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Columbia Laboratories Acquires Molecular Profiles
Columbia Laboratories acquires Molecular Profiles in multimillion-dollar deal.
FDA Issues Draft Guidance on Patient Counseling Info for Labeling
Teva Signs R&D Pact with a UK Research Institute
The alliance with Teva will focus on mechanisms and molecular targets related to the emergence of treatment-resistant cancer cells.
US Pharmacopeia Announces 2013-2014 Global Fellowships
For the 2013-2014 academic year, three $50,000 USP Global Fellowship awards have been presented.
European Medicines Agency Reorganizes
EMA releases details of restructuring.
FDA Issues Import Alert Against Ranbaxy Laboratories
FDA issues import alert due to cGMP violations at Ranbaxy's facility in Mohali, India.
Roche Nominates New Chairman
Roche nominates Christoph Franz, currently CEO of the Lufthansa Group, to succeed current Roche chairman Franz B. Hummer.
AMRI Announces Executive Leadership Changes
AMRI reported that Thomas E. D'Ambra, PhD. will retire as president and CEO.
Hospira Voluntarily Recalls Certain Lots of Bupivacaine
FDA reports that Hospira initiated on July 12, 2013 a voluntary recall of certain lots of bupivacaine HCl due to particulates floating and/or in the glass vial.
EMD Millipore Receives Recertification of GMP Compliance for Biodevelopment Centre
EMD Millipore receives recertification of GMP compliance for Biodevelopment Centre in Martillac, France.
First biosimilar mAb approved in Europe
Hospira's Inflectra (infliximab), which is a biosimilar to the reference biologic product, Remicade, has been approved by the EC for the treatment of inflammatory conditions.
Catalent Appoints First President of Asia Pacific Group
Catalent appoints David Heyens as President of Asia Pacific facility.
FDA Reissues Bioanalytical Method Validation Guidance
FDA updates guidance to reflect advances in technology.
Novartis Making Moves to Increase Biologics Manufacturing Capability
Novartis? half-billion dollar investment in a new biologics production plant in Singapore represents a strategic commitment to its growing biologics portfolio.
Takeda's Drug Vedolizumab is Granted Priority Review Status by FDA
Takeda's drug vedolizumab is granted priority review status for the treatment of adults with moderately to severely active ulcerative colitis.
Sigma-Aldrich, The Scripps Research Institute Translating Research into Commercial Applications
New partnership aims to eliminate months from the typical transition time required to move chemistry from the laboratory into commercial applications.
Cargill Makes Multimillion Investment in French Alginates Plant
Cargill invests to upgrade its alginate production plant in in Lannilis, Brittany, France.
MPI Research Breaks Ground on New Imaging Center
MPI's new Imaging Center is set to open in Spring 2014 at the company's headquarters in Michigan.
FDA Advisory Committee Recommends Approval for GSK and Theravance's COPD Drug
An FDA Committee voted to support approval of GSK and Theravance?s umeclidinium/vilanterol for treatment of chronic pulmonary disease.
FDA Specifies Unique Facility Identifier System
FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments.
EFPIA Responds to EMA Policy on Publication and Access to Clinical-Trial Data
The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests.
Hovione Receives Patent Approval for XCaps DPI
The device is an inexpensive, easy-to-use capsule-based DPI with high efficiency powder dispersion and has the versatility to treat a range of pulmonary diseases.
FDA Announces Safety Requirements for Opioid Analgesics
FDA revises boxed warnings for extended-release and long-acting opioid analgesics and postmarket study requirements.
VWR International, Thermo Fisher Sign Global Agreement
VWR International has signed a global distribution agreement with Thermo Fisher Scientific.
Horizon Pharma Receives FDA Aprroval for Sanofi Site to Manufacturing Its Product
Horizon Pharma reports that FDA has approved the use of Sanofi's manufacturing site in Compiegne, France to manufacture DUEXIS.
Myriad Genetics, Expands Companion Diagnostic Pact with AztraZeneca
Myriad Genetics and AstraZeneca expand their companion diagnostic pact for AztraZeneca?s investigational drug candidate olaparib.
Regulatory Authorities Discuss Elemental Impurities Standards
Mylan Completes Expansion of Vermont Transdermal Patch Facility
Mylan completes expansion of its transdermal patch facility in Vermont.
Sanofi and POZEN Sign Commercial Agreement for PA8140/PA32540 Tablets
Sanofi and POZEN sign a license agreement for the commercialization of omeprazole and aspirin combination product.
FDA Announces More Compounding Pharmacy Recalls
FDA inspections reveal possible inaccurate sterility testing.
