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The Readout Damian Garde & Meghana Keshavan

How a journal's censure inflamed debate over Biogen's Alzheimer's drug

Three researchers were chastised by a journal run by the Alzheimer’s Association after one of them tweeted a link to a yet-to-be-finished critique of of Biogen’s controversial drug aducanumab, and another failed to disclose a conflict of interest. The Alzheimer’s & Dementia journal told the authors in December they’d committed an “ethical violation,” as STAT's Damian Garde and Adam Feuerstein report

But others saw the move as something else: an effort by the Alzheimer's Association, which supports the approval of aducanumab, to retaliate.

“It’s a grotesque overreaction,” said Robert Howard, an Alzheimer’s researcher and professor of psychiatry at University College London who was not involved in the situation. “This is the sort of thing you would do if you discovered someone had committed research fraud or some really damaging piece of misconduct.”

Read more.

South Africa halts AstraZeneca-Oxford vaccine rollout

AstraZeneca’s Covid-19 vaccine, which was developed in partnership with University of Oxford, isn’t sufficiently effective against the new coronavirus strain that originated in South Africa, according to a study. The study in South Africa was small, and preliminary, but even so officials there are halting the rollout of the vaccine, STAT’s Matthew Herper writes.  

The developments increase concerns about the B.1.351 strain, and about the AstraZeneca-Oxford vaccine — which is expected to be one of the cheapest and most easily available Covid-19 vaccines in the world.  

Read more. 

After rocky road, BMS CAR-T drug gets approved

A new CAR-T drug, liso-cel, won FDA approval for patients with large B-cell lymphoma late last week — making it the third such cell therapy drug to be cleared. The Bristol Myers Squibb drug, which will be sold under the trade name Breyanzi, led to complete remission in 54% of the 250 patients tested. 

The drug has been closely watched thanks to a spate of regulatory delays and manufacturing stumbles: Breyanzi’s earlier woes caused BMS investors to miss out on a much-anticipated payout linked to its prior Celgene buyout.

The company said in a conference call last week that it expects to launch the CAR-T therapy “imminently.” 

Delving into 23andMe’s efforts to go public

Consumer genetics company 23andMe is going public, so STAT took a a close look at its accompanying SEC filing — and came up with some interesting observations. The company isn’t expecting to turn a profit for several years. Revenue has plunged since 2019, when it earned $441 million. And it doesn’t expect to generate that amount again annually until 2023, STAT’s Erin Brodwin and Katie Palmer write

Although the company is hoping its subscription business, 23andMe+, will help bring in more money, it expects that the largest driver of revenue will be in selling its consumer DNA insights to companies that might turn them into products.

The company’s doubling down on its drug discovery business, with plans to grow from eight validated targets in 2020, to 25 in 2022, to 37 in 2024. 

Read more.

More reads

  • Collaboration between the FDA and industry is essential to foster innovation in Alzheimer’s treatments. (STAT)
  • WTO is urged to ease trade rules so low-income countries can access drugs and vaccines. (STAT)
  • Vor Biopharma hits Wall Street with $170 million IPO. (FierceBiotech)

Thanks for reading! More tomorrow,

Damian

Monday, February 8, 2021

STAT

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