[Sanofi and the Biomedical Advanced Research and Development Authority have broken ground on a new formulation and fill facility at the company’s Swiftwater, Pennsylvania, campus. The plant is part of a third major manufacturing investment for BARDA at the site as part of a contract which was signed in 2019 to increase domestic production capabilities. (Photo by Chesnot/Getty Images)] Sanofi and the Biomedical Advanced Research and Development Authority (BARDA) are expanding their capacity to manufacture flu shots. They are breaking ground on a two-story formulation and filling facility at the company’s sprawling campus in Swiftwater, Pennsylvania. Sanofi will fill syringes and vials using isolator barrier technology as well as single-use technology to provide flexibility. This is the third major manufacturing investment for BARDA at the site as part of a contract signed in 2019 to increase domestic production capabilities for pandemic flu vaccines. The contract supports the ...
Adjuvants—ingredients that help boost the immune response in vaccines—have been used in vaccines for decades. But inducing a stronger immune response can result in more unwanted side effects, like swelling at the injection site or fever and body aches. Researchers at the Pritzker School of Molecular Engineering (PME) at the University of Chicago have found that adding small molecules called immunomodulators to vaccine adjuvants gives them the ability to better regulate the body’s response to vaccines. “If you think of adjuvants as a megaphone that stimulates the immune system, then you can think of immunomodulators as a sound mixer,” said Jeremiah Kim, a graduate student and co-lead author of the paper. “We’re able to selectively tune the immune response to reduce negative side effects.” In models, adding immunomodulators to a flu vaccine increased antibody response, and adding them to a typhoid vaccine reduced inflammation. The results were published in ACS Central Science. Graduate student Matthew Rosenberger was also a ...
by Howard Hughes Medical Institute Overview of GCaMP calcium indictors for neuronal imaging. When they sense calcium, GCaMP indicators cause neurons to produce green fluorescent light, allowing scientists to see which neurons and synapses are activated in living animals as they perform a task. Credit: Yan Zhang New ultra-fast sensors developed at Janelia can detect calcium ions nearly as fast as they are released from neurons, allowing scientists to tease out the individual, milliseconds-long signals passing between brain cells. Genetically encoded calcium indicators dubbed GCaMPs are used to track the activity of large populations of neurons in living animals by revealing the calcium ions that are released as signals pass between neurons. When they sense calcium, GCaMP indicators cause the neurons to produce green fluorescent light, allowing scientists to see which neurons and synapses are activated in living animals as they perform a task. GCaMP indicators have become brighter and more sensitive since ...
A blood test which can detect traces of cancer cells could spare thousands of patients unnecessary chemotherapy every year. A major bowel cancer trial is examining whether the test can show if surgery has removed all of the tumour. Doctors say half of patients with stage 3 bowel cancer are cured by surgery alone so by using chemotherapy they are over-treating many people. About 1,600 bowel cancer patients are being recruited to the UK study. Ben Cooke runs a hair salon on the King’s Road in Chelsea, London, and also works as a stylist for fashion shoots. In early March last year, he noticed some dark blood in his poo. He rang NHS 111 and was sent to A&E. He was diagnosed with stage 3 bowel cancer, which was successfully treated with surgery. The gold standard treatment is to then have intravenous chemotherapy to mop ...
Drugs that combat obesity are under consideration for the first time for the World Health Organization’s “essential medicines list,” used to guide government purchasing decisions in low- and middle-income countries, the U.N. agency told Reuters. A panel of advisers to the WHO will review new requests for drugs to be included next month, with an updated essential medicines list due in September. The request to consider obesity drugs was submitted by three doctors and a researcher in the United States. It covers the active ingredient liraglutide in Novo Nordisk’s obesity drug Saxenda, which will come off patent soon, allowing for cheaper generic versions. The panel could reject the request or wait for more evidence. A decision by the WHO to include Saxenda and eventual generics on the list for adults would mark a new approach to global obesity by the health agency. It could also pave the way for a newer, more ...
