The Readout Damian Garde & Meghana Keshavan

We're just two weeks away from the 2020 STAT Summit, where some of the biggest names in industry, academia, and policy will discuss how the pandemic has reshaped health and medicine — and where things go next. Speakers include Jennifer Doudna, Albert Bourla, Emma Walmsley, and Anthony Fauci. Get tickets here.

Biogen’s FDA day is nigh. Here’s what you need to know

Among this week’s byzantine federal processes that affect millions of people is a Friday FDA meeting to discuss the merits of aducanumab, Biogen’s endlessly debated treatment for Alzheimer’s disease. Preparing for that meeting involves hundreds of pages of documents, confusing FDA pronouncements, and opposing views from experts around the world.

So we made a cheat sheet.

When will the agency’s review be made public? Where do you find it? Which parts of it are important, and what does it mean if they come across a little harsh?

We discuss all of that, plus some explain the scientific debate, lay out the implications, and show you which pages to bookmark.

Read more.

Bristol’s psoriasis treatment meets study goals, beats rival Amgen drug

Bristol Myers Squibb said this morning that its investigational psoriasis treatment demonstrated superiority to placebo, achieving the goals of a large Phase 3 clinical trial.

The drug, deucravacitinib, treats psoriasis differently than currently approved medicines. And, if it's approved in just psoriasis and a related condition, psoriatic arthritis, it could be a blockbuster — generating nearly $1.5 billion in annual sales.

But, as STAT's Adam Feuerstein notes, the drug has the potential to treat a wide range of autoimmune diseases beyond psoriasis. It also has potential consequences for Amgen, which has a competing psoriasis drug.

Read more.

Philadelphia’s biotech hub is getting left behind

While the Bay Area and Bay State get most of the attention, Philadelphia has risen as a hub for biotech startups in recent years. But the local industry’s growth appears to be slowing, even among unprecedented success elsewhere in biotech. Is Philadelphia’s cluster on the downswing?

As STAT’s Kate Sheridan reports, the amount of venture capital flowing into the city’s biotech startups is down in 2020, which contrasts with record-breaking numbers for the sector as a whole. 

Experts pointed out that the sum can easily be swung by a few high-dollar deals, or lack thereof. But there could also be something systemic at work. Philadelphia has long been an epicenter for cell and gene therapy startups, owing to the prominence of the University Pennsylvania in both of those fields. But sentiment around each is not what it was back in 2017, which could have a cooling effect on the local industry in the future.

Read more.

What should Gilead do with its FDA voucher?

Thanks to the FDA’s approval of the Covid-19 treatment remdesivir, Gilead Sciences was awarded a coupon, worth hundreds of millions of dollars, that entitles its owner to speedy drug review. But does a company on pace to make about $2 billion on remdesivir this year really need such an enticement?

As STAT’s Ed Silverman reports, the advocates at Public Citizen argue it does not. The FDA program in question is designed to reward companies for developing drugs against diseases that pose a “material threat” to public health, an area often overlooked by the pharmaceutical industry. 

But Covid-19 has proved to be a rare moment in which public health and shareholder returns appear harmonious, at least for Gilead. The drug made $873 million in the last quarter and could do $1 billion more by the end of the year. Gilead’s multibillion-dollar windfall speaks for itself, Public Citizen argues, so why offer another reward?

Read more.

They’re doing an election today

Some time today or perhaps tomorrow or even next week, the U.S. will have counted the votes in the 2020 presidential election and we will know whether President Trump will get a second term or former Vice President Joe Biden will occupy the White House. And, unlike four years ago, Wall Street seems largely ambivalent about what it means for biotech.

While the prospect of a Clinton administration tanked biotech stocks back in the fall of 2016, Biden’s rising poll numbers in recent months have coincided with industry indices hitting all-time highs. That suggests either investors have faith in the seemingly flagging Trump campaign, or they’re thinking back to the eight years they spent under President Obama, which proved remarkably lucrative for the drug industry.

The other possibility is that they’re betting on stability. Biden has promised to raise corporate taxes and allow Medicare to negotiate over the price of drugs, ideas that would almost certainly impact drug companies’ profitability. Trump, by contrast, has presided over the kind of deregulation investors tend to favor, but not without proposing a range of often contradictory policies that, on the off chance one came to fruition, would be far more damaging to the industry. For investors, whose job is to manage risk, a Biden presidency might appear like the smarter bet.

More reads

  • Takeda price hikes for a GI drug may give some patients another kind of stomachache. (STAT+)
  • CureVac's COVID-19 vaccine triggers immune response in Phase I trial. (Reuters)
  • The scientific literature’s own pandemic. (In the Pipeline)
  • Doctors in Congress, new e-cigarette taxes, stem cells, and abortion rights: Here’s what STAT is watching tonight. (STAT)

Thanks for reading! Until tomorrow,

Tuesday, November 3, 2020


Facebook   Twitter   YouTube   Instagram

1 Exchange Pl, Suite 201, Boston, MA 02109
©2020, All Rights Reserved.
I no longer wish to receive STAT emails
Update Email Preferences | Contact Us
5cQ.gif?contact_status=<<Contact Status>>