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PhRMA is using its largesse in an unexpected place


Among the many millions of dollars PhRMA spends to bankroll political campaigns and initiatives, at least one line item stands out: The group has put $500,000 toward efforts to oppose a California ballot measure that would expand rent control protections across the state, an issue with no clear implications for the drug industry.

PhRMA says it’s getting involved because the ballot measure could make it harder for the state’s nearly 900,000 employees to find a place to live. But as STAT’s Rebecca Robbins and Lev Facher report in an exclusive story, some observers suspect that the trade group is using its financial muscle to score a victory over an HIV/AIDS activist who has repeatedly funded California initiatives aimed at limiting drug prices.

Read more.

Can biotech maintain its breathless IPO pace?

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There have been 43 biotech IPOs in 2018, with another five expected this month, putting the industry on pace for its biggest year of Wall Street debuts since the waning days of the last boom.

And, perhaps most important, they’re doing pretty well. The share prices of 2018’s IPO class are up about 25 percent in aggregate and 9 percent at the median. All the while, investors’ appetite for risk appears to be at an all-time high, as six of 2018’s successful IPOs come from companies that were yet test their therapies in human trials. Only one such company managed to go public in 2017.

This all sets the stage for Moderna Therapeutics, a $7.5 billion private firm that is said to be preparing what would be biotech’s biggest-ever IPO.

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Cancer trials have a diversity problem


Takeda’s Ninlaro is approved to treat multiple myeloma, a form of blood cancer that African-Americans are twice as likely to get as white Americans. And yet in the clinical trial that led to Ninlaro’s approval, just 1.8 percent of patients were black.

As ProPublica reports, that disparity is hardly unusual. African Americans are starkly under-represented in cancer trials, even when the disease in question disproportionately affects them. The problem stems from the failure of most drug companies to change things voluntarily and the FDA’s reluctance to force their hands.

“When it comes to clinical research in this country, there’s a credit card, and there’s a limit on the credit card,” said Dr. Rachel Sherman, the FDA’s principal deputy commissioner. “If we spend on one thing, it won’t get spent on another. We have to be judicious in what we require and what we demand and what we encourage.”

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NASH is still a biotech goldmine


NASH, the alarmingly prevalent fatty liver disease, has long been a kingmaker for biotech stocks, sending the likes of Intercept Pharmaceuticals, GenFit, and Madrigal Pharma soaring on the promise of a first-approved treatment.

Yesterday came Viking Therapeutics' turn. The company's share price doubled after it disclosed mid-stage data showing that its drug significantly reduced liver fat in a trial enrolling 45 patients.

That press release turned Viking into a billion-dollar company overnight, but it did little to resolve the lingering issues tied to the future of NASH treatments.

No one's exactly sure how many people actually have the disease. If the number is markedly lower than the 30 million figure cited by industry, treatments for NASH could be far less lucrative than investors think. And, conversely, if the disease really is that prevalent, drug makers could run into the familiar roadblocks of insurance companies demanding rebates and limiting patient access.

More reads

  • AbbVie is accused of paying kickbacks, using a stealthy network of nurses to promote Humira. (STAT)
  • Clovis Oncology pays $20 million to settle charges of misleading investors. (STAT Plus)
  • A 32-year-old's startup, inspired by a health scare, sells for $275 million. (Forbes)
  • What men say when I tell them I focus on funding female founders. (Financial Times)

Thanks for reading! Until tomorrow,

Megan

Wednesday, September 19, 2018

STAT

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