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Posted March 10, 2021

SOMERSET, NJ—Catalent has acquired Acorda’s dry powder inhaler (DPI) capsule manufacturing and packaging facility located in Chelsea, MA. The site features commercial- and clinical-scale DPI capsule manufacturing suites, including a PSD-7 spray dryer. This acquisition will expand the Catalent’s current capabilities, providing turnkey DPI solutions for initial development and device selection, capsule manufacture and packaging, product characterization, and release testing.

Posted March 8, 2021

SILVER SPRING, MD—The FDA granted conditional approval of Laverdia-CA1 (verdinexor) tablets as a treatment for dogs with lymphoma. The drug prevents certain proteins from leaving the nucleus of cancer cells, allowing these proteins to control the growth and prevent the spread of cancerous cells in dogs. It is the first conditionally approved oral treatment for dogs with lymphoma. The product is manufactured by Anivive Lifesciences, Long Beach, CA.

Posted March 7, 2021

ARLINGTON, VA—The International Pharmaceutical Excipients Council Federation (IPEC Federation) has published a revised edition of the IPEC General Glossary of Terms and Acronyms for Pharmaceutical Excipients. The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. The revised guide can be downloaded at https://ipecamericas.org/reference-center/document-depot.

Posted March 6, 2021

SILVER SPRING, MD—The FDA approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis. This is the first FDA-approved oral drug for the treatment of this condition. The product is manufactured by Aurinia Pharmaceuticals, Victoria, BC.

Posted March 5, 2021

NORTH BETHESDA, MD—The International Society for Pharmaceutical Engineering (ISPE) has published the second edition of the ISPE Good Practice Guide: Maintenance, which describes the current established good practices and provides a practical and consistent interpretation of the required elements of a pharmaceutical maintenance program. The updated guide includes consolidated basic and good practices categories, added clarification on terminology, and updated examples. The content of the second edition is aligned with the ICH Q9 risk-based approach with respect to maintenance and the industry as a whole. The guide can be purchased at ispe.org/publications/guidance-documents.

Posted March 4, 2021

SILVER SPRING, MD—The FDA approved an extended indication for Entresto (sacubitril/valsartan), making it the first and only approved therapy in the US to treat adult patients diagnosed with heart failure. This includes patients suffering from heart failure with reduced ejection fraction and heart failure with preserved ejection fraction. The approval of this expanded indication will also enable the potential treatment of more adults with left ventricular ejection fraction below normal. Entresto is manufactured by Novartis, East Hanover, NJ.

Posted March 3, 2021

LISBON, Portugal—Hovione has launched a screening service for spray-dried dispersions called ASD-HIPROS. The platform is a tool for identifying optimal and commercially viable amorphous solid dispersion formulations by spray drying. Using an advanced computational tool, the platform is able to rapidly screen for the best combination of polymers, drug loads, surfactants, and solvents. This is followed by producing scale-independent representative samples of the most promising formulations, which are evaluated for performance and stability.

Posted March 2, 2021

BRUSSELS, Belgium—ExciPact, an international non-profit organization that provides voluntary third-party GMP certification to excipient manufacturers, has certified JRS Pharma’s manufacturing site in Gujarat, India. The certification demonstrates that the site manufactures microcrystalline cellulose according to ExciPact’s GMP standards. Due to Covid-19 travel restrictions, these certificates offer customers risk assessment assurance without the need to travel.

Posted March 1, 2021

BELFAST, UK—Sepha, a supplier of pharmaceutical packaging and machinery, has launched a contract packaging service at its Belfast facility to meet the rising demand for small-batch production in the pharmaceutical, nutraceutical, and medical device industries. The service aims to provide cost-effective, low volume runs of blister and medical device packs with short turnaround times. The Belfast site will house a range of dedicated blister packaging equipment to accommodate small-batch packaging projects including cold-form and thermoform blisters, MAP packs, trays for medical devices, and temperature- and humidity-controlled packaging. The company will also offer a holistic blister packaging development service with QA and non-destructive leak testing.