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The Readout Damian Garde

Why biotech is like high school

When it comes to raising money for a biotech startup, the contents of one’s Rolodex can be just as important as the stuff in the lab dish.

That was Laura Indolfi’s experience in a five-year odyssey to raise money for her company, which succeeded only when she made the right social connections. And, as STAT’s Kate Sheridan reports, it’s backed up by experts. Venture capital firms are far more likely to invest in entrepreneurs they already know, research shows. And because those networks can often be insular, that can put women, people of color, and entrepreneurs from certain geographies at a disadvantage.

“The analogy of high school is pretty apt,” said Scott Shane, a professor at Case Western Reserve and a partner at Midwest-focused venture capital firm Comeback Capital.

Read more.

Novartis might still be on the FDA outs

Having spent the whole summer parsing Novartis’ relationship with the FDA after a data falsification scandal, it’s a little tough not to reach for one’s tinfoil hat upon reading the headline “Novartis’ Zolgensma gene therapy study halted by FDA on animal safety concerns.”

The news is this: The FDA told Novartis to pause a trial meant to expand Zolgensma’s use after the company disclosed a safety issue from an animal study. That issue, related to inflammation, had never popped up in prior animal studies, the company said, and has never manifest itself in actual human beings.

Considering the fact that the FDA went out of its way to chastise Novartis over how it handled a wholly unrelated issue involving Zolgensma data, it’s fair to ask: Is the company getting maximum scrutiny by way of further punishment? According to SVB Leerink analyst Mani Foroohar, the issue is “likely reflective of FDA taking a more stringent attitude” toward Zolgensma. And, as other analysts noted, it could affect Novartis’ business: A lengthy delay to Zolgensma’s further development could allow a rival treatment from Roche to seize market share.

Why Bill Gates isn’t throwing money at Alzheimer’s

Bill Gates has pledged billions to fund research into public health. But when it comes to Alzheimer’s disease, which affects nearly 6 million Americans, the billionaire’s contributions amount to a “drop in the bucket,” Gates’ science advisor acknowledged.

According to Niranjan Bose, who also serves as managing director of health and life sciences at Gates Ventures, that’s not for lack of interest. The drug industry, the NIH, and outside foundations have poured billions into Alzheimer’s research. Gates prefers to direct his money toward causes that aren’t getting such attention.

“We are not hearing that there are 30, 40 companies going unfunded,” Bose told STAT.

Read more.

When are we going to get a new FDA commissioner?

On Friday, Dr. Ned Sharpless, the man who currently runs the FDA, will see his term as acting commissioner expire. And as of this second, President Trump has not chosen a nominee to succeed him.

For nearly two months we’ve known that Dr. Stephen Hahn, chief medical executive at the MD Anderson Cancer Center, was going to be Trump’s pick. And for weeks, we’ve heard that Hahn’s nomination would coming any day now. But then it never arrived. 

There is, as has been true for nearly three years, a lot going on in the White House at the moment. But the delay to Hahn’s expected nomination means a delay to the months-long confirmation process and leaves the FDA in a prolonged state of long-term leadership limbo, dating back to Dr. Scott Gottlieb’s resignation in April.

More reads

  • New MS drug from Biogen and Alkermes wins approval. (Boston Globe)
  • California wildfires and power outages cause disruptions for scientists. (Nature)
  • Insurance, pharma figures spar over drug price legislation’s innovation impact. (STAT Plus)
  • New details emerge in case of first death from fecal transplant. (STAT)

Thanks for reading! Until tomorrow,

Thursday, October 31, 2019

STAT

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