By Brenda Goodman, CNN The CDC reported that two people in Michigan caught flu strains, such as the virus particles shown in green, that typically circulate in pigs. NIAD/NIH/Universal Images Group/Getty Images CNN — Two people have caught flu strains that normally circulate in pigs, the US Centers for Disease Control and Prevention said on Friday, and pig exhibits at agricultural fairs appear to be to blame. Each patient became ill with flu-like symptoms about 10 days after visiting pig exhibits at two different agricultural fairs in early and late July. Neither was hospitalized, and their infections do not appear to have spread to other people, the CDC said. Both cases were identified by the Michigan Department of Health. There are a few such cases in the U.S. each year, usually linked to swine exhibits at fairs. Still, the illnesses highlight the possibility that flu viruses have the ability jump ...
By Heather McKenzie Pictured: FDA Headquarters/iStock, Grandbrothers In a bittersweet decision for Biogen and Sage Therapeutics, the FDA approved the fast-acting therapy zuranolone Friday as the first pill for postpartum depression—but rejected the treatment for major depressive disorder. Zuranolone—to be marketed as Zurzuvae in postpartum depression (PPD) —is only the second treatment for this indication and the first pill that can be taken at home. Prior to Zurzuvae, there was only one FDA-approved treatment for PPD—Sage’s Zulresso (brexanolone)—but as it must be administered intravenously at a hospital, it is out of reach for many women, Fortune Well reported. Zurzuvae also marks a significant change from the current treatment paradigm, which consists of drugs that are longer acting, showing efficacy typically within six to eight weeks, Sage Chief Business Officer Chris Benecchi, told BioSpace in a previous interview. However, the fast-acting pill—jointly developed by Biogen and Sage—can improve symptoms in as ...
Published in the International Journal of Obesity, University of Minnesota Medical School and School of Public Health researchers led a study on the relationship between dietary intake and cardiovascular disease risk factors. Over 20 years, the research team examined people’s regular dietary intake, paying particular attention to non-nutritive sweeteners commonly found in artificial sweeteners. They found that long-term consumption of aspartame, saccharin, and diet beverages were linked to increased fat stores in the abdomen and fat within muscle. However, the study found no significant association between the artificial sweetener sucralose and these measures of fat volume. Brian Steffen (PhD, MSCR, Professor, Department of Surgery, University of Minnesota Medical School) said, “This study showed that habitual, long-term intake of total and individual artificial sweetener intakes are related to greater volumes of adipose tissue, commonly known as body fat. This was found even after accounting for other factors, including how much a ...
Function and form are deeply intertwined in biology. Knowing how organisms grow, adapt and reproduce requires understanding their physical structures. Hence the transformative power of the microscope across the past four centuries of science. Microscopy, or the field of microscope use, can now reveal the tiniest of structures through techniques such as microcrystal electron diffraction, or MicroED. Instead of passing light through a cell like an optical microscope, MicroED bombards crystalline samples with a stream of electrons to produce detailed information about their atomic configuration. Brent Nannenga (Associate Professor, Chemical Engineering, Arizona State University) said, “The method was developed to reveal or ‘solve’ the structure of proteins. Then researchers started applying it to compounds for pharmaceuticals and small organic molecules. However, it had not been demonstrated for nucleic acids, and the scientific community was asking whether it would work for DNA.” Nannenga and colleagues just answered that question. A research ...
After coming to the rescue during the mpox outbreak in 2022, vaccine maker Bavarian Nordic has agreed to help replenish U.S. stores of its smallpox/mpox shot. The U.S. Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic a new $120 million contract, primarily to cover the production of new bulk vaccine product, the company said in a press release Thursday. The bulk product order represents $96 million of the contract value. That portion will be manufactured and invoiced in 2023 and will “only partly restore the inventory,” Bavarian Nordic said. Bavarian Nordic will also manufacture and supply an additional $3 million worth of liquid-frozen doses in 2023. The rest of the contract will cover “additional services” totaling $21 million, with Bavarian Nordic getting its hands on most of that sum over the next two years. Throughout 2022 and 2023, Bavarian Nordic says it’s manufactured around 5.5 million smallpox/mpox ...
