The Hatch-Waxman Act of 1984, which gave rise to the modern generic drug market, was one of the most significant cost-reducing policy innovations of the last 40 years. In 2021 alone, the use of generic and biosimilar drugs saved $373 billion in health expenditures. More than 90% of prescriptions filled that year were for generics or biosimilars, up from just over 18% the year that Hatch-Waxman was passed. Today, however, generic drugs seem to be a victim of their success. Important categories of drugs — from antibiotics to chemotherapies to saline solution — experience persistent shortages and ..read more

In my work as a pediatric psychologist, I’ve been seeing a surge in the number of families with transgender or nonbinary children who are moving to Connecticut, where I live and work. In the past month, a real estate agent colleague has worked with 30 families with transgender children who were trying to find homes in central Connecticut, where they could get access to gender-affirming care. This influx is indicative of a grim reality: nearly half of respondents to the U.S. Trans Survey reported having thought about moving to another state because theirs considered, or passed, laws that target ..read more

LONDON — Claire Booth, a gene therapy researcher in London, had hoped that a biotech company would take her team’s work on an experimental medication for an ultra-rare children’s disease and get it to market. It didn’t happen. Now, in an unusual step, the hospital where she works is trying to get the medicine approved on its own. Booth, who leads the stem cell gene therapy program at London’s Great Ormond Street Hospital for Children, is trying to overcome the fact that many biopharma companies have abandoned promising genetic therapies for ultra-rare diseases or halted their research programs ..read more

Physicians, researchers, CEOs, reporters, and more gathered in downtown Boston Wednesday night to celebrate STAT’s 2024 STATUS List, which features 50 leaders in the life sciences. Members of this year’s list (and a few past honorees) spoke about what issues in their fields — ranging from investment to clinical research to bedside treatment — need to be prioritized in order to improve health care across the U.S. and the rest of the world. Equity and inclusion To achieve true equity in medical science “requires us to divest our research from the ivory towers of elite institutions,” said 2023 ho ..read more

After months of deliberation, the Colombian government has issued a compulsory license for an HIV medicine, the first time the country has taken such a step, one that also marks a significant move in the increasingly global battle over access to medicines. The license is designed so that tens of thousands of Colombians can obtain a lower-cost version of dolutegravir, a medicine that is manufactured and sold by ViiV Healthcare, a company that specializes in HIV treatments and is largely controlled by GSK. Dolutegravir is recommended by the World Health Organization as part of the preferred firs ..read more

WASHINGTON — Takeda Pharmaceuticals has left the biotechnology industry’s main lobbying group, the fourth departure of a major member since December, the company confirmed. “Takeda decided not to renew its membership with the Biotechnology Innovation Organization at the end of March 2024, aligned with the end of Takeda’s Fiscal Year,” a company spokesperson said. Pfizer, UCB, and WuXi AppTech also recently ended their membership with the trade group, though the circumstances of WuXi’s departure were unusual. In response to BIO’s opposition to a bill that would make it difficult for WuXi to do ..read more

WASHINGTON — Nearly two years after the Supreme Court overturned Roe v. Wade, justices are wrestling with a litany of state abortion restrictions, and whether they undercut federal law. The latest abortion battle before the court centers on national requirements that doctors do everything they can to stabilize an emergency room patient, including performing an abortion if necessary. The Biden administration sued Idaho in the months after the court’s Dobbs decision in 2022, arguing the state’s new abortion ban clashed with the requirements of the Emergency Medical Treatment and Labor Act&n ..read more

Genetic evidence of the H5N1 bird flu virus was found in grocery store milk in the United States this week, according to the Food and Drug Administration. The news follows the discovery that the avian flu has been detected in dairy cows. But what do traces of virus in pasteurized milk mean for consumers? In this video, STAT explains what is known about the safety of milk on grocery shelves. Read the rest ..read more

NEW YORK — Doctors have transplanted a pig kidney into a New Jersey woman who was near death, part of a dramatic pair of surgeries that also stabilized her failing heart. Lisa Pisano’s combination of heart and kidney failure left her too sick to qualify for a traditional transplant, and out of options. Then doctors at NYU Langone Health devised a novel one-two punch: Implant a mechanical pump to keep her heart beating and days later transplant a kidney from a genetically modified pig. Read the rest ..read more

The U.S. Department of Agriculture moved to try to limit spread of the H5N1 bird flu virus among dairy cattle on Wednesday, issuing a federal order that will require an animal to test negative for the virus before it can be moved across state lines. It also requires laboratories and state veterinarians to report to the USDA any animals that have tested positive for H5N1 or any other influenza A virus. In addition, farms that move cattle across state lines and have animals that test positive for H5N1 or any influenza A virus will be required to open their books to investigators, so they can tra ..read more