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
Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries
May 30th 2025In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
