Search Results for “EC” – Page 76 – media

AstraZeneca shares positive phase 3 results for Imfinzi combination in liver cancer

AstraZeneca (AZ) has shared positive results from a late-stage study of its immunotherapy Imfinzi (durvalumab) when used as part of a combination treatment in a subset of patients with hepatocellular carcinoma (HCC), the most common type of liver cancer. The phase 3 EMERALD-1 trial has been evaluating Imfinzi plus transarterial chemoembolisation (TACE) followed by Imfinzi with or without Genentech’s Avastin (bevacizumab) until progression versus TACE alone in more than 600 patients with unresectable HCC eligible for embolisation. Approximately 75% of all primary liver cancers in adults are HCC and up to 30% of patients are eligible for embolisation, a procedure that blocks the blood supply to the tumour and can deliver chemotherapy or radiation therapy directly to the liver. Despite being the standard of care in this setting, most of those who receive embolisation experience rapid disease progression or recurrence. “Patients with liver cancer eligible for embolisation experience high rates ...
- Source: drugdu
- 214
- November 18, 2023
LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

Dive Brief The Food and Drug Administration has authorized the first chlamydia and gonorrhea test with at-home sample collection. LetsGetChecked received de novo authorization for the Simple 2 Test, an over-the-counter kit that uses vaginal swabs or urine specimens to detect the bacteria that cause the two sexually transmitted diseases (STDs). The authorization will move sample collection from the doctor’s office to the home — potentially increasing testing of STDs, which are on the rise — and create a 510(k) pathway for rival diagnostics. Dive Insight Until this week, the FDA had only authorized at-home sample collection for one STD, HIV. Sample collection for all other STDs occurred at the point of care, for example, in a doctor’s office. People may be less likely to get tested at the point of care, particularly for frequently asymptomatic infections such as chlamydia and gonorrhea, because of concerns about confidentiality and convenience. The ...
- Source: drugdu
- 131
- November 18, 2023
UTS researcher tests new handheld device for rapidly and accurately identifying drug specimens

University of Technology Sydney (UTS) Centre for Forensic Science PhD candidate Harry Fursman is working on two fronts to prevent harm to people who use drugs: He is testing a new handheld device for rapidly and accurately identifying drug specimens and conducting ongoing chemical analysis of used syringes. Drugs that are contaminated or substituted with an unexpected substance are a leading cause of death among people who use drugs. In Sydney last week one person died and two people were taken to hospital due to heroin overdoses, after using what they thought was cocaine. Fursman aims to tackle this significant risk by providing objective insights into current trends and consumption habits among people who are injecting drugs. He will present his research on substance testing at the upcoming International Association of Forensic Sciences (IAFS) conference in Sydney on 20-24 November. Portable drug testing device: MicroNIR Fursman is testing a small ...
- Source: drugdu
- 155
- November 18, 2023
Roche’s subcutaneous Tecentriq recommended by CHMP for multiple cancer types

Roche has announced that an injectable form of its PD-L1 inhibitor Tecentriq (atezolizumab) has been recommended by the European Medicines Agency’s human medicines committee for multiple cancer types. The subcutaneous (SC) formulation of Tecentriq can cut treatment time by approximately 80%, the company said, with most injections taking between four to eight minutes compared with 30 to 60 minutes for an intravenous (IV) infusion. The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that Tecentriq SC be authorised for use in all indications in which the drug’s IV form has previously been approved, including certain types of lung, liver, bladder and breast cancer. The committee’s decision will now be reviewed by the European Commission and, if approved, Tecentriq SC will be the first injectable PD-L1 cancer immunotherapy in the EU. Levi Garraway, Roche’s chief medical officer and head of global product development, said: “Tecentriq has helped to ...
- Source: drugdu
- 168
- November 18, 2023
Which Tech Solutions Are Actually Having a Positive Impact on the Workforce Crisis?

Knowing that many tech solutions end up being not as effective as health systems would have hoped, two health system executives gave examples of tools they believe have made a significant impact on staffing issues at their organizations. One is a wearable patch that continuously monitors inpatients’ vital signs, and one is a platform that allows providers to fill open shifts with local nurses. By KATIE ADAMS Hospitals across the country continue to grapple with the workforce crisis, with reports showing that nearly half of U.S. healthcare workers plan to leave their roles by 2025. To address this sweeping problem, health systems are working to create workplace cultures that make staff feel supported, as well as adopting tech solutions to offload some of their workers’ daily tasks. But not every piece of shiny new tech will deliver on its promises to ease burnout among staff, Ardent Health Services CEO Marty ...
- Source: drugdu
- 170
- November 18, 2023
CorMedix Wins FDA Approval for Antimicrobial Drug Combo After Two Rejections

