Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and inspiring, because that oh-too predictable routine of online meetings, phone calls, and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So to give it a nudge in a better direction, we are firing up the...

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello! Today we learn whether AI might help hasten the development of n-of-1 therapies (hint: not yet), explore why the FDA hasn’t offered Orange Book guidance on drug-device combinations, and talk about CRISPR. A lot.Read the...

When it comes to a crucial controversy over pharmaceutical patents, the FDA has been MIA. For nearly 20 years, drug companies have asked the Food and Drug Administration for guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in an obscure, but highly important agency...

“Does it trouble you to answer that question?” one of New York’s highest paid attorneys asked Cliff Douglas, then a 36-year-old activist who had found himself at the center of a $10 billion libel lawsuit brought by the cigarette giant Philip Morris. Philip Morris’ lawyer Herbert Wachtell demanded to know: Were cigarette companies intentionally killing...

While many people immediately picture young adults when thinking about the current addiction and overdose epidemic, this crisis is affecting all generations. In fact, more than 7 million older Americans struggle with substance use disorders. Opioid use disorder, in particular, has skyrocketed among Medicare beneficiaries, with opioid overdose death...

The number of children who received their routine vaccinations declined during the pandemic, so public health officials have been focusing on getting kids back up to date. They should also be paying attention to adults as a new, first-of-its-kind report quantifying the economic impact of adult immunizations makes clear. Researchers at the nonprofit...