As with many conferences, the Cleveland Clinic’s 2020 Medical Innovation Summit went virtual this year. Still, the event featured the hotly anticipated top 10 list of innovations for 2021 that saw a range of therapies. Ranked in order of expected importance, the list was led by gene therapy for hemoglobinopathies. The top three innovations, including a novel drug for primary-progressive multiple sclerosis and smartphone-connected pacemaker devices, were highlighted in a special presentation.
Nine years after Amag Pharmaceuticals Inc.’s Makena (hydroxyprogesterone caproate injection) received accelerated approval to reduce the risk of preterm birth in certain at-risk pregnancies, the FDA is proposing its withdrawal from the U.S. market because the required postmarketing study didn’t show clinical benefit.
LONDON – Clinical care guidelines recommending the use of the HIV/AIDS combination lopinavir-ritonavir for the treatment of patients hospitalized with COVID-19 must now be updated, say the authors of a paper reporting the full results of a randomized U.K. study showing the antiviral is not effective in this context, published in The Lancet on Oct. 5.
LONDON – U.S. chipmaker Nvidia Inc. is investing £40 million (US$51.9 million) in building a supercomputer in Cambridge, U.K., to be dedicated to applying artificial intelligence in drug discovery and in health care.
Humanigen Inc. reported progress in COVID-19 treatment by deploying a drug candidate, lenzilumab, that was created to fight cytokine storms in CAR T patients. The drug is partnered for the latter with Gilead Sciences Inc., which rolled out pandemic news of its own related to the investigational broad-spectrum antiviral Veklury (remdesivir).
The American Federation for Aging Research (AFAR) is involved in supporting research designed to unravel the biology of aging and expanding the field, and this week it held a webinar on the “Business of Longevity: Moving Biomedical Advances into Biotech Opportunities.” The panelists reviewed the latest research and looked at what it will take to attract more investment and biotech companies into what remains a nascent area but one that offers tremendous commercial opportunities.
PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.
Attributing recent reductions in certain U.S. prescription drug prices to intense congressional scrutiny rather than a biopharma industry commitment to affordability, Rep. John Sarbanes (D-Md.) said Congress must put more guardrails in place and restructure how the industry does business.
Rather than the in-your-face, blame-and-shame show that was expected, the Sept. 30 drug pricing hearing before the U.S. House Oversight Committee was more a reminder of the policy differences between Democrats and Republicans on how best to make prescription drugs more affordable.
CAJICA, Colombia – Privately held Inosan Biopharma SA De Cv, of Mexico City, is racing to develop a biological treatment to cure COVID-19 patients. Inosan has mastered the technique of using horses to produce antibodies to heal patients bitten by poisonous creatures, such as snakes, spiders and scorpions.
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