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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.
California State Senate Passes Biosimilars Bill
Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.
Otsuka Pharmaceutical To Acquire Astex Pharmaceuticals
Otsuka's planned acquisition bolsters its pipeline in oncology and adds fragment-based drug-discovery technology.
Rockwell Collins to Sell Kaiser Optical Systems to Endress+Hauser
Rockwell Collins will sell Kaiser Optical Systems to Endress+Hauser.
MEDA to Acquires Acton Pharmaceuticals
Meda will acquire Acton Pharmaceuticals.
BioReliance Opens Clearance Services Laboratories in US
BioReliance opens Clearance Services Laboratories in Maryland for downstream bioprocessing studies.
Endo to Acquire Boca Pharmacal
Endo will acquire Boca Pharmacal in multimillion dollar deal.
Agilent Technologies Opens Spectroscopy Center
Agilent Technologies opens multimillion dollar Spectroscopy Technology Innovation Center in Australia.
CordenPharma to Acquire Peptisyntha SA from Solvay
CordenPharma will acquire Peptisyntha SA, based in Belgium.
FDA Approves Third Drug in BD Simplist Prefilled Injectable Line of Products
FDA approves BD Simplist product ondansetron injection, an injectable antiemetic.
Merck & Co. Gets FDA Nod to Manufacture Bulk Vaccine at North Carolina Facility
Merck & Co gets FDA approval to manufacture bulk varicella at its in Durham, North Carolina for use in chickenpox and shingles vaccines.
Zealand Announces Collaboration with Eli Lilly
Zealand will join efforts with Eli Lilly to design and develop therapeutic peptides for Type 2 diabetes and obesity.
Waters Corporation Announces CEO Transition Plan
CEO of Waters Corporation will retire within in the next two years.
Capsugel To Acquire Bend Research
Capsugel plans to acquire Bend Research to enhance its bioavailability-enhancement capabilities.
Baxter and Coherus Biosciences Collaborate On Biosimilars
Baxter and Coherus Biosciences colaborate to develop and commercialize a biosimilar version of etanercept for Europe, Canada, and, Brazil.
