| |   | Good morning, all. Damian here with head-scratching update to a cardiovascular saga, a look at the race to develop new contraceptives, and an example of why it's often wise to pivot in biotech. | | | Amarin’s long-debated heart drug might not work as advertised Amarin shocked the cardiovascular world in 2018 with the landmark finding that its pill, derived from fish oil, could prevent heart attacks for a select group of patients, data that led to an FDA approval. But a new analysis — funded by the company itself — raises significant questions about those results, leading some experts to call for a new clinical trial.
As STAT’s Matthew Herper reports, the issue is mineral oil. Amarin’s previous study, which found a 25% reduction in cardiovascular problems, used mineral oil as a placebo because it closely resembles the company’s drug, Vascepa. The new analysis looked at blood samples from patients in that trial and found that those who got mineral oil scored worse on seven measures correlated with heart trouble. That suggests Vascepa’s demonstrated benefit could be inflated by a surprisingly toxic placebo.
To Steven Nissen, a cardiologist at the Cleveland Clinic not affiliated with either study, “these findings are the closest thing I’ve seen in a long time to a smoking gun.”
Read more. | How do you stop a Covid surge? Why are clinical trials so white? And what are the limits of HIPAA?
We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Eric Boodman joins us to discuss whether an oft-cited federal law can shield reproductive health data from state law enforcement in the wake of Roe v. Wade being overturned. Then, STAT’s Angus Chen calls in to relate the story of an ambitious study and the quest to finally make clinical trials more equitable. We also explain a momentous FDA meeting and the debate over just what the Covid-19 vaccines of the future should contain.
Listen here. | Democrats' Last Chance for Drug Pricing Reform? The drug pricing debate remains a central conversation in Congress. On July 20, STAT sits down with key decision-makers about the latest developments from Capitol Hill and the White House. Join them. | The end of Roe has lit a fire under contraception biotechs After the Supreme Court overturned Roe v. Wade, biotechs developing new forms of birth control started scrambling to accelerate research, pressing insurers to cover approved products, and forging ahead with products that could be threatened by future rulings.
As STAT’s Jonathan Wosen reports, the companies at work on novel contraceptives feel a sudden sense of urgency. Legal experts have noted the reasoning behind the court’s majority opinion on Roe v. Wade could be used to overturn other rulings rooted in a constitutional right to privacy, including Griswold v. Connecticut, a 1965 case establishing the right of married couples to use birth control.
“Somehow, in the back of your mind, you think, ‘This can’t really be what the United States of America is going to do,’” said Saundra Pelletier, CEO of Evofem Biosciences, which markets a hormone-free birth control cream. “I truthfully reacted with this fanatical focus of, ‘We’ve got to make sure every single woman has access to contraception. We have to do our part.’”
Read more. | Celldex’s hard pivot is looking prudent Two years ago, after a series of clinical disappointments, Celldex Therapeutics shifted its focus from oncology to inflammatory disease. Yesterday, that decision started to pay off, as the company’s former cancer drug led to impressive results in a small trial enrolling patients with chronic hives.
As STAT’s Adam Feuerstein reports, four of eight patients treated with monthly infusions of the Celldex drug called barzolvolimab achieved a complete response, meaning total elimination of painful welts, skin inflammation, and itching. Another group of nine patients received double the dose of barzolvolimab spaced two months apart, with four achieving a complete response. Only two of eight patients infused with a placebo had a similar result.
Celldex will need much more data before it can take barzolvolimab to the FDA. But the early results suggest the drug might one day best the standard of care. And the data leave no doubt that Celldex was wise to make that pivot back in 2020.
Read more. | More reads - Democrats tweak their drug pricing plan in last-ditch effort to pass reforms, STAT
- Hedge funds scoop up biotech stocks after 'catastrophic' declines, Financial Times
- FDA recommends vaccine makers update Covid-19 shots to target Omicron, STAT
- A small gene therapy biotech, flush with ex-Sarepta and Bluebird leaders, guts CMC, Endpoints
| Thanks for reading! Until next week,  | | | |
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