The US government is blacklisting a group of research institutes in China for using ‘biotechnology processes to support Chinese military end uses and end users, to include purported brain-control weaponry.’
The government leveled an export ban on the Academy of Military Medical Sciences in China and 11 of its research institutes after determining that they were using genetic technologies to enable mass surveillance of Muslim ethnic minorities — including the Uyghurs — according to a report in the Financial Times.
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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.
Richard Pazdur (via AACR)
There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.
‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.
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The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.
Eli Lilly, Gilead, Thermo Fisher and other industry groups and nonprofits like BIO and USP are seeking some slight changes and more clarity from the International Council of Harmonisation on its new guidance related to continuous manufacturing.
The guidance, known as Q13, focuses on continuous manufacturing and its potential to lower manufacturing costs and reduce the physical footprint of manufacturing facilities compared to traditional batch manufacturing, according to USP. Continuous manufacturing also may improve quality control, lower the variability in manufactured products, and provide enhanced flexibility in production quantity and utilization of manufacturing lines.
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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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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For the first time, doctors will have a drug to combat acute graft-versus-host disease — a dangerous side effect of stem cell transplants in which donor cells attack the recipient — before it occurs.
The FDA has approved Bristol Myers Squibb’s Orencia to prevent aGVHD in combination with certain immunosuppressants, the company announced on Wednesday. Adults and kids two years and older can take the drug if they’re undergoing hematopoietic stem cell transplantation from an unrelated recipient.
https://endpts.com/us-blacklists-chinese-research-institutes-over-brain-control-efforts-as-investor-frets-roil-biotech-stocks/
