Copy

Sponsored by

 

The Readout Damian Garde & Meghana Keshavan

The week's biggest biopharma news — brought to you by a new face

Big news: CNBC senior health and science reporter Meg Tirrell is joining STAT’s weekly biotech podcast as our new co-host, alongside Damian Garde and Adam Feuerstein. She’ll be fully on board next week — but in the meantime, check out this week's episode, with a brief appearance from Meg and more. 

First, STAT’s Helen Branswell joins us to explain what happened at a closely watched FDA meeting on Covid-19 vaccines. Next, University of Michigan business professor Erik Gordon calls in to talk about why health care investors are going crazy for blank-check companies called SPACs. Finally, Damian and Adam preview one of the biggest events in recent biotech history: an upcoming FDA advisory panel to review aducanumab, Biogen’s controversial Alzheimer’s disease drug.

Read more.

A blow for blood plasma

Blood plasma offers no benefit over the standard of care to treat Covid-19, according to new data from the first randomized trial studying this therapy. The findings could renew the debate over blood plasma's value in treating the condition — and could also cast doubt on the FDA's decision to allow emergency access to the treatment, STAT’s Damian Garde and Matthew Herper write. The trial, which enrolled 464 adults at 39 hospitals in India, found that giving hospitalized patients a convalescent plasma infusion had no impact on their risk of growing sicker or dying. 

Some experts think the data are still too inconclusive to cast the idea aside, given that more than 80% of patients in the trial had already developed their own antibodies against the virus by the time they received the infusion. But others say the results might temper enthusiasm for the drug. "It certainly suggests it’s not the lifesaver that people thought it would be,” one expert told STAT. 

Read more.

The FDA has officially approved remdesivir 

Gilead’s antiviral drug remdesivir just scored the FDA's formal stamp of approval as a treatment for patients with Covid-19.  The agency first granted the drug an emergency use authorization in May, which allowed clinicians to administer the treatment to patients hospitalized with the virus. The drug, sold under the brand name Veklury, was approved for use in patients age 12 and older who are hospitalized. 

In an open letter — the latest in a string of such dispatches from Gilead — the company's chief medical officer Merdad Parsey said the drug has a “significant benefit” for “society at large.” Gilead will continue to test remdesivir in other settings, including outpatient and pediatric applications. 

FDA's vaccine advisers push analog tech

The FDA held an advisory committee yesterday to discuss the safety, efficacy, and potential approval of a Covid-19 vaccine. Many of the first vaccines are expected to come in two stages: An initial vaccine and a booster a few weeks later. One point of contention was how health providers might keep track of which vaccine a person needs to get. Jannell Routh of the CDC suggests relying on old school technology: When a person gets their first shot, they’ll get a physical card which indicates which vaccine they got. When the person goes in for a second shot, they’d present the card and get the right booster.

What could possibly go wrong?

More reads

  • Supporting U.S. public heath experts. (Nature Biotechnology)
  • ‘A matter of life and death’: Why a Brazilian lawmaker wants compulsory licensing for Covid-19 products. (STAT)
  • Fresh from early successes, RA Capital bags $461 million for new fund. (FierceBiotech)

Thanks for reading! More tomorrow,

Damian

Friday, October 23, 2020

STAT

Facebook   Twitter   YouTube   Instagram

1 Exchange Pl, Suite 201, Boston, MA 02109
©2020, All Rights Reserved.
I no longer wish to receive STAT emails
Update Email Preferences | Contact Us
5cQ.gif?contact_status=<<Contact Status>>