Industry Briefs: Feb. 6, 2012 - Pharmaceutical Technology

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PharmTech Europe

Industry Briefs: Feb. 6, 2012
A roundup of other company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

Company News

FDA has approved Merck & Co.’s Janumet XR (sitagliptin and metformin HCl extended-release), a combination therapy for treating Type II diabetes. Read More

Florida Biologix has announced that it now meets European GMP requirements for aseptic fill–finish. Read More

NextPharma has opened a cold-chain and logistics warehouse in Werne, Germany. Read More

OctoPlus and Ferring Pharmaceuticals have entered into a formulation development and manufacturing contract. Read More

SCM Pharma has agreed to develop and manufacture an injectable neonatal product under development by BrePco BioPharma. Read More

Sobi and Biogen Idec have updated their agreement regarding development and commercialization of long-lasting recombinant Factor VIII and Factor IX hemophilia programs, which includes Biogen Idec assuming manufacturing rights. Read More

Xceleron is investing $2.4 million to locate all of the company’s business in its custom-built facility in Germantown, Maryland, which is expected to be fully operational by Mar. 31, 2012. Read More

People News

Auxilium Pharmaceuticals has named Andrew I. Koven as executive vice-president, chief administrative officer, and general counsel, and has appointed Mark A. Glickman as senior vice-president of sales. Read More

PCI Synthesis has made several executive appointments. Elie Saikali has been named director of manufacturing, and Mehdi Yazdi has been named director of quality control and analytical services. Don Dickinson has been named director of business development, and Paul Nichols has been appointed as director of cGMP for PCI’s early-phase clinical drug-substance development and manufacturing capabilities. Read More

Syntagon has appointed quality assurance expert George Köllner to provide GMP and stand-alone duties. Read More


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Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

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