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The Readout Damian Garde & Meghana Keshavan

Biogen noticed the Aduhelm backlash

In the weeks following the FDA approval of Aduhelm, Biogen’s treatment for Alzheimer’s disease, each day has brought new criticism of the drug’s supporting data, its $56,000-a-year price, and Biogen’s imprecise plans for running another clinical trial to prove its benefits. Notably absent from that conversation has been Biogen itself.

That changed yesterday when Biogen put out an “update for the Alzheimer’s Disease community,” a bullet-pointed factsheet that, while light on new information, seemed specifically crafted to address the outrage. On the price, Biogen said it was “based on our belief in the impact of treatment as well as the size of the appropriate patient population” and added that if its assumptions end up being wrong, the company is “ready to work with public and private payers.”

Perhaps most notable were Biogen’s words on that new clinical trial. Back on June 7, the day of Aduhelm’s approval, Biogen CEO Michel Vounatsos told CNBC the company had “more than nine years” to deliver on that promise, a claim that, while not statutorily false, rankled FDA officials who thought it suggested a lack of urgency on the company's part. Cut to yesterday’s statement, and Biogen is now “working with urgency and putting resources and plans in place towards the goal of completing the confirmatory trial ahead of the nine-year timeframe.” The company didn’t commit to a start date, and its promise could well translate eight years, 11 months, and 30 days. But it’s a marked change in tone all the same.

The latest TIGIT twist is light on detail

TIGIT, cancer immunotherapy’s latest trendy target, has sparked the imaginations of academics, industry, and investors based on tantalizing data suggesting it might greatly expand the utility of existing medicines. But the most recent update on its potential, from Arcus Biosciences, is likely to raise more questions than answers.

As STAT’s Adam Feuerstein reports, Arcus said last night that its anti-TIGIT antibody showed “encouraging clinical activity” in a preliminary look at data from a study in lung cancer. The company didn’t disclose any data, and Gilead Sciences, which has the option license its treatment, is deferring a decision until later this year.

Arcus’s trial enrolled patients with newly diagnosed non-small cell lung cancer and compared the combination of domvanalimab, the company’s TIGIT treatment, with a PD-1 inhibitor against the latter drug on its own. A similar combination study from Roche found that combining TIGIT and PD-1 nearly tripled the response rate, setting a benchmark for the increasingly crowded field.

Read more.

Introducing ‘New GSK,’ now with 38% more revenue

With scores of slides, reams of jargon, and the threat of a shareholder revolt in the air, the powers that be at GlaxoSmithKline spent yesterday morning extolling the virtues of “New GSK,” the catchily named company that will forge into the future once the storied firm spins off its consumer business.

The plan, spelled out over a number of hours, includes increasing revenue from vaccines and drugs by 5% over five years and 38% by 2031, reflecting GSK’s faith in a pipeline of unproven medicines. The investor reaction was “lukewarm,” according to Bloomberg, which went with the headline “Glaxo CEO Walmsley Buys Time as Strategy Gets Modest Backing.”

But a little added time will benefit Emma Walmsley, who is facing an activist investor in the form of Elliott Management, which is reportedly trying to convince shareholders that it’s time for a regime change at GSK, New or otherwise. The company’s share price rose nearly 4% at market open yesterday before settling roughly 2% above its prior close, suggesting investors are willing to take GSK’s current management at its word, at least for now.

Are we sure there'll be demand for Covid booster shots?

The manufacturers of Covid-19 vaccines have been uniformly bullish about the future market for booster shots of Covid-19 vaccines. But yesterday's meeting of the Advisory Committee on Immunization Practices, a group that advises the CDC, might have dampened those prospects.

When the CDC asked ACIP members what they think should trigger a decision to recommend boosters for Americans, those who chimed in said they’d want to see data supporting a need to give everyone another dose. Current data suggest the authorized vaccines are working well, even against virus variants.

There was no vote taken. Still, the message was clear, said Norman Baylor, a former head of the FDA's Office of Vaccines. Baylor, who now runs Biologics Consulting, said the discussion demonstrated that decisions about whether to use booster shots will be made by public health leadership, not in industry board rooms, adding he expects the CDC and the FDA to work together on guidance for manufacturers spelling out what would trigger a decision to order booster shots. “I don’t think it’s going to be [that] … each company is going to decide, 'I’m going to make a booster and I want approval or authorization for this booster,’” he said. “It’s going to be a public health decision.”

Woodcock is 'not that concerned' about FDA criticism

Speaking of Aduhelm backlash, the majority has focused on the FDA, which bent its established rules to approve Biogen’s Alzheimer’s disease treatment based on biological evidence rather than clinical benefit. But Janet Woodcock, the agency’s acting commissioner and former long-time head of drug approvals, believes the FDA will be vindicated in time.

“I’m not that concerned because I believe more information will come out,” Woodcock told STAT’s Nicholas Florko. “There will still be people who disagree with the decision, but that is often the case with decisions we make.” Back in the 1990s, when the FDA began approving treatments for HIV based on so-called surrogate endpoints, the debate was “bitter and fierce,” she said. Today, those decisions are held up as exemplary.

As to the pressing matter of whether she’ll eventually shed that “acting” title, Woodcock said she’s had no contact with President Biden, whether about a nomination or anything else. Would becoming permanent FDA commissioner make her job easier? “Well, it might decrease the number of questions that people keep raising,” Woodcock said.

Read more.

More reads

  • Officials note ‘likely association’ between Covid-19 vaccines and rare heart condition in young people. (STAT)
  • Illicit Covid-19 drugs bound for Mexico seized by U.S. authorities. (Wall Street Journal)
  • CureVac founder withdraws candidacy for supervisory board. (Associated Press)
  • What the cancer research community can learn from the Covid-19 response. (STAT+)

Thanks for reading! Until tomorrow,

Thursday, June 24, 2021


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