Search Results for “FDA” – Page 99 – media

Innovative Test Improves Assessment of Patients with Mild Traumatic Brain Injury

Traumatic brain injury (TBI) occurs when external mechanical energy is transferred to brain tissue, causing cellular damage, dysfunction, and dysregulation. It is a significant public health issue, being a leading cause of death and disability globally, with approximately 69 million people affected each year. For clinicians assessing these patients, it is crucial to quickly ascertain the presence or absence of potentially life-threatening hemorrhages and neurological complications. TBI severity is evaluated using the Glasgow Coma Scale (GCS) and categorized as mild, moderate, or severe. Mild traumatic brain injuries (mTBI) are the most common, comprising 70-90% of all TBI cases, and they are the least likely to lead to acute medical emergencies. It is noted that about 90% of mTBI patients who receive computed tomography (CT) scans show no abnormal findings. Despite this, an estimated 82% of all TBI patients are scanned, many of which could potentially be unnecessary. These scans not ...
- Source: drugdu
- 85
- May 31, 2024
With M&A Deal, Click Therapeutics’ Digital Prospects in Metabolic Disease Get Better

Click Therapeutics is acquiring the assets of Better Therapeutics two months after that digital therapeutics developer announced it would lay off all employees and shut down. Better’s main asset is AspyreRx, an FDA-authorized mobile app for type 2 diabetes. By Frank VinluanDigital therapeutics developer Click Therapeutics is building up its prospects in cardiometabolic disorders by acquiring the assets of Better Therapeutics, a company whose technology platform yielded one FDA-authorized product and could serve as a springboard for a range of drug and digital treatment pairings. Better’s FDA-authorized prescription digital therapeutic, named AspyreRx, is a type 2 diabetes mobile app that helps patients modify behaviors in order to change the course of their disease. Artificial intelligence enables the software to personalize treatment plans to each patient. AspyreRx secured FDA authorization last summer, but Better struggled to commercialize the product on its own. Payer coverage decisions on the app were pending as ...
- Source: drugdu
- 69
- May 29, 2024
Lipoprotein Blood Test Detects Hereditary Cardiovascular Risk

Lipoprotein (a), or Lp(a), is increasingly recognized as a critical but under-acknowledged potential risk factor for cardiovascular diseases, which are a significant public health concern. Around 20% of the global population has high levels of Lp(a), which heightens their risk of conditions such as myocardial infarction and stroke. Elevated Lp(a) levels contribute to the accumulation of lipids within artery walls, facilitating plaque formation and heightening the risk of cardiovascular events. While factors such as menopause, and kidney or liver diseases, as well as hyperthyroidism can affect Lp(a) levels, over 90% of the variability in Lp(a) levels is due to genetic differences in the lipoprotein (a) (LPA) gene. Consequently, testing for Lp(a) is a crucial diagnostic tool that helps clinicians accurately evaluate cardiovascular risk, and its integration into routine diagnostics is anticipated soon. Roche’s (Basel, Switzerland) Tina-quant lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and ...
- Source: drugdu
- 99
- May 28, 2024
Lipoprotein Blood Test Detects Hereditary Cardiovascular Risk

Lipoprotein (a), or Lp(a), is increasingly recognized as a critical but under-acknowledged potential risk factor for cardiovascular diseases, which are a significant public health concern. Around 20% of the global population has high levels of Lp(a), which heightens their risk of conditions such as myocardial infarction and stroke. Elevated Lp(a) levels contribute to the accumulation of lipids within artery walls, facilitating plaque formation and heightening the risk of cardiovascular events. While factors such as menopause, and kidney or liver diseases, as well as hyperthyroidism can affect Lp(a) levels, over 90% of the variability in Lp(a) levels is due to genetic differences in the lipoprotein (a) (LPA) gene. Consequently, testing for Lp(a) is a crucial diagnostic tool that helps clinicians accurately evaluate cardiovascular risk, and its integration into routine diagnostics is anticipated soon. Roche’s (Basel, Switzerland) Tina-quant lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and ...
- Source: drugdu
- 117
- May 27, 2024
Q&A with Alvana Maliqi

Mike Hollan Cencora’s associate director of value and access strategy for its commercialization strategy & access solutions division discusses the current state of pre-approval information exchanges. Alvana Maliqi, Associate director of value and access strategy Alvana Maliqi served as lead author on Cencora’s latest research initiatives focused on pre-approval information exchange (PIE). She spoke with Pharmaceutical Executive about the research and how the industry can utilize this information more efficiently. Pharma Executive: What does the passage of the PIE legislation allow biopharma companies to do? Alvana Maliqi: The Consolidated Appropriations Act, 20231 (or pre-approval information exchange [PIE] legislation”) was signed into law in 2022, providing a safe harbor for pharmaceutical companies to proactively engage in PIE with payers about new products and/or new indications. Previously, this pathway was initially supported by the 2018 FDA Final Guidance for pre-approval communications. Since 2018, biopharma manufacturers are permitted to share unbiased, factual, accurate, ...
- Source: drugdu
- 127
- May 27, 2024
AstraZeneca Plans $1.5B Manufacturing Site for Global Production of ADC Cancer Drugs

