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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.
Infinity and AbbVie Collaborate to Develop Oncology Drug
The companies plan to develop and commercialize duvelisib (IPI-145).
DPT Laboratories Acquires Media Pharmaceuticals' Lakewood Facilities
DPT Laboratories acquired Media Pharmaceuticals' Lakewood, New Jersey facilities, providing space for aseptic processing suites and filling equipment.
Merck KGaA Breaks Ground on Facility in China
The new China facility will be Merck KGaA's biopharmaceuticals division's second largest worldwide.
FDA Releases Guidance Electronic Submission of Lot Distribution Reports
FDA releases draft guidance on electronic submission of lot distribution reports.
Catalent Adds Prefilled Syringe Line for Clinical Trial Supplies
Catalent's addition of an automated prefilled syringe clinical packaging line at its Philadelphia facility will support its work with Eli Lilly.
Pfizer's Vaccine for C. Difficile Receives FDA Fast Track Designation
Pfizer announced that its investigational vaccine candidate for the treatment of Clostridium difficile has been granted the Fast Track designation from FDA.
Pfizer Announces Approval of ELELYSO in Treatment of Type 1 Gaucher Disease
Pfizer announced that FDA approved ELELYSO for treatment of Type 1 Gaucher disease in adult and pediatric patients.
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.
Suppliers Seek to Boost Single-Use Technology
Attendees at the Bio-Process Systems Alliance annual summit discuss the benefits of single-use technology in biopharmaceutical manufacturing.
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.
Cubist Pharmaceuticals Recalls CUBICIN
Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.
New Blockbuster Drugs Will More than Triple Acute Coronary Syndrome Treatment Market Value by 2023
GlobalData's report looks at the growth of monoclonal antibodies in the market for acute coronary syndrome treatment.
Allied Minds and Bristol-Myers Squibb Advance Innovation in US Academia
Allied-Bristol Life Sciences will focus on converting university research into therapeutic candidates.