Dive Brief A former DePuy Synthes sales representative and team lead was arrested this week for allegedly defrauding a Boston area hospital and lying to federal authorities investigating whether he interfered with the hospital’s sterilization processes. Matthew Capobianco, 45, of Winchester, Massachusetts, was indicted on eight counts of wire fraud and one count of making material false statements, according to the U.S. Attorney’s Office in Boston. Johnson & Johnson unit DePuy Synthes, in an emailed statement, said all government claims against the company in the matter have been resolved. Dive Insight According to the Department of Justice indictment, Capobianco defrauded the hospital out of hundreds of thousands of dollars’ worth of spine products that he falsely represented as used in surgeries from January 2016 through June 2017. The Boston area hospital was not named in the DOJ’s statement. To boost his sales numbers and his compensation, Capobianco falsely represented on ...
Dive Brief Teleflex’s recall of its Arrow Endurance Extended Dwell Peripheral Catheter System was categorized by the U.S. Food and Drug Administration as a Class I event, the most severe type of recall. The company began the recall in May after receiving 83 complaints, including 18 reports of injuries. If the catheter separates while in a blood vessel, fragments could spread to other parts of the body and cause adverse events including heart attack and death, the FDA said in a notice. Hospitals should check if they have any of the 262,016 devices recalled in the U.S. and stop using the affected products. Teleflex is asking clinical staff overseeing patients who are currently using an affected product to weigh the risks and benefits of removing and replacing the device. Dive Insight Teleflex acquired Arrow International in 2007 to gain control of a portfolio of vascular access devices. That portfolio now ...
BBC NEW Florida and Texas are seeing some locally acquired cases of malaria – the first spread of the mosquito-transmitted disease inside the US in 20 years, officials warn in a health alert. Active surveillance for more cases is continuing, the Centres for Disease Control says. The risk of catching malaria in the US remains extremely low, it says. All five patients – four in Florida, one in Texas – have now had treatment. Malaria is caused by being bitten by an infected mosquito. People cannot catch it from each other. But the insects catch it from infected people – and the cycle continues. It is common in large areas of Africa, Asia and Central and South America but not the US. However, Anopheles mosquitoes, found throughout many parts of the US, can transmit malaria, if they have fed on an infected person. The risk is higher in areas where: ...
By Heather McKenzie https://www.biospace.com/ Bayer logo on a building under blue sky/Getty Images, Kena Betancur/VIEWpress/Corbis Bayer subsidiary BlueRock Therapeutics has taken another next step in its bid to bring a potentially curative therapy to Parkinson’s disease patients. Wednesday, the companies reported that bemdaneprocel, a stem cell therapy, was well tolerated with no major side effects in a Phase I study. Topline data from the trial of 12 patients also showed feasibility of transplantation and evidence that the cells survived and engrafted in the brain after one year, satisfying the study’s secondary endpoints. Full data will be presented in August at the 2023 International Congress on Parkinson’s Disease and Movement Disorders in Copenhagen. The therapy, also known as BRT-DA01, is the first to show positive results in a Phase I study for Parkinson’s, according to Bayer. Bemdaneprocel consists of dopamine-producing neurons derived from pluripotent stem cells. In Parkinson’s disease, patients lose ...
Vitamin D supplements may reduce the risk of major cardiovascular events such as heart attacks among people aged over 60, finds a clinical trial published by The BMJ. The researchers stress that the absolute risk difference was small, but say this is the largest trial of its kind to date, and further evaluation is warranted, particularly in people taking statins or other cardiovascular disease drugs. Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels and is one of the main causes of death globally. CVD events such as heart attacks and strokes are set to increase as populations continue to age and chronic diseases become more common. Observational studies have consistently shown a link between vitamin D levels and CVD risk, but randomized controlled trials have found no evidence that vitamin D supplements prevent cardiovascular events, possibly due to differences in trial design that ...
