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The Readout Damian Garde & Meghana Keshavan

Fibrogen runs into an 11th-hour FDA problem

Fibrogen and its partners at AstraZeneca were expecting the FDA to make a final decision on a new anemia drug later this month, but the agency’s surprising last-minute decision to convene a panel of outside experts suggests the drug’s future might be in doubt.

As STAT’s Adam Feuerstein reports, Fibrogen learned yesterday that the FDA planned to schedule a meeting of external advisers to discuss roxadusat, the company’s oral treatment for anemia. Enrique Conterno, Fibrogen’s CEO, declined to disclose the agency’s reasoning or any issues regulators have raised about roxadusat.

Read more.

Novavax’s variant-specific vaccine is coming mid-year

Much like Covid-19 vaccine leaders Moderna and Pfizer, Novavax has a plan to deal with the rise of worrisome viral variants, with clinical trials slated to start later this year.

Novavax has already crafted strain-specific versions of its original vaccine, the company said yesterday, and is testing them in monkeys. By the middle of this year, Novavax expects to start human studies of its variant-specific vaccines as well as for a multivalent one designed to protect against all known strains of the virus that causes Covid-19. 

It remains to be seen whether dealing with viral variants requires novel vaccines or simply booster shots of those that already exist. But we’ll soon find out. Moderna, like Novavax, is moving forward with a newfangled vaccine meant to protect against the variant known as B.1.351, which appears to weaken vaccine efficacy. Pfizer is planning to test a third dose of its existing vaccine, betting that boosting the immune response will protect against B.1.351.

Biotech’s SPAC leader stays ahead of its peers

While funds around the world stumble over one another to launch blank-check companies, Perceptive Advisors is already on its fourth, making the most of a financial trend whose shelf life might be limited.

Perceptive raised $130 million for the aptly named Arya Sciences Acquisition Corp IV, which is its fourth SPAC, or special-purpose acquisition company. The previous three have all found merger targets in the form of Immatics, Cerevel Therapeutics, and Nautilus Biotechnology. The fourth now begins a two-year search to do the same.

Perceptive’s prolific SPAC activity has already created sizable paper returns for the firm, which takes a 20% stake in the combined companies. It might also look wise in the years to come, when a glut of target-seeking SPACs threatens to drive up asset prices and dampen returns. By then, Perceptive might have moved on to finance’s next trend.

A plan to regulate drug costs without infuriating people

The debate over how to lower health care costs in the U.S. tends to swing between toothless practicalities and sweeping political impossibilities. A trio of experts believe they’ve found a middle way: Set up an independent, publicly funded brain trust that would parse an ocean of data in search of value.

It would be called the Institute of Health Technology Assessment, and it would unite scientists, economists, physicians, and other health care experts to analyze the evidence on the effectiveness and value of devices, medicines, procedures and any other innovations that can end up on a medical bill. The resulting insights would be public and thus equip all parties, from payers to providers to patients, with actionable information on effectiveness, cost, and value.

The institute, as its authors explain in STAT, would have no regulatory authority but would function as a sort of public utility for information on health technology. 

Read more.

Moderna’s vaccine success is paying off for its competitors

Moderna’s eight-fold valuation increase since the start of 2020 has been notably lucrative for the insiders who’ve sold millions of shares, but it’s also benefiting a pair of the company’s fellow travelers in the Covid-19 vaccine race.

AstraZeneca sold off its shares in Moderna over the course of last year, according to its annual report, booking a profit of roughly $1 billion. AstraZeneca’s faith helped put Moderna on the map back in 2013, and the company owned about 8% of Moderna at the time of its 2018 IPO.

The news follows Merck’s December announcement that it had liquidated its shares of Moderna, acquired in 2015 and augmented in 2018, for an undisclosed return. In the first nine months of 2020, Merck recorded $964 million in gains to its investment portfolio, “most of which relate to Moderna,” the company said.

More reads

  • The Trump administration secretly spent billions in hospital funds on Operation Warp Speed. (STAT)
  • Chinese hackers target Indian vaccine makers SII, Bharat Biotech, says security firm. (Reuters)
  • A nascent state effort would tax drug makers for not providing clinical evidence for price hikes. (STAT+)
  • Early Morphic data hint at a threat to Entyvio. (Evaluate Vantage)

Thanks for reading! Until tomorrow,

Tuesday, March 2, 2021

STAT

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