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Tablets & Capsules January/February 2021 7 uct development, and discuss the impact of excipient variability in the application of QbD principles during product development. The federation also published the guide "GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipi- ents." The guide was developed for excipient users to qualify both cer- tification bodies that issue excipi- ent GMP and GDP certificates and audit reports as well as Certification Scheme Owners. Both guides can be downloaded at ipecamericas.org/filedepot. Briefly noted… The FDA approved Zokinvy (lon- afarnib) capsules, which is the first treatment that reduces the risk of death due to Hutchinson-Gilford progeria syndrome and for the treat- ment of certain processing-deficient progeroid laminopathies in patients one year of age and older. It is manu- factured by Eiger BioPharmaceuticals. The agency also approved Orlad- eyo (berotralstat), the first once-daily oral therapy to prevent attacks asso- ciated with hereditary angioedema in adult and pediatric patients 12 years and older. It is manufactured by Bio- Cryst Pharmaceuticals. The FDA also approved an addi- tional indication for Xofluza (bal- oxavir marboxil) to treat post- exposure prevention of influenza (flu) for patients 12 years and older. It was previously only approved to treat uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. It is manufactured by Genentech. Gavreto (pralsetinib) has been approved by the FDA to treat adult and pediatric patients 12 years of age and older with advanced or meta- static RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thy- roid cancer who require systemic therapy and who are radioactive iodine-refractory. It is manufactured Blueprint Medicines. Drug, and Cosmetic Act. The guid- ances also describe the framework the FDA uses to evaluate proposed proprietary names. FDA approves first oral hormone therapy for advanced prostate cancer SILVER SPRING, MD—The FDA approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. It is the first orally administered drug that uses androgen deprivation therapy to lower the levels of hormones that help cancer cells grow. Orgovyx is manufactured by Myovant Sciences, Brisbane, CA. ISPE joins DAF ACT NORTH BETHESDA, MD— The International Society for Phar- maceutical Engineering (ISPE) has joined the Department of the Air Force Acquisition COVID-19 Task Force (DAF ACT) to advise on reg- ulatory, technical, and workforce elements in order to create a more robust and sustainable domestic pharmaceutical manufacturing base for active pharmaceutical ingre- dients (APIs) for critical medicines in the US. The report, "Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients," details the technical, regulatory, and workforce changes that stakeholders could consider to reduce the risks of API shortages and can be downloaded at ispe.org/ initiatives/regulatory. IPEC publishes QbD and GMP certification guides BRUSSELS, Belgium—The Inter- national Pharmaceutical Excipients Council (IPEC) Federation pub- lished "Incorporation of Pharmaceu- tical Excipients into Product Devel- opment using Quality-by-Design (QbD)." This guide is intended to introduce QbD and pharmaceutical formulation development concepts, explain the impact of QbD changes in pharmaceutical formulation prac- tices, describe what excipient users will likely require when apply- ing QbD principles during prod- • Lean, dense phase, plug-flow conveying of powders & small particles • Gentle - segregation & damage free • Conveying rates up to 10,000 lbs/hr • Safe, explosion free • Quiet, hygienic, reliable • No tools assembly Simply the best vacuum conveyor 609-265-0101 www.volkmannUSA.com PUT US TO THE TEST Courtesy of Weiss Pharmatechnik GmbH