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The Readout Damian Garde & Meghana Keshavan

The Covid-19 pandemic has been a jarring reminder of what happens when society lets its guard down against infectious disease, amplifying years of concern about antibiotic-resistant germs. Join STAT's Matthew Herper and Ed Silverman on Thursday for a discussion about the issue. Sign up here.

What’s at stake with Bluebird’s safety scare?

This week’s news that two patients dosed with a Bluebird Bio gene therapy developed cancer is an unquestionable setback for the company, but it could reverberate throughout the interconnected field — that is, if Bluebird concludes there was a causal link between its therapy and the cases.

As STAT’s Adam Feuerstein reports, it's also possible the diagnoses are the result of a chemotherapy agent used to prepare patients to receive the company's therapy, or perhaps random chance. Bluebird’s investigation of that issue will take “weeks, not months,” the company said, but concern over the outcome has already affected expectations.

AvroBio, Orchard Therapeutics, and Rocket Pharmaceuticals each saw their share prices fall by double digits this week. None has reported cancer cases, and they’re targeting different diseases, but each uses a gene therapy technology similar to Bluebird’s, and each relies on the same chemotherapy agent.

Read more.

Biotech’s latest big SPAC isn’t quite a rainmaker

Part of the allure of going public through a blank-check company is the chance to get all the benefits of an IPO — easier access to money and a higher valuation — without the headaches of an old-fashioned listing. But for the most recent merger target, the tissue-engineering firm Humacyte, cashing that blank check doesn’t appear to be lining the pockets of its earlier investors.

Humacyte has agreed to merge with Alpha Healthcare Acquisition Corp., a special-purpose acquisition company, or SPAC, founded by biotech investor Rajiv Shukla. Humacyte has raised about $480 million in private funds over its 16-year history, and yet the SPAC deal gives it a base valuation of just $800 million. It’s impossible to measure the return until Humacyte files its detailed financial statements, but the raw numbers don’t reflect the step-up in valuation commonly seen in biotech IPOs.

But Humacyte has plans to vastly eclipse its current state. Speaking to Endpoints, Shukla said the company’s technology gives it the potential to become a $50 billion enterprise, beginning with the launch of its first two lab-grown blood vessels in 2023. But Humacyte’s timelines have slipped in the past. Back in 2016, the company had plans to run a Phase 3 trial testing its product in hemodialysis with plans to submit for FDA approval in 2018. That did not come to pass.

Trump is gone, but some states are pressing forward with his drug pricing plan

President Trump’s plot to cap certain drug prices at their international rates never came to pass, but a handful of states are advancing on their own with measures that would do the same job.

As STAT’s Lev Facher reports, each bill would bar state employee insurance plans and some private-sector plans from paying more than the lowest price charged in select largest Canadian provinces for a group of drugs. The details vary, including the number of medicines affected, but the impetus is the same: Each state, frustrated by bureaucratic hurdles of importing drugs from Canada, is trying to import the prices instead.

The bills are fairly limited in scope, largely excluding the Medicaid programs that tend to be states’ largest insurers. But several could become law as early as this year, setting the stage for an illuminating experiment and an all-but-guaranteed legal challenge.

Read more.

Tech believes it can solve pharma reps’ pandemic problem

Spare a thought for the nation’s tens of thousands of pharmaceutical reps, for whom Covid-19 has disrupted the practice of flying around the country marketing drugs to doctors. The tech industry, armed with digital platforms and loads of data, believes it can help, both by filling the gaps brought on by the pandemic and by making the process of pitching more efficient.

As STAT’s Mario Aguilar reports, Covid-19 has all but halted face-to-face interactions between drug reps and prescribing physicians, with the majority of communication now taking place virtually. But that temporary barrier could be a means to streamline what can be a disorganized process, according to data-crunching firms in the space.

Companies like ODAIA and Komodo Health offer tools to automate some of the research and record-keeping that goes into the process, processing data from insurance companies and other sources to help reps better target physicians. “[I’m] not saying pharma reps are going to go away,” said Ken Winell, chief technology officer of the marketing agency Greater Than One, “but I think that what’s going to happen is they’ll be optimized.”  

Read more.

More reads

  • In lab experiment, Pfizer-BioNTech vaccine less potent against coronavirus variant. (STAT)
  • Neil Woodford needs permission to set up new firm, says FCA. (The Guardian)
  • Prosecutors seek six-year prison term for former MiMedx CEO. (Reuters)
  • Biden to nominate Brooks-LaSure to oversee CMS. (STAT)

Thanks for reading! Until tomorrow,

Thursday, February 18, 2021

STAT

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