The Singapore manufacturing site will be AstraZeneca’s first facility capable of handling all steps of antibody drug conjugate production. AstraZeneca aims to open the facility in 2029.Antibody drug conjugates have fast become a big piece of AstraZeneca’s revenue growth. The drugmaker is taking steps to ensure it has the production capacity to meet market demand for these cancer drugs, revealing plans for a $1.5 billion manufacturing site in Singapore to support its global supply of ADC medicines. Construction of the ADC manufacturing facility will receive support from the Singapore Economic Development Board, AstraZeneca said Monday. The company expects to begin design and construction of the facility by the end of this year. Construction of a new drug manufacturing site and receiving the regulatory approvals for commercial production can take several years. AstraZeneca aims to open its new site for ADC production in 2029. An ADC is a cancer therapy made ...
- Source: drugdu
- 75
- May 23, 2024
Henlius to Release Latest Clinical Data of HLX22 at 2024 ESMO GI

The 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) is set to take place from June 26 to June 29 in Munich, Germany. Henlius will share the latest clinical data of phase 2 study (HLX22-GC-201) of its novel anti-HER2 monoclonal antibody (mAb), HLX22, combined with HANQUYOU (trastuzumab, HLX02, trade name: HERCESSI™️ in U.S. and Zercepac® in Europe) and chemotherapy for the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer with Professor Jin Li of Shanghai East Hospital, School of Medicine, Tongji University as the leading principal investigator of this study. The results from HLX22-GC-201 were first released at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in January 2024, which showed that adding HLX22 to HLX02 (trastuzumab) and chemotherapy prolonged progression-free survival and enhanced antitumour response in patients with HER2-positive G/GEJ cancer in the first-line setting, with a manageable safety profile. The data released at 2024 ESMO GI are as follows: ...
- Source: drugdu
- 79
- May 23, 2024
European Commission Decision Is a Reprieve for PTC Therapeutics’ Rare Muscle Disease Drug

The PTC Therapeutics drug Translarna failed its confirmatory study in Duchenne muscular dystrophy. Analysts say the European Commission’s decision to not adopt the Committee on Medicinal Products for Human Use’s negative opinion on the drug is unusual, if not unprecedented. By Frank VinluanA PTC Therapeutics drug that failed a confirmatory study in the rare muscle-wasting disorder Duchenne muscular dystrophy may remain on the market in Europe for now. Regulators there took the rare step of declining to adopt a recommendation opposing renewal of the product’s marketing authorization. The PTC drug, Translarna, received conditional marketing authorization in 2014 based on Phase 2 data. The conditional nature of this pathway requires a company to seek annual renewals of the authorization until it generates the clinical data that supports a standard marketing authorization. In a placebo-controlled Phase 3 study, Translarna failed to achieve the main goal of showing a significant change according to ...
- Source: drugdu
- 67
- May 22, 2024
Amgen and AstraZeneca ponder label expansion for Tezspire in COPD

Amgen and AstraZeneca have highlighted the potential of Tezspire (tezepelumab) in chronic obstructive pulmonary disease (COPD) in a subgroup of patients in a Phase IIb study even though the trial missed the primary endpoint. The therapy failed to show a significant reduction in the annual rate of moderate to severe exacerbations compared to the placebo, the trial’s primary endpoint. The data from the placebo-controlled Phase IIa COURSE trial (NCT04039113) was presented at the American Thoracic Society (ATS) International Conference taking place in San Diego, US, from 16 to 21 May. However, a pre-determined subgroup analysis of COPD patients based on the levels of eosinophils, measured as baseline eosinophil count (BEC), showed significant reductions in COPD exacerbations. The therapy also demonstrated a 48% reduction in severe exacerbations compared to the placebo. Patients who received Tezspire while having a BEC of 150 cells/μL or more, which is associated with increased COPD-related emergency ...
- Source: drugdu
- 68
- May 22, 2024
Comprehensive cost and utilization of commercial CAR-T therapy in pediatric B-ALL patients

A new editorial paper was published in Oncoscience (Volume 11) on April 25, 2024, entitled, “The price of hope: CAR-T therapy in pediatric leukemia.” We stand at the crossroads of medical innovation, where cutting-edge scientific discoveries intersect with the resilience of the human body, providing hope to families grappling with a diagnosis of pediatric leukemia. In this new editorial, researcher Alex Hoover from the University of Minnesota Medical School’s Division of Pediatric Blood and Marrow Transplantation discusses the chimeric antigen receptor T-cell (CAR-T) therapy tisagenlecleucel (tisa-cel) -; a groundbreaking development in the treatment of B-cell lineage acute lymphoblastic leukemia (B-ALL) (the most common childhood cancer). Following the pivotal ELIANA trial, tisa-cel was approved in the United States for the treatment of refractory or second or greater relapse of B-ALL in patients under age 25. This innovative therapy involves genetically modifying a patient’s native T-cells – immune cells with the ability ...
- Source: drugdu
- 85
- May 21, 2024

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