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The Readout Damian Garde & Meghana Keshavan

Moderna secures nearly $500M for Covid-19

Moderna, the Cambridge-based vaccine developer that was one of the first into clinical trials with a Covid-19 vaccine, has secured U.S. government funding to accelerate progress of a vaccine it is making in conjunction with the National Institute of Allergy and Infectious Diseases.

The company, which hopes to begin a Phase 2 trial in the second quarter of this year and a Phase 3 potentially as early as the autumn, said yesterday it had received a commitment of up to $483 million from BARDA, the Biomedical Advanced Research and Development Authority. The money will be used in part to scale up Moderna’s production capacity.

While the company has not put a firm figure its manufacturing goal, CEO Stéphane Bancel said in a release that by scaling up the company should be able to produce millions of doses a month in 2020, and — with further investments — tens of millions a month in 2021, if its vaccine candidate, an mRNA vaccine, is successful.

Bancel also told STAT the company is in discussion with contract manufacturing organizations to secure additional capacity. “We are highly aware that, given almost everybody on the planet needs to be vaccinated, we’re going to need a lot of capacity and we are discussing with a lot of parties on how to help us get there,” he said.

Early data looking positive for Gilead’s remdesivir

In case you missed it yesterday, there was a glimmer of good news on Gilead's remdesivir, being tested as a treatment for Covid-19.

Patients treated with daily infusions are recovering quickly at a Chicago hospital, STAT’s Adam Feuerstein and Matthew Herper report. Their fever and respiratory symptoms are clearing up quickly, and nearly all of the patients with severe disease were discharged in less than a week.

“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital. She spoke during a video discussion of the remdesivir trial results with her colleagues. The discussion was recorded, and STAT obtained a copy of the video.

Read more.

What's the proper distance to stand from Sen. Mitch McConnell?

How many PowerPoint charts is too many? And when will Theranos get its day in court?

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First. STAT D.C. correspondent Nicholas Florko calls in to discuss President Trump's move to freeze funding for the World Health Organization and other surreal headlines coming out of the Capitol this month.

Then, our colleague Casey Ross joins us to explain the practice of contact tracing and how technology might help keep tabs on the spread of coronavirus. Later, Mike Huckman, a veteran of PR and pharma reporting, joins us to share some dos and don'ts when it comes to presenting data at a virtual conference. Finally, we discuss how the pandemic has delayed the summer's most-anticipated drama: Elizabeth Holmes' fraud trial.

Listen here.

Abbott’s rapid coronavirus test has some false negatives

The 13-minute coronavirus test from Abbott Laboratories, which was unveiled by President Trump on the White House lawn, is believed to have produced some false negatives — particularly in patients with low viral loads of the disease, STAT’s Matthew Herper reports

Abbott says changing how samples are collected should fix the problem. The test, though, has already been used hundreds of thousands of times.
 

Does anyone know how many patients the diagnostic tests miss?

“I’ll tell you, my pathologist colleagues are asking the same question,” one pathologist said. “And I don’t think anybody has a good sense of what the clinical sensitivity of not only the Abbott [test], but all these tests are.

Read more.

Potential in an experimental schizophrenia drug

Psychiatrists have a rather homogenous toolkit to treat schizophrenia: Almost all approved antipsychotic drugs target the same molecular pathway — the dopamine D2 receptor — and therefore behave in roughly the same manner. 

Sunovion Pharmaceuticals is attempting to change this: Its experimental antipsychotic drug, dubbed SEP-363856, uses a completely different molecular pathway to help mitigate symptoms of schizophrenia. Data from a 245-patient study was just published in NEJM, and suggests that unlike most antipsychotics, the Sunovion drug may have a mild side effect profile — and could target a wider range of symptoms.

However, some psychiatrists wonder if Sunovion’s novel mechanism is all that novel.

Read more.

More reads

  • Biopharma conferences are going virtual. Here's how not to present on Zoom. (STAT)
  • Designing precision antibiotics with inspiration from bacteria's survival strategy. (FierceBiotech)
  • FDA eases rules so compounders can make drugs for Covid-19 patients on ventilators. (STAT
  • New study seeks to surface data to produce a stronger measles vaccine. (STAT)

Thanks for reading! More next week,

Damian

Friday, April 17, 2020

STAT

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