By Tristan Manalac The FDA on Wednesday approved CorMedix’s DefenCath (taurolidine and heparin) to reduce catheter-related blood stream infections in adults with kidney failure who are on chronic hemodialysis through a central venous catheter. DefenCath is the first FDA-approved antimicrobial catheter lock solution in the U.S., according to CorMedix’s announcement. CorMedix expects DefenCath to be available in the inpatient setting in the first quarter of 2024. The company’s stock was trading 35% higher Wednesday morning in response to the approval, according to Seeking Alpha. CorMedix CEO Joseph Todisco in a statement said that DefenCath’s approval was a “major advancement” for preventing life-threatening infections and provides doctors “an option to reduce the risk of infections in a patient population already vulnerable due to underlying kidney failure.” DefenCath is a combination of the amino acid derivative taurolidine and the anticoagulant heparin. Taurolidine has demonstrated strong antimicrobial activity against gram-positive and gram-negative bacteria, ...
- Source: drugdu
- 181
- November 18, 2023
IO Biotech enrols 380 patients with advanced melanoma in phase 3 trial

The trial is evaluating an investigational cancer vaccine in combination with KeytrudaIO Biotech has announced that it has completed the enrolment of 380 patients in a phase 3 clinical trial of its investigational immune-modulating therapeutic cancer vaccine in advanced melanoma. The open-label, randomised clinical study being conducted in collaboration with Merck & Co – known as MSD outside the US and Canada – is comparing the candidate IO102-IO103 in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) versus Keytruda alone in patients with previously untreated, unresectable or metastatic melanoma. The cancer vaccine in combination with a PD-1 inhibitor has already demonstrated “approximately double the effect than would have been expected with PD-1 inhibitor monotherapy in this patient population,” said Mai-Britt Zocca, president and chief executive officer of IO Biotech, with results from a phase 1/2 study showing that 80% of patients achieved a response and 50% achieved a complete response. Furthermore, ...
- Source: drugdu
- 105
- November 17, 2023
Cytovale Snags $84M To Commercialize Early Sepsis Detection Test

Cytovale, a San Francisco-based medical diagnostics company, raised $84 million in Series C funds to advance the commercialization of its diagnostic test for early sepsis detection. Using standard blood draws, the test provides results in under 10 minutes. It is meant to detect sepsis in patients who present to hospital emergency departments. Sepsis kills more than 11 million people worldwide each year and contributes to 20% of all global deaths. The disease is also a leading cause of death in U.S. hospitals, and a septic patient’s risk of death increases by 8% each hour they go undiagnosed and untreated. Cytovale, a San Francisco-based medical diagnostics company, is seeking to tackle this issue with its early sepsis detection test. On Wednesday, the startup announced that it has raised $84 million in Series C funds to bring the test to more hospitals. The financing round, which takes Cytovale’s total funding amount to more than $122 million, was led by Norwest ...
- Source: drugdu
- 93
- November 17, 2023
Olympus receives Class I recall label for another bronchoscope safety issue

Dive Brief Olympus Corporation has issued another corrective action for numerous models of bronchoscopes after reports of injuries where patients may have suffered burns to their airways or lungs. The corrective action came after four adverse event reports of “endobronchial combustion during therapeutic procedures with Olympus bronchoscopes,” an Olympus spokesperson said in an emailed statement. The Food and Drug Administration labeled the corrective action as a Class I recall, though Olympus said in a Nov. 9 press release that no devices need to be removed. The recall affects nearly 68,000 devices according to an FDA report entry. Dive Insight Bronchoscopes are used for endoscopic diagnosis and treatment in the airways to the lungs. In an Oct. 12 letter to customers, Olympus warned healthcare personnel about the risks of conducting high-frequency cauterization with Olympus bronchoscopes in an oxygenated environment, which may result in combustion during cauterization. The company said in a ...
- Source: drugdu
- 146
- November 16, 2023
IU researchers receive $5 million grant to improve care for adolescents with opioid use disorder

IU School of Medicine researchers are taking steps to improve the accessibility and quality of care for adolescents experiencing opioid use disorder (OUD) and other substance use disorders (SUDs), thanks to a new $5 million grant from the National Institute of Health’s Helping to End Addiction Long-Term (HEAL) Initiative. The grant will fund the new project “Workforce and System Change to Treat Adolescent Opioid Use Disorder within Integrated Pediatric Primary Care” led by faculty from the Department of Psychiatry and Department of Pediatrics. The $5 million will be awarded across 5 years, with formative work happening in the first year before transitioning into a clinical trial phase. “Addressing the growing risk of overdose deaths among adolescents has become a critical concern, and Indiana unfortunately has one of the ten highest rates of adolescent overdose deaths in the United States,” said Zachary Adams, PhD, associate professor of psychiatry at Indiana School ...
- Source: drugdu
- 97
- November 16, 2023

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