As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. Case in point is a claim from a Louisiana woman who is suing both companies, alleging her use of Novo’s Ozempic (semaglutide) and Lilly’s Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, who used Ozempic for more than a year and then switched to Mounjaro, says the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs. The lawsuit claims that Bjorklund has suffered from “severe vomiting, stomach pain, gastrointestinal burning,” and has been hospitalized for stomach issues on “several” occasions. The prescribing labels for Ozempic and Mounjaro say the drugs “delay gastric emptying” and warn of the risk of gastrointestinal adverse ...
GSK has sued Pfizer in a US court, alleging infringement of the patents it holds on vaccines for respiratory syncytial virus (RSV). The lawsuit claims that Pfizer’s Abrysvo infringes on four of GSK’s patents that cover its rival vaccine, Arexvy. In May, Arexvy became the first RSV vaccine to be approved anywhere in the world after it received approval from the US Food and Drug Administration (FDA). The US approval of Pfizer’s vaccine followed shortly afterwards. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. Both companies’ vaccines aim to prevent lower respiratory tract disease caused by RSV in individuals aged 60 years or older and are expected to be available in the US before the next RSV season. A GSK spokesperson said that “intellectual property protections ...
The National Institute for Health and Care Excellence (NICE) has issued a draft Appraisal Consultation Document that does not recommend CSL Behring’s Hemgenix (etranacogene dezaparvovec) gene therapy for haemophilia B. The company has been seeking approval for use of the therapy in adults with severe or moderately severe haemophilia B without a history of factor IX inhibitors. In its guidance, NICE’s evaluation committee said that while there is clear evidence that the therapy reduces the number of bleeding episodes haemophilia B patients have each year, there is not enough evidence on how well it works in the long term, meaning cost-effectiveness estimates are “uncertain”. It also cited problems with the indirect comparison between the gene therapy and factor IX replacement therapies. Haemophilia B is a genetic bleeding disorder resulting from missing or insufficient levels of blood clotting factor IX, a protein needed to produce blood clots to stop bleeding. Patients ...
Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen. Instead of a single-agent regimen, the FDA on Wednesday cleared Lonsurf to be used alongside bevacizumab for previously treated metastatic colorectal cancer. Patients who have tried an anti-VEGF inhibitor such as bevacizumab—originally developed by Roche as Avastin—may also qualify for this new combo. The Lonsurf-bevacizumab cocktail proved to be more efficacious than Taiho’s drug alone. Compared with Lonsurf monotherapy, the new combination significantly reduced the risk of death by 39% in a group of patients who had previously received a maximum of two prior chemotherapy regimens and an anti-VEGF agent, plus, in some cases, an anti-EGFR therapy such as Eli Lilly’s Erbitux. In that phase 3 trial, patients who received the combo lived a median 10.8 months, while ...
Dive Brief Augmedics, a developer of surgical navigation technologies, will acquire the digital health assets of Surgalign Holdings for $900,000 in cash and assume unspecified liabilities after making a successful bid in a bankruptcy court auction. Surgalign, which is selling its assets under court supervision after filing for Chapter 11 bankruptcy protection, said in a statement on Friday that Xtant Medical Holdings also was selected in a bidding process to acquire its hardware and biologics assets for a cash purchase price of $5 million, along with the assumption of certain liabilities. Augmedics, in a separate statement, said the purchase of Surgalign’s digital health assets and intellectual property will strengthen its augmented reality and AI portfolio. Dive Insight Deerfield, Illinois-based Surgalign filed for bankruptcy in June, a year after the Securities and Exchange Commission charged the company with accounting fraud. The SEC accused Surgalign, formerly RTI Surgical Holdings, of shipping future ...
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.