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ePT--the Electronic Newsletter of Pharmaceutical Technology
Actavis, Cardinal, FDA, more
Hafnarfjordur, Iceland (Feb. 13)–Actavis (www.actavis.com) has acquired the active pharmaceutical ingredient division of Sanmar Specialty Chemicals Ltd. (Chennai, India, www.sanmargroup.com/index.htm). The acquisition is expected to complement Actavis's existing manufacturing capabilities in Chennai. The price was not disclosed.
Los Angeles, CA (Feb. 13)-Bone Biologics (www.bonebiologics.com) has selected Cytovance Biologics LLC (Oklahoma City, OK, www.cytovance.com) to provide process development and manufacturing of its recombinant protein for spinal fusion surgery. Cytovance specializes in producing antibody and recombinant protein products derived from cell cultures.
Dublin, OH (Feb. 9)-Cardinal Health303, Inc. (www.cardinal.com) has signed a consent decree with the US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) for condemnation and permanent injunction related to its Signature Edition infusion pumps. Cardinal has agreed to stop manufacturing and distributing the SE infusion pumps until manufacturing deficiencies have been corrected and the devices are made in complience with CGMP requirements and the Quality System regulation for medical practice. Cardinal will be able to service and repair the pumps that were already in the hands of customers before the decree was entered. The pumps were found to have a defect known as a "key bounce," in which the pump would recognize a single keystroke as a double key stroke, possibly resulting in over-medication.
Marlborough, MA (Feb. 13)-Cytyc Corporation (www.cytyc.com) has entered into an agreement to acquire Adeza Biomedical Coporation (Sunnyvale, CA, http://phx.corporate-ir.net/phoenix.zhtml?c=182397&p=irol-irhome) for $452 million. The offer is expected to commence within the next week and the tender offer is expected to be completed before the end of March 2007.
Rockville, MD (Feb. 12)-The US Food and Drug Administration (FDA, www.fda.gov) announced revisions to the labeling for the antibiotic Ketek, which is produced by Sanofi Aventis (Paris, en.sanofi-aventis.com). Changes include removing two of the three previously approved indications-acute bacterial sinusitus and acute bacterial exacerbations of chronic bronchitis-from the drug's label. Ketek will continue to be prescribed for community-acquired pneumonia of mild to moderate severity. Ketek will also carry a "boxed warning," stating that Ketek is contraindicatioed in patients with myasthenia gravis.
Austin, TX (Feb. 14)-Mystic Pharmaceuticals, Inc. (www.mysticpharmaceuticals.com) plans to expand its R&D center to include clinical manufacturing operations for opthalmic and intranasal drug delivery systems and pharmaceutical products currently under development. The expansion plans include the construction of two cleanroom manufacturing suites, expansion of research labs, and the deployment of pilot-scale manufacturing lines to produce Mystic's "VersiDoser" drug-delivery systems. The facility is expected to be fully operational by mid-2007.
Oss, The Netherlands and Princeton, NJ (Feb. 13)-Organon (www.organon.com) has entered into an alliance with Pharmacopeia (www.pharmacopeia.com) to discover, develop, and commercialize therapeutic products. Under the agreement, Pharmacopeia will receive an up-front payment of $15 million and additional payments in research funding over the five-year term of the research portion of the alliance. Development of any compounds produced will be primarily handled by Organon.
Randolph, NJ (Feb. 13)-Pharmacy Creations (www.pharmacycreations.com) has responded to an FDA warning letter dated October 31, 2006. In their response, Pharmacy Creations disputes the authority of FDA to conduct a closeout inspection of their premises, citing a 2006 federal court decision that states that compounding pharmacies are exempt from inspections as long as they are compliant with local laws and dispense drugs pursuant to the receipt of a prescription from a licensed practitioner. Pharmacy Creations claims that it compounds drugs in dosages that are substantially different from those available on the commercial market and has never been cited for violations of state or local regulations in connection with its compounding practices. The company further refutes FDA's claims that Pharmacy Creations produces drugs in excess of actual prescription orders.
Palo Alto, CA (Feb. 13)-Telik, Inc. (www.telik.com) implemented a corporate restructuring plan that is intended to reduce spending while advancing the company's product development programs. Under the plan, the company's workforce will be reduced by approximately 25%, leaving Telik with approximately 120 employees.
San Diego, CA (Jan. 30)-Artes Medical, Inc. (www.artesmedical.com) promoted Peter. C. Wulff to executive vice-president. Wulff will continue to serve as the company's chief financial officer, a position he has held since 2005.
Los Angeles, CA (Feb. 14)-Cougar Biotechnology, Inc. (www.cougarbiotechnology.com) appointed Richard B. Phillips, PhD, vice-president of regulatory affairs and quality assurance. Phillips will lead the company's interaction and liaison with FDA and with European and other regulatory agencies. He also will be responsible for the company's compliance with good clinical, good laboratory, and good manufacturing practices. Phillips joins Cougar from Amgen, Inc., where he served as director of regulatory affairs and global regulatory leader for "Vectibix."