The pharmaceutical company that makes Wegovy slimming jabs is funding the expansion of weight-loss services across England as it seeks to boost sales of its obesity drugs, the Observer can reveal. Novo Nordisk is paying the salaries of staff on NHS obesity teams and financing the launch and redesign of services, including giving £206,000 to a health partnership to transform its treatment of obesity. The Danish firm also has financial links to the co-chair of an NHS England weight management advisory group, and paid her almost £50,000 in lecture, consulting and other fees in just two years. Novo Nordisk’s funding arrangements are under the spotlight after an Observer investigation in March found it had paid £21.7m to UK health organisations and professionals in three years before the approval of its Wegovy injections for NHS use. In some cases, recipients of the funding went on to praise Wegovy or support its approval for use on the NHS without ...
British researchers are developing a testosterone hormone patch to help combat symptoms linked to menopause, which if successful would be a world first that could help women secure better access to a hormone that is widely available to men but is subject to fierce debate over whether it should be used to alleviate symptoms of menopause in women. Testosterone patches are going to be tested to treat menopause symptoms. KEY FACTS The patch is being developed to help boost the sex drive of women with symptoms of menopause, according to news reports. Women’s natural production of testosterone drops drastically after menopause and low levels can cause issues including headaches, loss of libido, impaired focus and tiredness. While there are a plethora of testosterone replacement therapies available to men around the world, the few available to women are in the form of creams and gels, which are tough to dose properly and can ...
Bad dreams are common and rarely are a sign of significant health concerns. However, several new studies have found potentially troubling associations between frequent or persistent nightmares and future cognition. These findings, along with recent insights into a potential intervention, have resulted in the top trending clinical topic this week. Previous investigations have found a link between sleep problems in adulthood, including nightmares, and the onset of neurodegenerative diseases. A recent analysis determined a possible association between distressing dreams during childhood and cognitive health concerns (see Infographic). A prospective, longitudinal analysis used data that included all people born in Britain during a single week in 1958. At age 7 years (in 1965) and 11 years (in 1969), mothers were asked to report whether their child experienced “bad dreams or night terrors” in the past 3 months. Among 6991 children (51% girls), 78.2% never had bad dreams, 17.9% had transient bad ...
Cancer drug information leaflets for patients in Europe frequently omit important facts, while some are “potentially misleading” when it comes to treatment benefits and related uncertainties, researchers have found. Cancer is the biggest killer in Europe after heart conditions, with more than 3.7m new cases and 1.9m deaths every year, according to the World Health Organization. Medicines are a vital weapon against the disease. But critical facts about them are often missing from official sources of information provided to patients, clinicians and the public, according to a study led by researchers from King’s College London, Harvard Medical School and the University of Sydney, among others. “Regulated information sources for anticancer drugs in Europe fail to address the information needs of patients,” the study’s authors wrote in The BMJ journal. “If patients lack access to such information, clinical decisions may not align with their preferences and needs.” To receive and participate in medical care, patients ...
The pressure on pharmacy benefit managers (PBMs) is ramping up. Both Congress and the Federal Trade Commission (FTC) are probing alleged anti-competitive practices by PBMs, and they’re doing so in parallel. Given the intense bipartisan pressure on PBMs, it’s increasingly likely that action of some kind will be taken to reform the drug pricing system. Last month, in a bipartisan vote of 18-9, the Senate Committee on Commerce, Science and Transportation advanced a bill, the Pharmacy Benefit Manager Transparency Act, to increase PBM transparency and crack down on what legislators and many policymakers are calling “deceptive practices.” Specifically, the bill stipulates what it deems are “unlawful activities” for PBMs to engage in. These include spread pricing – charging payers more than PBMs pay the pharmacy for a medication and then keeping the “spread” or difference as profit – and clawing back reimbursement payments from pharmacies. Regarding claw backs, PBMs assess direct and ...
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