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The Readout Damian Garde

Synthetic biology is all grown up and ready to lobby

Synthetic biology, the business of using technology to one-up nature, has for years been a fairly quirky corner of the often buttoned-up world of life sciences. Now, however, as its banner companies have outgrown their garages and started making real money, synthetic biology is evolving into a proper industry, one with money to spend in Washington.

As STAT’s Nicholas Florko and Rebecca Robbins report, synthetic biology companies just launched the sector’s first lobbying group, and yesterday they gathered at the White House for a summit in their honor. Next is a trip to Capitol Hill to schmooze with House staffers, all part of a broad effort to bring the technology into the mainstream.

“We’re starting to grow up a little bit,” said Jason Kelly, CEO of Gingko Bioworks, one of the founding companies of the new lobbying group, known as the Bioeconomy Alliance. “We’re kind of like teenagers, the synbio industry. We’re a little awkward but starting to have a little more responsibility.”

Read more.

Some harsh truths about Cel-Sci's cancer drug

Multikine, an immunotherapy for head and neck cancer, is destined to fail in Phase 3 — or so says STAT’s Adam Feuerstein. And yet, in the months since his treatise on the predicted fate of the small-cap biotech, Cel-Sci’s stock has instead tripled. 

Was Adam wrong about Cel-Sci? No way. It’s a ploy, he says, in which the company continues to release misleading information about the Multikine trial. He put together a series of myths and facts regarding the study of the experimental treatment.

Read more.

There could be a biotech famine in 2020

Inventing drugs is a cash-intensive endeavor, and a big part of why the vast majority of biotech companies pursue IPOs is that the public markets provide a convenient way to raise the money they’ll inevitably need. But what becomes of the companies that run low on cash in a down market?

The analysts at EvercoreISI looked at cash balances across the biotech industry to figure out just who might need a trip to the Wall Street ATM in 2020, an election year that could be rough on investor sentiment when it comes to drug companies. It turns out that big companies, those worth more than $1 billion, have mostly stored up enough money to survive a lengthy winter. 

But the smaller firms aren’t so fortunate. According to EvercoreISI, the roughly 140 biotech companies worth less than $500 million are on track to go broke in 2021, which means they’ll need to raise a cumulative $10 billion between now and then. If investor sentiment worsens in 2020, we could see companies raising money at a discount, taking on toxic debt, or just outright going out of business.

Public Citizen decries preterm birth drug

Makena, a drug used to prevent premature birth, is one of the earliest and best-known examples of price-gouging in pharma. Now, however, an even bigger question looms about the decades-old drug. Does it even work? 

The latest evidence says no. This past spring, a confirmatory study testing the drug’s efficacy flopped — finding that Makena was no better than placebo in preventing preterm birth. The drug’s up for regulatory review on Oct. 29.

Now, the consumer advocacy group Public Citizen is urging the FDA to immediately withdraw the drug. It also argues that the FDA made a mistake back in 2011 when it allowed Makena to follow the accelerated approval pathway, because data from its Phase 3 study was “seriously flawed” as well. 

Read more.

More reads

  • Biotech has a supply problem. (Wall Street Journal)
  • Buttigieg’s balancing act: He wants far lower drug prices even as he hopes the drug industry will ‘thrive.’ (STAT Plus)
  • New biotech aims to develop a reversible form of gene editing. (Boston Business Journal)
  • Beyond the Sacklers: Free-trade policies contributed to the opioid epidemic. (STAT)

Thanks for reading! Until tomorrow,

Tuesday, October 8, 2019


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