Robert Califf (Graeme Sloan/Sipa via AP Images)
As Rob Califf likely makes his return as FDA commissioner next month, his confirmation hearing yesterday offered a peek into some of the larger obstacles he’s going to face in the coming months and years.
The pandemic isn’t going away anytime soon with Omicron, and some vaccines and therapeutics may need to be tweaked or pulled from the market entirely as they prove to be ineffective against the new variant. The FDA, meanwhile, needs to get back on even footing with some longer-term direction.
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Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
Crowd gathering at the Westin St. Francis for JPM in 2019 (Endpoints News)
Well, see you in January 2023.
In a surprise about-face, #JPM22 will now be fully virtual after organizers of the popular biotech conference decided to pull the plug on a live event in San Francisco given fears over the Omicron variant and a growing chorus of drugmakers opting out.
The move is no big surprise after reports swirled about some of the industry’s biggest players nixing plans to attend live and pressuring the bank to reconsider the annual meet at the Westin St. Francis. STAT reported Tuesday that Moderna and Amgen, among other large drugmakers, had already pulled out.
A nurse administers a COVID-19 booster shot to Joe Rigdon at a vaccination site in Eastmonte Park, Altamonte Springs. (Photo by Paul Hennessy/SOPA Images/LightRocket via Getty Images)
When Laura Burns went to get her first Covid-19 shot last January, no one had warned her that the vaccines might not work for her.
Burns, the recipient of a double-lung transplant in 2016, knew to be careful about the medicines she took. She consulted with her transplant team when the Pfizer and Moderna shots were authorized and only signed up after being told the vaccines would likely be safe for her, which they were.
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Jay Bradner, President, Novartis Institutes for BioMedical Research
John Carroll: Well, hello everybody. This is John Carroll. I’m the editor of Endpoints News, the editor and founder of Endpoints News. I’m here with Jay Bradner, the president of the Novartis Institutes for BioMedical Research. Jay, we’re going to be talking about ASH in just a second, but you’ve just recently celebrated your sixth anniversary as president of NIBR. And I’m curious, it’s such a significant amount of time for anybody to spend in one career phase. And looking back over the last six years, is everything fundamentally different about the research process and the translational arena that you’re in?
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The US government is shifting its distribution of mAb infusions to fight the coronavirus, deciding to go from supplying tens of thousands of doses of GlaxoSmithKline and Vir’s mAb treatment sotrovimab in recent months to zero doses for the entire month of December.
That halt has led to speculation the government was prioritizing the distribution of Regeneron mAb combo of casirivimab and imdevimab and Eli Lilly’s combo of bamlanivimab and etesevimab because both companies have indicated that their infusions might not work as well against the Omicron variant (when compared to Delta).
Harpreet Singh, Immatics CEO (Credit: Allogeneic Cell Therapies Summit)
Just a few weeks after offering a positive readout on its first early clinical-stage offering, the transatlantic biotech Immatics is back with news that the research crowd around Rupert Vessey at Bristol Myers Squibb has anted up $150 million in cash to get on at the ground floor with one of their still-preclinical efforts.
This time the news is centered on IMA401, Immatics’ most advanced bispecific, which uses one binder to latch on to MAGEA4/8 while another is used to whip up T cell activity against tumor cells where that’s a common antigen. For now, that’s still a preclinical effort, with the first human trial set to launch in the first half of next year.
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Massachusetts biotech Keros Therapeutics now has a deal with Hansoh Healthtech, a Hansoh Pharmaceutical Group subsidiary, in the form of an exclusive license.
The deal was announced earlier this week, with Hansoh getting the license from Keros to develop, manufacture and commercialize KER-050 within China, Hong Kong and Macau.
KER-050, an engineered ligand trap and Keros’ lead drug candidate, is in Phase II trials for myelodysplastic syndrome and a bone marrow cancer known as myelofibrosis. The drug is designed to increase the production of platelets and red blood cells and treat low blood cell counts such as anemia, according to Keros.
David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)
Eli Lilly set an ambitious goal before its investor day on Wednesday, promising to have new five approved drugs in the next two years.
Those five will be led by donanemab, the anti-amyloid antibody for Alzheimer’s disease for which Lilly expects to complete a rolling submission in 2022’s first quarter. Lilly is attempting to use the same accelerated approval pathway controversially granted to Biogen for aducanumab earlier this year and plans to pit the drugs head-to-head in a Phase III study.
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Alex Nichols & Brian Fiske, Mythic Therapeutics co-founders
While most biotech startups begin with a light bulb moment or in-licensed technology, Mythic Therapeutics’ roots trace back to a dining room table and an empty notebook.
Alex Nichols and Brian Fiske shared an office at Flagship before they left a few years ago to create something independent. They wanted to identify a meaningful problem for patients and solve it. Several notebooks later, they landed on a mission: creating a safer, more effective antibody-drug conjugate.
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