Thursday, August 24, 2017

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

Biotech's next big data readout

There’s a big biotech binary coming. Not that one. Within the next month, Sage Therapeutics is expected to reveal whether its most advanced drug can improve the lives of patients with epilepsy so severe that only a medically induced coma stops their seizures.

The trial is a big deal for patients with no other options, and it’ll majorly swing Sage’s share price. As STAT’s Adam Feuerstein reports, analysts expect Sage’s value to fluctuate by as much as 50 percent depending on the outcome. 

What’s more, the data will help shape public opinion of Sage’s most hotly debated project, a treatment for postpartum depression. A big success will make the company look clever; a total failure will only stoke existing skepticism.

Read more on STAT Plus.

Stem cell scientists: Beware the mouse model

Using humanesque mice is unreliable when testing immune response from stem cell transplantation, according to recent research from Stanford published in Cell Reports

Human stem cell transplantation is a compelling new frontier for many scientists and companies — and it's being developed primarily on these animal models.

But the researchers found that mice which have been genetically altered to embody human traits still don’t have a comparable immune system. So a humanized mouse will likely allow a transplanted stem cell to prosper, while a person will likely reject it. 

Conclusion? Stay ever-cautious about all that compelling preclinical data. Translation into people remains tricky.

What’s going on at Shire?

Something’s afoot at Shire, which is still digesting its last multibillion-dollar megadeal. First the head of R&D left, and now the CFO is on his way out, leading more than a few investors to get spooked that bad news is in the offing.

Shire CEO Flemming Ornskov, in what was perhaps a show of faith, just bought 8,400 shares of his own company. But those shares are trading at their lowest value since April 2014, so his faith is apparently less than contagious.

What do you think? Is Shire on a downward spiral, or simply scaling a prolonged bump on the way to a bright future? Click to vote:

Things are only getting worse, and shares will fall further.

This is but a blip, and shares will trade higher.

Doesn’t matter — they’ll get bought before January.

The margarine argument for fetal tissue research

Indiana University is embroiled in a legal battle with its home state, which objects to the use of aborted fetal tissues in medical research. IU is asking a federal court to deem that ban unconstitutional, the Wall Street Journal writes. 

The ban was signed into law last year in Vice President Mike Pence’s waning months as governor of Indiana. 

This is the first time medical researchers have led such a lawsuit. Their argument: The regulation interferes with free trade across state borders. The precedent they cite: Old laws, since stricken, that used to ban the selling margarine or fresh meat more than 100 miles from their origin. 

The plaintiffs note that the fetal tissues used by an IU neurobiologist were acquired from Washington state through an NIH grant — and thus, they argue, should qualify as an “article of commerce.” Much like margarine.

IU also maintains that the law violates the First Amendment by stifling academic freedoms and allows for discrimination against researchers who have worked with embryonic tissues. 

If IU’s argument wins, expect similar challenges in other states, such as South Dakota and Louisiana. 

More reads

  • Omeros defends its drug, but still won’t answer basic questions. (STAT)
  • The pharmaceutical industry’s false dilemma. (Financial Times)
  • Inside Teva's rocky quest to find a new CEO. (Bloomberg)
  • The pros and cons of gene editing. (The Onion)

Have a news tip or comment you want to send us?

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Thanks for reading! Until tomorrow,

Damian & Meghana

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