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Questioning combination therapies, Biogen's dubious courage, & Califf on agency teamwork

 

The Readout Damian Garde & Meghana Keshavan

Meghana here with your last edition of The Readout of the week. Let's get to it.

Combination therapies may not work as intended

Pairing synergistic drugs that work in tandem to combat tumors more efficiently has been a goal for a long while. But a new study suggests that combination therapies aren’t all they’re cracked up to be, STAT’s Angus Chen writes. Instead of working as a team, cancer drugs given together seem to work independently, and aren’t particularly beneficial when used together.

“We were so embedded in the mindset that [searching for synergy] is the way to do things,” the study’s co-author told STAT. “It’s been a real journey of questioning my assumptions, discovering data that contradicts everything you thought you knew about something. Exciting and scary and almost like a loss of faith.”

It’s important to note, however, that combinations are often successful, even if they individual treatments aren't necessarily working together. When it's difficult to gauge which drugs will actually shrink tumors, a cocktail of medications can actually improve the odds.

Read more.

That doesn't seem so courageous

After Biogen slashed the price of the Alzheimer's drug Aduhelm by half, from $56,000 to $28,200, CEO Michael Vounatsos described the move as “courageous.” STAT’s Ed Silverman, however, begs to differ in a new Pharmalot View.

“Simply put, he’s out of touch,” one biotech economics expert told STAT. “He’s expecting a pat on the back for lowering the price of a $56,000 drug to $28,200? That doesn’t make it a bargain. It’s like saying ‘Have I got a deal for you!’ It shows bad judgment and bad stewardship. I think the company needs new leadership.”

Read more.

Why does everyone hate biotech stocks?

Can Big Science create an actual business? And what are Martin Shkreli’s job prospects?

We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. With biotech in the dumps, we talk to Oppenheimer analyst Jared Holz about why the world has soured on the sector and what it means for the future of medicine. Then, STAT’s Matthew Herper joins us to explain the latest big idea from biotech’s big thinkers: a company called Altos Labs, which has raised $3 billion to do something or other. We also discuss the latest news in the life sciences, with a cameo from Shkreli and an update on Omicron.

Listen here.

Califf wants agency cooperation on accelerated approvals

Robert Califf, soon-to-(probably)-be FDA chief, elaborated on his opinion of accelerated approvals, Endpoints points out. While he agrees that some drugs ought to be approved quickly, he thinks there are flaws in obtaining post-market confirmatory evidence of their efficacy. Califf thinks that agencies like CMS and FDA ought to work together to decide whether a drug is safe and effective, rather than back to back, as if in a relay race.

“FDA runs the first lap, gets to the end, drops the baton down on the ground, and someone else like CMS has to figure out where the baton is, pick it up and start all over,” he said. In his prior tenure as commissioner, Califf noted that he saw “the power of federal agencies working together with common purpose.” Looks as though, if confirmed, this could be a priority once again.

More reads

  • A vaccine to prevent all Covid is within reach. Here's how to grab it. (Bloomberg)
  • FDA urges doctors to prioritize blood draws as collection tube supplies dwindle. (FierceBiotech)

Thanks for reading! Until next week,

@megkesh
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Friday, January 21, 2022

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