The public is getting too rosy about a coronavirus vaccine, experts warn
Researchers are consistently setting speed records when it comes to the development of vaccines for the novel coronavirus. But the growing conventional wisdom — that a vaccine will be widely available in the fall — is deeply and dangerously mistaken, according to experts.
As STAT’s Helen Branswell reports, early clinical trials are already under way for a few vaccine candidates, and, in an absolute best-case scenario, that means one or more of them could be available for emergency use in about five months.
But that hardly means life will go back to normal. Under an emergency use authorization, the limited supply of vaccine would be designated for front-line workers and the most vulnerable. It could be another year before there’s enough supportive evidence and manufacturing capacity to supply the entire world.
Read more.
As STAT’s Helen Branswell reports, early clinical trials are already under way for a few vaccine candidates, and, in an absolute best-case scenario, that means one or more of them could be available for emergency use in about five months.
But that hardly means life will go back to normal. Under an emergency use authorization, the limited supply of vaccine would be designated for front-line workers and the most vulnerable. It could be another year before there’s enough supportive evidence and manufacturing capacity to supply the entire world.
Read more.
CytoDyn’s CEO made $12 million as a ‘sacrifice’
Yesterday we mentioned Nader Pourhassan, CEO of CytoDyn, who discretely made $12 million in stock sales while talking up the company’s unproven treatment for Covid-19. Now we have an explanation: He did it for the good of CytoDyn.
As STAT’s Adam Feuerstein reports, Pourhassan appeared on an ersatz news broadcast, staged by a stock-promotion firm, to come clean about his stock sale. The transaction was a so-called cashless exercise of options, meaning the CEO borrowed $3.8 million to buy shares from CytoDyn, sold them for nearly $16 million, and then immediately paid back the loan and pocketed the difference.
He did it not to enrich himself, Pourhassan said, but because CytoDyn needs money to pay for manufacturing. It could have raised cash on the open market, but that might have damaged the stock price. So Pourhassan did the $3.8 million options deal “to give the company enough funds to be able to be OK for another 5 to 6 weeks,” he said, adding “I try to sacrifice for the company any time I can.”
Read more.
As STAT’s Adam Feuerstein reports, Pourhassan appeared on an ersatz news broadcast, staged by a stock-promotion firm, to come clean about his stock sale. The transaction was a so-called cashless exercise of options, meaning the CEO borrowed $3.8 million to buy shares from CytoDyn, sold them for nearly $16 million, and then immediately paid back the loan and pocketed the difference.
He did it not to enrich himself, Pourhassan said, but because CytoDyn needs money to pay for manufacturing. It could have raised cash on the open market, but that might have damaged the stock price. So Pourhassan did the $3.8 million options deal “to give the company enough funds to be able to be OK for another 5 to 6 weeks,” he said, adding “I try to sacrifice for the company any time I can.”
Read more.
The White House is worried about Canada seizing remdesivir
That’s among the revelations in a whistleblower complaint from Rick Bright, the ousted head of BARDA, which included a memo to the Covid-19 task force warning that Canada might seize Gilead Sciences’ drug from production facilities in the country.
As STAT’s Nicholas Florko reports, Bright’s complaint is full of allegations of politicizing science, nepotism, and disrespect for BARDA’s role as an objective organization. Bright, who was unwillingly demoted last month, will testify before a subcommittee of the House Energy and Commerce Committee on May 14.
The Gilead connection comes from White House adviser Peter Navarro, who wrote on Feb. 14 that all upstream manufacturing of remdesivir is done in Canada with only the final step conducted in the U.S. “In the case of a full-blown crisis in the hemisphere,” Navarro wrote, it would be easier for Canada to figure out that final step than for the U.S. to replicate the upstream process, allowing Canada to corner the supply of the in-demand drug.
Read more.
As STAT’s Nicholas Florko reports, Bright’s complaint is full of allegations of politicizing science, nepotism, and disrespect for BARDA’s role as an objective organization. Bright, who was unwillingly demoted last month, will testify before a subcommittee of the House Energy and Commerce Committee on May 14.
The Gilead connection comes from White House adviser Peter Navarro, who wrote on Feb. 14 that all upstream manufacturing of remdesivir is done in Canada with only the final step conducted in the U.S. “In the case of a full-blown crisis in the hemisphere,” Navarro wrote, it would be easier for Canada to figure out that final step than for the U.S. to replicate the upstream process, allowing Canada to corner the supply of the in-demand drug.
Read more.
Akebia’s anemia pill hits the mark in pivotal studies
Akebia’s once-a-day pill for anemia succeeded in a pair of late-stage trials, bringing it one step closer to FDA approval and affirming some Nobel Prize-winning science.
As STAT’s Adam Feuerstein reports, Akebia’s treatment met its goals by measuring up to the standard injectable therapies for anemia, which carry significant heart risks. By contrast, Akebia’s therapy improved overall heart safety by 4% compared to the injectable treatment. Two more Phase 3 studies are expected to read out this summer, and if all goes well, Akebia could win FDA approval in 2021.
The drug works by blocking a bodily protein called hypoxia-inducible factor, or HIF. Doing so tricks the body into thinking it’s in a low-oxygen environment and thus producing more oxygen-carrying red blood cells. The scientists who discovered HIF won the Nobel Prize in medicine last year.
Read more.
As STAT’s Adam Feuerstein reports, Akebia’s treatment met its goals by measuring up to the standard injectable therapies for anemia, which carry significant heart risks. By contrast, Akebia’s therapy improved overall heart safety by 4% compared to the injectable treatment. Two more Phase 3 studies are expected to read out this summer, and if all goes well, Akebia could win FDA approval in 2021.
The drug works by blocking a bodily protein called hypoxia-inducible factor, or HIF. Doing so tricks the body into thinking it’s in a low-oxygen environment and thus producing more oxygen-carrying red blood cells. The scientists who discovered HIF won the Nobel Prize in medicine last year.
Read more.
More reads
- Were researchers wrong to move the goalposts on remdesivir? In the end, it may not have mattered. (STAT)
- Alexion to buy Portola in $1.4 billion effort to diversify. (Bloomberg)
- New CRISPR-based test for Covid-19 could be a simple, cheap, at-home diagnostic, scientists say. (STAT)
- Regeneron's Covid-19 antibody treatment could be ready by fall. (Business Insider)
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