The World Health Organization has prequalified Coartem Baby, the first and only antimalarial for babies. Novartis developed this combination drug in partnership with Medicines for Malaria Venture.
GSK’s bepirovirsen met the main goal of two Phase 3 studies, achieving functional cure rates for patients with chronic hepatitis B infection after six months of treatment. This antisense oligonucleotide therapy could provide a treatment alternative to antiviral drugs that patients must take for life.
How to turn analytics into actual policy outcomes.
A report supporting the CDC’s revisions says the U.S. is an outlier in the number of diseases and the total number of vaccine doses recommended in its pediatric vaccine schedule. But some physician groups say comparisons to other countries can be misguided and removing vaccines from the schedule puts children’s health at risk.
Merck’s Cidara Therapeutics acquisition brings a lead program with potential to become a first-in-class drug for preventing influenza infection. A Phase 3 study is already underway, timed to coincide with the start of the flu season in the Northern Hemisphere.
Phase 3 results for the Novartis malaria drug “GanLum” show it was comparable to the standard of care and led to cure rates that top the threshold recommended by the World Health Organization. If approved, this new combination drug would become the first novel malaria therapy in more than 25 years.
The six new drugs awarded FDA Commissioner’s National Priority Vouchers brings to 15 the total number of therapies selected for the new pilot program. Under this program, the FDA says the standard 10- to 12-month review time could be shaved down to “within months.”
Small practices play a critical role in healthcare delivery, but they cannot continue to absorb ever-increasing administrative demands without consequences.
By making RT-PCR testing a routine option in outpatient and urgent care settings — and by educating all stakeholders along the clinical continuum — we can significantly reduce unnecessary antibiotic use, protect the effective drugs we still have, and ensure that bacterial infections remain treatable for future generations.
Novartis malaria drug Coartem has expanded its approval to include babies. The combination drug, originally formulated as a tablet, has a new dose strength and formulation designed for treating newborns and young infants who develop malarial infections.
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Enterprise EHR boosts scalability, interoperability, and governance for large healthcare systems.
Radiant Biotherapeutics’ Multabodies are antibodies engineered to offer better binding strength to their targets. The preclinical startup’s lead program goes after a cancer immunotherapy target being pursued by several biotech companies already in early clinical development.
Emergent BioSolutions’ smallpox vaccine, ACAM2000, now has an additional FDA approval covering mpox. It’s one of two FDA-approved mpox vaccines, joining Jynneos from Bavarian Nordic.
GSK is taking over development of an avian influenza vaccine candidate as a bird flu outbreak continues in U.S. dairy cows. Meanwhile, CureVac is restructuring and returning its attention to cancer vaccines, which was the initial focus of the mRNA company.
Bavarian Nordic will concentrate on its portfolio and pipeline of infectious diseases vaccines, including top seller Jynneos, approved for mpox and smallpox. The company only had one clinical-stage cancer vaccine program.
Marburg virus has no FDA-approved vaccines or therapies, but a vaccine candidate from the National Institutes of Health now has encouraging results from a U.S. clinical trial. Next steps include tests in more countries including Ghana, where a Marburg outbreak was declared last summer.