This news isn’t “berry” good if you like strawberries. A hepatitis A outbreak has resulted in at least five people infected and two people hospitalized, according to the Centers for Disease Control and Prevention (CDC). This, in turn, has left those selling certain brands of frozen organic strawberries in a bit of a jam. The U.S. Food and Drug Administration (FDA) has indicated that the likely culprits behind this outbreak are soft, juicy, and red. We’re talking about strawberries—not all strawberries, but those specifically imported in 2022 by a supplier from particular farms located in Baja California, Mexico. That’s led to two companies that used these strawberries in their frozen products and one retailer to issue voluntary recalls. One of these companies is California Splendor, Inc., based in San Diego, California. They’ve recalled certain lots of their Kirkland Signature 4-lb. bag Frozen Organic Whole Strawberries that have been sold in Costco stores in Los Angeles ...
Vanda Pharmaceuticals has scored a legal win in its long-running dispute with the FDA surrounding the agency’s 2018 rejection of Hetlioz in jet lag disorder. After months of litigation and years of back-and-forth, a court ruled that the FDA must turn over records relating to its denial of the label expansion, Vanda said in a Wednesday release (PDF). After the drug rejection in 2018, the company disputed the decision and last July requested an FDA hearing. The FDA “privately” agreed to the hearing but never published a notice in the Federal Register, meaning the process couldn’t move forward, Vanda said in its September lawsuit. Aside from its lawsuit, the company has been seeking records through a Freedom of Information Act request. In the suit, Vanda argued that the agency failed to act on its application and on its hearing request within timelines stipulated by the law. When Vanda filed the ...
Stanford Medicine researchers have shown that prior SARS-CoV-2 infection reduces killer T cells’ response to vaccination. These cells are crucial for eliminating the virus from the body. March 28, 2023 – By Bruce Goldman T cells are more difficult to measure than antibodies, but they play a crucial role in fighting pathogens.Kateryna Kon/Shutterstock.com The Pfizer/BioNTech mRNA vaccine directed at COVID-19 is much better than natural infection at revving up key immune cells called killer T cells to fight future infection by SARS-CoV-2, the virus that causes COVID-19, Stanford Medicine investigators have found. The scientists also showed, in a study published online in Immunity, that getting infected by SARS-CoV-2 before getting vaccinated lowers the vaccine’s otherwise exceptional ability to spur proliferation and activation of killer T cells directed at SARS-CoV-2. Their finding suggests that those hoping to avoid the manifold health risks associated with COVID-19 would do well to get vaccinated before they contract ...
People who are vaccinated or who take Paxlovid during a Covid-19 infection have a lower risk of developing long Covid, new research shows. The US Centers for Disease Control and Prevention defines long Covid as new, returning or ongoing health issues more than four weeks after an initial infection. According to the CDC, 1 in 5 Covid-19 survivors ages 18 to 64 and 1 in 4 survivors 65 or older have an ongoing health issue that might be attributable to Covid-19 infection。 A study published Thursday in JAMA Internal Medicine analyzed data from 41 studies, including more 860,000 people around the world. Of the four studies with vaccination information of nearly 250,000 people, those who had been vaccinated against Covid-19 had almost half the risk of long Covid than people who weren’t vaccinated. “These findings are important because they enable us to better understand who may develop ...
GSK has reported positive top-line results from a phase 3 study of its five-in-one meningococcal vaccine candidate, MenABCWY, in healthy individuals aged ten to 25 years. Invasive meningococcal disease (IMD) is an uncommon but serious illness that can cause life-threatening complications or even death, with the highest incidence occurring in children and adolescents. Five Neisseria meningitides serogroups – A, B, C, W, and Y – account for nearly all IMD cases, but there are currently no licensed vaccines that offer simultaneous protection against all of them. In the US, two separate vaccines needing four injections are required to protect against all five serogroups. This regimen, together with low awareness of the disease, can lead to poor immunisation rates, with an estimated coverage of only 31% of adolescents in the US. It is hoped that GSK’s MenABCWY, which combines the antigenic components of its licensed Bexsero (MenB) and Menveo (MenACWY) meningococcal ...
