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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
- 109
- 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 ...
- Source: drugdu
- 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 ...
- Source: drugdu
- 110
- 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
- 102
- 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
- 96
- November 17, 2023
Pfizer to Cut 500 Jobs at UK Site as Part of $3.5B Cost-Savings Campaign

Pictured: Sign at Pfizer’s headquarters in New York/iStock, JHVEPhoto Pfizer is planning to lay off around 500 of its staffers and terminate its Pharmaceutical Sciences Small Molecule functions at its facility in Sandwich, Kent in the U.K., according to several media reports on Tuesday.The business scale-back comes amid Pfizer’s sweeping cost-reduction plan announced last month, which will see the company generate $3.5 billion in savings through 2024. At the time, the company noted that the “cost realignment” initiative would include layoffs across its global operations, though the exact number of affected employees is still unknown. Local news outlet Kent Online reported that Tuesday’s layoffs were also part of a redundancy consultation program at the Sandwich site.In an emailed statement to Fierce Pharma, a Pfizer spokesperson clarified that the Sandwich facility would remain operational but “with a different size.” There are currently 940 employees at the U.K. site. It is the latest Pfizer location to ...
- Source: drugdu
- 127
- November 17, 2023
Alkermes Spins Off Oncology Business with $275M to Focus on Neuroscience

Pictured: Cancer cell surrounded by cytokines/iStock, Marcin Klapczynski Alkermes on Wednesday announced that it has completed the spinoff of its oncology business to become a pure-play neuroscience company. Mural Oncology will begin trading on the Nasdaq starting Thursday, with Alkermes shareholders receiving a share of Mural for every 10 shares of Alkermes. Mural is launching with $275 million, which is expected to fund it through the fourth quarter of 2025, and an interleukin-2 cytokine as its most advanced asset. Nemvaleukin alfa is being studied as a monotherapy for advanced mucosal or cutaneous melanoma in Phase II and is in a Phase III study in combination with Keytruda for platinum-resistant epithelial ovarian cancer. The therapeutic is designed to avoid the hallmark toxicities of IL-2 immunotherapies. The studies are potentially registrational with readouts expected in early 2025. Additional assets include therapies targeting IL-18 and IL-12. Mural will nominate a development candidate for each program in ...
- Source: drugdu
- 129
- November 17, 2023
Ipsen, Genfit Build Case for Rare Liver Disease Drug with Phase III Data

By Tristan Manalac Pictured: Illustration of diseased liver/iStock, Mohammed Haneefa Nizamudeen Ipsen and partner Genfit on Monday posted promising data from the Phase III ELATIVE trial for their investigational dual peroxisome activated receptors agonist elafibranor, further building the candidate’s case for regulatory approval in primary biliary cholangitis. More than half of patients treated with elafibranor achieved the study’s primary endpoint of biochemical response, defined as having normal bilirubin concentrations alongside a substantial decrease in alkaline phosphatase levels, maintained below a particular threshold. Only 4% of placebo comparators met these biochemical response criteria. Elafibranor also normalized alkaline phosphatase levels in 15% of treated patients, compared to none in the placebo group. In terms of safety, ELATIVE found that elafibranor was well-tolerated with an adverse event profile that was similar to placebo. Common side effects included abdominal pain, diarrhea, nausea and vomiting. In a statement, Christelle Huguet, executive vice president and head ...
- Source: drugdu
- 206
- November 16, 2023
Jazz Inks $770M Deal with GSK Spinout Autifony, Nabs Two Neuro Assets

By Tyler Patchen Pictured: A neurosurgeon analyzes an MRI/iStock, gorodenkoff GSK spinout Autifony Therapeutics has entered into an exclusive global licensing deal potentially worth $770.5 million with Jazz Pharmaceuticals for two different ion channel targets associated with neurological disorders. Under the deal announced on Tuesday, the U.K.-based biotech Autifony will receive an undisclosed upfront payment from Jazz and is eligible to receive development, regulatory and commercial milestone payments as well as royalties on any future net sales. Autifony, which is focused on developing treatments for central nervous system disorders and other brain diseases, will spearhead the drug discovery and the preclinical development of the two ion channel targets. Prior to the completion of preclinical development, Jazz will take over clinical development and assume responsibility for manufacturing, regulatory actions and commercialization. “Jazz has an exceptional track record of rapidly advancing neuroscience development programs and effectively commercializing novel therapies that offer improvements ...
- Source: drugdu
- 124
- November 16, 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
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- November 16, 2023

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