Health News Roundup: US FDA seeks 'boxed warning' for CAR-T cancer therapies; J&J profit edges past Street view after deals delay Stelara competition 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. Gilead's Trodelvy fails to meet main goal in lung cancer trial Gilead Sciences said on Monday its drug, Trodelvy, failed to significantly improve survival for previously treated patients with advanced non-small cell lung cancer (NSCLC) in a late-stage study, sending its shares down more than 10%.

Health News Roundup: US FDA seeks 'boxed warning' for CAR-T cancer therapies; J&J profit edges past Street view after deals delay Stelara competition and more
Representative image Image Credit: ANI

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.

Gilead's Trodelvy fails to meet main goal in lung cancer trial

Gilead Sciences said on Monday its drug, Trodelvy, failed to significantly improve survival for previously treated patients with advanced non-small cell lung cancer (NSCLC) in a late-stage study, sending its shares down more than 10%. The California-based drugmaker was testing Trodelvy, which belongs to a class of treatments known as antibody drug conjugates, in patients with both squamous and non-squamous NSCLC - the most common type of lung cancer.

Fate of most remaining Zantac lawsuits weighed by Delaware judge

GSK, Pfizer and other pharmaceutical companies are urging a judge in Delaware this week to find that evidence plaintiffs' lawyers want to use in about 72,000 lawsuits claiming that the discontinued heartburn drug Zantac caused cancer is not supported by science. If they are successful, that could end much of the long-running litigation over the drug and greatly reduce the risk of hefty damage awards or settlements, which has weighed on companies' shares in recent years.

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.

EU drug watchdog to consider wider use of Wegovy weight-loss drug

The European Union's drug regulator will this week consider wider use of Novo Nordisk's weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks. Approval could help the Danish drugmaker better argue its case for making the drug available via public sector health systems in Europe.

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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