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Meet This Year's CPhI Pharma Awards Winners
Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.
FDA Releases Q&A on DQSA
FDA releases question and answer draft guidance on drug product tracing and licensing requirements.
Salix Looks to Actavis After Terminating Cosmo Deal
New rules from the Treasury Department regarding inversion affect merger activity in the pharmaceutical sector.
Jagged Little Pill: Drug Delivery Through the Use of Microneedles
Delivery of large protein biopharmaceuticals may now be administered orally with the help of microneedles, according to researchers at MIT.
Hospira's Australian Manufacturing Plant Receives FDA Warning Letter
Impurities, particulates, and a lack of communication are among Hospira's recent violations described in a warning letter from FDA.
HydRIS Vaccine Stability Device Could Revolutionize Cold-Chain Requirements
Nova Bio-Pharma Technologies' new vaccine stability device eliminates the need for cold storage.
Making ZMapp: Production of Experimental Drug to Treat Ebola Is Now A Priority
Manufacturing drugs from biological sources sometimes can't be rushed, even when a rare disease becomes more widespread.
New Tax Rules May Deter Future Pharma M&A
Inversions in the pharmaceutical sector could become less lucrative as a result of new tax laws.
NIH Seeks to Improve Vaccine Response with New Adjuvants
NIH seeks new therapeutic products to bolster the protective properties of vaccines.
Baxter International Plans to Open R&D Center for Baxalta
Baxter International announced it will form a R&D center in Cambridge, Massachusetts for its new biopharmaceutical company, Baxalta.
New Report Details Players and Pipelines in the Biosimilar Space
A new Thomson Reuters BioWorld report outlines the more than 700 biosimilars that are currently in development and the emerging business opportunities that exist in the biopharmaceutical space.
FDA and NIH Win Award for IP Licensing of Meningitis Vaccine
Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.
FDA Releases First-Ever Purple Book for Biosimilar Characterization
The Purple Book will list biologic and biosimilar products and will serve as a guide for interchangeability.
NIH Funds Tissue Chip for Drug Screening
NIH continues funding for tissue chips to be used in the development of therapeutics.
FDA Releases REMS Report
FDA report details risk mitigation projects.
USP Supports WHO Biologics Naming Proposal
USP expresses its support for a consensus-based global approach to the naming of biologics.
UPS' Pain in the Supply Chain Results
Regulations, product protection, and cost management are top concerns of supply chain decision makers.
Merck KGaA Announces Acquisition of Sigma-Aldrich for $17 Billion
Merck KGaA will expand the reach of its EMD Millipore division with the purchase of life-sciences company Sigma-Aldrich.
PCI Acquires Biotec
PCI's acquisition of Biotech Services International expands the packaging services provider's presence in Europe.
Pandemic Vaccine Facility Dedicated in Texas
Texas A&M dedicates national pandemic influenza vaccine manufacturing facility.
Guideline Delineates How to Implement GS1 Standards to Support DSCSA
GS1 publishes a healthcare industry guideline describing how to implement GS1 standards to support requirements of the 2013 US Drug Supply Chain Security Act.
GSK Fined in China Bribery Scandal
GSK is found guilty of offering bribes to doctors and is fined $489 million.
GPhA Supports Restricted Access Bill
GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.
Baxter Names New Biopharmaceutical Company Baxalta
Baxter announced that its new biopharmaceutical company will be named Baxalta when the company separates into two publicly traded companies in mid-2015.
Baxter Initiates Voluntary Recall of Potassium Chloride Injection
Baxter International initiated a US voluntary recall of one lot of potassium chloride injection due to mislabeled shipping carton.
European Commission Grants Lilly and Boehringer Ingelheim's Insulin Glargine Product Marketing in EU
European Commission granted the first biosimilar insulin to receive regulatory approval in Europe.
European Commission Approves RoACTEMRA for Treatment of RA
Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.
ProBioGen Plans Expansion
ProBioGen, a biopharmaceutical drug manufacturer in Berlin, spends ?20 million to double its workforce.
PDA Announces Technical Report on Drug Shortages
PDA will publish a technical report on quality risk management aspects of drug shortages in early 2015.
University of Toronto Announces Collaboration with Janssen and Johnson & Johnson Innovation
Three-year agreement will support research on treatments for major brain disorders in Neuroscience Catalyst project.
