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The Readout Damian Garde

Adieu, biotech boom times?

Two of the largest biotech IPOs ever unfolded last week. And, as a bellwether perhaps of biotech tides ebbing, neither did quite that great.

BioNTech, a German maker of patient-tailored, RNA-based cancer immunotherapies, priced its shares at $15 each — raising $150 million overall, and valuing the company at $3.4 billion. However, since its Oct. 10 Nasdaq debut, shares have dropped to $13.82.

Meanwhile, Vir Biotechnology — a San Francisco-based infectious disease drug developer — launched Friday at $20 a share, raising $142.9 million. The shares have since crashed nearly 30% in after-market trading, hovering around $14 a share. 

Earlier this month, ADC Therapeutics decided to back out of a planned IPO, citing “adverse market conditions.” Indeed.

Unicorns: Not all rainbows and sprinkles

Ever wonder how the ever-elusive biotech unicorn is birthed? Ever wonder if that billion-dollar valuation really is a billion? Ever want to see the word “canard” used correctly and seamlessly in a spoken sentence? 

Check out Damian Garde’s quick video explainer on how that biotech unicorn grew its horn. (And no, it’s not a matter of CRISPRing a horse — this is a money thing, guys.) 

Watch here. 

A new way to evaluate cancer drug prices

As the debate over drug pricing rages on, the price of cancer drugs, in particular, has been a focus. But figuring out how to calculate costs for these expensive, but potentially life-saving, drugs is complicated equation, economists Alice Chen and Dana Goldman write. It’s tricky to find the right metric by which to figure out a cancer drug’s value — and price it. 

They propose mean survival gain — that is, the average length of time patients survival after half the trial participants have died — as a new metric to evaluate a drug’s efficacy. The most commonly used metric looks at the median, which ends up obscuring the nuances of a drug’s efficacy, they say. 

“We need to take account the mountaintop view, not just the price per square foot,” they write. 

Read more.

A quiet FDA reorg

Buried in boilerplate language is a revolutionary shift in regulatory policy at the FDA, writes Peter Pitts, president of the think tank Center for Medicine in the Public Interest. 

Pitts, who also once served as an FDA associate commissioner, writes that a recent press release titled “Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality” indicates important and noteworthy change at the agency. 

For instance, there will be more folks conducting product and clinical review. And it’ll shore up and centralize drug policy review in the Office of New Drug Policy. These changes show that “laying claim to the regulatory gold standard is a moving target,” Pitts writes. 

Read more.

More reads

  • Pfizer posts detailed phase 3 data on its Dupixent rival (Fierce Biotech)
  • FDA approves new Eli Lilly drug to ‘resolve’ migraine pain in two hours (CNBC)

Thanks for reading! More tomorrow,

Damian

Monday, October 14, 2019

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