Just the name, Strategic National Stockpile (SNS), evokes the image of a huge warehouse, or a series of warehouses spread across the U.S., strategically stocked with all the medical supplies, diagnostics and drugs that will be needed nationwide to respond to any health emergency brought on by terrorists, nuclear attacks, pandemics or other public health hazards. The reality is so much more – and so much less.
Almost all solid tumors are treated with multiple drugs because the combinations have better efficacy than single-agent treatments. But finding those combinations can be difficult in an ever-growing sea of pair-wise combinations.
In a BIO Digital session on “The Convergence of Health and Tech: Personalizing Medicine Beyond the Imaginable,” panelist Ray Deshaies, Amgen Inc.’s senior vice president of global research, said he was excited for the future of drug research, noting that there is an evolving trend away from the development of monospecific drugs designed to exert their effect on just one specific target.
A new U.K. trial evaluating drugs for hospitalized patients in the early stages of COVID-19 has elected to test Evelo Biosciences Inc.'s anti-inflammatory monoclonal microbial, EDP-1815, after an earlier trial found it led to favorable anti-inflammatory activity in psoriasis patients.
A second attempt by Nabriva Therapeutics plc to win U.S. approval for the antibiotic Contepo (fosfomycin) has been undone by COVID-19. Manufacturing issues stymied the original NDA. This time, restrictions of FDA staff travel to Europe sunk the venture, leading to a new complete response letter (CRL) for the candidate as a potential treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.
On June 17, the FDA approved checkpoint blocker Keytruda (pembrolizumab, Merck & Co. Inc.) “for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [?10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.”
The U.S. District Court for the Northern District of West Virginia ruled against Biogen Inc., of Cambridge, Mass., and in favor of Mylan NV, of Hertfordshire, U.K., in a patent dispute regarding Biogen’s blockbuster multiple sclerosis drug, Tecfidera (dimethyl fumarate).
After 30 years of following the same rules to ensure Medicaid receives the lowest price available for prescription drugs, the U.S. Centers for Medicare & Medicaid Services (CMS) is starting to adapt those rules for the 21st century.
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
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