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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.
Hospira Recalls Certain Lots of Intravenous Products
Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.
Report Explores Factors Contributing to Success and Failure in Cancer Treatments
A report from PhRMA highlights how drugs that failed in clinical trials are a crucial part of development for melanoma, lung cancer, and brain cancer.
Endo to Acquire Auxilium Pharmaceuticals
Endo will acquire Auxilium Pharmaceuticals in a cash and stock transaction for approximately $2.6 billion.
IDT Biologika Certifies Facility to Fill and Lyophilize Biologics and Vaccines
IDT Biologika completes large-scale biologics finishing facility in Dessau, Germany.
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.
FUJIFILM Diosynth Biotechnologies Releases Mammalian Expression Platform
The Apollo platform can be used throughout a product?s entire lifecycle.
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.
Amgen Reports Positive Phase III Results for Biosimilar of Humira
ABP 501, a biosimilar candidate for Humira, was shown to have a immunogenicity and efficacy profile comparable to that of the innovator product.
Genentech Receives FDA Priority Review for Diabetic Retinopathy Treatment
FDA granted Genentech priority review for its diabetic retinopathy treatment, Lucentis.
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.
Ascension Health Bans Genentech Sales Reps After Losing Drug Discounts
A change in the supply chain for three important Genentech cancer medications elicits a strong reaction from one of the nation's largest operators of hospitals.
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.
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.
