Tuesday, September 5, 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.


Welcome to biotech’s make-or-break September


(Jennifer Keefe/STAT)

After a rollicking August sent the Nasdaq biotech index to its highest value since late 2015, the industry is now barreling into a September brimming with major binary events that could either wreck the rally or reinstate the boom.

We figured that called for a scorecard.

We already know Otonomy bombed out with its big late-stage effort in Ménière’s disease, and we know Novartis won a pioneering — and ahead-of-schedule — FDA approval with a CAR-T for blood cancer.

Soon we’ll find out whether Alnylam Pharmaceuticals can indeed become a commercial company, whether Axovant Sciences can live up to its market cap, and whether Sage Therapeutics really is onto something in neuroscience. We’ll be updating the card all month as data roll in, so stay tuned.

What do you get the scientific field that already has everything?

Gene editing is soon to join the ranks of ornithology, animal husbandry, and speleology. CRISPR is getting its very own academic journal.

You can be forgiven for feeling like Nature, Science, and the rest of the top-tier rags have basically become CRISPR journals already, what with the steady flow of advances and applications in gene editing. But Kevin Davies, the Mary Ann Liebert executive leading the launch of The CRISPR Journal, believes there's enough news, views, and peer reviews to fill an entire publication devoted to gene editing.

"If ever a field could be said to have captured as much excitement and carry as many implications as the revolutions brought about by the development of CRISPR technology, that to me serves as an ample rationale for launching a journal," Davies said.

Read more on STAT Plus.

An R&D chief for Novartis CEO

On the heels of two huge Novartis wins — the CAR-T approval and the positive readout from its heart disease-focused canakinumab trial — the drug giant is shaking things up, moving up a 41-year-old R&D pro (as opposed to a business whiz) to be its chief executive.

Dr. Vas Narasimhan, an 11-year Novartis vet, served most recently as its head of development — overseeing a $9 billion budget. The Harvard-trained physician replaces CEO Joe Jimenez, and seems poised to take the company in a new, innovation-heavy direction.

“I’ve been CEO for eight years and I’ve been pretty public about the fact that I didn’t think a CEO should stay much longer than that,” Jimenez told Bloomberg. “You come in, you see what you want to change, you change it, and then it’s time to pass it on to a successor.”

On that $475,000 — or $0 — pricing model

Since we’re still on the subject, a bit more about Novartis and CAR-T: The drugmaker is offering a money-back guarantee — saying that if a patient doesn’t respond to the therapy in the first month, it’ll forego any payment. But is that an effective pricing strategy? 

Ed Silverman explores the issues at play in his latest Pharmalot View column.

More reads

  • Toxic reaction kills Cellectis’ first CAR-T patient, forcing trial halt. (Endpoints)
  • Sanofi quietly pulls the plug on its Zika vaccine project. (STAT)
  • What's hot at ESMO 2017? (Medscape)
  • Friday was a slow news day, and the internet fixated on the FDA commissioner's pants. (Twitter)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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