Health News Roundup: Indivior to pay $30 million to settle health plans' Suboxone claims; US FDA approves Pfizer's maternal RSV vaccine to protect infants and more
Indivior is still facing claims by drug wholesalers that bought Suboxone from the Virginia-based company directly, with a trial scheduled in October. Japan health ministry panel recommends approval of Alzheimer's treatment Leqembi A Japanese health ministry panel on Monday recommended approval of the Alzheimer's disease treatment Leqembi, following standard approval for the drug granted by U.S. regulators last month.
Following is a summary of current health news briefs.
Indivior to pay $30 million to settle health plans' Suboxone claims
Indivior has agreed to pay $30 million to settle a class action lawsuit filed in a U.S. court by health plans accusing the drugmaker of illegally suppressing generic competition for its opioid addiction treatment Suboxone. The settlement, disclosed on Saturday in a filing by lawyers for the health plans in federal court in Philadelphia, must still be approved by a judge. Indivior is still facing claims by drug wholesalers that bought Suboxone from the Virginia-based company directly, with a trial scheduled in October.
US FDA approves Pfizer's maternal RSV vaccine to protect infants
The U.S. Food and Drug Administration on Monday approved Pfizer's respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third trimester of pregnancy to protect their babies. The approval allows the vaccine to be given to women 32 to 36 weeks into a pregnancy to prevent lower respiratory tract infection and severe disease in infants until they are six months old, the company said.
Japan health ministry panel recommends approval of Alzheimer's treatment Leqembi
A Japanese health ministry panel on Monday recommended approval of the Alzheimer's disease treatment Leqembi, following standard approval for the drug granted by U.S. regulators last month. The expert panel's decision sets the stage for official approval of the drug, co-developed by Japan's Eisai and U.S.-based Biogen.
Biden administration to urge Americans get new COVID-19 boosters
The Biden administration plans to urge all Americans to get a booster shot for the coronavirus this autumn to counter a new wave of infections, a White House official said on Sunday. The official said that while the Centers for Disease Control and Prevention are reporting an increase in infections and hospital admissions from the virus, overall levels remain low.
US FDA puts Gilead Sciences blood cancer drug studies on hold
Gilead Sciences said on Monday the U.S. health regulator placed a clinical hold on studies of its blood cancer drug, just a month after the company scrapped a late-stage trial due to efficacy concerns. The company gained access to the drug, magrolimab, with its $4.9 billion buyout of Forty Seven Inc in March 2020.
Boehringer latest to sue US over drug price negotiation plan
Boehringer Ingelheim sued the U.S. government in an attempt to block a program that gives the Medicare health insurance plan the power to negotiate lower drug prices, joining other drugmakers and business groups claiming that it would stifle development of new medicines. In a complaint filed on Friday in federal court in New Haven, Connecticut, the privately-held German drugmaker said the program violates the U.S. Constitution by giving federal regulators too much power to dictate drug prices.
Regeneron's Eylea could return to growth after nod to high-dose version- analysts
A quicker-than-expected U.S. approval for Regeneron Pharmaceuticals' high-dose eye disease drug, Eylea, should help return the blockbuster treatment back to growth in the next few years, Wall Street analysts said. The U.S. Food and Drug Administration approved the newer version of the drug on Friday, a few weeks ahead of schedule. In June, the agency had declined to approve it due to manufacturing issues at contract manufacturer Catalent.