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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, ...
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- 188
- November 18, 2023
BMS Drug Augtyro Gets FDA Approval to Treat ROS1-Positive NSCLC

By Tyler Patchen The FDA has approved Bristol Myers Squibb’s tyrosine kinase inhibitor Augtyro (repotrectinib) to treat patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer, augmenting the company’s arsenal of cancer and NSCLC treatments. According to BMS’s Wednesday announcement, the drug is meant to “minimize interaction” that can lead to certain forms of treatment resistance in ROS1-positive NSCLC patients. The FDA approved the drug based on the TRIDENT-1 study evaluating Augtyro in TKI-naïve and TKI-penetrated patients. Results showed that for TKI-naïve individuals, the objective response rate (ORR) was 79%, with a median duration of response of 34.1 months. For patients that were TKI-penetrated and had no chemotherapy, the ORR was 38%, with a median duration of response of 14.8 months. “New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” Jessica J. Lin, the ...
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- 190
- November 18, 2023
New WHO initiative to prioritise endemic pathogens for vaccine development

The World Health Organization (WHO) has commissioned 16 ‘Vaccine Value Profiles (VVPs)’ to prioritise key endemic pathogens to accelerate vaccine development. The VVPs are a result of collaboration between several pathogen and vaccine experts.Led by the Product Development and Research (PDR) team in WHO’s immunisation, vaccines and biologicals department, the aim of the VVPs is to advance the development of vaccines for pathogens that pose the biggest threat to public health and socio-economic burden, particularly in low- and middle-income countries. The forthcoming supplement in the journal Vaccine will feature the VVPs of 16 pathogens with vaccines in late-stage clinical development to provide comprehensive summaries of critical evidence to provide guidance for vaccine funding, research initiatives, and clinical and policy development strategies. They will comprise state-of-the art, publicly available data and information that highlights the current understanding of anticipated vaccine development, the implementation of feasibility studies and the public health impact ...
- Source: drugdu
- 171
- November 17, 2023
Kesin Pharma expands antibiotic reach with liquid suspension approval

Kesin Pharma has announced the availability of a liquid suspension of antibiotic drug metronidazole to treat patients with bacterial infections.Marketed as Likmez 500mg/5mL, the drug is the first-ever ready-to-use oral suspension of metronidazole to receive US Food and Drug Administration (FDA) approval.The medication requires no refrigeration. Offered in a strawberry peppermint flavour, it has a shelf life of two years. The most common adverse reactions to Likmez include nausea, headache, vomiting and diarrhoea. Through a partnership with Saptalis Pharmaceuticals, Kesin is the exclusive US commercialisation partner for Likmez. New York-based Saptalis Pharmaceuticals specialises in the development and manufacturing of generic and branded products in liquid and semi-solid dosage forms. Metronidazole is used to treat skin infections, rosacea, and mouth infections, including infected gums and dental abscesses. It’s also used to treat conditions such as bacterial vaginosis and pelvic inflammatory disease. Following the approval, Kesin Pharma president and CEO Narasimhan Mani said: ...
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- 127
- November 17, 2023
Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity

In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.Novo has unveiled a new phase 3 trial pitting CagriSema, a fixed-dose combination of Wegovy and the investigational drug cagrilintide, against Lilly’s Zepbound in people with obesity, according to a clinicaltrials.gov entry. The study plans to enroll 800 patients, and those with diabetes are excluded. Its primary goal is to evaluate how well the two companies’ therapies could help people lose weight relative to each other after 72 weeks of treatment.In addition, the trial will measure the number of patients in each arm who’ve achieved at least 25% or 30% weight reduction at the end of treatment. Other secondary endpoints include changes in cholesterol levels, triglycerides, waist circumference, systolic blood pressure and serious side effects. The Novo trial comes about seven months after Lilly launched a head-to-head phase 3 study testing Zepbound—also known ...
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- November 17, 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, ...
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- November 17, 2023
AdventHealth CEO’s 3 Rules For Employee Retention

Healthcare’s shortage of workers might be the biggest issue plaguing the industry. Low staffing levels are not only putting more pressure on workers who are already burnt out, but they’re also leading to employee strikes and a lower quality of patient care.To address this pressing issue, health systems across the country are working to ensure their hospitals are places where workers feel heard and supported. Last week at the Reuters Total Health conference in Chicago, AdventHealth CEO Terry Shaw shared three key pillars that the health system uses to create a people-first culture among its workforce that numbers 92,000 caregivers across nine states. Execs don’t have the best vantage point A few years ago, AdventHealth learned that its executives don’t always have the right answers like they may think they do, Shaw pointed out.“I asked my group of 450 executive leaders to prioritize what they thought our team of ...
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- 109
- November 17, 2023
Vicarious delays surgical robot as integration challenges, R&D cuts slow development

Dive Brief Vicarious Surgical has extended the timeline for developing its surgical robot by 12 to 18 months to preserve cash, pushing out an anticipated filing for authorization until early to mid 2026.Seeking to reduce cash burn by up to $20 million next year, the medtech company is downsizing its R&D team and reducing spending on contractors. The changes, which will force Vicarious to do tasks in sequence, rather than in parallel, and “integration challenges” delayed the project. CFO Bill Kelly told investors on a Monday earnings call that the spending plan will enable Vicarious to keep going into 2026, but BTIG analysts warned the company is “walking a very tight rope” and downgraded the stock. Dive Insight Vicarious is developing a surgical robot that is designed to provide abdominal access and visualization through a single port. In July, the company said the integration and build of system units ...
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- November 17, 2023
NeuroOne picks former Cardiovascular Systems VP as new COO

NeuroOne Medical Technologies (Nasdaq:NMTC) announced that it appointed Christopher R. Volker as its chief operating officer (COO). Volker joins the Eden Prairie, Minnesota-based neurotech company from Abbott. He previously served as VP and GM of international at Cardiovascular Systems (CSI), which Abbott acquired earlier this year. “Chris’ appointment further strengthens our executive leadership team and deepens our capabilities as we build for future commercial growth and expansion into other clinical applications,” said NeuroOne CEO Dave Rosa. “We are excited to benefit from his broad experience in business development, commercial expansion, finance and health economics, and reimbursement.”NeuroOne commercially launched its Evo sEEG electrode line in the U.S. earlier this year. The electrodes provide up to 30 days of recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.The company is also targeting an FDA clearance this year for its first therapeutic device, the OneRF ablation system, which uses already-implanted sEEG electrodes to ...
- Source: drugdu
- 95
- 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
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- November 17, 2023

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