Recommended by 2024 CBCS Guidelines

Recently, the Chinese Breast Cancer Society Breast Cancer Diagnosis and Treatment Guidelines (2024 Edition) (hereinafter referred to as the CBCS Guidelines) has been updated and released. As one of the most important and authoritative Chinese diagnosis and treatment norms in the field of breast cancer, the CBCS Guidelines follow the international pace and cutting-edge progress, and comprehensively summarize and elaborate on breast cancer screening, examination, diagnosis and treatment, and reporting. In this guideline recommendation, two new indications for Hengrui Pharmaceuticals’ innovative drugs have been added, which are the first-line treatment regimen of piretinib combination for HER2-positive metastatic breast cancer, and the first- and second-line treatment regimen of dalsirib for HR-positive HER2-negative metastatic breast cancer (MBC). Thus, both innovative drugs have been recommended by the 2024 CBCS guidelines for the marketed breast cancer indications. Breast cancer has become the number one malignant tumor worldwide and is one of the most common ...
- Source: drugdu
- 218
- 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
- 101
- January 7, 2024
HANSIZHUANG Combined with Chemotherapy for the First-line Treatment of sqNSCLC

Shanghai, China, January 5th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was published in Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3. This publication serves as further evidence of the exceptional performance of HANSIZHUANG in the field of lung cancer. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital. Results of the overall population ASTRUM-004 were initially presented at the IASLC 2023 World Conference on Lung Cancer (WCLC 2023) in the form of oral presentation. Additionally, the data from its Asian subgroup were showcased in a poster session at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2023. Previously in 2022, the new drug application (NDA) of serplulimab for ...
- Source: drugdu
- 96
- January 7, 2024
Rapid Bedside Test to Protect Newborns from Life-Threatening Illnesses

Group B Streptococcus (GBS), a bacterial strain, is the leading cause of severe infections in newborns in the UK. Around one in four pregnant women in the UK are carriers of GBS, often unknowingly, and during childbirth, there’s a 50% chance of transmitting the bacteria to the baby. While most exposed infants remain healthy, approximately one in 1,750 will develop early-onset GBS infections, including sepsis, pneumonia, or meningitis, which can have severe consequences. The UK currently employs a ‘risk factor-based screening’ approach, providing antibiotics during labor to women identified with GBS during pregnancy or those with a previous baby affected by GBS. However, this strategy fails to detect many GBS carriers, with about 65% of early-onset GBS infections in newborns occurring in babies whose mothers had no identified risk factors. Now, a research project is examining the potential of a rapid bedside test for safeguarding newborns from life-threatening illnesses transmitted ...
- Source: drugdu
- 180
- January 6, 2024
Machine Learning Model Calculates Chemotherapy Success in Patients with Bone Cancer

The calculation of Percent Necrosis (PN) — the proportion of a tumor considered inactive or “dead” following chemotherapy — serves as a vital predictor of survival outcomes in osteosarcoma, a type of bone cancer. For instance, a PN of 99% signifies that 99% that the tumor is dead, indicating the patient’s positive response to chemotherapy and potentially better survival prospects. Pathologists typically assess PN by meticulously examining, interpreting, and marking up whole-slide images (WSIs), which are detailed cross-sections of specimens (like bone tissue) prepared for microscopic examination. Nevertheless, this traditional method is not only time-consuming and demands specialized expertise but also suffers from significant variability among observers. This means two pathologists might report differing PN estimates from the same WSI. Now, a machine learning model created and trained to calculate PN has shown that its calculation was 85% correct when compared to the results of a musculoskeletal pathologist, with the ...
- Source: drugdu
- 134
- January 6, 2024
Nalu Medical raises $65M for neurostim tech

BY SEAN WHOOLEY Nalu Medical announced today that it closed a $65 million equity financing to support its minimally invasive neurostimulation product. Carlsbad, California–based Nalu had its round led by new investor Novo Holdings. All existing significant investors — including Gilde Healthcare, MVM Partners, Endeavor Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida and Aperture Venture Partners — participated, too. Nalu plans to use the proceeds to accelerate commercial growth and expand clinical and health-economic evidence. It also wants to use the funds to continue product development and scale operations. The company’s FDA-cleared spinal cord stimulation and peripheral nerve stimulation technology treats patients with chronic neuropathic pain. It delivers gentle electrical pulses to the nervous system to modulate pain signals before they reach the brain. Nalu system includes a fully featured, battery-free, miniaturized implantable pulse generator (IPG). An externally worn therapy disc wirelessly powers the IPG and ...
- Source: drugdu
- 206
- January 6, 2024
FDA Grants Fast Track, Breakthrough Designations to CG Oncology Inc’s Cretostimogene Grenadenorepvec

Pharmaceutical Executive Editorial Staff Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors. The FDA granted Fast Track and Breakthrough Therapy designations to CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 tumors.1 The novel, intravesically delivered oncolytic immunotherapy is currently being evaluated in the Phase III BOND-003 and the Phase II CORE-001 clinical trial in combination with pembrolizumab (Keytruda) in the same indication. An investigator-sponsored clinical trial is evaluating cretostimogene grenadenorepvec in combination with nivolumab (Opdivo) for the treatment of muscle invasive bladder cancer. The regulatory action was based on data from an ongoing clinical trial program, including the Phase III BOND-003 trial (NCT04452591), which ...
- Source: drugdu
- 157
- January 6, 2024
Lilly makes website to simplify access to obesity drug Zepbound, plus diabetes and migraine meds

Eli Lilly has created a website to make it easier for patients to access medicines including its hot obesity drug Zepbound. The website, LillyDirect, combines telehealth and pharmacy services to provide access to Lilly’s portfolio of diabetes, migraine and obesity medicines. Companies including the weight loss program providers Noom and WeightWatchers have begun offering telehealth services to help people access Lilly’s Zepbound and Novo Nordisk’s Wegovy. Drugmakers have kept in their lane, though, developing and manufacturing medicines without getting into the business of connecting patients to physicians and delivering products to their homes. LillyDirect marks a shift in strategy, at least for Lilly. The website features sections to help people access healthcare, either remotely or in person, and details of how to send prescriptions to LillyDirect Pharmacy Solutions to get home deliveries of Lilly drugs. Lilly CEO David Ricks set out the thinking behind LillyDirect in a statement, framing the ...
- Source: drugdu
- 168
- January 6, 2024

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