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The Readout Damian Garde & Meghana Keshavan

Yes, but what's the aducanumab angle?

Yesterday brought the unsurprising news that a pair of amyloid-targeting treatments for Alzheimer’s disease failed in a clinical trial. But in 2020, virtually all news in Alzheimer’s is filtered through the lens of Biogen and its controversial treatment. So we asked: What does this mean for aducanumab?

The answer, depending on whom you asked, is basically this: The latest failures certainly don’t amount to good news. The study in question, called DIAN, was specifically engineered to avoid the amyloid stumbling blocks of the past. 

At the same time, experts pointed out, DIAN was different from Biogen’s supporting studies, which enrolled thousands of early-stage Alzheimer’s patients regardless of their genetic status. 

Read more.

Why the coronavirus is keeping biotech up at night

As China imposes sweeping restrictions to contain the coronavirus outbreak, a biotech industry increasingly dependent on outsourced work is worried about costly delays.

As STAT’s Kate Sheridan reports, biotech startups with vendors in China are concerned that the country’s crackdown on travel might suspend scientific work and delay their progress in drug development. So far, the effects have been minor, executives said, but the prospect of a months-long pause has led some biotech leaders to tap Western vendors just in case.

“We’d rather spend more money and have an overabundance of resources in the short run if, in fact, China comes back online in a few weeks or a month, instead of being completely out of the game for an extended period of time,” one biotech executive said.

Read more.

Being Moderna is expensive

Moderna Therapeutics made history in late 2018, raising $600 million in the largest-ever biotech IPO. The former unicorn’s burn rate might be record-setting as well.

Looking at Moderna’s most recent financials, the company was on pace to spend more than $600 million in 2019. Moderna has since expanded its pipeline and promised to get some early-stage therapies into human trials, an endeavor likely to only increase the cost of doing business.

And so it was no surprise last night when the Cambridge, Mass., company launched a $500 million stock offering. Cash is likely running a little low, and Moderna’s share price is trading near an all-time high thanks in part to its work developing a vaccine for the novel coronavirus. Might as well raise money.

But Moderna’s wide pipeline is still years away from producing a product that actually generates revenue, and it’ll be instructive to see how investors react as the ambitious company returns to the well time and again for much-needed cash.

Exelixis succeeds on a do-over

In 2014, Exelixis tried to develop a drug for prostate cancer, but the clinical trial ended in failure and nearly shut down the company. A second attempt has delivered better, tumor-shrinking results, according to data released last night, while still leaving some important questions unanswered. 

A combination regimen for prostate cancer consisting of Exelixis’ targeted cancer drug Cabometyx and Roche’s checkpoint inhibitor Tecentriq could be filed with the Food and Drug Administration in 2021; if approved, the therapy would help Exelixis achieve its aggressive goal of more than quadrupling Cabometyx sales by the end of 2025. 

But as Adam Feuerstein also reports, not all prostate cancer doctors believe Exelixis’ new combination therapy will work better than old-fashioned chemotherapy. And competitors, including Merck and Bristol-Myers Squibb, are lurking close behind.

Read more.

Most Republicans ran from Pelosi’s drug plan. This one’s running on it

Some Republicans dismissed it as a “socialist takeover of the health care system,” or, more concisely, the “Fewer Cures Act.” But to GOP Rep. Jaime Herrera Beutler, the House Democrats’ drug negotiation bill is more than just a good policy; it’s a cornerstone of her re-election campaign.

As STAT’s Lev Facher reports, Herrera Beutler is facing a tough campaign in her southern Washington district, one Democratic leaders see as flippable in 2020. She was one of only two Republicans to vote for Speaker Nancy Pelosi’s Lower Drug Costs Now Act, and that might be the issue that keeps her in her seat.

Herrera Beutler’s is illustrative of a problem some House Republicans will face in November. Voters increasingly see high drug prices as a key priority, and polling suggests they favor the Democrats’ approach to the issue.

Read more.

More reads

  • Family builds $3.8 billion fortune, one pint of blood at a time (Bloomberg)
  • Interview with FDA’s OND director: approval standards, transparency, and more. (Regulatory Focus)
  • Priscilla Chan charts an ambitious, unglamorous course to fight disease. (Her husband is involved, too.) (STAT)
  • Trump doesn’t want the FDA to regulate tobacco. (STAT)

Thanks for reading! Until tomorrow,

Tuesday, February 11, 2020


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