Health News Roundup: US FDA seeks 'boxed warning' for CAR-T cancer therapies; CDC says JN.1 variant accounts for about 86% of COVID cases in US and more
Separately, the New Jersey-based drugmaker has tentatively agreed to pay about $700 million to settle an investigationbrought by more than 40 states into the marketing of its talc products, J&J told the Wall Street Journal. Biden administration urges US Supreme Court to reverse abortion pill curbs A 2023 judicial decision that would curb access to the abortion pill threatens to disrupt the authority of the Food and Drug Administration (FDA) and harm the American healthcare system, President Joe Biden's administration told the U.S. Supreme Court on Tuesday, urging the justices to reverse the ruling.
Following is a summary of current health news briefs.
CDC says JN.1 variant accounts for about 86% of COVID cases in US
The U.S. Centers for Disease Control and Prevention (CDC) on Monday estimated COVID subvariant JN.1 to account for about 85.7% of cases in the United States, as of Jan. 19. The agency said JN.1 remains the most widely circulating variant of SARS-CoV-2 in the country and globally.
US FDA seeks 'boxed warning' for CAR-T cancer therapies
The U.S. health regulator on Monday asked a host of drugmakers, including Gilead Sciences, Johnson & Johnson and Novartis, to add a serious warning on the label of their cancer therapies that use CAR-T technology. The other cancer therapies include Bristol Myers Squibb's Breyanzi and its partnered therapy, Abecma, with 2seventy bio, J&J unit Janssen and Legend Biotech's Carvykti, Novartis AG's Kymriah, and Gilead unit Kite's Tecartus and Yescarta.
France's Sanofi boosts rare disease business with about $2.2 billion Inhibrx deal
French healthcare company Sanofi has agreed to buy U.S. biotech firm Inhibrx in a deal valued at up to $2.2 billion, bolstering its drug development portfolio with an experimental treatment for a rare genetic disease. The companies said the deal will give Sanofi access to Inhibrx's INBRX-101, currently in the second of three phases of clinical trials, while its other experimental drugs will be spun off into a separate company, with Sanofi retaining an 8% stake.
J&J profit edges past Street view after deals delay Stelara competition
Johnson & Johnson on Tuesday reported quarterly results just above Wall Street expectations, helped by strong sales of its blockbuster psoriasis drug Stelara, which is expected to face fresh U.S. competition from biosimilar versions next year. Separately, the New Jersey-based drugmaker has tentatively agreed to pay about $700 million to settle an investigationbrought by more than 40 states into the marketing of its talc products, J&J told the Wall Street Journal.
Biden administration urges US Supreme Court to reverse abortion pill curbs
A 2023 judicial decision that would curb access to the abortion pill threatens to disrupt the authority of the Food and Drug Administration (FDA) and harm the American healthcare system, President Joe Biden's administration told the U.S. Supreme Court on Tuesday, urging the justices to reverse the ruling. The Justice Department filed a written brief outlining its main arguments to preserve broad access to the pill, called mifepristone, in its appeal of an August decision by the New Orleans-based 5th U.S. Circuit Court of Appeals that barred telemedicine prescriptions and shipments by mail of the drug.
Cameroon begins routine malaria shots in global milestone
The global fight against malaria took a stride forward on Monday as Cameroon started the world's first routine vaccine programme against the mosquito-borne disease, although Reuters journalists witnessed few people in clinics receiving the shot. Around 40 years in the making, the World Health Organization (WHO)-approved RTS,S vaccine developed by British drugmaker GSK is meant to work alongside existing tools such as bed nets to combat malaria, which in Africa kills nearly half a million children under the age of five each year.
Martin Shkreli's lifetime drug industry ban upheld
Martin Shkreli, known for once hiking the price of a life-saving drug more than 4,000%, cannot return to the pharmaceutical industry after a federal appeals court on Tuesday upheld his lifetime ban. A three-judge panel of the 2nd U.S. Circuit Court of Appeals in Manhattan said a lower court judge acted properly in imposing the ban and ordering Shkreli to repay $64.6 million because of his antitrust violations.
Walgreens to explore sale of Shields Health for over $4 billion - Bloomberg News
Walgreens Boots Alliance is exploring a sale of specialty pharmacy company Shields Health Solutions, Bloomberg News reported on Tuesday, citing people familiar with the matter. The sale could be valued at more than $4 billion, the report added.
Intuitive beats estimates as rebound in surgeries boost demand for its robots
Intuitive Surgical beat Wall Street estimates for fourth-quarter revenue and profit on Tuesday, as a recovery in surgeries lifted demand for its robots used in minimally invasive procedures. Medical device makers have largely noted as "temporary" the impact of powerful new weight-loss drugs such as Novo Nordisk's Wegovy and Eli Lilly's Zepbound on sales of products used to perform abdomen surgeries.
J&J agrees to resolve 42 U.S. states' talc investigations
Johnson & Johnson on Tuesday said it had reached a tentative settlement to resolve probes by U.S. states into whether it misled consumers about the safety of its talc products, which thousands of lawsuits claim can cause cancer. The deal includes 42 states and Washington, D.C. The company tentatively agreed to pay about $700 million to settle the states' claims, according to the Wall Street Journal.
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