Health News Roundup: US appeals Texas abortion pill ruling as states stockpile the drug; Britain to encourage smokers to swap cigarettes for vapes and more
U.S. District Judge Matthew Kacsmaryk's ruling on Friday, which followed a March 15 hearing, was a preliminary injunction that would essentially ban sales of mifepristone while the case by anti-abortion groups before him continues in the Northern District of Texas. US FDA advisers to weigh full approval for Eisai-Biogen's Alzheimer's drug The U.S. Food and Drug Administration (FDA) plans to hold a meeting of its outside experts in June to discuss full approval of the Alzheimer's drug developed by Eisai Co Ltd and Biogen Inc, according to a federal filing on Monday.
Following is a summary of current health news briefs.
US appeals Texas abortion pill ruling as states stockpile the drug
The U.S. government on Monday appealed a Texas judge's decision to suspend the Food and Drug Administration's 23-year-old approval of a key abortion drug, saying the ruling endangered women's health by blocking access to a pill long deemed safe. In a filing with the 5th U.S. Circuit Court of Appeals, the Department of Justice called Judge Matthew Kacsmaryk's decision on the drug mifepristone "especially unwarranted" because it would undermine the FDA's scientific judgment and harm women for whom the drug is medically necessary.
Britain to encourage smokers to swap cigarettes for vapes
Up to one million smokers will be encouraged to swap cigarettes for "vapes", with pregnant women offered financial incentives to make the change in what will be a world first, the British government said on Tuesday. Under the scheme, almost one in five smokers will be given a vape - an e-cigarette - starter kit along with support to help quit smoking, the Department of Health (DoH) said.
J&J talc unit 2nd bankruptcy must be dismissed, cancer victims' lawyers say
Johnson & Johnson’s second attempt to resolve talc lawsuits in bankruptcy should be dismissed as an unprecedented fraud designed to deny plaintiffs just compensation, lawyers representing cancer victims argued in a Monday court filing. The attorneys contend J&J defied a January appeals court rejection of its first attempt to settle the litigation, noting that a J&J subsidiary refiled for Chapter 11 about two hours after a court dismissed its first bankruptcy. The lawyers blasted the move as the "largest intentional fraudulent transfer in United States history."
Explainer-Texas judge suspends approval of abortion pill. What happens next?
U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas on Friday suspended approval of the abortion pill mifepristone, which will essentially make sales of the pill illegal in the U.S., while a legal challenge proceeds. The legal battle over medication abortion is only beginning and could wend its way through multiple levels of appeals courts over a period of months or years before it is resolved. Here is what you need to know about the case as it further unfolds:
US judge suspends approval of mifepristone in latest abortion setback
A U.S. judge in Texas on Friday suspended the two-decade-old approval of the abortion pill mifepristone while a legal challenge proceeds, dealing another setback to abortion rights in the United States. Adding to the volatile legal landscape around abortion, a federal judge in Washington state on Friday issued a seemingly conflicting injunction that prevented federal regulators from altering access to the same abortion drug.
Pfizer, Biogen among hundreds of US drugmakers calling for abortion pill ruling reversal
Executives from more than 300 biotech and pharmaceutical industry companies, including Pfizer Inc and Biogen Inc, signed an open letter on Monday calling for reversal of a federal judge's decision to suspend sales of the abortion pill mifepristone. A U.S. judge on Friday suspended the U.S. Food and Drug Administration's 2000 approval of the drug, effectively banning sales while a case brought by anti-abortion groups before him continues in the Northern District of Texas.
U.S. spending $5 billion to speed up development of new COVID vaccines
The U.S. government is spending over $5 billion on an effort to speed up the development of new COVID-19 vaccines and treatments, a Department of Health and Human Services (HHS) spokesperson and a Biden administration official said on Monday.
The investment, dubbed "Project NextGen" and first announced by White House and HHS officials in an interview with the Washington Post, aims to provide better protection from coronaviruses, including the one that causes COVID-19, that might become future threats.
Analysis-Texas abortion pill ruling could undermine US drug regulator
A federal judge's decision last week to suspend the U.S. Food and Drug Administration's (FDA) approval of abortion pill mifepristone could severely weaken the agency if allowed to stand, health policy and legal experts said. U.S. District Judge Matthew Kacsmaryk's ruling on Friday, which followed a March 15 hearing, was a preliminary injunction that would essentially ban sales of mifepristone while the case by anti-abortion groups before him continues in the Northern District of Texas.
US FDA advisers to weigh full approval for Eisai-Biogen's Alzheimer's drug
The U.S. Food and Drug Administration (FDA) plans to hold a meeting of its outside experts in June to discuss full approval of the Alzheimer's drug developed by Eisai Co Ltd and Biogen Inc, according to a federal filing on Monday. The drug, Leqembi was granted accelerated approval by the FDA in January for patients in the earliest stages of the mind-wasting disease.