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The Readout Damian Garde & Meghana Keshavan

Here’s every major biotech event for the rest of the year

Biogen’s date with the FDA, Cytokinetics’ shot at a comeback, and Amgen’s chance to shake up oncology are still to come in what has already been an unprecedented year for biotech.

As STAT’s Adam Feuerstein reports, the fourth quarter of 2020 is loaded with events that could change narratives around the industry. Beyond Biogen’s well-covered FDA panel on the Alzheimer’s disease treatment aducanumab, Amgen will have pivotal data on a cancer target once thought to be undruggable, and Cytokinetics will finally disclose the results of a massive study focused on heart failure.

There will also be news from Vertex Pharmaceuticals, Intercept Pharmaceuticals, and, of course, the many companies developing vaccines and therapies for Covid-19.

Read more.

Pharma endures Rep. Porter’s white board

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A handful of pharma industry CEOs had a painful afternoon in Congress yesterday after a group of newly elected Democrats skewered their records on drug pricing in stinging, direct terms.

As STAT’s Nicholas Florko reports, the most memorable exchange came from California Rep. Katie Porter, a former consumer protection attorney who has made a name for herself by embarrassing executives with prosecutorial questions and a white board. The target was Celgene, represented by former CEO Mark Alles, who struggled to explain years of price increases to the cancer drug Revlimid, neatly laid out on Porter’s white board.

The back-and-forth was part of a three-hour hearing on the results of a lengthy congressional investigation into the pricing practices of Teva, Celgene, Amgen, and Mallinckrodt, and there’s more to come later today. But it seems unlikely the proceedings will amount to more than just sound bytes. Beyond the more theatrical moments, members of the House Oversight Committee spent most of their time debating who has the better plan to lower drug prices: Republicans or Democrats.

Read more.

G1, and its new CEO, are out to prove Wall Street wrong

“Short the launch” is among biotech’s oldest clichés, based on the belief that small companies are quite good at developing new medicines but more than a little lacking when it comes to actually commercializing them. G1 Therapeutics, expecting its first FDA approval in February, is changing CEOs and betting it can defy that trend.

Come Jan. 1, G1 CEO Mark Velleca will cede the reins to Jack Bailey, a pharmaceutical veteran and current board member. Velleca has led G1 since 2014, when the company, co-founded by National Cancer Institute Director Ned Sharpless, was yet to start its first clinical trial. Now G1, whose share price has fallen 55% in 2020, has the chance to prove it can market medicines as well as it develops them.

“A lot of emerging R&D companies making the transition to commercial have faltered,” Velleca said. “I think the Street tends to handicap companies in that situation. ... It’s a show-me story, and we look forward to showing.”

Read more.

Suddenly Trump trusts pharma?

President Trump’s tumultuous relationship with the drug industry took a turn this week after he implied that companies he once accused of “getting away with murder” now hold the keys to his re-election.

As STAT’s Matthew Herper writes, Trump, during Monday's debate with former Vice President Joe Biden, made it clear that he trusts the likes of Pfizer, Johnson & Johnson, and Moderna more than his government’s scientists when it comes to the timing of a vaccine for Covid-19. 

“They can go faster than that by a lot,” Trump said after moderator Chris Wallace cited the many experts who don’t believe a vaccine will be widely available until the summer. “It’s a very political thing because people like this would rather make it political than save lives.”

It’s worth noting that the companies Trump cited have, at least publicly, said pretty much the same things about timing as the scientists he has contradicted. But Trump’s diction marks a striking departure from his usual view of the drug business, and it implies that an industry he once vilified is the only thing that can deliver the vaccine his perceived political foes want to delay.

Read more.

More reads

  • For the first time, drug makers and PBMs must jointly face an insulin price fixing lawsuit. (STAT Plus)
  • Moderna chief says its vaccine won’t be ready before the U.S. election. (Financial Times)
  • China’s biotechnology boom turns suppliers into M&A targets. (South China Morning Post)
  • Cancer drug bet pays off for biotech CEO with 3,600% stock surge. (Bloomberg)

Thanks for reading! Until tomorrow,

Thursday, October 1, 2020

STAT

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