Science, Policy, Biotech Thomas Culman Science, Policy, Biotech Thomas Culman

Managing pain without opioids is on the horizon – if we decide it’s worth it

Thanks to the relentless efforts of scientists at Vertex Pharmaceuticals, there will likely soon be a novel non-opioid pain medicine. How insurance plans, including Medicare, decide to cover this drug will make a world of difference to whether we get even better non-opioid options down the road — and whether this progress makes a dent in the ongoing opioid misuse crisis.

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Science, Biotech, Culture Chris Morrison Science, Biotech, Culture Chris Morrison

How Jnana picked PKU

Starting with a blank slate is exciting – the ability to create a platform, a pipeline, a team from scratch is a big reason why one comes to biotech – but it requires a fearless and innovative team and bold investors and partners. The story of how PKU became the first killer app for Jnana’s SLC discovery platform -- a key pivot point in demonstrating the platform's value -- is emblematic of the calculated risk taking that we embrace in biotech.

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Policy, Biotech Peter Kolchinsky Policy, Biotech Peter Kolchinsky

Egypt and hepatitis C cures — the gift that keeps on giving

In covering how Egypt managed to eradicate hepatitis C, the New York Times rewrites a key bit of history that betrays its misunderstanding of global drug pricing. Egypt’s access to the life-saving Harvoni was a gift from Gilead, not a result of a bare knuckle negotiation. It’s important to understand and explain the increasingly vulnerable system that underpins that gift before bad policy dismantles it.

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Finance, Biotech Chris Morrison Finance, Biotech Chris Morrison

Shutting down Silverback — a Q&A with Laura Shawver

Silverback Therapeutics’s wind-down and reverse merger process can serve as a template for other companies when their clinical trials fail. The company’s response to its setback also teaches us about scenario planning, the importance of moving quickly when a key program doesn’t deliver hoped-for data, and why we should look ahead to a biotech ecosystem that anticipates the consequences of – and opportunities stemming from – its inevitable clinical setbacks.

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Policy, Finance, Biotech Chris Morrison Policy, Finance, Biotech Chris Morrison

Alnylam is doing what the IRA is telling it to do

The recent announcement by Alnylam Pharmaceuticals that it was holding off on a planned Phase 3 pivotal study for vutrisiran (marketed as Amvuttra in its sole approved indication so far, hATTR amyloidosis with polyneuropathy) in Stargardt disease illustrates how the Inflation Reduction Act is already having a negative impact on small molecule and orphan drug R&D prioritization. Alnylam’s announcement also brought out skeptics of the biotech industry, who argue the new law is being scapegoated by innovators who want to overturn its Medicare drug-negotiation provisions.

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Policy, Biotech Chris Morrison Policy, Biotech Chris Morrison

Navigating a storm that threatens American biotechnology

Over the past four decades, David Beier has observed and participated in the evolution of the US biotechnology industry for several key vantage points. The industry’s success and freedom to innovate, he says, has been underpinned by – and helped create – a marketplace that was open enough to fully reward risk-taking investors devoting capital to cutting edge science. Today, that success faces new threats.

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Policy, Biotech Chris Morrison Policy, Biotech Chris Morrison

The NIH, R&D, and the first mile of the marathon - a conversation with John LaMattina

A conversation with former Pfizer research head John LaMattina about the persistence of the misperception that NIH invents the drugs that biopharma companies sell, the chance encounters that can lead to breakthroughs years or even decades later, and the tough math facing investors and heads of research across the industry when deciding whether to invest in a project that’ll only enjoy nine years of market exclusivity.

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Policy, Biotech Chris Morrison Policy, Biotech Chris Morrison

Innovation and biopharma M&A: feature, not bug

If the FTC begins to look askance at M&A between commercial-stage biopharmaceutical companies and the innovative smaller biotechs that so often are the sources of new medicines, that would be bad news for future R&D and the patients who depend on our industry for life-saving medicines. That they might do so in the name of preserving or protecting innovation in the first place would add insult to injury.

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Policy Chris Morrison Policy Chris Morrison

Post-launch, pre-cliff: The R&D Congress ignores

Often, a drug’s initial approval only hints at its full therapeutic potential and the eventual number of patients who may benefit over time. Continued R&D investment can unlock much more utility before the drug ultimately goes generic, but those investments require adequate incentives.

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Science, Biotech Peter Kolchinsky Science, Biotech Peter Kolchinsky

Nektar’s IL-2 legacy: The two sides of failure

Though its program failed in clinical trials, Nektar kicked off an appreciation for what might be possible with a better IL-2. As other companies carry on with programs in part inspired by Nektar’s early data and vision, we explore failure in biotech, ignoring the naysayers, and the value of carrying on when the odds are slim.

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