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World Courier Facility Receives UK Distribution Authorisation
World Courier receives pharmaceutical storage and transportation accreditation in the United Kingdom.
Thermo Fisher Licenses Cell-Based Platform from Sygnis
The technology platform measures protein-protein interactions.
Shimadzu Scientific Instruments Names Katsuaki Kaito as President
Katsuaki Kaito has been named president of Shimadzu Scientific Instruments.
European Commission Approves Opdivo
The decision makes Bristol-Myers Squibb’s therapy the first PD-1 checkpoint inhibitor approved in Europe.
Amgen’s PCSK9 Inhibitor, Repatha, Wins EC Nod
Amgen says the approval makes Repatha the first PCSK9 inhibitor to be approved in the world.
BARDA Taps Emergent BioSolutions for the Manufacture of Ebola mAbs
The $19.7 million contract will assist Emergent with the development of cGMP lots of three Ebola mAbs.
CSafe Adds Service Center for Controlled-Temperature Shipping in Switzerland
CSafe and AES will support controlled-temperature shipping through the Basel, Switzerland airport from their new service center.
Eisai Transfers North Carolina Facility to Biogen
Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.
Biosimilar Manufacturers Must Wait Six Months After Approval to Market Product
A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.
Baxter Recalls IV Solution for Insect in Bag
Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.
2015 CPhI Pharma Awards
The 2015 CPhI Pharma Awards honors innovation in all phases of small-molecule and large-molecule drug development.
House Passes Short-Term Funding Bill
The bill would authorize spending of approximately $8.1 billion on transit projects through 2015 while legislators plan a long-term bill that could have implications for the pharmaceutical industry.
Valeant to Acquire Amoun Pharmaceutical
Amoun, Egypt's largest drugmaker, will be sold to Valeant for $800 million.
FDA and Manufacturers Map Out PDUFA Reform Priorities
A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.
FDA Reviews Drug Development
FDA releases a report that analyses why some diseases are lacking treatment options.
FDA and EU Regulators Strategize Future Collaboration
The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.
EMA Releases API Bioequivalence Studies Guidance
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
Sanofi Announces New, Global Business Unit Structure
Sanofi's new business-unit structure focuses on growth drivers.
GSK Ships Flu Vaccine
GSK accelerates delivery timeline for US quadrivalent flu vaccine.
Experts Join CPhI Panel
Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.
Faculty and Student Research Cited by AAPS Foundation
AAPS Foundation announces 2015 new investigator grant and graduate student fellowship winners.
ABC Laboratories Acquired by EAG
Evans Analytical Group expands into the pharmaceutical/biopharmaceutical industry with acquisition of ABC Laboratories.
Mylan’s Withdrawn Difficult-to-Administer Prefilled Syringe Still on Market, Sparks FDA Concern
Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.
EMD Millipore Introduces Flexible Single-Use Bioreactor
The Mobius 2000-L single-use bioreactor from EMD Millipore offers configurable software, hardware, and single-use Flexware assemblies for suspension and adherent cell-culture applications.
Celgene to Buy Receptos for $7.2 Billion
The acquisition will bolster Celgene’s immunotherapy pipeline.
Vetter Introduces New Syringe Closure System for Highly-Sensitive Compounds
Consisting of a needle hub and a needle shield, the new syringe closure system is partly produced by means of a two-component injection molding process of polypropylene and thermoplastic elastomer.
Fresenius Kabi and Calea Fined for Faulty Prefilled Syringes
Two companies have been fined a total of GBP550,000 for faulty insulin syringes, which contained no drug and caused the death of a diabetic patient.
Agilent Technologies and the Bioprocessing Technology Institute Partner on Glycan Analysis Initiative
The collaboration will address the need for novel analytical approaches for the characterization of glycans.
FDA Bans Emcure Pharma’s India Plant
FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.
Neurological Disorders Drug Development Pipeline has 420 Candidates, Says New Report
A report released by PhRMA in conjunction with the Epilepsy Foundation reveals that the pipeline is dominated by biologics.