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IBC vs. IRB: What’s the Difference?

Advarra

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What do the Regulations Say about IBC Review? What do the Regulations Say about IBC Review?

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US FDA grants orphan drug status to IN8bio’s INB-400 and INB-410

Pharmaceutical Technology

This marks the first-ever designation for genetically modified gamma-delta T cell therapies. INB-400, an autologous, genetically engineered gamma-delta T cell therapy, is the company’s DeltEx chemotherapy-resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology.

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Bone Therapeutics inks iPSC related research partnership

BioPharma Reporter

A new deal sees Bone Therapeutics gain access to iPSC derived, genetically engineered MSCs.

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Why do Community Members Need to Participate in IBC Review Meetings?

WCG Clinical

1 This is an important requirement, as the NIH Guidelines were originally created partly in response to public concerns surrounding recombinant DNA and genetic engineering. Many of those original concerns of the 1970s and 1980s surrounding genetic engineering have lessened over time.

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Q&A: A decade on, what’s next for CAR-T therapies?

Pharmaceutical Technology

But I think we’ve never had more tools than we have now in synthetic biology, genetic engineering, enhanced potency design switches and CRISPR. Exa-cel is almost certainly going to the first CRISPR engineered product [to be approved]. AZ: How can regulators ensure that they nurture future innovations in the field?

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South African variant may cut response from Pfizer/BioNTech shot, study finds

pharmaphorum

Researchers from the University of Texas Medical Branch based their findings on lab tests using SARS-CoV-2 coronaviruses that were genetically engineered to have the same mutations as those in the strain that is causing scientists so much concern.

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BE labeling Rule Challenge Largely Fails but Court Takes Issue with Electronic and Text Message Disclosure Options

FDA Law Blog

Plaintiffs challenged the use of the term bioengineered (rather than GMO or genetically engineered), the limitation of the mandatory disclosure being required only if the food contains detectable modified genetic material and the options of using a QR code disclosure or a text message for the disclosure statement.