Most patients who are admitted to hospitals with acute viral infections are given antibiotics by their doctors or health care providers as a precaution against bacterial co-infection. Yet new research suggests this practice may not improve their survival rates. Researchers investigated the impact of antibiotic use on survival in more than 2,100 patients in a hospital in Norway between the years 2017 and 2021, Reuters reported. ‘SILENT PANDEMIC’ WARNING FROM WHO: BACTERIA KILLING TOO MANY PEOPLE DUE TO ANTIMICROBIAL RESISTANCE The researchers found that giving antibiotics to people with common respiratory infections was unlikely to lower the risk of death within 30 days. At the height of the COVID-19 pandemic, antibiotics were prescribed for around 70% of COVID-19 patients in some countries, Reuters also said. This potentially has contributed to the scourge of antibiotic-resistant pathogens known as superbugs. The new data has not been published in a medical journal ...
Renee Martray of South Carolina has severe and permanent corneal scarring resulting in vision loss. She says it’s like trying to peer through eyeglasses that have been dipped in oil. Nancy Montz of Ohio developed a corneal ulcer, spent three weeks in the hospital and lost vision in her left eye. Carla Oliva of Florida developed a severe eye infection and, when treatment failed, had to have her right eye removed. She’s now legally blind. The women said their problems began after they used EzriCare Artificial Tears, which is part of a US Centers for Disease Control and Prevention and US Food and Drug Administration investigation into a multistate outbreak of a rare strain of bacteria. EzriCare said in a statement last month that when it learned of the investigation January 20, it was not aware of any testing that definitively linked the outbreak to its product. “Nonetheless, we immediately ...
On March 21, Selecta Biosciences and Sobi announced positive pivotal results from two phase III studies (DISSOLVE I and DISSOLVE II). These two placebo-controlled, randomized clinical trials were designed to evaluate the safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout. Gout is an autoinflammatory disease in which patients experience severe pain and debilitating inflammatory arthritis due to deposits of pro-inflammatory sodium urate (MSU) crystals. Patients with chronic refractory gout often have a high tissue MSU burden, which can lead to frequent gout attacks and chronic arthritis. Gout is the most common inflammatory arthritic disease in the United States. SEL-212 has the potential to reduce serum uric acid and MSU deposition in patients with chronic refractory gout. Recombinant uricase is highly immunogenic in the human body. Through Selecta’s proprietary ImmTOR platform, SEL-212 has the potential to alleviate the formation of anti-drug antibodies, ...
India has cancelled the manufacturing licence of a firm whose cough syrups have been linked to 18 child deaths in Uzbekistan. The WHO in January had warned against the use of two cough syrups made by Marion Biotech, saying they were substandard. Marion Biotech denies the allegations. After the deaths were reported in Uzbekistan, India’s health ministry had suspended production at the company. On Wednesday, authorities in Uttar Pradesh state – where Marion Biotech is based – said they were now “permanently” cancelling the company’s licence. “The firm based in Noida city cannot carry out any manufacturing now,” drug inspector Vaibhav Babbar told the Hindustan Times newspaper. The BBC has reached out to state authorities for a statement. Marion Biotech has not responded to BBC’s request for comment. India is the world’s largest exporter of generic drugs, meeting much of the medical ...
Roche Holding AG, a Swiss multinational healthcare company, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its new cancer treatment. The drug, known as Polivy, is designed to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin’s lymphoma. This approval is significant for Roche, as DLBCL is one of the most common types of non-Hodgkin’s lymphoma and a highly aggressive form of cancer. Polivy is a first-in-class antibody-drug conjugate that targets CD79b, a protein that is highly expressed on the surface of B-cell lymphomas. The drug is designed to bind to the CD79b protein and deliver a toxic payload directly to cancer cells, without affecting healthy cells. This approach is known as targeted therapy and is considered to be a significant advancement in cancer treatment. The FDA’s decision was based on the results of a phase ...
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