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FDA Advisers to Consider RSV Vaccine to Protect Newborns
The U.S. Food and Drug Administration’s independent vaccine advisers are meeting Thursday to discuss whether a new vaccine to protect infants from the common respiratory syncytial virus, known as RSV, is safe and effective.
If the agency approves the vaccine, it will be the first to protect babies against RSV — a goal scientists have been working toward for decades.
The maternal vaccine is a single-dose shot that would be given to pregnant people late in pregnancy. It would trigger the development of antibodies that are passed on to the fetus and provide protection for about the first 6 months of the baby’s life.
WHO Recommends New COVID Shots Should Target Only XBB Variants
A World Health Organization (WHO) advisory group on Thursday recommended that this year’s COVID-19 booster shots be updated to target one of the currently dominant XBB variants.
New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered.
The group suggested no longer including the original COVID-19 strain in future vaccines, based on data that the original virus no longer circulates in human beings and shots targeting the strain produce “undetectable or very low levels of neutralizing antibodies” against currently circulating variants.
COVID-19 vaccine makers like Pfizer/BioNtech (PFE.N), Moderna Inc (MRNA.O) and Novavax Inc (NVAX.O) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating strains.
The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected.
U.S. FDA Staff Flag ‘Serious’ Safety Risks for Intercept’s Fatty-Liver Disease Treatment
The U.S. health regulator’s staff reviewers on Wednesday raised a string of concerns with Intercept Pharmaceuticals’ (ICPT.O) treatment for a type of fatty liver disease, sending the drugmaker’s shares plunging 22%.
The U.S. Food and Drug Administration‘s reviewers flagged an increased risk of diabetes and liver injury from using the oral tablets, called obeticholic acid (OCA), for the treatment of nonalcoholic steatohepatitis (NASH).
On Wednesday, the FDA’s reviewers listed the increased risk of sludge formation in the gall bladder, and imbalance of certain lipids, as some of the risks with the drug. “During the course of our review, FDA identified modest benefits and serious risks of OCA for treatment of NASH,” the staff said.
Several drugmakers including Novo Nordisk (NOVOb.CO) and other smaller companies such as Madrigal Pharmaceuticals Inc (MDGL.O) and Akero Therapeutics Inc (AKRO.O) are racing to enter what is expected to be a multi-billion dollar U.S. market.
Health Experts on Twitter Overwhelmingly Exaggerated Risk of Kids Getting Monkeypox: Study
During last summer’s monkeypox (mpox) outbreak, medical professionals on Twitter were four times more likely to exaggerate the risk of the viral disease spreading among children than share accurate information, a new study suggests.
Mpox is spread through intimate skin contact, including sex, kissing, and sharing bedding or clothing. Data from the United States and several other countries indicated that it predominantly affects men who have sex with men — a pattern that emerged early on and continued throughout the 2022 outbreak. No evidence suggests that schools are a high-risk environment for mpox transmission or that children are a high-risk population for infection.
For their study, researchers at the George Washington University and the University of California at San Fransisco identified 262 posts sent by 188 credentialed Twitter accounts, including those of health professionals and health reporters, between May and October 2022. Those posts all discuss the risk of mpox to children and young people in schools and contain the keywords “school,” “monkeypox,” “mpox,” and “pox.”
Among all 262 posts, according to the analysis, 47 (18%) were accurate, while 215 (82%) overstated the risk of mpox infection in children, predicted that mpox would spread widely in schools, and argued that schools should be closed or delayed to prevent or slow down mpox transmission. Among all the unique authors, an overwhelming 163 (87%) posted such fear-based messaging.
Long-Term Side Effects of Tepezza Cause Hearing Loss, Lawsuits Allege
Although Tepezza was introduced as a breakthrough new treatment for thyroid eye disease (TED), a growing number of individuals are now pursuing Tepezza hearing loss lawsuits, alleging that the manufacturer withheld important information about long-term side effects, which could have been avoided if warnings had been provided about the importance of monitoring for hearing damage during treatment.
Given common questions raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will consider oral arguments next week about whether each of the lawsuits over long-term side effects of Tepezza should be consolidated before one judge, as part of an MDL or multidistrict litigation.
Leading up to the hearing, at least three new complaints have been filed this week, each raising nearly identical allegations. However, it is widely expected that this just represents the tip of an iceberg of lawsuits that will be brought in the coming years, each claiming that Tepezza side effects caused hearing loss.
Pfizer to Raise $31 Billion in Debt Offering to Fund Seagen Acquisition, SEC Filing Shows
Pfizer plans to raise $31 billion through a debt offering to fund its proposed acquisition of cancer drug maker Seagen, for what would be its largest takeover since 2009, according to a new filing with the Securities and Exchange Commission. Pfizer expects to complete the $43 billion Seagen buyout later this year or in early 2024.
The pharma giant’s debt offering would be the biggest since CVS Health sold $40 billion of bonds in 2018 to finance its acquisition of health insurer Aetna.
Pfizer’s move comes as other corporations including Apple, T-Mobile and Merck rush to tap the U.S. bond market ahead of a potential spike in borrowing costs sparked by the debt ceiling standoff.
Walgreens to Pay San Francisco $230 Million for Its Role in Opioid Epidemic
Walgreens has agreed to pay $230 million to San Francisco for its role in the city’s opioid epidemic following last year’s landmark trial that found the pharmacy chain liable for not performing proper screenings.
San Francisco City Attorney David Chiu announced the deal outside San Francisco City Hall today. If approved, the settlement would end claims from the last defendant of a 2018 lawsuit enacted by the city against the opioid industry.
The case was the first of its kind in the region and the first to include defendants along the pharmaceutical supply chain, including drug manufacturing, distributors and pharmacies. A federal judge found Walgreens liable for “substantially contributing to the opioid epidemic in San Francisco.”
This Opioid Addiction Drug Is Rarely Misused. So Why Is There so Much Regulation?
Buprenorphine, an important drug in fighting the opioid crisis, has long been closely monitored over concerns it would be abused. But a first-of-its-kind government oversight report released Thursday finds Medicare recipients rarely misuse the drug, which is considered an underused tool to treat opioid addiction and stem overdose deaths.
The report concluded buprenorphine is “critical to addressing the nation’s opioid crisis” but likely isn’t prescribed enough. Fewer than 1 in 6 Medicare enrollees who are addicted to opioids take the medication even as drug overdose deaths soar.
