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The Readout Damian Garde & Meghana Keshavan

Novavax Covid-19 shot is 90% effective, but far less so for novel variant

A Covid-19 vaccine from Novavax is nearly 90% effective, preliminary results from a 15,000-volunteer trial show — but another study suggests that it’s far less effective against the coronavirus strain first identified in South Africa. A 4,400-volunteer study in South Africa showed that the vaccine was only 49% effective, though it was slightly more effective — 60% — among the subset of people that did not have HIV. 

It’s too early to tell whether this is enough data to warrant U.S. approval, STAT’s Matthew Herper and Damian Garde write, though the company said it’ll discuss the findings with U.K. regulators. The company plans on producing about 2 billion doses of its vaccine this year. The U.S. has already agreed to buy 100 million of these, and has the option to acquire more. 

Read more.

Amgen KRAS drug a ‘milestone in oncology’

Amgen’s KRAS-blocking drug shrank tumors in 37% of patients with advanced lung cancer, delaying tumor progression by nearly seven months. The drug, called sotorasib, has been carefully watched by researchers and investors alike, STAT’s Adam Feuerstein writes, because it’s attacking cancer cells with a genetic mutation — KRAS — that was previously thought unreachable. 

“This is a milestone in oncology because KRAS is the most frequent genetic driver of human cancer,” the study’s principal investigator told STAT. “Despite 40 years of hard research we have not been able to crack it until now.” 

KRAS-targeting drugs could let doctors to treat a larger proportion of patients with advanced lung cancer. Sotorasib is already under review by the FDA, EMA, and four other regulatory agencies around the world — and is expected to be approved later this year. 

Read more.

When are we getting more Covid-19 vaccine data? 

Is CRISPR having a dot-com moment? And how do we separate disinformation from healthy dissent?

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss the implications of Johnson & Johnson's any-day-now data on a one-shot vaccine for Covid-19. Then, Kevin Davies, executive editor of the CRISPR Journal, joins us to talk about the strange boom in genome editing stocks and the future of the revolutionary technology. Finally, we talk to Megan Ranney, an emergency room physician and Brown University professor, about the challenges of Covid-19 science communication in a post-Trump world.

Listen here.

Decentralized trials need teamwork

Clinical trials are in dire need of revamping, and one popular suggestion has been to simply decentralize them — allowing for patients to participate in studies from their own homes. That could mean using digital tools for remote monitoring, employing home health providers to participate in care and data collection, and relying on local labs and imaging centers, among other things. But more collaboration is key, according to the co-chairs of the Decentralized Trials and Research Alliance — a group of 50 key players in the clinical trials continuum. They say there needs to be better representation in clinical trials, and there needs to be a collective push to make decentralization a reality. 

“Now is the time for this community to seize the moment, enabled by the pandemic, to work together to harness the momentum toward decentralizing research and the technologies needed to improve trials for those they are intended to help — patients,” they write. 

Read more.

More reads

  • Roche taps into quantum computing for Alzheimer's disease research. (FierceBiotech)
  • Governments sign secret vaccine deals: Here's what they hide. (New York Times)

Thanks for reading! More next week,

Damian

Friday, January 29, 2021

STAT

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