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FDA Approves Utility Therapeutics’ Pivya to Treat Uncomplicated Urinary Tract Infections in Adult Females

Don Tracy, Associate Editor Pivya has shown efficacy against bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. The FDA announced that it has approved Pivya (pivmecillinam), for the treatment of uncomplicated urinary tract infections (UTIs) in adult females. According to the agency, the approval supports a communal health issue, with close to half of all women experiencing at least one UTI in their lifetime. Before reaching approval, Pivya, which is now available, was given Priority Review and Qualified Infectious Disease Product designations. As part of its support against UTIs, Pivya was designed to fight specific bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. The FDA based their approval on positive results from three different clinical trials comparing various Pivya dosing regimens to placebo, a different oral antibacterial drug, and ibuprofen. In all three trials, Pivya demonstrated a higher level of effectiveness in treating UTIs ...
- Source: drugdu
- 102
- April 28, 2024
Chiatai Tianqing Enrolls Subjects in Phase III Clinical Study of D-1553 Tablets for the Treatment of KRAS G12C Mutation-Positive Non-Small Cell Lung Cancer

Chiatai Tianqing Pharmaceutical Group Co., Ltd. is conducting a randomized, controlled, double-blind, dual-simulation, multi-center, Phase III clinical study to evaluate D1553 versus docetaxel in the treatment of locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation-positive lung cancer that has failed prior standard therapy (D1553-III-01). “. Now recruiting nationwide. Trial Drug Profile D-1553 tablets are a novel targeted KRAS G12C mutation inhibitor, registered and classified as a chemical drug class 1. On December 29, 2023, China’s National Drug Administration (NMPA) has accepted the New Drug Marketing Application for D-1553 Tablets 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 KRAS G12C mutation confirmed by testing. In August 2023, Chiatai Tianqing entered into a license and collaboration agreement with Yifang Bio to obtain the exclusive license rights for the ...
- Source: drugdu
- 76
- April 28, 2024
Sanders takes aim at US drug prices of Novo’s Ozempic and Wegovy

Senator Bernie Sanders has targeted the high drug prices of Novo Nordisk’s Ozempic and Wegovy, revealing that the Senate Committee on Health, Education, Labor, and Pensions (HELP) is investigating the “outrageously high” US prices of the blockbuster diabetes and obesity drugs. In a 24 April letter addressed to Novo Nordisk CEO Lars Fruergaard Jørgensen, Sanders, who serves as the HELP Committee chair, has requested answers from the multinational pharma by 8 May. The letter said the committee is investigating future reductions of the list and net prices of both Ozempic and Wegovy, R&D spending, cost and volume of goods sold, and prices paid by government payers. Additionally, Sanders requested that Novo Nordisk explain the price discrepancy between Wegovy and Ozempic given that they are different versions of the same drug, semaglutide, sold under two brand names. Sanders had previously put forth a proposal to cap prices on federally-funded drugs in ...
- Source: drugdu
- 77
- April 28, 2024
New heart disease calculator more accurately predicts patients’ risk of CVDs

Researchers from the universities of Oxford, Nottingham and King’s College London (KCL) have shown that a new heart disease calculator can accurately predict an individual’s ten-year risk of cardiovascular diseases and identify high-risk patients. Published in Nature Medicine, the QR4 tool could save over 2,500 chronic obstructive pulmonary disease (COPD) patients a year, promoting earlier recognition of the disease and its associated cardiovascular risk. Currently the leading cause of death globally, CVDs are responsible for an estimated 17.9 million deaths each year, according to the World Health Organization. They are disorders of the heart and blood vessels. Researchers from KCL, along with the QRISK team based at the universities of Oxford and Nottingham, conducted a large-scale epidemiological study involving over 13 million UK citizens, which revealed an increased risk of severe cardiovascular events in female patients with COPD. The team identified seven new unique risk factors common to all genders ...
- Source: drugdu
- 106
- April 28, 2024
CMT Research Foundation funds study investigating treatment for CMT1X disease

The CMT Research Foundation (CMTRF) has invested in a study being led by researchers at the University of Illinois at Chicago to investigate whether a commercially available drug could potentially treat X-linked Charcot-Marie-Tooth disease (CMT1X). The study will determine whether the drug can improve symptoms in mouse models of CMT1X. Recognised as a rare, peripheral neuropathy disease that is estimated to affect more than 2.6 million people globally, Charcot-Marie-Tooth disease (CMT) is a group of inherited conditions that damage the peripheral nerves, which are found outside the main central nervous system. Currently the second most common form of CMT, CMTX1 is caused by mutations in the gene that encodes for the connexin 32 gap junction protein. Associated with inflammation, the condition is said to contribute to the damage of the protective covering of nerve cells, which leads to disease symptoms including muscle weakness, atrophy and numbness. The study, led by ...
- Source: drugdu
- 105
- April 28, 2024
New Method Offers Sustainable Approach to Universal Metabolic Cancer Diagnosis

