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The Readout Damian Garde & Meghana Keshavan

The other, other Covid vaccine with data overdue

While there’s been plenty of attention on the persistent delays that have afflicted Novavax’s promising Covid-19 vaccine, don’t forget about CureVac, the third-place mRNA company, which could have pivotal data any day now.

After promising to have late-stage results as early as April, CureVac said yesterday that it expects data on its vaccine in the second quarter, after which it will file for emergency authorizations. In earlier studies, CureVac’s vaccine generated antibody levels comparable with those in patients who had recovered from Covid-19, and the company has run preclinical tests suggesting it protects against emerging variants of the virus.

But CureVac’s approach to mRNA is different from its rivals at Moderna and BioNTech. Those two companies use chemically modified mRNA, designed to prevent an unwanted immune response to the foreign material. CureVac on the other hand uses an unmodified mRNA, which the company believes can improve efficacy by stirring up a greater immune reaction. Whether that makes a difference in Covid-19 remains to be seen, but it’s worth noting that CureVac’s first major mRNA project, a prostate cancer vaccine, failed in Phase 2 back in 2017.

Here’s more evidence of FDA conservatism

No one really knows what’s going on with the FDA right now. There’s a leadership vacuum at the top, a new administration in the White House, and enough seemingly discordant regulatory decisions to argue for or against the idea that the FDA is cracking down on drug companies. The latest evidence, from Travere Therapeutics, is a point in the “for” column. 

Yesterday, Travere said that the FDA reviewed its data on the rare disease treatment sparsentan and concluded that it simply wasn’t sufficient for an approval application, telling the company to come back once it had more complete information. That means Travere won’t be able to file sparsentan in the second half of this year, as it had previously expected, and the company’s share price fell about 16%.

The tricky thing about reading these FDA tea leaves is that they almost never come from the agency itself — with one notable recent exception — and each perceived case of regulatory whip-cracking has enough nuance to support diverging conclusions. Then there’s the fact that the FDA is not a centralized politburo but rather a series of subagencies with their own priorities and internal hierarchies. All of which is to say, this probably doesn’t tell us anything about whether Biogen’s Alzheimer’s disease treatment is getting approved.

The latest pharma legal battle is about coupons

The drug industry’s largest trade group is suing the federal government over a rule designed to limit how much patients pay for medicine, arguing that it would ruin the industry's own programs designed to limit how much patients pay for medicine.

It’s confusing, as STAT’s Ed Silverman reports, but it centers on coupons. For years, drug companies have used co-pay coupons and discount cards to limit patients out-of-pocket costs, and the federal government has ignored those discounts when calculating the lowest price of a given medicine to set Medicare reimbursement. Last year, however, the government set a rule that would require drug companies to ensure the full value of those coupons ended up in patients’ pockets, and if they can’t, the discount will extend to Medicare.

PhRMA thinks that’s unfair, and it’s suing.

Read more.

Patient advocates: Bring on a DARPA for health

Among the lessons of the past year is that of Operation Warp Speed, the superlatively successful project that proved rapid scientific progress is possible as long as there’s political will and ample investment. Now, patient advocates say, the Biden administration has the chance to replicate that with a DARPA for health.

Writing in STAT, two leading advocates say the proposal to create an Advanced Research Projects Agency for Health, or ARPA-H, could have Warp Speed-like potential — if it’s done right. According to UsAgainstAlzheimer’s co-founder George Vradenburg and Friends of Cancer research founder Ellen Sigal, the organization needs dedicated funding and independence from other federal agencies if it hopes to succeed.

It also needs to be agnostic when it comes to science, they write, “structured to support innovation and transformational capabilities that have broad application across multiple diseases rather than focusing solely on disease-specific research.”

Read more.

More reads

  • Is the Sputnik V vaccine too good to be true? Without the data, it’s hard to know. (STAT)
  • SEC considering new rules to tackle risky SPACS, chief tells Congress. (Reuters)
  • How a New York private equity giant became Boston’s biggest commercial landlord and biotech investor. (Boston Globe)

Thanks for reading! Until tomorrow,

Thursday, May 27, 2021

STAT

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