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Biogen's case against Medicare, parsing CFOs, and a curious Covid-19 treatment

 

The Readout

Good morning! Damian here with the latest twist in the Aduhelm saga, a lucrative biotech curiosity, and invitation to speculate about Pfizer's future.

What if Biogen just sues Medicare?

Now that Medicare has adopted a strict policy that promises to make Aduhelm a commercial nonentity, Biogen might deploy its attorneys in a last-ditch effort to rescue the polarizing drug.

As STAT’s Nicholas Florko reports, while Biogen hasn’t disclosed plans to sue the government, the company has said it doesn’t believe Medicare’s restrictions on reimbursement for Aduhelm would stand up in court. And a number of legal experts said Biogen might have a shot at challenging the decision.

The implications of such a lawsuit stretch beyond Aduhelm and beyond Alzheimer’s disease. If Biogen were to succeed, it could rein in Medicare’s authority, potentially empowering the drug industry by removing a powerful tool for limiting the government’s spending on new drugs and devices.

Read more.

Reading CFO tea leaves

On Wall Street, virtually everything major pharmaceutical companies do gets filtered through the lens of “What does this mean for deals?” With that in mind, Pfizer’s latest executive recruitment might be warmly received among the moneychangers.

The company’s new chief financial officer will be David Denton, Pfizer said yesterday, joining the company from the home-improvement retailer Lowe's. But it’s Denton’s prior position that has turned heads: He was CFO of CVS during its run of buying up pharmacy benefits managers and presided over the company’s $70 billion acquisition of Aetna in 2017, the then-biggest merger in health care history.

Pfizer, which is flush with cash thanks to Paxlovid and its Covid-19 vaccine, is under pressure from investors to spend that money on something that can grow the business in a post-pandemic world. Denton’s résumé suggests the company might be thinking big.

Biotech stocks still go up sometimes

While the whole biotech sector is still down nearly 25% for the year, yesterday brought a reminder that, every now and again, drug stocks still rocket upward on unexpected data.

The beneficiary this time is Veru, a company that both develops cancer drugs and markets female condoms, which said its oral treatment for Covid-19 succeeded in a Phase 3 trial, nearly tripling its stock price. According to Veru, the drug showed a 55% relative reduction in deaths among patients with Covid-19 at high risk for severe disease, and the company plans to seek an emergency authorization from the FDA.

It remains to be seen whether the data, gathered from just 150 patients, hold up to scrutiny. And even if the FDA is eventually convinced, it’s unclear whether there’d be meaningful demand for Veru’s drug among the existing treatment options for Covid-19. But at least for a day, Veru was the toast of biotech.

Immunotherapy’s old guard shines in lung cancer

Giving lung cancer patients a PD-1 blocking immunotherapy before surgery can help prevent the disease from coming back, according to a new study, validating yet another use of the blockbuster class of medicines.

As STAT’s Matthew Herper reports, patients in the study who received three courses of Bristol Myers Squibb’s Opdivo in combination with chemotherapy were 37% less likely to have an “event” — defined as progression of disease that prevented surgery, any progression of disease after surgery, or death — than those getting chemotherapy alone. An accompanying editorial in the New England Journal of Medicine called the result “practice-changing.”

The question is whether physicians and patients, who don’t generally opt for chemotherapy before surgery, will embrace the idea. The solution may come from trials being conducted by Bristol, Roche, Merck, and AstraZeneca that give immunotherapy both before and after surgery.

Read more.

More reads

  • New insulin policy would entice drugmakers to lower prices. STAT
  • Moderna names Dentsply Sirona senior exec as new CFO. Reuters
  • FDA scolds Bausch Health for misleading claims about a psoriasis cream. STAT+
  • Field mice seek refuge in FDA’s Maryland headquarters. Politico

Thanks for reading! Until tomorrow,

@damiangarde
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Tuesday, April 12, 2022

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