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The Readout Damian Garde & Meghana Keshavan

You won’t like the FDA when it’s angry

The FDA is almost monastically conservative when it comes to public statements about drugs in clinical trials, sitting silently almost no matter what companies, scientists, or investors claim. As it turns out, there are limits to that.

As STAT’s Adam Feuerstein reports, yesterday the FDA took the extraordinary step of issuing a lengthy statement on an unapproved Covid-19 treatment from the biotech company CytoDyn, explaining that the therapy failed in two clinical trials.

The FDA’s words are starkly opposed to CytoDyn’s own description of the trials, including CEO Nader Pourhassan’s March claim that “these results are the best results ever achieved for this population in a Phase 3 clinical trial.” Pourhassan later said CytoDyn was working with the FDA on a “conditional” emergency use authorization for leronlimab, though no such designation exists.

Read more.

Cel-Sci has no data but a lot to say

Speaking of biotech companies with debatable public relations strategies, Cel-Sci, the firm that has spent more than a year not disclosing the results of pivotal trial, has been making the rounds with investors to explain that, once those data are ready, it’ll be important to look at all of the endpoints, not just the primary one.

As STAT’s Adam Feuerstein reports, some investors read that as pre-emptive damage control. Multikine, Cel-Sci’s drug, completed a Phase 3 study in head and neck cancer last year, and yet the company has not disclosed whether it actually prolonged survival. Instead, CEO Geert Kersten has claimed that the company’s contractors are still analyzing the data.

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It’s AbbVie’s turn in the shame cycle

AbbVie CEO Richard Gonzalez is the next pharmaceutical executive to lashing lashing tongues, gnashing teeth, and squeaking whiteboards of Congress as he prepares to testify before a House committee today. But after years of verdant threats and barren policy, does any of this matter?

As STAT’s Nicholas Florko reports, Wall Street is unmoved. AbbVie’s share price is tilting toward all-time highs, and analysts see little risk that congressional ire could snowball into legislation that could harm the company’s business. 

The committee has zeroed in on AbbVie’s best-selling medicines, Humira and Imbruvica, and the company’s established tactic of filing hundreds of patents to stave off competition. Panel chair Rep. Carolyn Maloney (D-N.Y.) has promised to reveal new “internal documents” detailing AbbVie’s methods. But if past hearings are any indication, there will be quite a few strong words but little in the way of ramifications for AbbVie.

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What will becomes of second-generation Covid vaccines?

Partners Medicago and GlaxoSmithKline said this morning that their vaccine for Covid-19 met its goals in a Phase 2 study, generating antibody responses that were about 10 times higher than those seen in patients recovering from the virus. But with vaccine supplies increasing around the world, the process of confirming that result could be complicated.

The news is that the Medicago vaccine, which combines a spike protein with a GSK adjuvant, boosted antibody production with mild to moderate side effects and no severe adverse events. The partners began a Phase 3 study in March, enrolling patients in Canada, the U.S., U.K., and Brazil. 

That puts them in the same situation as Sanofi, also working with GSK, which disclosed positive Phase 2 results of its own yesterday. In each case, they’ll be recruiting subjects in countries where vaccines are increasingly available, providing little incentive for volunteers to enroll in a trial where they might be assigned to receive a placebo. And the timeline for having an approved product creates uncertainty when it comes to demand. The best-case scenario for each vaccine is that it might be used as a booster shot if SARS-CoV-2 proves to be an endemic virus.

More reads

  • Luck is not a strategy: The world needs to start preparing now for the next pandemic. (STAT)
  • Ginkgo nabs 'DNA,' biotech's most sought after ticker, for free in sweetener from NYSE. (Endpoints)
  • Biden to send 20 million doses of U.S.-authorized vaccines abroad for first time. (Reuters)
  • How Ashish Jha became network TV’s everyman expert on Covid. (STAT)

Thanks for reading! Until tomorrow,

Tuesday, May 18, 2021

STAT

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