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CDC Advisors Back RSV Vaccine for Older Adults, With Caveats — ACIP Stops Short of Full-Throated Endorsement, Recommends a Talk With Medical Provider First
The CDC‘s advisors on Wednesday recommended the newly approved respiratory syncytial virus (RSV) vaccines for older adults but opted not to give their strongest endorsement.
In a series of two votes, the Advisory Committee on Immunization Practices (ACIP) said that adults 60 and older may receive one dose of the recently approved RSV prefusion F protein-based vaccines after discussions with their health provider.
Originally, the CDC had asked ACIP to vote on broadly recommending the vaccines to people 65 and older, but that plan got tweaked during discussions earlier in the day.
The CDC noted that despite a signal for increased risk of Guillain-Barré Syndrome or other neurologic inflammatory events in the trials, the risks of these adverse events were not known and that the agency would rely on ongoing post-marketing surveillance by manufacturers to continue monitoring these safety concerns.
FDA Approves Eli Lilly-Boehringer’s Diabetes Drugs for Children
The U.S. Food and Drug Administration (FDA) on Tuesday approved Eli Lilly (LLY.N) and partner Boehringer Ingelheim’s drugs Jardiance and Synjardy to treat type 2 diabetes in children.
The drugs were approved as additions to diet and exercise to improve blood sugar control in children aged 10 years and above with type 2 diabetes, the most common form of the disease.
Empagliflozin, which works by increasing the excretion of glucose in the urine, offers an alternative to pediatric patients for whom the diabetes drug metformin has been the only oral treatment.
Novo Nordisk Says EMA Raised Safety Signal on Drugs Including Semaglutide
A thyroid cancer safety signal was raised by the EU’s drugs watchdog last month over several Novo Nordisk (NOVOb.CO) products including semaglutide, which is used in popular diabetes and obesity medicines Ozempic and Wegovy.
The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs, Novo Nordisk said. Such a signal from the EMA does not mean that the medicine is the cause of any reported adverse events.
Lars Otto Andersen-Lange, media relations director at Novo Nordisk, said the Danish media outlet B.T. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide.
EMA’s safety signal also included GLP-1 drugs from competitors Eli Lilly (LLY.N), AstraZeneca (AZN.L) and Sanofi (SASY.PA). The companies have until July 26 to provide supplementary information requested in April, EMA said.
Daily Use of Low-Dose Aspirin May Increase Anemia Risk in Healthy Older Adults: Study
Long-term use of low-dose aspirin is associated with a 20% increased risk of developing anemia and a decline in blood iron levels in older adults, according to a new analysis of a National Institutes of Health-funded clinical trial.
The report published in the Annals of Internal Medicine revealed that a group of 19,114 healthy adults at least 65 years old were randomly assigned to take 100mg of aspirin or a placebo to determine the effect of low-dose aspirin on incident anemia, hemoglobin and serum ferritin concentrations.
At the end of the trial, researchers from Australia, New Zealand and the United States determined that taking low-dose aspirin on a daily basis appeared to increase anemia and reduce the levels of ferritin and hemoglobin. The results were independent of major bleeding.
Tel Aviv University Removes Sackler Family, Makers of OxyContin, From Medical School’s Full Name
Tel Aviv University announced on Wednesday that it has removed the Sackler family from the full name of its medical school after decades of donations from the makers of OxyContin.
The move came after years of petitions to pull the longtime donors’ name from the campus while the Sacklers faced extensive lawsuits for their role in the opioid epidemic.
Last month an American court approved a plan for the maker of OxyContin to settle thousands of legal claims connected to the opioid epidemic while shielding the billionaire owners of Purdue Pharma, the Sackler family, from additional lawsuits.
Pharmaceutical Lobbyists Challenge Biden’s Drug Law in Friendly Territory
The top lobbying organization for the pharmaceutical industry yesterday filed the fourth lawsuit challenging Democrats’ law that gives Medicare the power to negotiate the prices of certain drugs, this time in a Texas district court.
Why it matters: More lawsuits give the industry more opportunities for success. And filing in this particular court means the case would run through the staunchly conservative 5th Circuit Court of Appeals.
State of play: PhRMA’s lawsuit was preceded by ones filed earlier this month by Merck, the U.S. Chamber of Commerce and Bristol Myers Squibb.
White House Meets With Drug Firms on Cost of Overdose-Reversal Drugs
White House officials met with pharmaceutical company representatives Tuesday in an effort to address long-standing concerns about the affordability of overdose-reversal drugs that the Biden administration views as crucial to saving lives amid the nation’s raging opioid crisis.
The meeting was held with representatives from 10 companies, including Emergent BioSolutions, which later this summer will start selling without a prescription an overdose-reversal drug called naloxone. Critics have slammed Emergent for plans to price the nasal spray, sold under the brand name Narcan, at “less than $50” per two-dose kit, which they say is too expensive for many people, let alone those who regularly use drugs.
Representatives from Emergent, Pfizer, Hikma, Padagis, Amphastar Pharmaceuticals, Teva Pharmaceuticals, Adamis Pharmaceuticals and U.S. WorldMeds, which all make or market forms of naloxone, attended Tuesday’s meeting, as did Aptar Pharma, which makes the devices that deliver the nasal spray. Executives from Indivior also were present; that company recently gained FDA approval for prescription Opvee, a nasal spray of nalmefene, another reversal medication touted as a powerful antidote to synthetic drugs such as fentanyl.
The summit unfolded as pharmaceutical companies face criticism that they are trying to cash in on stronger and more expensive opioid reversal drugs despite the availability of cheaper and proven injectable naloxone.
