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Disposable Systems Valuable in Responding to Emergencies and Epidemics
Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.
Are IPRs Impacting the Pharmaceutical Industry?
As more patents make their way through IPRs, the balance of how the pharmaceutical industry selects between IPRs and district court litigation will likely evolve.
GSK’s Malaria Vaccine Gets Positive Opinion from EMA
EMA gives GSK’s malaria candidate vaccine a positive opinion for the prevention of malaria in young children in sub-Saharan Africa.
FDA Issues Guidance on Analytics and Method Validation
The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.
EMA Revises Class Waiver List to Support Pediatric Drug Development
This move is expected to stimulate the exploration of many more medicines for use in children.
Academic Groups Recognized for Drug Delivery Papers
The Catalent Applied Drug Delivery Institute and AAPS recognize four groups for emerging scientific talent and academic excellence.
FDA Issues Warning Letter to Drug Compounder
FDA warns an Arkansas compounding company that it is in violation of the FDCA.
SafeBridge Updates Potent API and Drug Manufacturer Status
SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.
Capsugel Expands Capabilities at its Edinburgh Facility
Investment at Capsugel’s Edinburgh, Scotland facility will expand the company’s liquid- and semi-solid-fill capsule manufacturing capacity.
MedImmune Forms Cell Engineering Pact with University of Sheffield
MedImmune will provide funding and in-kind contributions to support University of Sheffield research projects to address key challenges in cell engineering.
DPx Holdings Sells Fine Chemicals Business
Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.
World Courier Receives UK Wholesale Distribution Authorisation
World Courier receives pharmaceutical storage and transportation accreditation in the United Kingdom.
Shimadzu Scientific Instruments Names New President
Katsuaki Kaito has been named president of Shimadzu Scientific Instruments.
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.
Insect in IV Solution Prompts Baxter Recall
Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.
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.
EMA Releases API Bioequivalence Studies Guidance
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
FDA and EU Regulators Strategize Future Collaboration
The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.
AMRI Acquires Gadea Pharmaceutical Group
AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.
AAPS Foundation Recognizes Faculty and Student Research
AAPS Foundation announces 2015 new investigator grant and graduate student fellowship winners.
CPhI Adds Expert Panel Members
Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.
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.
EAG Acquires ABC Laboratories
Evans Analytical Group expands into the pharmaceutical/biopharmaceutical industry with acquisition of ABC Laboratories.
Best Practices for Stability Testing of Biologics
Experts discuss crucial aspects of measuring the stability of biologics, which exhibit greater variability in stability testing than do small-molecule drugs.
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.
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.
