| | | |   | Hello, everyone. Damian here with a check-in on the immortal amyloid hypothesis, a glimpse at Bluebird Bio's financial future, and a look at how the Fed affects biotech. | | | Will biotech stocks ever recover? How well do Covid-19 vaccines work for kids? And can anything stop the amyloid hypothesis?
We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Longtime biotech investor Les Funtleyder joins us to explain why the recent interest rate hike is bad for biotech and just what it will take for the industry to get out of its slump. Then, vaccinologist and FDA adviser Paul Offit calls in to talk about the impending authorization of Covid-19 vaccines for young children and what it means for the future of the pandemic. We also explain the latest disappointing clinical trial in Alzheimer’s disease and some perplexing data on Pfizer’s Covid-19 antiviral.
Listen here. | It’s like Bluebird’s success never happened  Bluebird Bio went into last week with no less than its corporate survival on the line, facing a two-day FDA examination that would help determine whether a pair of its gene therapies would ever win approval. And yet, despite winning unanimous support for both, the company’s valuation is right back where it was before the meetings took place.
Bluebird suspended trading of its shares for the June 9 and 10 FDA hearings. On Monday morning, its stock opened at more than double its previous price, reflecting investors’ optimism that a company on the brink of insolvency would almost certainly have actual products to market in the near future. Then, over the ensuing week, Bluebird gradually fell back below $3 a share, as though nothing had changed from the week before.
The market reaction could create a near-term headache for Bluebird, which is running low on cash and would benefit from a stock offering. The company’s financial future might now rest on an FDA incentive program. Each of Bluebird’s gene therapies, if approved, would entitle the company to a priority-review voucher, a tradable asset that entitles its holder to an expedited FDA review. Such vouchers have recently sold for upward of $100 million each, money Bluebird could use to extend its runway. | Over a decade later, what’s next for the future of immunotherapy? Since 2011, the FDA has approved over three dozen novel immunotherapy treatments for patients with various forms of cancer. While these therapies have improved outcomes for some patients, there are others whose tumors don’t respond well enough to these medicines. Learn how the next generation and personalization of immunotherapies will help deliver more options for people with cancer. | What Roche’s Alzheimer’s failure means for the field Yesterday’s failure of an Alzheimer’s disease treatment from Roche doesn’t bode well for a trio of similar medicines now in late-stage development, but each contender is different enough to keep hope alive among the more optimistic observers in neuroscience.
Roche’s treatment, called crenezumab, targets brain plaques called beta-amyloid, which are thought to drive the advance of Alzheimer’s. This week’s news that crenezumab failed to delay cognitive decline in patients predisposed for the disease is by no means good news for Biogen’s lecanemab, Roche’s gantenerumab, or Eli Lilly’s donanemab, three amyloid-directed antibodies that will have Phase 3 data in the next 12 months or so.
But, as always seems to be the case when the topic is amyloid, there are a few ways to look at it. Earlier data suggested crenezumab has only middling effects on clearing plaques, which is likely related to its mild side-effect profile. The other three treatments seem to be more potent, and accordingly more toxic, which could bode well for their efficacy. On the other hand, the crenezumab study failed despite enrolling patients with no symptoms of Alzheimer’s and treating them for up to eight years. That suggests the other three studies, which are shorter and involve patients with more advanced disease, might be less likely to detect a significant benefit. | Pharma’s love of reformulation just makes drugs more expensive That’s according to a pair of physicians who argue that the industry practice of tweaking aging medicines — like switching from tablet to pill or embracing “extended release” — does more for corporate profits than patient health.
Writing in STAT, Ravi Gupta and Joseph Ross contend that drug companies often delay reformulating their products until generic competition is on the horizon, functionally extending their monopolies even after patents expire. And while the modifications vary in importance, they’re usually minor, with mixed evidence on whether, say, a longer-lasting version of an old drug actually improves patient adherence.
To Gupta and Ross, drug companies are gaming the system, and it would take a combination of legislative and regulatory changes to ensure the industry’s incentive is to invest in useful new medicines, not lucrative tweaks to old ones.
Read more. | More reads - Romney accuses White House of ‘patently false’ information about Covid-19 funds. STAT
- Japan’s Kyowa Kirin eying $1 billion sale of pharma assets. Bloomberg
- Three burning questions about the first brain reference charts. STAT
| Thanks for reading! Until next week,  | | | |
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