💊 Tracing the evolution of bird flu; AI finds cure for osteoporosis in malaria drug; Doherty Institute joins CEPI lab network
#453 | Zimbabwe localises manufacturing with help from Cuba; Big day for UCB; Biocon's Malaysia unit gets another setback
Hello, and welcome back to The Kable. As distressing as world events might be, the world keeps spinning nevertheless. And generating life sciences news in the process.
Zimbabwe is collaborating with Cuba to establish manufacturing facilities for vaccines and other pharmaceuticals, aiming to boost the local drug industry and reduce reliance on imports. Health and Child Care Minister Dr Douglas Mombeshora emphasised the partnership's importance, mentioning plans for comprehensive medical outreach in remote areas and a potential training program for Zimbabwean doctors with Cuban specialists.
Even though the pandemic is “over”, Covid vaccine development continues, as demonstrated by Argentina's recent approval of the ARVAC Cecilia Grierson, the first vaccine fully developed in the country. A collaboration between the National University of San Martín, CONICET, and the Cassará Lab, this vaccine, adaptable to new SARS-CoV-2 variants, offers promise not just for local usage but also for reducing Argentina's significant vaccine imports and fostering exports.
In corporate updates, Brussels-based UCB has received US FDA approvals for Bimzelx, a plaque psoriasis treatment, and Zilbrysq, a drug for generalized myasthenia gravis (gMG) in adults with specific antibodies. Acquired in a $2.5 billion deal from Ra Pharmaceuticals in 2019, Zilbrysq is the first once-daily, self-administered gMG therapy, while the nod for Bimzelx has positioned it as a potential blockbuster for psoriasis treatment.
In a significant step towards restoring racial equity - well, in the US at least, an initiative backed by major pharmaceutical companies has launched with the goal of establishing the largest research database for African ancestry genomics. Spearheaded by Meharry Medical College, a historically Black medical university, and supported by companies such as Regeneron Genetics Center, AstraZeneca, and Roche, the "Together for CHANGE" initiative seeks to gather genomic data from up to 500,000 participants and promote STEM programs in diverse communities. This initiative is especially vital given that only 2% of studied genetic information originates from people of African ancestry, underscoring the importance of expanding research in this area.
Pfizer will pay $2 million to settle allegations by the US Department of Labor (DOL) of underpaying female employees at its New York City headquarters. While Pfizer denied these claims, attributing them to "minor pay discrepancies" from years prior, they have chosen to resolve the dispute “to focus on core business initiatives”. Sure, Jan. Alongside the settlement, Pfizer has committed to setting aside $500,000 for future salary adjustments and will provide additional training to its management.
India’s Dabur says that its subsidiaries are among companies being sued in the US and Canada over allegations that their hair relaxer products led to ovarian and uterine cancers, among other health issues. The company said these ongoing cases are based on an "unsubstantiated and incomplete" study, with the financial implications of the potential settlements or verdicts yet to be determined.
Biocon Biologics' insulin facility in Johor, Malaysia has been labelled as "official action indicated"by the US FDA, which might result in potential delays in product approvals from this facility. In response, the company has submitted a Corrective and Preventive Action plan to the agency and stated that it believes this status will not significantly impact the manufacturing and distribution of commercial products for the US market.
The Peter Doherty Institute for Infection and Immunity has joined CEPI’s Centralised Laboratory Network, becoming the first Australian lab in this global group that standardises the testing of epidemic and pandemic vaccines. This network, established in response to the pandemic, ensures consistent testing protocols across all member labs, facilitating harmonised data that can expedite vaccine development and regulatory decisions. As the 16th member spanning 14 countries, the Doherty Institute's inclusion enhances regional testing capacity and supports CEPI’s stated aim of developing vaccines against new threats within 100 days of their identification.
The WHO has just released guidelines on regulatory considerations for AI in health, emphasising the significance of ensuring AI systems' safety, effectiveness, and rapid availability. The WHO guidelines prioritise access of AI tech to sensitive health data while emphasising the need for robust legal and regulatory frameworks to protect privacy and data integrity, and ensure the avoidance of biases, misinformation, and cybersecurity threats.
And finally, since the inception of antibiotics, it has been known that bacteria can develop resistance to these drugs. The WHO says we're presently trailing in this battle against AMR, as resistance rises and the development of new antibiotics lags. The Conversation sought global expert opinions on the continued efficacy of antibiotics in the next 50 years. Seven out of seven experts believed they would remain effective.
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