Listen: What the mifepristone case means, GLP-1 skepticism, & Chinese biotech
STAT
by Damian Garde, Allison DeAngelis, and Adam Feuerstein
3h ago
Who gets to sue the FDA? Is pharma caught in a trade war? And what does “AF” stand for? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Sarah Owermohle joins us to explain the Supreme Court case that could have dramatic effects on access to medication abortion — and the development of new medicines. We also discuss the latest news in the life sciences, including a contrarian take on a new obesity treatment, a congressional effort to ban Chinese biotech companies, and how we managed to make 300 episodes of this podcast. Read the rest ..read more
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STAT+: Payments by drug and device makers to doctors remain widespread, but also vary considerably
STAT
by Ed Silverman
4h ago
The financial ties between drug and device makers and some physicians remains pervasive, despite concerns such relationships may influence medical practice, according to a new analysis of payments made over a recent 10-year span. From 2013 to 2022, pharmaceutical and device companies made more than 85 million payments totaling $12.1 billion to approximately 826,300 physicians. And 94% of those payments were associated with at least one marketed medical product. Among the products for which the most payments were made included blood thinners and a robotic surgical system. The analysis also reve ..read more
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STAT+: A contrarian view on Viking Therapeutics, biotech’s hottest obesity stock
STAT
by Adam Feuerstein
8h ago
This is the inaugural edition of Adam’s Biotech Scorecard, a new subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered every Thursday to their inbox. Hello! Welcome to the premiere issue of Adam’s Biotech Scorecard. I’m excited to get started. Let’s do this! (By the way, the AF in the logo are my initials, not the “other” AF.) The contrarian view of Viking Therapeutics The developer of a dual-acting GLP-1/GIP treatment for obesity is riding high on positive data and takeout speculation. The drug, called VK2735, has shown impressive weight loss with minimal gastroi ..read more
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STAT+: Pharmalittle: We’re reading about a GLP-1 side effect, U.K. clinical trial transparency, and more
STAT
by Ed Silverman
8h ago
Top of the morning to you and a fine one it is. Despite cloudy skies hovering over the Pharmalot campus, our spirits remain sunny. How so? We will trot out a bit of wisdom from the Morning Mayor, who taught us that “every new day should be unwrapped like a precious gift.” So while you tug on the ribbon, we will proceed by brewing another cup of stimulation. Today, our choice is glazed doughnut. Sweets for the sweet, as they say. Meanwhile, here is the latest menu of tidbits for you to peruse. We hope your day is meaningful and productive and you accomplish much. And as always, do keep in touch ..read more
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STAT+: U.K. becomes the first country to release detailed data on sponsors that fail to register clinical trials
STAT
by Ed Silverman
8h ago
The United Kingdom has released comprehensive data showing which institutions have failed to register their clinical trials, a move that was hailed by transparency advocates who say this marks the first time that a country has taken such a step. Last week, the Health Research Authority posted complete registration information for 1,545 trials, including the name of the study, the sponsor, and registration number for the trial. Until now, the agency had provided only annual snapshots showing the proportion of trials that are registered, and had not previously published registration information ..read more
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How GLP-1’s moved from research labs to national TV
STAT
by Meghana Keshavan
10h ago
Today is the inaugural publishing day for Adam’s Biotech Scorecard — a subscriber-only newsletter offering senior reporter Adam Feuerstein’s no-holds-barred perspective on the rapidly shifting world of biotech. Sign up to get it in your inbox here. Hello! It’s Meghana. Today, we’re reading about the world’s costliest drug, plus we learn about immune senescence and a potential cause for a kidney autoimmune disease. Read the rest ..read more
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STAT+: Why the world’s most expensive drug might not be all that overpriced
STAT
by Jason Mast
12h ago
The staff of the Institute for Clinical and Economic Review, or ICER, are known as the nerds of the drug industry: bespectacled killjoys who emerge a few times a year to scold drugmakers for pricing their latest cancer or MS advance far beyond reason. But last year, its staff sat down and concluded a forthcoming treatment was worth up to $3.9 million — more than any medicine in history, more than a 45-year supply of Humira, the autoimmune drug often held up as an emblem of America’s runaway drug spending.  It was a testament to the power of a new class of gene therapies to deliver somethi ..read more
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Covid’s scientific silver lining: A chance to watch the human immune system respond in real time
STAT
by Helen Branswell
12h ago
While an increasingly anxious world watched a new coronavirus spread across the globe in early 2020, veteran immunologist Rafi Ahmed quickly grasped that his field was about to experience something truly extraordinary. His former student Ali Ellebedy was gnawed by frustration as Covid shutdowns stalled his influenza research; it took until the summer, when mass vaccination planning hit his radar, before the same realization kicked in. For scientists who study the human immune system, the penny dropped at different points in the early frenetic months of the Covid-19 pandemic. Looking back now ..read more
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Ozempic-like drugs linked to low, but increased risk of post-endoscopy pneumonia, study finds
STAT
by Elaine Chen
12h ago
Diabetes and obesity GLP-1 drugs like Ozempic, which can delay stomach emptying, have introduced a predicament for patients undergoing surgeries and endoscopies — the patients in some cases may still have food in their stomach even if they’ve fasted, raising concerns that they could accidentally breathe food into their lungs during the procedures. These concerns have been based on anecdotes, and it’s so far unclear how big an issue this is, but a new study published in Gastroenterology Wednesday offers some early clues. It links GLP-1 drugs to a higher risk of aspiration pneumonia — lung infec ..read more
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Who can sue the FDA? Answering Justice Alito’s question from the mifepristone arguments
STAT
by Sarah Owermohle
12h ago
WASHINGTON — Supreme Court Justice Samuel Alito had a clear question at Tuesday’s arguments over the abortion pill mifepristone: If the doctors who brought that case can’t sue the FDA over a drug’s label, who can? And when? “Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful? And maybe what they did was perfectly lawful, but shouldn’t somebody be able to challenge that in court?” Alito asked the government’s lawyer. Read the rest ..read more
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