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J&J COVID Vaccine No Longer Available in the U.S.
The COVID-19 vaccine from Johnson & Johnson is no longer available in the United States, according to the U.S. Centers for Disease Control and Prevention. All remaining doses expired last week, and the CDC directed providers to dispose of any that they had left over.
About 19 million people in the U.S. have received the J&J vaccine since it first became available. But more than 31.5 million doses have been delivered to states and other jurisdictions, leaving about 12.5 million doses unused, according to CDC data.
Last year, the CDC limited the emergency use authorization of the vaccine to adults for whom other vaccines aren’t appropriate or accessible due to the risk of a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine.
Judge Orders FDA to Accelerate Release of COVID Vaccine Trial Data to Just 2 Years
A federal judge in Texas this week ordered the Food and Drug Administration (FDA) to make public data it relied on to license COVID-19 vaccines — Moderna’s for adults and Pfizer’s for children — at an accelerated rate, requiring all documents to be made public by mid-2025 rather than, as the FDA wanted, over the course of around 23.5 years.
In a decision hailed as a win for transparency by the lawyer representing the plaintiffs (the parents of a child injured by a COVID-19 vaccine) in a lawsuit against the FDA, the Texas judge ordered the FDA to produce the data about 10 times faster than the agency wanted.
“Democracy dies behind closed doors,” is how U.S. District Judge Mark Pittman opened his order, issued on May 9, which requires the FDA to produce the data on Moderna’s and Pfizer’s COVID-19 vaccines at an average rate of at least 180,000 pages per month.
FDA Approves New Menopause Drug for Hot Flashes, Sweating and Chills
The Food and Drug Administration has approved a once-a-day pill for dealing with uncomfortable hot flashes brought on by menopause.
The new drug, Veozah (fezolinetant), differs from the traditional treatment of boosting the hormones estrogen and progestin to reduce menopause symptoms, which include sweating, flushing and chills. Developed by Astellas Pharma, Veozah blocks a chemical in the brain called neurokinin B (NKB), which regulates body temperature.
The drug carries an FDA warning about potential liver damage. Women will need to be screened for liver damage or infection before getting a prescription, then get a blood test every three months for nine months to monitor for safety problems, according to the FDA label. The most common side effects: abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated levels of liver enzymes.
The Tokyo, Japan-based Astellas Pharma said the drug will cost $550 for a one-month supply. That price is before insurance coverage is factored in — and before other discounts typically negotiated by insurers and pharmacy benefit managers.
Sanofi, AstraZeneca Study Results Add Support for Their RSV Drug in Infants
Sanofi and AstraZeneca released new study results on Friday that showed their antibody drug for respiratory syncytial virus reduced hospitalizations for infection-related respiratory disease by 83% in infants.
The drug, sold as Beyfortus, won approval in Europe in November as a preventive treatment for babies in their first RSV season and is due a decision by U.S. regulators in the third quarter. The results released Friday add to earlier data that showed the drug to be 75% effective in reducing RSV-related hospitalizations over placebo.
The study results are the latest in a series of drugmaker successes against RSV after decades of unfruitful efforts, including a vaccine that worsened infections in the 1960s. A research breakthrough 10 years ago gave scientists and pharmaceutical companies a better target to aim at, leading to a flurry of new efforts.
Last week, the Food and Drug Administration approved the first vaccine for RSV, clearing GSK’s shot Arexvy for older adults, who are also vulnerable to the disease. The shot could soon be followed onto the market by Pfizer’s vaccine, called Abrysvo. The U.S. regulator is expected to decide whether to clear the shot for preventing infections in older adults this month. An advisory committee supported its approval but raised concerns about side effect risks.
First U.S. Cases of Treatment-Resistant Ringworm Found in Patients in New York City
The U.S. Centers for Disease Control and Prevention is reporting the first known cases of antifungal-resistant ringworm in the United States and urging providers to be on the lookout for such infections.
The details of the cases were reported to the CDC in February and shared in a report published Thursday. The patients — two unrelated women in New York City — first had symptoms in 2021 and 2022. One patient had no international travel history, suggesting some community spread in the U.S.
Despite the name, ringworm is not caused by a worm; rather, it is caused by one of 40 species of fungus. In this case, the infections were caused by Trichophyton indotineae, a recently discovered fungus. Cases were first concentrated in patients in South Asia, but they’ve now also been found in countries in Europe. These are the first known U..S cases.
Pfizer Shines in Doctor Poll, Winning Praise for Innovative Ads and Leadership Across Therapeutic Areas
Physicians like Pfizer. That is the takeaway from a survey of 160 doctors, which found the Big Pharma is seen as a leader in three out of five therapeutic areas and is recognized for its innovative ads.
That’s according to a new report out by ZoomRx, which asked docs for their views on how drugmakers perform on a range of metrics in five therapeutic areas. Pfizer topped the leaderboard in cardiovascular, vaccines and oncology. Only AbbVie in immunology and Biogen in neuroscience prevented Pfizer from completing a clean sweep of the five therapeutic areas.
A closer look at the oncology data shows what Pfizer is doing right. More than half, 53%, of respondents named Pfizer as a leader in oncology, putting it joint first with AstraZeneca on that measure. And the Big Pharma put daylight between itself and rivals on other metrics, with 60% of physicians naming it as a top source of innovative cancer advertisements. AstraZeneca came second on the innovative ad metric at 50%.
Exclusive: Wegovy, Other Weight Loss Drugs ‘No Silver Bullet,’ Says WHO Amid Obesity Review
New highly-effective weight loss drugs such as Novo Nordisk’s (NOVOb.CO) Wegovy are not a “silver bullet” for addressing the rapid rise in global obesity rates, the World Health Organization’s nutrition chief told Reuters, as the agency conducts its first review of obesity management guidelines in more than 20 years.
The global health body is first revising guidelines for treating children and adolescents with obesity, and will then update recommendations for adults, said Francesco Branca, WHO director of nutrition and food safety.
As part of the work, the WHO has commissioned the Mario Negri Institute for Pharmacological Research, in Milan, Italy, to assess the evidence for the use of all drugs for children and adolescents — from older options like GSK‘s (GSK.L) Xenical to newer, more effective treatments like Wegovy and Eli Lilly and Co’s (LLY.N) Mounjaro, Branca told Reuters.
Studies suggest people are likely to have to take the drugs for the rest of their lives to keep the weight off. The American Academy of Pediatrics has recommended using such medicines in children aged 12 or older with obesity, even though the long-term impacts have yet to be studied.
U.S. Supreme Court Rejects Teva Challenge to $235 Million GSK Award in Patent Dispute
The U.S. Supreme Court on Monday declined to hear Teva Pharmaceuticals USA Inc’s (TEVA.TA) challenge to a $235 million award to GlaxoSmithKline LLC (GSK.L) in a patent dispute over generic drugs involving a heart medication.
The justices turned away Israel-based Teva’s appeal of a lower court’s ruling reinstating the jury award for U.K.-based GSK. The case involves “skinny labels,” which allow generic drugmakers to avoid patent lawsuits if a generic drug’s label omits potentially infringing uses of a brand-name drug.
GSK sued Teva in Delaware federal court in 2014 over its generic version of GSK’s heart drug Coreg. Teva argued that it followed U.S. Food and Drug Administration instructions to “carve out” from its label a patented method for using the drug to treat heart failure.
