Washington
Pharma might lose a powerful friend in the Senate
The corruption charges against Sen. Bob Menendez threaten to end a long political career and cost the pharmaceutical industry a rare ally in the upper ranks of the Democratic Party.
As STAT's Sarah Owermohle reports, more and more of Menendez's colleagues have called for his resignation in light of an indictment alleging he and his wife accepted hundreds of thousands of dollars to influence military aid.
The New Jersey senator has long been an outspoken ally for the industry, sometimes even diverging with his party to shield drugmakers from pricing reforms. And he has been rewarded for it. Executives from Pfizer, Bristol, and Merck were among several top drugmakers and industry groups that funneled cash to Menendez's campaign in early 2021, just as the Democrats were prioritizing drug price negotiation plans that ultimately passed last year. None of those executives donated to other senators, Republican or Democrat, during that time.
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Research
The Sudafed saga has a lesson for science
This month's micro-scandal around over-the-counter Sudafed and the fact that its active ingredient appears pretty much useless made headlines around the world. Some experts saw it as a sad reminder of just how poorly our society collects data on old drugs.
As STAT's Matthew Herper writes, there had long been concerns about whether phenylephrine, found in Sudafed and other decongestants, had any real value to patients. But it took years for anyone to rigorously study it because there is generally no financial incentive to conduct clinical trials on generic drugs, meaning the standard of evidence for cheap, widely available medicines is often much weaker than for expensive, brand-name drugs.
To Harlan Krumholz, a Yale cardiologist who is known as an expert on medical evidence, "almost every medicine that is for symptoms" should be a candidate for a phenylephrine-style examination. And there's even a mechanism to do it: The Patient-Centered Outcomes Research Institute, created by the Affordable Care Act, is an institute chartered with conducting clinical research for the public good. All that's missing is the execution.
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M&A
Intercept's long, winding road to nonexistence
A single press release made Intercept Pharmaceuticals the hottest biotech company in the world. In 2014, a week before the J.P. Morgan Healthcare Conference, Intercept said its treatment for the liver disease NASH had worked so well that its mid-stage clinical trial was stopped early. The stock price quadrupled, and so began a pharmaceutical gold rush to find what would be the first treatment for the increasingly prevalent disease.
Nine years and a 98% stock price decline later, Intercept will soon be no more. The Italian pharmaceutical firm Alfasigma agreed to pay roughly $800 million in cash for the company, adding up to an 80% premium to its recent trading price. The deal, which isn't expected to run into regulatory issues, is slated to close before the end of the year.
The end of Intercept closes a volatile chapter in recent biotech history, but the industry's quest to treat NASH has only intensified. A drug from Madrigal Pharmaceuticals is up for FDA approval following a successful trial in which the drug both reduced liver fat and improved fibrosis, and earlier-stage medicines from Viking Therapeutics, 89bio, and Akero Therapeutics have also demonstrated promising results in clinical trials.
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