They hired a new CEO from Catalent and announced they would focus on just helping manufacture the drugs that other companies developed. It was a trial by wildfire for Kewalramani, who had already been an unlikely choice as CEO. The he of large biotechs are almost exclusively businesspeople, executives whose chief job is to sell the drugs the company has already developed and find other companies to acquire.
She called Regev.
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The teacher looked at Shawver. All, historically, have been men. That shift has now paid off handsomely. In Focus. But it works. Do it. Within 15 minutes of receiving the infusion, the first patient had serious trouble breathing.
Special report: twenty extraordinary women blazing trails in biopharma r&d — covid and beyond
Endpoints Staff editor endpointsnews. We'll e-mail you a link to set a new password. Image credit: Shutterstock. Instead, on that bone-chillingly cold day last spring, she was at a makeshift desk in the dimly lit basement of her home outside Boston, a bivouac chosen because it was closest to the Wifi router.
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. It was as ambitious a plan as a biotech had ever put forward, spanning medical disciplines from hematology to nephrology and technologies from old-fashioned pills to new forms of CRISPR gene editing, and they needed someone with unimpeachable scientific chops to carry it out.
If Kewalramani and her team can, they will change the face of medicine: Not just for one rare disease but several, and a few not so rare ones as well. The idea seemed promising enough.
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The move ostensibly will push later Covid vaccine entrants to go the long route and submit a full BLA with more manufacturing and safety data rather than use the shortened EUA process. Log in to your e-mail. But it equipped her for the new task. By then it was This was On the walk back that night, she turned to Jacks with an epiphany. By the time a group of scientists reported an attempt to treat colon cancer with engineered T cells drawn from patients, expanded and armed with artificial surface proteins inthe experimental therapy — known as CAR-T, short for chimeric antigen receptor transduced T cells — had turned from an eccentric therapeutic proposal to a somewhat viable approach being tested in the clinic.
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For two covid patients, life and death rests on ‘el tubo’
You can watch the full event here. Change my password Get a magic link. But why leave? LOG IN. About You. In the world of small public biotechs, one mishap can be punishing.
The drug was shelved as Thios closed up shop. The pandemic hit Vertex at the worst possible time.
He taught Ma to dream big. The FDA late Tuesday said that for the remainder of the pandemic, it may decline to review and process further EUA requests for Covid vaccines, unless a developer has already engaged with the agency.
The COVID pandemic cast a spotlight on the expanding role of real-world evidence RWE and the window it provides into a more thorough understanding of the patient journey. So she did it.
Premium subscription required Unlock this article along with other benefits by subscribing to one of our paid plans. Tuesday, though, was a time for throwing some dice on Nasdaq, and waiting to see how fortunes could be divvied up in the IPO to come. And that AP chem teacher?
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The target, HER2, was one of the most extensively studied targets in cancer, implicated in cancers of breast, bladder, ovary, pancreas, and more. In the end, they killed it. Now, just as Leiden passed the torch, the entire world was collapsing.
She was sent to the hospital, intubated, and died five days later. If you're already an Endpoints subscriber, below for a magic link that lets you log in quickly without using a password.
They had big plans for the role — for what they called Vertex 3. Please note this link is one-time use only and is valid for only 24 hours. The question boils down to how you choose among them — and who will be the last ones standing. Developers are finding that the capture of all relevant data—from randomized clinical trials and real-world evidence—can safely expedite new therapies for patients with high unmet needs. If you need more, then you take more.
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She knew she would go back. Rather than giving up, both academic and industry researchers are doubling down, thanks in part to the big success in the hematologic space and the large market that awaits anyone who can finally unlock any kind of solid tumors with CAR-T.
Yet the trial took a shocking and tragic turn. It was April 1, You take it for granted. There should have been family photos on the desk, scientists buzzing in the labs beneath, and, feet away, executives she knew and trusted, briefing her on potential cures for sickle cell disease and diabetes. Then inher phone rang. The year wasand the stars were aligned. Kewalramani, while striking a less abrasive tone than her predecessor, has pledged to keep the same pricing strategy moving forward.