Industry Briefs: August 27, 2012
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.
Company News
Bend Research has opened a new cGMP spray-drying facility for high-potency drugs in Bend, Oregon. Read More
Bristol-Myers Squibb (BMS) has discontinued the development of BMS-986094, an investigational nucleotide polymerase inhibitor for treating hepatitis C. Read More
Claris Lifesciences has announced that it has ended its supply agreement with Pfizer. Read More
FDA has approved Gilead’s Stribild, a once-daily, single tablet regimen for treating HIV. Read More
Sanofi’s subsidiary Genzyme has received a Refuse to File letter from FDA for its biologics license application for Lemtrada (alemtuzumab), a monoclonal antibody to treat relapsing multiple sclerosis. The agency requested that the company modify the presentation of the data sets to enable the agency to better navigate the application. Read More
Synergy Pharmaceuticals has acquired FV-100, an orally available nucleoside analogue for treating shingles, from BMS. Read More
West Pharmaceutical India Packaging, an indirect subsidiary of West Pharmaceutical Services, has begun construction of its new compression molding facility in Sri City, India. The plant will become part of West’s global supply chain for its pharmaceutical packaging operations. Read More
The Wistar Institute of Philadelphia has signed a three-year collaborative agreement with DavosPharma to develop novel therapeutics. Read More
WuXi PharmaTech has agreed with TaiMed Biologics to manufacture Ibalizumab (TMB-355) in support of Phase II and III clinical trials. Read More
People Notes
DPT Laboratories has named Gene Ciolfi vice-president and general manager of the company’s Center Excellence for Sterile and Specialty Products. Read More
Hovione has appointed Conrad Winters as the company’s drug product development director. Read More
Roche has appointed Daniel O’Day as the head of Roche Pharma, effective Sept. 1, 2012. Roland Diggelmann will assume the position head of Roche diagnostics. Read More
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.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
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.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
