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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The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.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FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.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.
Sartorius Opens New York Demonstration Lab
A new demonstration facility in New York gives Sartorius’ customers hands-on access to bioprocessing systems and lab instruments.
New Cell-Culture Media Compaction Technology Introduced
EMD Millipore debuts a new cell-culture media compacting technology that will turn messy, dry powders into granules.
EDQM Releases 2014 Annual Report
The directorate highlights achievements accomplished during the year of its 50th anniversary.
Stress and Protein Instability During Formulation and Fill/Finish Processes
This article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.
ICH Steering Committee to Meet in Japan
The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.
FDA Releases Guidance on CMC Changes for Biologics
The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.
