jueves, 15 de octubre de 2020

Vertex shelves experimental rare lung disease drug

Vertex shelves experimental rare lung disease drug

The Readout

Damian Garde & Meghana Keshavan

Vertex gets an unfamiliar taste of disappointment

Vertex Pharmaceuticals shelved an in-development drug yesterday on account of some alarming side effects, a rare setback for a company accustomed to success.

As STAT’s Adam Feuerstein reports, Vertex is moving on from VX-814, designed to treat a rare, inherited lung disease, after patients in a Phase 2 clinical trial reported liver enzymes that were eight times higher than normal, a potential sign of liver damage. The company is still developing a separate, structurally different medicine for the same disease.

The failure of VX-814 doesn’t change the narrative for Vertex, whose franchise of cystic fibrosis treatments brought in $4 billion last year and are expected to keep growing. But it does illustrate that the company’s goal of expanding beyond CF is by no means guaranteed to succeed.

Read more.

Pharma’s political dollars might go that much further in the statehouse

While the drug industry’s high-dollar contributions to federal candidates get most of the attention, comparatively small bets on state races might do more to shape policy.

As STAT’s Lev Facher reports, well over one-quarter of all state lawmakers nationwide have accepted money from the pharmaceutical industry since the beginning of 2019, according to a new analysis. And in some states, taking pharma cash is the norm. More than 79% of Illinois lawmakers have cashed such a check. In California, it’s above 85%.

STAT’s analysis, conducted in partnership with the National Institute on Money in Politics, reveals the drug industry has poured over $5 million into state legislators’ campaigns in the past two years alone.

Read more.

Biotech IPOs aren’t popping like they used to

Biotech was already in record-breaking territory when October began, raising about $10 billion in IPO money with the average offering trading up roughly 30% on its debut. But the fourth quarter’s early returns suggest demand might be tailing off a bit as winter approaches.

The month’s eight biotech IPOs are, on average, up about 15%. If you exclude Kronos Bio, which has soared 66% since its IPO, the average return is just 7%. And the latest debutant, Codiak Biosciences, isn’t terribly encouraging: The company priced its shares at $15, opened trading yesterday at $13 and then closed at $12.12, a -19% one-day return.

The industry is already playing with house money when it comes to IPOs, as it beat 2018’s record fundraising haul before the summer was over. But if the recent pace keeps up, biotech might not be able sustain that momentum into 2021.

How a talk radio transcription error moved $1 billion

Earlier this week, listeners of WBLQ AM, your source for news and views in Westerly, R.I., might have caught morning show host Frank Prosnitz’s interview with Onyema Ogbuagu, a Yale University infectious disease specialist who happens to be an investigator in Pfizer’s ongoing trial of a Covid-19 vaccine.

In that interview, Prosnitz asks Ogbuagu when we might learn whether the vaccine works, and Ogbuagu, echoing earlier statements from Pfizer, said the investigators hope that “by November-ish” the trial might reach its first interim analysis.

But in the accompanying writeup on WhatsUpNewp.com (“Local, independent news for Newport County, Rhode Island, and beyond”) “November-ish” became “Nov.1,” and “first” interim analysis became “next” interim analysis. Errors happen, as readers of this email newsletter will have noticed. But things got a little strange when WBLQ’s game of telephone reached Wall Street yesterday.

If Pfizer and its partners at BioNTech were already looking forward to a “next” analysis, it would mean the first one came and went, which would mean the independent data monitors didn’t see overwhelming benefits from the vaccine. On Twitter, there was a panic, and BioNTech’s share priced dropped about 7%, erasing $1 billion in market value. Eventually, one Twitter user dug up the original audio, and everyone calmed down, but not before giving us all a lesson in patience and media literacy.

More reads

  • AstraZeneca loses first-of-its-kind lawsuit filed by Dutch insurer over patent maneuver. (STAT Plus)
  • Vaxart was served a grand jury subpoena in July over its controversial role in OWS-funded preclinical study. (Endpoints)
  • Covid-19 clinical trial pauses ‘show the system is working.’ (STAT)

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