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FDA Issues Warning Letter To McNeil Healthcare; Charles River Laboratories Will Suspend Operations At Massachusetts Facility.
Altea Therapeutics (Atlanta, GA) entered a preclinical and clinical development agreement with KAI Pharmaceuticals (South San Francisco, CA) to develop certain KAI proprietary peptides using Altea’s PassPort transdermal delivery system. The two companies will examine the transdermal delivery of some KAI compounds.
Catalent Pharma Solutions (Research Triangle Park, NC) acquired advanced fine-powder filling capability. Catalent’s purchase of Harro Höfliger’s Omnidose filling equipment allows it to offer customers fully scaleable, dry-powder inhaler (DPI) filling capability. In other news, Catalent installed and qualified a ZED in-line blister card sealer at its Clinical Supply Services facility in Philadelphia.
Celgene (Summit, NJ) completed its acquisition of Gloucester Pharmaceuticals (Cambridge, MA) following the required waiting period. Under the terms of the merger agreement, Celgene acquired Gloucester Pharmaceuticals for $340 million in cash plus up to an additional $300 million payable upon achievement of certain future regulatory milestones.
CEL-SCI (Vienna, VA), a late-stage oncology company and developer of vaccines and therapeutics for infectious diseases, completed the validation process for all utilities and manufacturing equipment at its manufacturing facility in Maryland. The validation will allow CEL-SCI to move forward with its drug-manufacturing plans for the investigational cancer drug Multikine. The facility is now ready to offer contract manufacturing services.
Charles River Laboratories International (Wilmington, MA), a contract-research organization, will suspend operations at its Preclinical Services facility in Shrewsbury, Massachusetts, by mid 2010. The suspension is expected to reduce the company’s operating costs by $20 million this year.
Compass Pharma Services (Clifton, NJ) expanded its blister-packaging capacity for contract pharmaceutical packaging and contract vitamin packaging customers by installing a new, high-speed blister-packaging machine. The new blister-packaging system (Uhlmann thermoformer UPS4) operates at 50 cycles /min.
GenVec (Gaithersburg, MD) signed a drug-development deal with Novartis (Basel). The two companies will collaborate to discover treatments for hearing loss and balance disorders. GenVec is licensing the worldwide rights to its preclinical hearing-loss and balance-disorders program to Novartis. In return, GenVec will receive a $5-million up-front payment, and Novartis has purchased $2 million in GenVec common stock. GenVec will also receive money from Novartis for a research program focused on developing additional adenovectors for hearing loss.
FDA issued a Warning Letter to McNeil Healthcare (Fort Washington, PA), a subsidiary of Johnson & Johnson (New Brunswick, NJ), on Jan. 15, 2010, regarding one of its Puerto Rico facilities (Sector Montones, Las Piedras). An inspection concluded on Jan. 8, 2010,"identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals," said the letter. Specific violations included the "failure to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;" "failure of your Quality Control Unit to ensure a thorough investigation in accordance with 21 CFR. § 211.192 with conclusions and follow up accomplished as required by 21 CFR. § 211.198;" and "failure to submit NDA-Field Alert Reports (FARs) within three working days of receipt of information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug products as required by 21 CFR. § 314.81 (b)(1)(ii).
Pillar5 Pharma (Arnprior, Ontario), a newly formed Canadian company, acquired the former Pfizer manufacturing site in Arnprior, Ontario, from Keata Pharma.
Adolor (Exton, PA) appointed Michael D. Adelman vice-president, marketing and sales; David P. Geoghegan vice-president, manufacturing; and Kevin Darryl White vice-president, regulatory affairs.
The Association of Clinical Research Organizations elected William Sharbaugh, chief operating officer of PPD (Wilmington, NC), its chair for 2010; and Joe Herring, chairman and chief executive officer of Covance (Princeton, NJ), its chair-elect.
CEL-SCI (Vienna, VA) appointed Todd S. Burkhart vice-president of manufacturing/facilities and commercial operations for its manufacturing facility. He has more than 30 years experience in the manufacture and process development of biologicals, medical devices, and other active pharmaceutical ingredients (APIs).
The global Parental Drug Association has elected Maik Jornitz as its chair. He is group vice-president, product management filtration/fermentation technologies at Sartorius Stedim Biotech (Aubagne, France). Anders Vinther was elected as the group’s chair-elect. He is vice-president of corporate quality system & support at Genentech (South San Francisco, CA).