Industry News
FDA Approves CMO Facilities for Halozyme Product
FDA approved a Cook Pharmica facility and a Patheon facility for manufacturing of Halozyme products.
Industry Stakeholders Tackle the Use of Biological Qualifiers at WHO Naming Session
Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.
ISPE Releases its Drug Shortages Prevention Plan
The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.
CPhI Releases Part 3 of its Annual Industry Report
CPhI released Part 3 of its annual industry report featuring three experts in the pharmaceutical industry.
NIH Invests in Biomedical Research Data
The National Institutes of Health announces grants for the development of strategies for the utilization of biomedical data sets.
CSL Behring Announces Global Facility Expansions
CSL Behring announced that it plans to invest $450 million to expand its Melbourne, Australia and Kankakee, Illinois facilities, which will increase production of albumin and plasma intermediates.
Change is Afoot at CPhI
New investments, expansions, and company rebranding are discussed at CPhI.
FDA Releases Guidance on Critical Path Innovation Meetings
FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.
FDA Releases Guidance on OTC Pediatric Drug Products
FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.
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FDA releases question and answer draft guidance on drug product tracing and licensing requirements.
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.
