Suddenly ‘DSMB’ is a household phrase
Yesterday, the NIH paused an ongoing study of Eli Lilly's experimental treatment for Covid-19, news that came less than 24 hours after Johnson & Johnson made a similar move in its massive SARS-CoV-2 vaccine trial. In each case, they followed the advice of the all-important, seldom-discussed experts who keep tabs on every well-run trial.
The NIH paused its Lilly study, testing the company's antibody therapy in combination with Gilead Sciences’ remdesivir, on the recommendation of a data and safety monitoring board, or DSMB. The board will reconvene Oct. 26 to analyze the data, keeping the company and its investigators blind to the details in the name of preserving a study’s scientific validity.
This is all routine, as trial experts have pointed out, but it brings fresh uncertainty to the already unprecedented process of developing treatments and vaccines for Covid-19.
Read more.
The NIH paused its Lilly study, testing the company's antibody therapy in combination with Gilead Sciences’ remdesivir, on the recommendation of a data and safety monitoring board, or DSMB. The board will reconvene Oct. 26 to analyze the data, keeping the company and its investigators blind to the details in the name of preserving a study’s scientific validity.
This is all routine, as trial experts have pointed out, but it brings fresh uncertainty to the already unprecedented process of developing treatments and vaccines for Covid-19.
Read more.
Maybe this is peak SPAC
Biotech’s blank-check trend, which has led to nearly 20 IPOs in 2020, might be starting to see its shadow.
Yesterday, a special purpose acquisition company, or SPAC, downsized its proposed IPO by 15%, planning to raise $85 million instead of its previously sought $100 million. The SPAC, run by the biotech investment firm MPM Capital, proposes to raise cash from investors and then find a private company to buy and take public through a reverse merger that sidesteps the standard trappings of an IPO.
MPM’s downsizing doesn’t necessarily imperil the planned IPO, but it does mark the first semi-negative headline for a biotech SPAC in 2020. With so many blank-check firms roosting for deals, investors might see diminishing returns ahead for new SPACs. Furthermore, the vast majority of SPACs have a two-year deadline to find a deal lest they have to give all their money back, which could lead to a game of M&A musical chairs and some overvalued startups.
Yesterday, a special purpose acquisition company, or SPAC, downsized its proposed IPO by 15%, planning to raise $85 million instead of its previously sought $100 million. The SPAC, run by the biotech investment firm MPM Capital, proposes to raise cash from investors and then find a private company to buy and take public through a reverse merger that sidesteps the standard trappings of an IPO.
MPM’s downsizing doesn’t necessarily imperil the planned IPO, but it does mark the first semi-negative headline for a biotech SPAC in 2020. With so many blank-check firms roosting for deals, investors might see diminishing returns ahead for new SPACs. Furthermore, the vast majority of SPACs have a two-year deadline to find a deal lest they have to give all their money back, which could lead to a game of M&A musical chairs and some overvalued startups.
As goes J&J
Johnson & Johnson, by virtue of being the largest health care company in the history of humankind, tends to be something of a bellwether for the drug industry. And its latest earnings report, reflecting three months of pandemic-imperiled business, suggests pharma might return to normalcy faster than many feared.
J&J’s drug revenue came in about 1% higher than Wall Street’s consensus, adding up to $11.4 billion. The company estimated that Covid-19 cut about 2% from its revenue on the quarter, which is better than the roughly 3.5% hit J&J took in the three months prior.
As SVB Leerink analyst Geoffrey Porges noted, J&J isn’t yet out of the woods. The company’s U.S. revenue underperformed expectations, which he attributes to the protracted impacts of Covid-19 in J&J’s home country. But the company reaffirmed its pre-pandemic revenue guidance, a promising sign that pharma might weather 2020 after all.
J&J’s drug revenue came in about 1% higher than Wall Street’s consensus, adding up to $11.4 billion. The company estimated that Covid-19 cut about 2% from its revenue on the quarter, which is better than the roughly 3.5% hit J&J took in the three months prior.
As SVB Leerink analyst Geoffrey Porges noted, J&J isn’t yet out of the woods. The company’s U.S. revenue underperformed expectations, which he attributes to the protracted impacts of Covid-19 in J&J’s home country. But the company reaffirmed its pre-pandemic revenue guidance, a promising sign that pharma might weather 2020 after all.
Can we really get widespread Covid-19 vaccination by April?
Health and Human Services Secretary Alex Azar has said the U.S. should be able to widely administer a vaccine for Covid-19 by April. To Helen Branswell, STAT’s senior reporter covering the pandemic, that’s not impossible, but it’s probably best described as “aspirational.”
“I think delivering the vaccine is going to be at least as hard as making it in the first place, if not harder,” Branswell said yesterday in the latest edition of STAT+ Conversations. “There’s just a lot of things that have to happen to get vaccine from warehouses to locations where it can be administered into arms.”
The hour-long conversation also touches on the latest epidemiological data, the develop of Covid-19 therapeutics, and whether its safe to spend time with family this Thanksgiving.
Watch the full interview.
“I think delivering the vaccine is going to be at least as hard as making it in the first place, if not harder,” Branswell said yesterday in the latest edition of STAT+ Conversations. “There’s just a lot of things that have to happen to get vaccine from warehouses to locations where it can be administered into arms.”
The hour-long conversation also touches on the latest epidemiological data, the develop of Covid-19 therapeutics, and whether its safe to spend time with family this Thanksgiving.
Watch the full interview.
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