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The Readout Damian Garde

How a ‘cabal’ throttled progress in Alzheimer’s


For decades, the powers that be in Alzheimer’s disease research believed so strongly in one explanation for the disorder that they thwarted alternative ideas, according to dissenting scientists. And that dogmatic approach has meant spending billions of dollars over 30 years with no treatments to show for it.

In more than two dozen interviews with STAT’s Sharon Begley, scientists detailed the systematic silencing of heretical approaches to Alzheimer’s, which affected which studies got published in top journals, which scientists got funded, who got tenure, and who got speaking slots at reputation-buffing scientific conferences.

“Things shifted from a scientific inquiry into an almost religious belief system, where people stopped being skeptical or even questioning,” said Zaven Khachaturian, who used to direct external research at the NIH’s aging division.

Read more.

Trump’s FTC hasn’t been friendly to pharma


Bristol-Myers Squibb’s plans to close that $74 billion Celgene merger are getting delayed thanks to the Federal Trade Commission.

The company said yesterday that it needs to sell off a top-selling Celgene psoriasis drug to appease the federal regulator, which was apparently concerned that an investigational Bristol treatment could create anticompetitive issues. Bristol’s share price fell more than 6%.

The FTC’s opinion came as a shock to analysts, who pointed out that the two drugs in question have different mechanisms of action and seemed capable of legally coexisting at a combined company. But it’s also part of a trend of strict federal views on drug industry mergers. Roche, which counts chronic hemophilia treatments among its product portfolio, has spent months going back and forth with the FTC over a planned acquisition of Spark Therapeutics, a company developing gene therapies for the same disease.

Perhaps that shouldn’t be a surprise. President Trump’s slate of FTC leaders took office with a particular focus on pharma, STAT reported last year, planning what one antitrust lawyer called a “very aggressive review of both mergers involving pharmaceutical companies and drug price changes.”

Here come the billion-dollar biotech IPOs


June has been a banner month for biotech IPOs, with five listings amassing nearly $3 billion in cash. The next test: Are investors willing to support unicorn valuations?

This week, BridgeBio Pharma and Adaptive Biotechnologies are expected to price their long-awaited offerings. BridgeBio is seeking a roughly $1.7 billion valuation, and Adaptive is aiming for more than $2 billion.

So far this year, three companies have debuted at valuations north of $1 billion, but the returns have been mixed. Alector, working in neurodegenerative disease, is down about 5% since its IPO, and the NASH-focused NGM Biopharmaceuticals has fallen 14%. Gossamer Bio, which went public at a $1.1 billion valuation, has risen 39% in the months since.

A take: The latest FDA approval was a huge mistake


On Friday, the FDA approved a treatment meant to increase women’s sexual desire, a drug with marginal effects and a sizable risk of nausea. And that, argues STAT’s Adam Feuerstein, is why approving it was the wrong decision.

First, there’s the efficacy: In clinical trials, only 8% more of the women who took the drug saw an even modest increase in sexual desire. And when it came to distress, the difference between drug and placebo was 4%. Then there’s safety: 40% of women treated reported nausea, and the treatment led to a darkening of the gums and skin on the face and breasts in about 1% of women.

That all adds up to drug whose benefits don’t justify its risks, according to Feuerstein, and yet the FDA approved it anyway. That’s bad for patients, he argues, and it could end up being bad for AMAG Pharmaceuticals, the company that will now try to market a problematic product.

Read more.

PatientsLikeMe finds a buyer

PatientsLikeMe, the health technology firm forced into a fire sale by the Trump administration, has a new owner.

As STAT's Matthew Herper reports, the company has been purchased by UnitedHealth Group. The sale comes just month after it became public that the Committee on Foreign Investment in the U.S., a federal interagency group, had raised concerns about a stake held in the company by iCarbonX, a Chinese firm focused on genetic research.

Read more.

More reads

  • After FDA approval, drug makers often commit to follow-up studies. Few are new, a review finds. (STAT Plus)
  • How Big Pharma suppresses biosimilars. (Wall Street Journal)
  • Top biotech investor looking beyond the 'sexy' parts of healthcare as he places his next bets. (Business Insider)
  • Krystal Biotech shares rise after skin drug gets expedited review from FDA. (MarketWatch)

Thanks for reading! Until tomorrow,

Megan

Tuesday, June 25, 2019

STAT

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