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R&D Pipeline Value Jumps 18% to $493 Billion
EvaluatePharma report shows continued pharma and biotech sector confidence.
GSK Invests $95 Million in Gene Control Research
GSK announces it will invest $95 million to launch a US-based non-profit research institute, Altius, to research technologies and approaches in understanding gene control.
FDA Launches New REMS Website
The agency streamlines risk and mitigation information.
New SGS Lab Upgrades QC Service Offerings
A new SGS Life Science Services laboratory outside Paris is designed for bio/pharmaceutical quality control testing.
Purification in Batch and Continuous Modes
BioSC Lab biochromatography system performs protein purification in batch and continuous modes.
Thermo Fisher Scientific Adds Facility in Scotland
Dry media powder for the production of biotherapeutics and vaccines will be produced in a new facility in Scotland, in addition to an existing facility in New York.
Allergan Acquires Kythera for $2.1 Billion
Kythera announces that it entered into a definitive agreement to be acquired by Allergan for $2.1 billion.
Continuous Manufacturing Shines at BIO
Penn Announces Gene Therapy Collaboration with WuXi
The University of Pennsylvania announces that it will collaborate with WuXi AppTech to research and develop gene vectors derived from recombinant viruses.
BIO to Add Innovation to Name
The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.
EMA Creates Pediatric Drug Pilot Project
The agency launches initiative to stimulate pediatric drug development.
New England Biolabs to Build Manufacturing Plant
A new GMP facility in Massachusetts will produce enzymes and other reagents for in-vitro diagnostics.
CPhI Adds Biologics Development Innovation Award
CPhI Worldwide announces five new categories for the 2015 CPhI Pharma Awards.
Amgen's Repatha Gets FDA Advisory Panel Nod
An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.
REGENXBIO and WuXi AppTec Collaborate on Gene Therapy Manufacturing
The exclusive manufacturing collaboration will establish production for adeno-associated virus gene-therapy treatments incorporating REGENXBIO’s NAV Technology.
FDA Panel Recommends Approval of Praluent
An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).
Novasep Inks Partnership Agreements with Two Japan-Based Companies
The supplier will add Allied Laboratories and AR Brown to its list of global partners.
FDA Releases Guidance on Treatment for Duchenne Muscular Dystrophy
The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.
Patheon Files Registration For IPO
A year after its merger with DSM Pharmaceutical Products, Patheon announces that it has filed an IPO.
Green Cross Biotherapeutics Constructs Manufacturing Facility in Canada
The Canadian Green Cross facility will produce intravenous immunoglobulin and albumin.
FDA Guidance Seeks More Effective Postapproval Change Strategies
FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.
Biosimilar Labeling Practices Under Fire in New Citizen Petition
In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”
Amgen and Sandoz: Battle Over Neupogen Biosimilar “Shall” Continue
Turkey Expands Reach in Pharma Market
CPhI Pharma Insights’ Turkey Market Report reveals, the growth and strategic plans for the future of the pharmaceutical industry in Turkey.
FDA Officials Comment on China Visit
Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.
Drug Contamination Problems Hit NIH
Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.
FDA Issues Warning Letter to API Manufacturer
The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.
Contamination Shuts Down NIH Pharma Development Facility
FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
Bringing a Biologic from the Bench to the Marketplace
Michiel E. Ultee of Ulteemit BioConsulting discusses converting an early drug discovery into a product that is ready for clinical testing.
Baxter Partners with Mayo Clinic and Velocity to Form New Company
Baxter announces that it will partner with Mayo Clinic and Velocity Pharmaceutical to form Vitesse Biologics, a Baxalta-managed company focused on immunology, hematology, and oncology.