Globally, more than one billion people suffer from a high rate of missed disease diagnosis, highlighting the urgent need for more precise and affordable diagnostic tools. Such tools are especially crucial in ecologically sensitive and resource-limited areas, underscoring the importance of developing solutions that can enhance health outcomes sustainably under limited resources. Metabolic diagnosis is a promising approach but currently faces hurdles related to the suitability of biospecimens and the reliability of analytical tools. At Shanghai Jiao Tong University (Shanghai, China), researchers have developed a new diagnostic method that combines dried serum spots (DSS) with nanoparticle-enhanced laser desorption/ionization mass spectrometry (NPELDI MS). This method enables the rapid and cost-effective diagnosis of various cancers with an accuracy comparable to that of traditional serum tests. Utilizing an eco-friendly and simple protocol, this innovative tool can significantly lower the high percentages of undiagnosed cases in less economically developed regions. For instance, it could ...
- Source: drugdu
- 178
- April 26, 2024
Blood Test Accurately Predicts Lung Cancer Risk and Reduces Need for Scans

Lung cancer is extremely hard to detect early due to the limitations of current screening technologies, which are costly, sometimes inaccurate, and less commonly endorsed by healthcare professionals compared to other screening types. Despite smoking being the primary risk factor, up to 20% of lung cancer cases occur in individuals who have never smoked. The prevailing method for lung cancer screening involves low-dose CT (LDCT) scans. These scans are not only expensive but also prone to generating both false positives and negatives, besides exposing patients to radiation. Consequently, merely about 10% of individuals recommended for screening actually undergo regular scans, a stark contrast to the higher participation rates seen with mammography for breast cancer and colonoscopy for colorectal cancer. As such, lung cancer is often diagnosed at an advanced stage, when treatment options are limited. Researchers are now developing a new blood test aimed at earlier and more accurate detection ...
- Source: drugdu
- 109
- April 26, 2024
FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer. By Frank Vinluan on April 24, 2024 One quirk of the most common type of pediatric brain cancer is that as a child gets older, the tumors eventually stop growing. The reasons for this tumor senescence aren’t fully understood, but pediatric low grade glioma, or pLGG, still wreaks plenty of havoc until then, says Sam Blackman, a pediatric oncologist and the co-founder and head of R&D for Day One Biopharmaceuticals. “Whether it’s the tumor pressing on an optic nerve creating blindness, damage to the hypothalamus or pituitary gland causing profound endocrine disorders, or pressure on motor structures in the brain causing hemiparesis or loss of ...
- Source: drugdu
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- April 26, 2024
FDA Approves Amneal’s Naloxone Hydrochloride Nasal Spray as an OTC Treatment for Opioid Overdose

Don Tracy, Associate Editor Company aims to provide affordable emergency treatment from overdoses of heroin, fentanyl, and prescription opioids. Amneal Pharmaceuticals announced that the FDA has approved its OTC Naloxone Hydrochloride (HCI) nasal spray for use in counteracting opioid overdoses. As a generic of Narcan, this nasal spray has also been shown to neutralize overdoses caused by heroin, fentanyl, and prescription opioids. With Naxolone officially available, the company stated that this action provides another affordable option to prevent overdoses, which causes more death in people under the age of 50 years than any other cause.1 “With today’s launch, Amneal is proud to help address this public health emergency by providing naloxone nasal spray at an affordable price and without a prescription. Our business is deeply rooted in a commitment to helping others. By enhancing access to naloxone nasal spray, we hope to get this affordable emergency treatment into the hands ...
- Source: drugdu
- 80
- April 26, 2024
GLP-1/GIP Dual-Target Receptor Agonist (THDBH120 for Injection) Clinical Trial Approval for Weight Loss Indication Declaration

Tonghua Dongbao Pharmaceutical Co. (hereinafter referred to as the “Company”, “Tonghua Dongbao”), a wholly-owned subsidiary of Tonghua Dongbao Zixing (Hangzhou) Biomedicine Co., Ltd. has recently obtained the clinical trial approval for THDBH120 for weight loss indication from the Center for Drug Evaluation (CDE) of the State Drug Administration. THDBH120 for injection for the indication of weight loss drug clinical trial approval notice. The approval of the clinical application for THDBH120 for weight loss indication for injection signifies that the company’s GLP-1 pipeline in the field of overweight and obesity treatment has also stepped into the phase of clinical trials, which is of milestone significance. In the future, the Company will accelerate the research and development progress of THDBH120 for injection in diabetes indication and weight loss indication, and further explore and tap the potential of other indications to maximize the value of the product. THDBH120 for injection has a huge ...
- Source: drugdu
- 98
- April 26, 2024

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