Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
In the Lab: An Mpox mRNA Vaccine That’s Outperforming Its Old-School Predecessor
The recent global mpox outbreak trained a bright spotlight on the need for safe and effective Orthopoxvirus vaccines, especially in light of continuously looming zoonotic threats and the potential for these pathogens to spread rapidly worldwide.
Now, a collaborative group of U.S. scientists is testing a candidate mRNA mpox nanoparticle vaccine with the hope of developing an immunization that is superior to the current mpox shot.
The research team mostly hails from the private and federal institutions that produced one of the highly successful COVID mRNA vaccines: Moderna Inc., in Cambridge, Mass., and the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Md. The new study also included collaboration with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in Fort Detrick Md.
Writing in Science Translational Medicine, the researchers say the aim of the new mRNA vaccine for mpox is to have a shelf-ready inoculation in the event of a future outbreak. Having a vaccine in hand, they say, alleviates scrambling to figure out what might work most effectively as cases mount and doctors ask for the best immunization strategy to ward off additional infections.
CDC Responds to Claims About Chinese Biolab in California
The Centers for Disease Control and Prevention (CDC) has said it “strongly disputes” criticism of the federal agency contained in a major new report, produced by the House Select Committee on the Chinese Communist Party (CCP), concerning an alleged secret bio lab in Reedley, California.
According to the report, thousands of vials containing potentially dangerous or unknown substances, including some labeled “Ebola” and “HIV,” were uncovered during an inspection of what was initially thought to be a vacant warehouse.
The facility was uncovered in December 2022 by Jesalyn Harper, a Reedley code enforcement official who spotted a green hose sticking out of the building, and then went in to investigate. Inside, Harper found an array of laboratory equipment, medical-grade freezers, mice for experiments and vials containing writing in English, Mandarin and an unknown code. Several individuals wearing lab coats were also discovered who claimed to be Chinese nationals.
In response to Harper’s discovery, the city launched an investigation that eventually involved the California Department of Public Health, the federal Food and Drug Administration, the CDC and the FBI.
CDC experts identified a number of potentially infectious agents at the Reedley site, including chlamydia, HIV, Hepatitis B and C, malaria, SARS-CoV-2, Dengue virus and the rubella virus. However, according to the report, they refused to test a number of unlabeled vials, along with a fridge labeled “Ebola,” which were destroyed before their exact content could be ascertained.
J&J Settles First Talc Cases to Go to Trial After Failed Bankruptcies
Johnson & Johnson (JNJ.N) on Thursday said it has settled two lawsuits claiming its talc products caused cancer, the first such cases to go to trial since a federal court rejected the company’s plan to move its talc liabilities into bankruptcy court.
The settlements resolved lawsuits brought by two men, Rosalino Reyes and Marlin Eagles, who said they developed mesothelioma related to asbestos in J&J talc powder and was part of a broader deal to settle all talc cases brought by the law firm representing them, Kazan, McClain, Satterley & Greenwood, the company said. Reyes’ family continued his lawsuit after he died in 2020.
The company faces more than 50,000 lawsuits over talc, most by women with ovarian cancer. It has said that its talc products are safe and do not contain asbestos.
Big Pharma Scrambles to Feed Demand for Weight-Loss Treatments Amid Rising U.S. Obesity Rates
Obesity rates in the U.S. have been rising steadily for well over a decade and some of the world’s biggest drug developers are tapping into the growing treatment market.
Novo Nordisk reported another surge in profits and revenue during its most recent quarter with a big assist from Wegovy, an injectable treatment for weight loss approved by the Food and Drug Administration in 2021.
Obesity care sales rose 174% through the first three quarters of 2023 for Novo Nordisk, driven by the U.S. market. Demand for Wegovy, which is a high-dose version of the diabetes treatment Ozempic, has been high enough to warrant ongoing supply restrictions while the company works to increase production.
Novartis and Eli Lilly’s injectable treatments will likely face competition in the future. Pfizer is developing danuglipron, a potential oral medication for obesity. Biotechnology giant Amgen is also developing an obesity treatment.
CDC Releases 77,000 Additional Doses of RSV Shot for Infants Amid Shortage
The Centers for Disease Control and Prevention (CDC) said it was releasing 77,000 additional doses of a respiratory syncytial virus (RSV) drug from Sanofi and AstraZeneca to help improve its availability.
The additional doses of Beyfortus will be distributed immediately to physicians and hospitals through the Vaccines for Children Program, which covers the cost of the shots for uninsured and underinsured kids, as well as commercial channels, the CDC said.
Shortages of the drug have been plaguing the country since it was approved in August. Pediatricians and hospitals have been struggling to stock the immunization due to what Sanofi said was “unprecedented” demand for the drug to prevent RSV in infants.
CDC and FDA said they will continue to be in close contact with manufacturers to ensure the availability of additional doses through the end of this year and for early 2024 to meet the demand.
Barefoot Workers and Cracked Floors Were Found at a Factory That Made Recalled Eyedrops, FDA Says
An Indian company that recently recalled eyedrops sold in the U.S. had a host of sanitation and manufacturing problems, including barefoot workers, cracked floors and altered records, U.S. health inspectors found.
Food and Drug Administration officials uncovered more than a dozen problems at the Mumbai plant operated by Kilitch Healthcare India, according to a preliminary inspection report posted by the agency. The factory produced more than two dozen varieties of eyedrops that were subject to an FDA safety warning last month.
The products were sold by CVS Health, Target, Rite Aid and other national retailers who said they would be removed from store shelves. New details about the plant’s problems emerged after FDA inspectors visited the plant late last month.
U.S. FDA Approves AstraZeneca’s Breast Cancer Drug Combination
The U.S. Food and Drug Administration on Thursday approved AstraZeneca‘s (AZN.L)Truqap in combination with an older drug, providing another treatment option for patients with the most common type of breast cancer.
The FDA decision allows the use of the drug, chemically known as capivasertib, in combination with the British drugmaker’s older cancer treatment faslodex.
The Truqap combination enters a competitive market of breast cancer treatments, which include AstraZeneca-Daiichi Sankyo’s Enhertu and Gilead’s (GILD.O) Trodelvy.
Common side effects of the drug include diarrhea, decreased hemoglobin, nausea and fatigue, among others.
Senior U.S. FDA Official Woodcock to Retire Next Year
U.S. Food and Drug Administration (FDA) Principal Deputy Commissioner Dr. Janet Woodcock, who led the regulator during the height of the COVID-19 pandemic as acting chief, plans to retire early next year, the agency said on Thursday.
Woodcock, 75, is an FDA veteran who twice led its pharmaceutical division for at least a decade in each instance. There she reshaped the drug approval process, relaxing the criteria needed for certain drugs to reach the market.
Daiichi Sankyo Signs Pact to Supply 1.4 Million mRNA COVID Vaccine Doses in Japan
As Daiichi Sankyo holds out for local approval of its Omicron-adapted mRNA shot for COVID-19, the company has struck up a major supply pact in its native Japan.
Friday, Daiichi said it had reached an agreement with Japan’s Ministry of Health, Labor and Welfare (MHLW) to supply its shot — coded DS-5670 — for a vaccination program against COVID that kicked off this fall.
Under the deal, Daiichi is on deck to supply Japan with 1.4 million doses of its shot in the 2023 fiscal year, assuming the vaccine wins approval from MHLW. Daiichi submitted a supplemental application for DS-5670 in September.
