FDA ISSUES WARNING ON CAR-T THERAPY
The U.S. Food and Drug Administration (FDA) has mandated major pharmaceutical companies like Gilead Sciences, Johnson & Johnson, Novartis, and Bristol Myers Squibb to add severe warnings to the labels of their CAR-T cancer therapies, due to the risk of T-cell malignancies. CAR-T therapy, a process involving the modification and reintroduction of T-cells to combat cancer, has been linked to a form of T-cell blood cancer in some patients post-treatment. While companies like Novartis and J&J have agreed to update their labels for therapies like Kymriah and Carvykti, they have not confirmed a direct causal relationship between the therapies and the malignancies. The FDA’s directive follows reports of such cancers in patients treated with CAR-T therapies. Despite the concerns, industry analysts believe the demand for these therapies will remain stable, although the safety concerns could affect the broader application of the technology. Companies have responded proactively to the FDA’s request, with Gilead committing to collaborate on label updates, and Bristol Myers evaluating its next steps. No definitive causal link has been established yet, and the companies maintain confidence in the safety profiles of their treatments. (Reuters)
WRONG MOVE.
The University of Pennsylvania (UPenn) Museum plans to inter the remains of 19 Black individuals from the controversial Morton Cranial Collection. Critics, including a descendant community group and anthropologists, accuse the museum of insufficient efforts in identifying the individuals and consulting descendant communities. Archival research revealed one individual has Native American ancestry, complicating repatriation under NAGPRA. The Penn Museum, acknowledging ethical concerns, aims to inter the remains in a historically Black cemetery, a decision challenged by those who argue the museum retains excessive control over the process. Despite the museum’s intent to respect the remains, the controversy highlights broader ethical considerations in handling historical collections, with critics urging a more thorough, inclusive approach before interment. (Science)
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GUARDRAILS FOR SPACE.
The 1957 launch of Sputnik by the Soviet Union prompted global fears of space militarization, leading to the UN’s Outer Space Treaty in 1967, which declared space a global commons for peaceful purposes. Today, the space near Earth is crowded with satellites, predominantly owned by U.S. entities, notably Elon Musk’s SpaceX. This dominance raises concerns of orbital colonialism and potential breaches of the treaty. In response, nations, especially in the global south, are investing in space law expertise to ensure equitable space utilization. The Manfred Lachs Space Law Moot Court Competition is a key platform for nurturing future space lawyers, exemplified by a Zimbabwean team’s recent participation. This push for legal knowledge aims to shape the evolving space law, ensuring a balanced future in space amidst the growing commercial and debris-related challenges. (Wired)
HACKERS COMPROMISE VPN.
Hackers, suspected to be Chinese government operatives, are exploiting critical vulnerabilities in Ivanti VPN appliances, gaining full control over the devices. Out of 26,000 exposed VPNs, 492 remain compromised, with the highest number in the US. The attacks, possibly aimed at espionage, have prompted urgent mitigation efforts. Despite no official patches from Ivanti yet, governmental agencies have been ordered to implement preventive measures. The vulnerabilities, affecting all Ivanti Connect Secure versions, allow attackers to remotely execute code and install backdoor malware, enabling extensive network access and credential harvesting. Security firms emphasize the gravity of the threat and urge immediate action, including possible VPN suspension, to mitigate these severe vulnerabilities and protect networks from potential espionage activities. (Ars Technica)
EU MAKES ITS AI MOVE.
The European Union is pushing to enhance its position in the generative AI sector by launching a package aimed at supporting AI startups. This includes improved access to high-performance computing infrastructure for AI model training and fostering necessary skills and talent. Despite the EU’s extensive network of supercomputers, there’s a recognition that these facilities need to be optimized for AI development, a gap highlighted by the swift emergence of tools like OpenAI’s ChatGPT. The package, named the “AI innovation package,” is part of the Commission’s broader strategy to create a robust AI ecosystem in Europe. It proposes initiatives like AI Factories for resource consolidation and easier startup access, financial support, and policy revisions to allow more flexible upgrades of computing infrastructures. This initiative accompanies the AI Act, aiming to ensure AI startups are “trustworthy” and abide by EU values and regulations. The plan includes significant financial investment and infrastructural upgrades, with a focus on aligning with EU’s values and fostering innovation in AI, recognizing the strategic importance of AI technologies for future competitiveness. (Techcrunch)
ETHICAL CONCERNS REGARDING CHINESE STUDIES.
Yves Moreau, a computational geneticist, has been raising ethical concerns about biometric data collection from vulnerable groups. He highlighted a 2022 PLoS ONE paper on Tibetan genetic data, suspecting Chinese security force involvement, citing the collection method and Human Rights Watch reports of mass DNA collection. His concerns led to the paper’s retraction by the publisher PLOS. Moreau has flagged 96 similar papers over five years, with only 12 retracted, criticizing publishers for prolonged investigations. His activism began in 2016, opposing Kuwait’s DNA profiling law, and later exposing China’s genetic profiling in Xinjiang, targeting Uyghurs and other minorities. Moreau argues that such research lacks informed consent and serves oppression, demanding retraction to prevent academic complicity. His efforts have prompted some publishers to revise consent policies, but challenges remain in verifying consent and addressing data in genetic databases. (Nature)
GENE THERAPY GIVES HEARING BACK TO THE DEAF.
Aissam Dam, an 11-year-old born deaf in Morocco, became the first person in the U.S. to receive gene therapy for congenital deafness at the Children’s Hospital of Philadelphia. Despite growing up without hearing and minimal formal communication, this treatment aimed to correct his rare form of deafness caused by a mutation in the otoferlin gene. The therapy, injecting a virus carrying functional otoferlin genes into the cochlea, was a success, introducing Aissam to a world of sounds. This pioneering trial, part of broader international research, marks a significant advance in gene therapy, potentially opening doors for treating other forms of congenital deafness. Challenges in patient selection and the complexity of delivering the therapy to the inner ear were overcome, showcasing the potential for genetic interventions in addressing sensory disabilities. (New York Times)
Thanks for reading. Let’s be careful out there.
WORDS: The Biology Guy.
IMAGE CREDIT: NASA.
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