Almac, a contract development and manufacturing organization, launched selectAZyme, an offering of biocatalysts, including reductases, transaminases, hydrolases, and nitrilases. The offering also includes metabolite synthesis for oxidative and glycosylated products.
American Regent, a supplier of injectable products, resumed the shipment of its product line on May 5, 2011. On Apr. 21, 2011, Luitpold Pharmaceuticals, American Regent’s parent company, temporarily suspended distribution of all drug products manufactured at its Shirley, New York, facility. The suspension followed an FDA inspection and follow-up meeting on Apr. 14, 2011.
The company formed by the merger of specialty-pharmaceutical firms Axcan and Eurand was named Aptalis Pharma. The merger was completed in February 2011.
INC Research, a contract research organization (CRO), agreed to acquire CRO Kendle for $232 million. Kendle’s board of directors approved the transaction, which is expected to close in the third quarter of 2011, subject to approval by Kendle’s shareholders, customary closing conditions, and regulatory approval.
Iroko Pharmaceuticals, a pharmaceutical services company, selected Aptuit as a contract manufacturing partner to produce Phase III supplies of low-dose nanotechnology formulations of multiple nonsteroidal anti-inflammatory drugs. Aptuit will also make batch material to satisfy requirements for product registrations.
The CRO Parexel instituted a restructuring plan in its early-phase program, which is scheduled to begin in the fourth quarter of fiscal year 2011. The amount of the restructuring is estimated at $15 million, of which approximately $4 million is expected to be recorded in the fourth quarter.
Precis Engineering is providing mechanical, electrical, plumbing, process engineering, and commissioning services for Morphotek's new $80-million, 60,000-ft2 manufacturing pilot plant currently under construction in Exton, Pennsylvania. The Morphotek facility will house a biologics plant, laboratories, a cGMP cell-culture core area, warehouse storage, and offices to support the company's production of biologics for early-stage clinical trials. The facility is scheduled to be completed in the spring 2011, and operations are slated to begin in 2012. Morphotek a biopharmaceutical subsidiary of Eisai.
sanofi-aventis changed its name to Sanofi. The name change was voted into effect by shareholders at the company’s annual shareholder meeting on May 6, 2011.
Contract manufacturing organization SCM Pharma secured a sterile filling and packaging project with Molteni Therapeutics, an Italian specialty-pharmaceutical company. The project involves a drug substance being developed for the topical treatment of infected skin lesions using photodynamic therapy.
FDA issued the specialty-pharmaceutical company Warner-Chilcott a Warning Letter in response to a video about Atelvia (risedronate sodium) delayed-release tablets that its sales team had posted on YouTube. FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) received a complaint about the video, which is titled “Brooke Stacey SA, TX Atelvia.” In the Warning Letter, the agency said that the video “makes representations about the use of Atelvia, but fails to present any risks associated with [the drug’s use] and fails to disclose the drug’s indication. The video also presents dosing claims for Atelvia that omit material facts and that are misleading.” Warner-Chilcott is required to confirm receipt of FDA’s letter by May 19.
Almac appointed Todd Kole as vice-president of clinical project services and as a member of the executive leadership team.
CMC Biologics, a contract biopharmaceutical manufacturer, hired Claes Glassell as its CEO.
Contract service provider Penn Pharma named Mark Dean-Netscher as chief operating officer. He will be responsible for overseeing the operation of the company’s special and global contract manufacturing and development services.
Pfizer CentreSource appointed Cristin B. Grove as director of global contract manufacturing. She most recently served as business development manager for Pfizer Global Supply.
Pharmaceutical Research and Manufacturers of America has named Rod Hunter as senior vice-president of international advocacy, effective June 10, 2011. Hunter will report to Chip Davis, executive vice-president of advocacy.Valerie Palumbo joined contract research organization PharmaNet Development as senior vice-president of corporate quality assurance.