Industry Briefs: June 25, 2012
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.
Company News
Bristol-Myers Squibb and Pfizer have received a Complete Response Letter from FDA for Eliquis (apixaban), for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Read More
Impax Laboratories and Tolmar have entered into a multiproduct agreement for the development, supply, and distribution of generic topical prescription drug products. Read More
FDA has issued Janssen R&D a Complete Response Letter for Xarelto (rivaroxaban) for the reduction of secondary cardiovascular events in patients with acute coronary syndrome Read More
PharmaNet/i3 has launched PharmaNet/i3 Strategic Resourcing, a new provider of staffing and functional service provider services. Read More
Quotient Clinical and Capsugel have announced a collaboration for the development and clinical assessment of lipid-based formulations. Read More
Takeda North America has changed its name to Takeda Pharmaceuticals USA. Read More
WIL Research Company has selected Thermo Fisher Scientific’s Q Exactive mass spectrometer systems to expand its capabilities for regulated bioanalysis, drug discovery, metabolism, and structural identification services.
People News
Takeda has announced a new assignment of directors, the appointment of corporate officers and a change of senior leadership. Key appointments include Masato Iwasaki as director and senior vice-president of Pharmaceutical Marketing, and Deborah Dunsire as director, president, and CEO of the company’s subsidiary Millennium Pharmaceuticals. 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.
