For decades, the pharmaceutical industry’s approach to mental health was a playbook of conservative, incremental innovation. The market was saturated with me-too drugs — slight variations on existing antidepressants and antipsychotics that offered predictable, modest returns. For investors, it was a safe bet. For patients suffering from the most severe forms of mental illness, it…
File this under “unintended consequences.” Over the past few months, the U.S. Patent and Trademark Office has pursued new policies that its officials insist will preserve patents from unnecessary legal challenges and strengthen the system for protecting innovation. But critics — including some drug companies — argue the moves would undercut a valuable process for confirming…
Damian Garde is a reporter at large, live and feature journalism, covering the global drug industry and contributing to STAT’s industry-leading events. AbbVie is ending a decade-long partnership with Calico Life Sciences, an Alphabet-funded biotech company focused on aging research, and laying off chemists working on discovering new drugs. The moves, detailed in internal emails…
WASHINGTON — Health secretary Robert F. Kennedy Jr. has said he does not want to take vaccines away from Americans. But at a closed-door meeting of Food and Drug Administration vaccine scientists in September, a top official suggested doing just that. Scientists listened as Tracy Beth Høeg, a lieutenant to FDA Commissioner Marty Makary, laid…
WASHINGTON — The Food and Drug Administration named Richard Pazdur, its longtime overseer of cancer therapies, as top drug regulator on Tuesday. Pazdur replaces former Center for Drug Evaluation and Research Director George Tidmarsh, who exited the agency earlier this month amid accusations of using his regulatory authority to advance a personal vendetta against a…
Isabella Cueto covers the leading causes of death and disability: chronic diseases. Her focus includes autoimmune conditions and diseases of the lungs, kidneys, liver (and more). She writes about intriguing research, the promises and pitfalls of treatment, and what can be done about the burden of disease. You can reach Isabella on Signal at isabellacueto.03….
Mergers and acquisitions are a spectator sport. You couldn’t hope for a better match to watch than the competition between Pfizer and Novo Nordisk over Metsera, a rollup of several experimental weight loss drugs founded three years ago. It had political intrigue, Big Pharma gamesmanship, and suspense, until Pfizer triumphed with a $10 billion offer….
Biotech is booming in China, and that’s no accident. While the most closely tracked U.S. index of biotech stocks is up more than 20% this year, Chinese biotech stocks are doing even better, staging a dazzling market rebound. The Hang Seng Biotech Index, which tracks the 30 largest biotech firms in Hong Kong, has climbed…
President Trump last week hailed his deal with pharma companies to cut the price of blockbuster weight loss drugs as a major win for his administration and for increasing drug affordability. The question is how big of a difference the agreement will make for patients. The deal is expected to significantly expand access to GLP-1…
WASHINGTON — The Food and Drug Administration is struggling to select a new head of its drug center after the sudden and chaotic exit of the previous director, George Tidmarsh. Richard Pazdur, the director of the FDA’s Oncology Center for Excellence, was approached about the job and turned it down, two sources told STAT. The Pink…