CDC advisors advocate a vaccine for susceptible adults in future outbreaks

Vials of the JYNNEOS Monkeypox vaccine are prepared at a pop-up vaccination clinic in Los Angeles, California on August 9, 2022. Patrick T Fallon | AFP | Getty Images Independent advisors to the Centers for Disease Control and Prevention on Wednesday unanimously recommended giving the two-dose Jynneos vaccine to adults at risk of Mpox in …

Moderna (MRNA) This autumn Outcomes 2022

Modern on Thursday missed fourth-quarter earnings expectations as costs rose from excess manufacturing capacity and lower demand for its Covid-19 vaccine, the company’s only product on the market. Moderna reported quarterly earnings of $3.61 per share, down 68% from the same period in 2021 when it posted $11.29 per share. The number fell short of …

FDA says Guillain-Barre syndrome is a possible danger for a Pfizer RSV vaccine

This 1981 photo provided by the Centers for Disease Control and Prevention (CDC) shows an electron micrograph of respiratory syncytial virus, also known as RSV. CDC via AP The Food and Drug Administration sees a possible risk of Guillain-Barre syndrome Pfizer‘s RSV vaccine for older adults and has asked the company to conduct a safety …

Democratic companies are suing the FDA over restrictions on the abortion capsule

Boxes of mifepristone, the first pill to be given in a medical abortion, are prepared for patients at the Women’s Reproductive Clinic of New Mexico in Santa Teresa, the United States, January 13, 2023. Evelyn Hockstein Reuters A coalition of a dozen Democratic attorneys general sued the Food and Drug Administration on Friday to force …

Medicare denies Alzheimer’s Affiliation’s request for protection for remedies like Leqembi

Medicare will not offer broader coverage of Alzheimer’s drug Leqembi until there is more evidence that the treatment is appropriate and necessary, according to the federal agency that runs the program for seniors. The Centers for Medicare and Medicaid Services denied an Alzheimer’s Association request for unrestricted coverage of antibody treatments approved by the Food …

West Virginia seeks to dismiss lawsuit over entry to abortion capsules

West Virginia’s Attorney General is asking a judge to dismiss a lawsuit aimed at overturning state restrictions on the abortion pill. Attorney General Patrick Morrisey on Tuesday asked federal court in the Southern District of West Virginia to dismiss the lawsuit brought by GenBioPro, which manufactures the generic version of the abortion pill called mifepristone. …

Pfizer RSV vaccine for infants might get FDA approval this summer time

David Paul Morris | Bloomberg | Getty Images PfizerThe vaccine, which protects infants from respiratory diseases, could receive Food and Drug Administration approval by the end of this summer. Pfizer said Tuesday the FDA is expediting review of the vaccine. The agency is expected to make a decision on whether to delete the shot in …

Moderna CEO Bancel is ready to testify earlier than the Senate on the Covid vaccine worth hike

Modern CEO Stéphane Bancel is due to testify before the Senate Health Committee in March about the company’s price for its Covid-19 vaccine if the shots are sold on the private market. Senator Bernie Sanders, chair of the health panel, confirmed in a statement Wednesday that Bancel would appear at a hearing titled, “Taxpayers paid …

The maker of Alzheimer’s drug Leqembi expects full FDA approval this summer time

Tek Image/Science Photo Library | Science Photo Library | Getty Images Japanese drugmaker Eisai expects the Food and Drug Administration to fully approve its Alzheimer’s treatment Leqembi this summer, which would expand access to the expensive new antibody under Medicare. US CEO Ivan Cheung said the FDA, which granted accelerated approval in January, could grant …

Senators are asking Medicare to cowl Alzheimer’s therapies

U.S. senators Friday called for Medicare to offer broad coverage of Alzheimer’s treatments approved by the Food and Drug Administration, warning that the current restrictions are costing patients valuable time as their disease progresses. “Given the progressive nature of this terminal disease, we encourage you to take action now to ensure patients have immediate access …