Opinion: STAT+: How I’m helping companies think through whether they should...
We have a knack in the U.S. for blurring behavior and medicine. Look at weight. For a long time, we’ve treated obesity as a moral failing, a lack of willpower. That was wrong. Now we’re treating weight...
View ArticleOpinion: STAT+: One way to create resilient drug supply chains: incentivize...
My first exposure to pharmaceutical shortages happened in 2017 as a new-to-practice nurse working on an inpatient oncology unit. A hurricane in Puerto Rico had left the U.S. short of sodium chloride...
View ArticleOpinion: STAT+: What Mark Cuban gets wrong about prescription drugs
Mark Cuban, the Dallas Mavericks owner and “Shark Tank” star, has been making headlines recently with his direct-to-consumer venture, Cost Plus Drugs. The company sells generic prescription drugs and...
View ArticleOpinion: STAT+: Sanofi CEO Paul Hudson: The right way to bring AI into pharma
While it’s widely accepted that the pharma industry is innovative in R&D, it is also true that it can be slow at embracing technological revolutions. Many people have criticized pharma companies...
View ArticleOpinion: STAT+: The IRA needs changes to better support patients with rare...
This time last year, members of Congress were working around the clock to draft and pass the Inflation Reduction Act. One of their goals was to address government spending on health care. But they...
View ArticleOpinion: STAT+: The problem with potential changes to the biosimilar...
Biosimilars are no longer a new and untested class of medicines. Today, they provide critical treatment options across multiple therapeutic areas. Since the Biologics Price Competition and Innovation...
View ArticleOpinion: STAT+: How payer-participating trials could help transform clinical...
Earlier this year, Food and Drug Administration Commissioner Robert M. Califf proposed something radical: that private health care insurance companies (payers) should participate in clinical research...
View ArticleOpinion: STAT+: Preventive drugs may be the best solution to the antibiotic...
The antibiotics crisis is a silent pandemic that threatens to knock modern society back into the medieval age of therapeutic leaches and serum therapy. A world where an accidental scratch in the rose...
View ArticleOpinion: STAT+: How to make the EU’s new Joint Clinical Assessment process...
Today, the criteria used to assess the clinical value of new pharmaceuticals and medical devices varies widely across Europe, making it more challenging for biopharma companies to efficiently launch...
View ArticleOpinion: STAT+: The PATCH Act’s approach to securing medical devices actually...
In August 2013, the FDA made news when it issued cybersecurity guidance for medical devices. But several years earlier, government officials recognized the risk: Soon after the FDA made its...
View ArticleOpinion: STAT+: A bold approach to pay for weight loss drugs for everyone who...
The news about anti-obesity drugs keeps getting better. In November, data presented at the American Heart Association meeting added cardiovascular benefit to value in combating obesity and diabetes....
View ArticleOpinion: STAT+: Health care AI requires a new Hippocratic oath
It was no surprise when the Biden administration recently outlined in a broad executive order the challenges AI poses and what is needed to address them, including within health care. AI has enormous...
View ArticleOpinion: STAT+: Dana-Farber CEO Laurie Glimcher has always been a trailblazer...
Dr. Laurie Glimcher learned early on from her father, a prominent physician-researcher, that success in science was built on a basic principle: Big discoveries require big risks. The younger Glimcher...
View ArticleOpinion: STAT+: The necessary roughness of 2023 has set up a very promising...
What a week — this year’s might have been the busiest JPM I’ve ever had. I’m not saying that to brag, it’s a statement about the industry. There was even one tweet from STAT’s Adam Feuerstein calling...
View ArticleOpinion: STAT+: Some countries are moving to digital prescription drug...
Getting a new prescription can be overwhelming: medication schedules, foods to eat or avoid, interactions between different drugs. Having all of these details in accessible, printed documents keeps...
View ArticleOpinion: STAT+: A California court is setting a dangerous precedent over drug...
The assault on the development of new lifesaving therapies continues apace. Recently, the First Appellate Division of California Appeals held that companies not only have to defend products they have...
View ArticleOpinion: STAT+: A year in, the U.S. is still not taking advantage of...
It’s been one year since the launch of the first adalimumab biosimilar for Humira in the United States, which was followed by eight additional adalimumab biosimilar launches. These nine FDA-approved...
View ArticleOpinion: STAT+: It’s time to rethink everything about our approach to...
In many ways, psychiatry is still flying blind. People experiencing mental health conditions are prescribed various drugs until one (or a combination) finally works — a painful process that can take...
View ArticleOpinion: STAT+: Medical devices makers are trying to take a page from Uber’s...
In a recent survey of U.S. companies, medical device makers reported spending $31 million on average to bring a new product to market under the Food and Drug Administration’s 510(k) pathway for those...
View ArticleOpinion: STAT+: How AI can help satisfy FDA’s drug, device diversity...
The Food and Drug Omnibus Reform Act of 2022 (FDORA), which was passed as part of the Consolidated Appropriations Act of 2023, will encourage greater diversity in clinical trials and help ensure new...
View Article