Industry News
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.
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.
PCI Acquires Biotec
PCI's acquisition of Biotech Services International expands the packaging services provider's presence in Europe.
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.
GPhA Supports Restricted Access Bill
GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.
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.
Research Shows Protein's Ability to Prevent HIV Cell Replication
Researchers show TIM-1 proteins and lipids play role in blocking HIV-1 cells and Ebola from replicating.
ISPE Previews Drug Shortages Prevention Plan
ISPE released an advance look at the Introductory Summary of its Drug Shortages Prevention Plan.
PSC Investments Acquires Sterile Injectable Fill/Finish Facility
PSC Investments announces the acquisition of a high potency, sterile fill/finish pharmaceutical manufacturing facility.
Case Study Interprets Continuous Process Verification Guidance
The BioPhorum Operations Group has published a resource to help the biopharmaceutical industry deliver a consistent approach to continued process verification.
ISPE Names John Bournas as President and CEO
Former healthcare association executive selected to lead International Society for Pharmaceutical Engineering.
CPhI Announces 2014 Expert Panel and Report
CPhI 2014 panel additions to provide global insights from the contract services sector.
ASTM International Forms Committee on Industrial Biotechnology
ASTM International develops Committee E62, a new technical committee focused on industrial biotechnology.
Canadian Consortium Extends Funding for Drug Research
OCE and OBI partner with CQDM on $3 million inter-provincial drug discovery innovation programs.
BioOutsource to Open New Massachusetts Lab Facility
BioOutsource will expand its US presence, opening a new laboratory facility in Massachusetts to support the company's biosimilar and biosafety service offerings.
Regional Partnership Designed to Spur Biotech Development in California and France
Eurobiomed and Biocom sign a cooperation agreement at the BIO International Convention.
PlantForm and PharmaPraxis Establish Joint Biosimilar Development Venture
PlantForm and PharmaPraxis announce plans to develop six biopharmaceutical targets for the Brazilian market.
BIO 2014 Breaks Partner Meeting Record
BIO 2014 hosted more than 29,000 one-to-one partnering meetings.
Study Demonstrates Performance of SMARTag Platform
New toxicology study demonstrates decreased mortality and better tolerability of ADC generated with Smartag platform versus conventional technology.
FDA Issues Warning Letter to GSK Biologicals
GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.