Dive Brief The Food and Drug Administration has granted Becton Dickinson 510(k) clearance for its updated Alaris infusion pump, paving the way for the company to begin distributing the system again and to remediate or replace all older versions of the device in the field, BD said Friday. The FDA’s green light comes two years after the company filed a new submission for modifications to the pump, which delivers medications and other fluids intravenously to patients, following a series of recalls due to system malfunctions. A large installed base of Alaris systems remains in hospitals. BD said it will address all recall requirements still open to bring those devices into compliance with the FDA clearance, including hardware, software and cybersecurity updates. Dive Insight Widely used in healthcare, infusion pumps from a number of manufacturers have been among the devices that frequently appear on the ...
The NHS has announced that almost a million more people (900,000) will become eligible for a shingles vaccination with the newly available vaccine, Shingrix, starting in September. The decision was made after the Joint Committee on Vaccination and Immunisation (JCVI) recommended that the Shingrix vaccine be given to a wider cohort of people after trials showed that the vaccine was highly effective and safe for people in those groups. Shingles is an infection that can occur at any age. It causes a rash that can be extremely painful and the pain can remain for many years after the rash has disappeared. Although it cannot be transmitted from other people, it develops in people who have previously been infected with chickenpox over their lifetime. Studies have shown that nine out of ten adults are already infected with the virus that causes shingles, and around one in four ...
Bruker Optics announces the launch of the MOBILE-IR II – a portable, battery-powered Fourier Transform Infrared (FT-IR) spectrometer that delivers the high spectral performance of a laboratory benchtop system. This powerful mobile spectrometer will enable users worldwide to bring routine and advanced FT-IR applications to the field. The MOBILE-IR II is intended to “mobilize” established use-cases of FT-IR spectroscopy, and also to enable new applications that demand mobility, flexibility, and spectral performance. Key application examples include the identification of illegal substances during police or border control operations, the characterization of recycled goods for sorting, the use in warehouses for mobile incoming goods inspection, or in mobile laboratories for the exploration of natural resources. Its IP65-class protection makes the MOBILE-IR II waterproof, dustproof and stable for field applications. A built-in battery powers the device during off-grid operations and safeguards it against power blackouts. The additional IP67 carry-case makes it ...
A long-standing and contentiously debated question is the extent to which US federal food assistance programs contribute to or deter healthy beverage intake. Findings of a new study in the Journal of Nutrition Education and Behavior show that while beverage intake patterns rarely differed between mothers and young children who participated only in the Supplementation Nutrition Program for Women, Infants, and Children (WIC), only the Supplemental Nutrition Assistance Program (SNAP), or neither program, those whose households participated in both programs consumed high amounts of sugar-sweetened beverages (SSBs). Bottled water intake, which is common among communities with high distrust of tap water and can be an economic burden for low-income families, was also common among mothers participating in WIC and SNAP. While both WIC and SNAP aim to improve families’ food security, the programs operate quite differently. WIC benefits allow the purchase of specific foods and beverages and are only available to pregnant and breast-feeding women ...
Pictured: Sign of U.S. Department of Health & Human Services at its headquarters in Washington/iStock, JHVEPhoto The Centers for Medicare and Medicaid Services will now provide broader coverage for Eisai and Biogen’s Alzheimer’s disease therapy Leqembi (lecanemab), the federal agency announced Thursday. The Medicare coverage expansion comes after Leqembi won the FDA’s traditional approval, making it the first anti-amyloid and disease-altering treatment to do so. Eisai and Biogen were granted accelerated approval for Leqembi in January and soon commenced their bid for full approval with data from the Phase III Clarity-AD study. According to CMS, only patients enrolled in Medicare and with physicians participating in a qualified registry will be eligible for reimbursement—provided their doctors collect their data as real-world evidence for Leqembi and submit it to a registry. Coverage is restricted to those who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with evidence of beta-amyloid deposits in the brain. “With FDA’s decision, CMS will ...
