Novartis received EU approval for Rydapt to treat acute myeloid leukemia with the FLT3 genetic mutation. The drug, already approved in the US, also gained approval for three kinds of advanced systemic mastocytosis.
A guidance was released by the UK's Medicines and Healthcare products Regulatory Agency to guide medical device makers and notified bodies on human factors and usability engineering. The document includes an overview of device standards and regulations, looks at different usability engineering strategies, details safety considerations and principles that improve use of the device, and includes tables comparing the new rules with the previous ones.
UK drugmakers IONTAS and Glythera are collaborating on the development of antibody drug conjugates to treat difficult cancers. The technology enables monoclonal antibodies to deliver treatment inside targeted cells, improving efficacy while sparing healthy tissue.
Australia is launching a nationwide effort called the Zero Childhood Cancer initiative to diagnose and offer personalized treatment of childhood cancers. A clinical trial is projected to enroll more than 400 children in the next three years as physicians and scientists collaborate on research and treatment.
In Japanese clinical trials, Shire's Intuniv, or guanfacine hydrochloride, for adult attention-deficit/hyperactivity disorder met its primary endpoint. The selective alpha-2A adrenergic receptor agonist performed better than placebo in the change from baseline on an ADHD rating scale.
The WHO in a new report says not enough antibacterial drugs are under development to meet the threat of drug-resistant infections, noting that only eight of 51 in development can be termed novel treatments. "There is an urgent need for more investment in research and development for antibiotic-resistant infections including TB," said WHO Director-General Tedros Adhanom Ghebreyesus, who added that if the need isn't met, "we will be forced back to a time when people feared common infections and risked their lives from minor surgery."
The FDA's final guidance on the naming of biologics (originator and biosimilar), issued this year, is in the implementation process and will have an impact on manufacturers, supply chain, end users and safety systems. All stakeholders will need systematic approaches to ensure adherence -- both prospectively and retrospectively. How will these changes affect your systems and products? What will be your next steps? Download the Biosimilars Navigation Guide and get up to speed on the latest scientific and regulatory topics related to biosimilars.