City parks and green spaces help counter heat, boost biodiversity, and instill a sense of calm in the urban jungle. They also help slow biological aging, with people who have access to green spaces found to be on average 2.5 years biologically younger than those who do not, according to a new study published Wednesday in Science Advances. “Living near more greenness can help you be younger than your actual age,” Kyeezu Kim, the study’s lead author and a postdoctoral scholar at Northwestern University’s Feinberg School of Medicine, told AFP. “We believe our findings have significant implications for urban planning in terms of expanding green infrastructure to promote public health and reduce health disparities.” Exposure to green spaces has previously been linked with better cardiovascular health and lower rates of mortality. It’s thought that more physical activity and social interactions are at play, but whether parks actually slowed down aging ...
Dive Brief: Regeneron Pharmaceuticals is facing a delay for a much-anticipated new version of its best-selling eye medicine after failing to win U.S. approval on Tuesday because of a manufacturing issue. The Food and Drug Administration issued a complete response letter for the high-dose version of Eylea, citing inspection findings at a third-party facility that fills vials of the medication. Regeneron said it’s working with the FDA and the third party to resolve the issues “as quickly as possible.” Importantly, the FDA did not cite any issues with the drug’s safety or efficacy and isn’t asking for new clinical trials. The agency also did not find any issues with the labeling or manufacturing of the actual drug substance, Regeneron said. Dive Insight: While the issue sounds relatively minor, any delay is significant for Regeneron, and the company’s shares tumbled around 11% during trading sessions on Tuesday and Wednesday. Eylea is ...
Sanofi has announced positive results from a phase 2b trial of amlitelimab in adults with moderate-to-severe cases of atopic dermatitis, one of the most common inflammatory skin diseases. Typically referred to as eczema, atopic dermatitis affects an estimated 16.5 million adults in the US, with nearly 40% affected by moderate-to-severe cases. The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, feet, face and neck. Sanofi’s amlitelimab is an investigational anti-OX40-ligand monoclonal antibody that is designed to rebalance the immune system by blocking inappropriate activation and proliferation of pro-inflammatory effector T cells and promoting expansion of anti-inflammatory regulatory T cells. The company says the candidate “has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders”, including moderate-to-severe atopic dermatitis and asthma. The dose-ranging STREAM-AD study has been evaluating amlitelimab in adult patients ...
Cellusion plans to begin a Phase I/II trial for its bullous keratopathy candidate CSL-001 in 2024, says CEO Shin Hatou. After this, the company will begin a US Phase I/II study for the therapy in 2025, notes Hatou. The Tokyo, Japan-headquartered company aims to submit an investigational new drug (IND) application to the US Food and Drug Administration (FDA) in 2025. Hatou says the company may look to increase funding in the next few years either through further financing rounds or a possible initial public offering. Cellusion would be interested in continuing to work with its current investors and remains open to new investment opportunities to achieve this, he adds. Takuya Kaneko, Cellusion’s chief financial officer (CFO), says that the company aims to launch sales of CSL-001 in Japan by 2027. He says the company is looking for an alliance partner to support the product’s development in the US and ...
Merely a month into an FDA approval, AbbVie and Genmab’s bispecific drug Epkinly has chalked up a positive readout that might enable an expansion in blood cancer, although the exact regulatory path remains unclear. Epkinly significantly beat back tumors in 82% of patients with relapsed or refractory follicular lymphoma in a phase 1/2 trial, the companies said Tuesday. The patients had received a minimum two—and a median three—prior lines of systemic therapy. The median duration of response hasn’t been reached in Epkinly’s study, and investigators are still following patients. The companies also didn’t disclose the complete response rate. Full results from the study will be shared at a future medical meeting. Epkinly snagged an FDA approval for previously treated diffuse large B-cell lymphoma (DLCLC) in May, and AbbVie and Genmab said they will talk to regulators about next steps in FL, an indolent form of lymphoma. If approved in the ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.