viernes, 27 de marzo de 2020

Gene therapy delays & the implications of Covid-19 serology

The Readout
Damian Garde & Meghana Keshavan

What is biotech's new normal?

STAT’s Matthew Herper and Adam Feuerstein went and did some experimenting yesterday, broadcasting a live video chat (from their homes, of course) about biotech in uncharted territory.  
They fielded a wide range of questions, including one on whether drug pricing will continue to be a public point of contention in the wake of Covid-19.
“I don’t think that people are going to come to this conclusion that ‘oh, pharma is great’ and whatever they want to do is fine,” Adam says. “Right now that’s being suppressed… but those issues will come back.”

When can we stop distancing?

Does the “deep state” meet over Zoom? And could the amyloid hypothesis come through at last? 
We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. First, our STAT colleague Helen Branswell joins us to discuss the latest news on the coronavirus pandemic and the sudden celebrity of Anthony Fauci, a longtime National Institutes of Health scientist who has been dragged into a partisan squabble. 
Then, we talk to Carolyn Magill, the CEO of a health tech company called Aetion, about how real world evidence could help in the fight against Covid-19. Finally, we’re joined by Andrea Pfeifer, CEO of AC Immune, about her company’s treatment for Alzheimer’s disease and a fascinating study in Colombia. 

The need for serologic Covid-19 tests

One of the biggest priorities in tackling Covid-19 is testing — particularly point-of-care diagnostics that can determine if a patient has been infected with the novel coronavirus. But just as important is another kind of test — serology tests that indicate whether a person has been infected with the virus, and therefore may now be immune. 
Such tests, which are in development, could be particularly helpful in determining who could be allowed to return to work. 
“We need to identify all those people here who not only knew they had the coronavirus but maybe weren’t sure because they didn’t get tested or because they had minimal symptoms,” one former White House aide told STAT’s Andrew Joseph. “You can imagine asking them to take the key roles in our economy to keep things moving.” 

MS patients must wait for this BMS win

Bristol Myers Squibb won FDA approval for a new multiple sclerosis treatment last night, but it could be months before patients can get their hands on it.
As STAT’s Adam Feuerstein reports, Bristol Myers concluded that the “responsible course of action” is to delay the launch of the drug, called Zeposia, until the coronavirus pandemic subsides. The U.S. health care system is struggling to deal with an escalating number of Covid-19 cases, making this a dangerous time to be telling patients to consult their doctors about a new drug.
Instead, the short-term beneficiaries of Zeposia’s approval are investors, specifically those who were Celgene shareholders before Bristol Myers bought the company. Zeposia, formerly known as ozanimod, is the first of three Celgene drugs that need to win approval in order for shareholders to get a cash payout. The FDA’s decision brings them that much closer to it.

Bluebird gene therapy delayed a year in U.S.

Bluebird Bio has delayed its LentiGlobin filing with U.S. regulators by what looks to be an entire year — and, remarkably, the hold-up doesn’t have much to do with Covid-19. The FDA has asked Bluebird for more information about its gene therapy for beta thalassemia, Biopharma Dive writes, and the company won't hand it over until mid-2021.
Meanwhile, in Europe, LentiGlobin has already achieved approval under the name Zyntego. There are some coronavirus-linked delays  — although the gene therapy’s launch is underway in Germany, dosing the first patient there is now delayed to the second half of 2020. 

More reads

  • Congress set to overhaul the way the US regulates over-the-counter drugs. (STAT)
  • Despite another delay, Intercept says its NASH drug remains on track. (Biopharma Dive)
  • Covid-19 prompts Pfizer to stop enrollment in most studies. (FierceBiotech)

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