The companies will work together to discover, develop, and commercialize immunotherapies for patients with solid-tumor cancers in a collaboration worth $695 million (EUR 603 million) per program. / read more /
The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing. / read more /
Evonik sets new standard for enteric coatings:
EUDRAGIT® FL 30 D-55 is an advanced, new combination polymer solution for enteric coatings that integrates the respective benefits of two existing, well-accepted monographs. It is highly flexible, plasticizer-free, and can be sprayed with a smooth, fast and no-stick process. As a single product, preparation times can be reduced by up to 70%. Visit Evonik at CPhI (booth 9K20), AAPS (booth 2127) or email healthcare@evonik.com Learn more
Insmed's Arikayce (amikacin liposome inhalation suspension) is the first drug approved under the agency's Limited Population Pathway for Antibacterial and Antifungal Drugs, established to support development of antibiotics for unmet medical needs. / read more /
FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials. / read more /
Rentschler Fill Solutions received a certificate of GMP compliance from the Austrian Agency for Health and Food Safety for its new aseptic fill/finish facility. / read more /
As counterfeiting, API manufacturing issues, and illegal diversion increase vulnerability, could dispensers and even patients play a greater role in securing the pharma supply chain? / read more /
Partnerships, mergers, and new services indicate that biologics are continuing to influence CMOs' and CDMOs' decisions to expand their biopharmaceutical services. / read more /
While food, shelter, and clothing are the primal essentials for life, hope—as embodied by modern medicine—has now become part of that human expectation. / read more /
This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.
