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Posted October 10, 2018

SALT LAKE CITY, UT—The Laura and John Arnold Foundation, Houston, TX, the Peterson Center on Healthcare, New York, NY, and the Gary and Mary West Foundation, San Diego, CA, have each committed $10 million to founding Civica Rx, a new not-for-profit generic drug company that will be headquartered here. They join seven large US hospital systems, representing approximately 500 hospitals, as governing members of Civica Rx. The not-for-profit company will initially focus on 14 hospital-administered generic drugs with the goal stabilizing the supply of essential medications and expects to release its first products as early as 2019.

Posted October 7, 2018

ROCKVILLE, MD—USP will no longer display unique ingredient identifier (UNII) Codes in excipient monographs in the USP–NF online as of November 1, 2018, which coincides with the publication of USP 42–NF 37 . The organization is seeking to open a dialogue with stakeholders to determine the utility of UNII codes for excipients.

Posted October 6, 2018

SILVER SPRING, MD—The FDA approved Kalydeco (ivacaftor) to treat cystic fibrosis in children ages 12 to 24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco based on clinical and/or in vitro assay data. The drug is manufactured by Vertex Pharmaceuticals, Boston, MA, and is the first and only approved CFTR modulator for this age group.
In other news, the agency also approved Galafold (migalastat) to treat adults with Fabry disease, a rare and serious genetic disease that results from buildup of fat in the blood vessels, kidneys, heart, nerves, and other organs. It is the first oral treatment for this medical condition and is manufactured by Amicus Therapeutics, Cranbury, NJ.

Posted October 4, 2018

SILVER SPRING, MD—The FDA published a guidance for industry, “Quality Attribute Considerations for Chewable Tablets,” which finalizes a draft guidance issued in June 2016. The document describes the critical quality attributes that should be considered when developing chewable tablets; recommends that the selected acceptance criteria be appropriate and meaningful indicators of product performance throughout the shelf life of the product; offers recommendations for product labeling to differentiate chewable tablets and help prevent patients from swallowing whole intact tablets; and provides additional clarification regarding the Chewing Difficulty Index, which was developed internally by the agency.

Posted October 3, 2018

NORTH READING, MA—TraceLink, a provider or track-and-trace network products for life science supply chains, announced that it has closed a $93 million investment round. This investment will support the digitalization of the global pharmaceutical supply chain through the integration of real-time information sharing and expand into adjacent application areas, such as supplier collaboration, patient communities, personalized medicine, predictive care, and gene therapies. The company will also use the funds to further support its R&D and services organizations. Investors include Georgian Partners, Vulcan Capital, Willett Advisors, FirstMark Capital, Volition Capital, F-Prime Capital, and Goldman Sachs.

Posted September 27, 2018

PHILADELPHIA, PA—PCI Pharma Services, a biopharmaceutical CDMO, announced its acquisition of clinical trial supply services provider Sherpa Clinical Packaging, San Diego, CA. This acquisition expands PCI’s ability to support customers from the early phases of clinical product development through commercial launch.

Posted September 25, 2018

ST. LOUIS, MO—Ribus, a functional ingredient manufacturer, will officially launch the Clean Label Alliance (CLA) on November 9 at this year’s SupplySide West show in Las Vegas, NV. The purpose of this industry group is to assist and guide dietary supplement companies in efficiently producing clean-label supplements by providing resources and solutions from industry leaders. In addition to Ribus, the group includes Biogrund, Bosch Packaging Technology, Lonza, and Natoli Engineering.

Posted September 25, 2018

WHITE BEAR LAKE, MN—Wilson Tool International, a manufacturer of tablet press punches, dies, and accessories, announced the acquisition of the tablet press tooling division of Thomas Engineering, Hoffman Estates, IL. Wilson Tool will relocate all of Thomas Engineering’s tablet press tooling manufacturing equipment, processes, materials, and inventory to Wilson’s global headquarters in White Bear Lake, MN. Thomas Engineering plans to focus on its tablet coating machinery business.

Posted September 25, 2018

SOMERSET, NJ—Catalent Pharma Solutions, a pharmaceutical CDMO, announced a commercial supply agreement with Aucta Pharmaceuticals, North Brunswick Township, NJ, to manufacture Aucta’s vigabatrin drug product in stick packs. This agreement follows Catalent’s successful formulation of vigabatrin into a stick-pack dosage form using its proprietary FlexDose services. This will be the first FDA ANDA to employ Catalent’s FlexDose services.

Posted September 5, 2018

AURORA, CO—The National Institutes of Health (NIH), Bethesda, MD, awarded researchers at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado (CU) a $2 million grant to research an edible, milk-based chemotherapy treatment. By binding the drug molecules with exosomes, particles found in cow’s milk, researchers may be able to produce a chemo treatment that will not be broken down in stomach acid before it reaches the bloodstream, providing an alternative to typical IV chemo treatments. Researchers are currently running experiments to test strategies for loading the API into the milk exosomes.