Search Results for “EC” – Page 309 – media

BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod

By PharmaCompass BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod This week’s Phispers is a double bill with news from last week and the first days of the New Year. Bristol Myers Squibb (BMS) and AstraZeneca have been on year-end shopping sprees with the former picking up Karuna Therapeutics for a whopping US$ 14 billion and the latter expanding its already dominant presence in China through an acquisition and a deal. Novo Nordisk is investing over US$ 2 billion, this time in Ireland, to meet the skyrocketing demand for its blockbuster diabetes and weight-loss drugs, Ozempic and Wegovy. In drug approvals, AstraZeneca and Ionis Pharmaceuticals’ drug Wainua became the first self-administered treatment in the United States for a rare nerve damage disease. In trial news, a potential first-in-class small molecule that was on course to becoming the first new drug approved in 20 years ...
- Source: drugdu
- 122
- January 8, 2024
Cryoablation induces systemic metabolic changes in patients with paroxysmal atrial fibrillation

Announcing a new article publication for Cardiovascular Innovations and Applications journal. Cryoablation (CRYO) is a novel catheter ablation technique for atrial fibrillation (AF). However, uncertainty persists regarding the role of metabolic modifications associated with CRYO. This study was aimed at exploring whether CRYO influences the metabolic signature – a possibility not previously investigated. Paired serum samples from patients with AF (n = 10) were collected before and 24 h after CRYO. Untargeted metabolomic analysis was conducted with LC-MS. Univariate and multivariate analyses were applied to identify differential metabolites between samples. Pathway enrichment and Pearson correlation analyses were performed to reveal the perturbed metabolic pathways and potential interactions. Levels of 19 metabolites showed significant changes between baseline and 24 h after CRYO. Pathway analysis revealed that the perturbed metabolites were enriched in unsaturated fatty acid biosynthesis, retrograde endocannabinoid signaling, and neuroactive ligand-receptor interactions. Pearson correlation analysis indicated strong correlations among differential ...
- Source: drugdu
- 97
- January 8, 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
- 108
- January 8, 2024
Lilly Pens Open Letter Raising Concerns Regarding Use of Mounjaro for Cosmetic Weight Loss

Don Tracy, Associate Editor Company cites potential safety risks for patients who ignore the intended indication of Mounjaro and Zepbound. In a letter to the public, Eli Lilly and Company warned against the use of its medicines for cosmetic weight loss. Citing the fact that neither Mounjaro or Zepbound are indicated for cosmetic purposes, the pharma company stressed that both are intended to treat serious diseases, with Mounjaro focusing on type 2 diabetes and Zepbound for obesity in specific BMI ranges of a BMI of 30 kg/m2 or greater or those who are overweight with a BMI ≥ 27 kg/m2 or greater. Additionally, caution is advised for patients with severe gastrointestinal conditions and the medications should only be prescribed by licensed healthcare professionals. “Patients should consult with their healthcare providers to determine whether Mounjaro or Zepbound is right for them,” the company stated in a press release. “Mounjaro and Zepbound ...
- Source: drugdu
- 176
- 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
- 166
- January 7, 2024
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
- 182
- 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
- 169
- 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
- 84
- January 7, 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
- 94
- 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
- 152
- January 6, 2024

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