Eli Lilly and Co.'s FDA win with Baqsimi (glucagon) nasal powder, the first non-injected therapy to gain clearance for emergency treatment of hypoglycemia, makes the rescue of severely hypoglycemic patients quicker and easier, and coming down the pike are more treatments that could simplify therapy.
The FDA's Arthritis Advisory Committee (AAC) Thursday will consider a supplemental new drug application for Boehringer Ingelheim GmbH's Ofev (nintedanib) capsules as a treatment for systemic sclerosis-associated interstitial lung disease (SSc-ILD).
The U.K.'s National Institute of Health and Care Excellence (NICE) said Monday it will be reviewing the methods it uses to develop guidance on drugs, medical devices and diagnostics so it can optimize its evaluation methods to ensure high quality and good value.
Given improvements that Basel, Switzerland-based Novartis AG made to its patient access program for Kisqali (ribociclib), the U.K.'s National Institute for Health and Care Excellence (NICE) is recommending the drug, used with fulvestrant chemotherapy, as an option for people with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer who have had previous endocrine therapy.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.
Two decades in the making, a mutual recognition agreement between the FDA and EMA is now fully implemented. Slovakia was the last EU member state to get the FDA's seal of approval for its conduct of drug manufacturing inspections.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) received mixed comments from stakeholders on whether it was necessary to implement a formal good clinical practices inspections program in Australia. Many comments questioned how inspectional findings from a proposed pilot program would be released, but most agreed that a formal inspections program would raise compliance and enhance international competitiveness.
The Institute for Clinical and Economic Review (ICER) unveiled its preliminary list of potential assessment topics for next year. The list is based on the projected timing and likelihood of FDA approval, and whether an evidence review would suggest specific actions for payers, physicians, patients and policymakers to improve clinical practice.
The World Health Organization (WHO) Tuesday updated its list of essential medicines, with a focus on cancer and other global health challenges. WHO added 28 drugs for adults and 23 for children to the medicines list and specified new uses for 26 drugs already on the list.