In a boost for Gilead Sciences, the California Supreme Court agreed to review a contentious legal theory that thousands of HIV patients have used in a closely watched case to argue drugmakers can be held negligent for failing to develop a medicine. Earlier this year, a state appeals court ruled the company could be held liable for halting further development of an HIV medicine that was safer than an HIV drug it was already selling. Back in 2004, Gilead explained its decision by maintaining the medicines were not sufficiently different, but internal documents produced in court suggested the com ..read more

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, we’re nearing the end of my second week writing this newsletter. I want to know what you think! Share your feedback in this survey if you haven’t already. Read the rest ..read more

Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus again, but our spirits remain sunny, nonetheless. Why? We recall a bit of insight from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is pistachio creme. Remember, a prescription is not required. So no need to mess with rebates. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day ..read more

WASHINGTON  — The Drug Enforcement Administration is reversing a regulation that had been expected to create shortages of morphine and other opioid injectables, according to a DEA letter to drugmakers obtained by STAT. The DEA dictates the quantity of controlled substances that drug companies are allowed to make. Until this year, those quotas were set annually for Schedule II drugs, such as morphine and other injectable opioids that hospitals regularly use.  In December, the DEA announced that it would use quarterly quotas instead. The goal was to prevent shortages. Some drug manufac ..read more

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy. So grab that cup of stimulation and get started. Our flavor today is mocha hazelnut, for those tracking our habits. Now, though, the time has come to get busy. So please grab your own cup and dig in to the items of interest asse ..read more

A controversial provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare Part D nearly $15 billion from 2015 to 2021 on just 15 medicines during that period, according to a new analysis. The provision is known as skinny labeling, which refers to a move by a company that seeks regulatory approval to market a generic or biosimilar medicine for a specific use, but not for other patented uses for which the brand-name drug is prescribed. By doing so, the company seeks to avoid lawsuits in which the brand-name manufacturer could claim patent infringe ..read more

The U.S. Federal Trade Commission expanded its campaign against pharmaceutical companies for filing what it calls “junk” patent listings pertaining to 20 different brand-name treatments for asthma, COPD, diabetes and weight loss, including the blockbuster Ozempic diabetes medicine sold by Novo Nordisk. The move is part of an effort by the Biden administration to curb alleged patent abuses by the pharmaceutical industry. Drug companies have increasingly been accused of filing improper or inaccurate patents to make it harder for generic companies to sell lower-cost alternatives to Americans. The ..read more

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello, I’m up bright and early today to report on earnings, with the help of some coffee (with pasteurized milk) and the soundtrack for the new Challengers movie. Read the rest ..read more

The pharmaceutical industry saw its reputation slip last year among patient advocacy groups thanks to growing concern about the rising prices for medicines and a lack of confidence prompted by increasing shortages, according to a new survey. Of more than 2,500 groups queried, 57% reported that the industry maintained an “excellent” or “good” reputation as it goes about the business of developing and providing medicines. Although the findings suggest a clear majority of patients are largely satisfied with drug companies, this represents a decline — albeit, a slight one — after several years in ..read more

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 coffee kettle to brew some cups of stimulation. Our choice today is mocha almond. Please feel free to join us. Meanwhile, we have once again assembled a few items of interest for you. Best of luck on your journey today and, of course, do keep in ..read more