Industry News
Theorem Clinical Research, Charles River Form Alliance
Theorem Clinical Research?s alliance with Charles River Laboratories will provide nonclinical testing programs in the areas of bioanalysis, immunogenicity, and immunology.
EMD Millipore Receives Recertification of GMP Compliance for Biodevelopment Centre
EMD Millipore receives recertification of GMP compliance for Biodevelopment Centre in Martillac, France.
FDA Reissues Bioanalytical Method Validation Guidance
FDA updates guidance to reflect advances in technology.
VWR International, Thermo Fisher Sign Global Agreement
VWR International has signed a global distribution agreement with Thermo Fisher Scientific.
California State Senate Passes Biosimilars Bill
Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.
Waters Corporation Announces CEO Transition Plan
CEO of Waters Corporation will retire within in the next two years.
BioReliance Opens Clearance Services Laboratories in US
BioReliance opens Clearance Services Laboratories in Maryland for downstream bioprocessing studies.
FDA Approves Third Drug in BD Simplist Prefilled Injectable Line of Products
FDA approves BD Simplist product ondansetron injection, an injectable antiemetic.
Agilent Technologies Opens Spectroscopy Center
Agilent Technologies opens multimillion dollar Spectroscopy Technology Innovation Center in Australia.
Amarin Targets Novasep as Fourth Supplier of Vascepa API
Amarin released the submission of an sNDA to FDA seeking approval for Novasep Group.
Sanofi Pasteur Selects Freeslate to Improve Formulation Development
Sanofi Pasteur has purchased Freeslate?s Biologics Formulation System for accelerating research in vaccine and protein formulation development.
Single-Use Continuous Chromatography Overcoming Limitations of Traditional Protein Purification
Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.
FDA Reviews Outdated Guidance Documents
CDER withdraws some outdated guidance documents and makes plans to finalize others.
Alice E. Till Selected AAPS President-Elect
Till, a PhRMA vice president, will lead AAPS starting in November; Executive Council and Section leadership positions were also announced.
FDA Warns of Possible Contamination of Sterile Products from Compounding Pharmacy
FDA receives adverse event reports related to calcium gluconate infusions.
ScinoPharm, Sundia MediTech Partner for Pharma Outsourcing in China
ScinoPharm Changshu Pharmaceuticals and Sundia MediTech form an alliance for contract research and manufacturing services in mainland China.
Lonza Licenses Gene Expression Technology to Sorrento
The companies sign a nonexclusive research license agreement, giving Sorrento's access to Lonza's GS Xceed Gene Expression System.
Gallus Biopharmaceuticals Enters Clinical Supply Agreement with Genzyme for Niemann Pick Type B Disease
Gallus Biopharmaceuticals has signed a development and manufacturing supply agreement with Genzyme.
FDA Issues Final Guidance for Oversight of Clinical Investigations
The guidance describes a risk-based approach to monitoring of clinical trials.
Oncobiologics and InVentive Health Clinical Form Biosimilars Pact
The companies initially focused on five biosimilar products.
LSNE Successfully Completes MHRA Inspection
Lyophilization Services of New England (LSNE) received a Certificate of GMP Compliance for its New Hampshire facility.
Pfizer Licenses Potelligent CHOK1SV Cell Line
The licensed cell line combines BioWa's engineered glycosylation Potelligent Technology with Lonza's GS Gene Expression System.
ICH Guideline for Elemental Impurities Moves to Step 2b
A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.
FDA Publishes Generic-Drug User Fees
FDA releases FY 2014 generic-drug user fees.
EMA Reorganizes
EMA restructures organization.
EMA Seeks Public Consult on Bioequivalence Concept Paper
EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.
Clinical Manufacturing Site Approved for Molecular Profiles
Molecular Profiles has opened a new clinical manufacturing facility following a successful inspection from the Medicines and Healthcare products Regulatory Agency.
Almac Adds Contained Drug Handling Capabilities
Almac's Clinical Services business unit has expanded its service offering for dispensing and bottling solid dosage products.
Vetter Offers Sterile Water for Injection Syringes with Five Years Stability Data
Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.
EMD Millipore Opens New R&D Center
The facility, which includes state-of-the-art formulation, analytical and synthetic laboratories as well as a customer training center, will focus on bioavailability enhancement and oral dosage formulations.
