Tuesday, June 13, 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.

Did Merck just shift the narrative in the PD-1 race?

Ever since Bristol-Myers Squibb’s (arguably hubris-related) misstep in lung cancer, Merck’s Keytruda has been the consensus leader in immuno-oncology. But a possibly worrying — and vexingly vague — new safety concern could sow some seeds of doubt.
Here’s what we know: Merck paused enrollment in a pair of multiple myeloma trials “to better understand more reports of death” among patients receiving Keytruda. Patients already in the trials will keep getting therapy, Merck said, and the company pretty much left it at that.
Here’s some context: Bristol-Myers, AstraZeneca, and Roche all have trials in progress that test their checkpoint inhibitors in myeloma, and not one has disclosed similar problems. It’s far too early to even guess at what’s going on with Keytruda, but investors working to handicap a multibillion-dollar competition will certain make note of Merck’s setback.

When it comes to biosimilars, the news is always weird for Amgen

Amgen had a bad day at the Supreme Court. In a unanimous ruling, the justices effectively cut six months off of the time it takes to get a biosimilar treatment on the market, imperiling Amgen’s profits on some aging blockbuster drugs.
And yet Amgen had a good day at the Supreme Court, as that same ruling will make it easier for the company to launch its own biosimilars, which would eat into the revenues of rivals including AbbVie, Roche, and Johnson & Johnson.
Amgen’s odd position illustrates a new normal for some of the world’s biggest drug makers, who are at once insisting that their biosimilars are wondrous products that can save the system money and that their competitors’ treatments are poor facsimiles that are “piggybacking on the fruits” of other people’s innovation.
And the next phase could be even more interesting, as companies will lobby payers and physicians to switch patients onto their own biosimilars while doing everything possible to keep rivals from doing the same.

When #engagement goes awry

Well then. (@BIOConvention)

Maybe you’re among the 16,000 or so people planning to attend the BIO International Convention in San Diego next week. Perhaps, while marshaling your business cards and polishing your pitch, you thought, “Say, I wonder if the official convention Twitter account has any good tips on packing for the show?”
And then maybe you saw the above tweet and found yourself troubled by BIO’s decision to advance a take on gender dynamics that Henny Youngman might find regressive. You wouldn’t have been alone.
“This is bad and you should feel bad,” went one representative response. “Well this is a lovely piece of sexism to find in my science,” went another. “Free advice,” offered one tweeter, “delete this, think really hard about it, and write a meaningful apology.”

The tweet was deleted about 20 minutes after it went up. We asked BIO about it and got the following statement from Joanne Duncan, president of the organization's membership and business operations division:

"Earlier today, a BIO staff member tweeted what was intended to be a fun, light-hearted tweet about packing that fell flat. The tweet certainly does not reflect BIO’s positions on diversity and equality, and we apologize to anyone offended by the post. That said, we look forward to this year’s BIO International Convention in San Diego."

Is biopharma 'getting away with murder?'

A resolution to Trump's January proclamation is still TBD: The Senate health committee likely won’t be answering any questions on price gouging and murder any time soon. Today, it holds a highly anticipated public hearing on drug pricing  — but as STAT’s Erin Mershon reports, industry won’t be in the spotlight.

Instead, legislators plan to focus on issues like value-based pricing, supply chain, and ways to encourage generic competition. 

Read more on STAT Plus.

Last chance to hang with us in Boston

It’s not too late to register for today’s event in Boston, brought to you by STAT and our friends at the Atlantic. On the docket are CRISPR pioneer Feng Zhang, Joyce Tung of 23andMe, and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, among many others. And on the biotech side, executives from Roivant Sciences, Spero Therapeutics, Syros Therapeutics, and ImmusanT will chat about the state of entrepreneurialism in the startup world.
Register here.

More reads

  • It’s time to make it legal for Americans to order prescription drugs from abroad. (STAT)
  • Cell therapies could win regulatory approval, but can the process ever be economically viable to satisfy investors? (Financial Times)
  • BioNTech brings antibody production into the body. (EP Vantage)
  • How Google is investing in life sciences startups. (CB Insights)
  • Shock U.K. election result creates uncertainty for biotech. (FierceBiotech)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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