Moderna on Wednesday said it struck a deal with Chinese officials to research, develop and manufacture messenger RNA medicines in the country, despite rising tensions between the U.S. and China. The Massachusetts-based biotech company signed a memorandum of understanding and a related land collaboration deal to develop drugs that will “be exclusively for the Chinese people” and won’t “be exported,” a Moderna spokesperson told CNBC. Chinese media outlet Yicai first reported on Tuesday that Moderna was slated to make its first investment in China that could be worth around $1 billion, citing unnamed sources. The outlet also reported that Moderna CEO Stéphane Bancel was visiting Shanghai. The Moderna spokesperson did not confirm the report or comment on the size of the deal. “These agreements are focused on strengthening health security by targeting unmet needs and contributing to the ecosystem of medical solutions available to patients in China,” the spokesperson said. ...
Purolite, a subsidiary of Ecolab that produces purification resins for drug manufacturing, earmarked at least $190 million to build a production plant that will employ 170 workers.The facility, which will produce a variety of products for the healthcare and drug manufacturing industries, will be located in Landenberg, Pennsylvania, according to a June 6 press release from Gov. Josh Shapiro’s office. Resins are used to purify process streams during drug manufacturing and are considered critical to final product quality although they are not part of the finished product. The facility is expected to be completed by the first half of 2025. It will represent the first site in Purolite’s U.S. biologics division. “Purolite’s new facility will help bring security of supply to our global pharmaceutical and biotech customers, enabling lifesaving drugs to reach patients fast,” Hayley Crowe, Purolite’s senior vice president and general manager, said in the release. Purolite received a ...
Eisai is the latest drugmaker to be hit with a ransomware attack.The Japanese company said it “immediately” set up a company-wide task force after suffering a cyberattack Saturday night. Now, it’s working to respond with external experts and law enforcement officials, Eisai said in a statement. The possibility of data leaks is currently under investigation, the company said. Eisai expects it will take “some time to gauge the full extent of the incident.” During the response, Eisai took some of its computer systems, both inside and outside of Japan, offline. For now, its corporate websites and email systems remain operational. As for the impact on the company’s earnings, Eisai is “carefully examining” any potential impact on its earnings forecast and will announce “as soon as possible” if revisions are necessary. Japan has seen an increasing amount of cyberattacks recently, according to The Japan Times. An official at the National Center ...
The World Health Organization on Saturday launched a global network to help swiftly detect the threat from infectious diseases, like COVID-19, and share the information to prevent their spread. The International Pathogen Surveillance Network (IPSN) will provide a platform for connecting countries and regions, improving systems for collecting and analyzing samples, the agency said. The network aims to help ensure infectious disease threats are swiftly identified and tracked and the information shared and acted on to prevent catastrophes like the COVID pandemic. The network will rely on pathogen genomics to analyze the genetic code of viruses, bacteria and other disease-causing organisms to understand how infectious and deadly they are and how they spread. The data gathered will feed into a broader disease surveillance system used to identify and track diseases, in a bid to contain outbreaks and to develop treatments and vaccines. ‘Ambitious’ goals WHO chief Tedros Adhanom Ghebreyesus hailed ...
IMAGE SOURCE,GETTY IMAGES Image caption, Monkeypox is caused by the monkeypox virus, a member of the same family of viruses as smallpox BBC By Michelle Roberts Digital health editor Monkeypox is no longer a global public health emergency, the World Health Organization (WHO) has said, almost a year after the threat was raised. The virus is still around and further waves and outbreaks could continue, but the highest level of alert is over, the WHO added. The global health body’s chief Tedros Adhanom Ghebreyesus called on countries to “remain vigilant”. It can be passed on by close contact with someone who is infected. What is monkeypox? Its official name is Mpox and it is caused by the monkeypox virus, a member of the same family of viruses as smallpox, although it is much less severe. Initial symptoms include fever, headaches, swellings, back pain, aching muscles. Once the fever breaks ...
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