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US Marshals Seize Unapproved Drugs
Ascend Laboratories and Masters Pharmaceuticals cited in seizure of $11 million in unapproved drugs.
Hospira Issues Recall Due to Particles from Glass Defects in Vials
Hospira has recalled one lot of labetalol hydrochloride injection, USP, due to visible particulates.
AstraZeneca Rejects Pfizer's Final Offer
AstraZeneca rejects Pfizer's final offer of $118 billion for a proposed merger of the two companies.
SGS Announces Appointments at New Facility in California
SGS makes two senior appointments at its new GMP/GLP laboratory in Carson, California.
Advanced Scientifics and Chemic Laboratories Announce Joint Cooperation Agreement
Advanced Scientifics and Chemic Laboratories enter a three-year joint cooperation agreement to collaborate on product development projects.
EMA Opens Registration for European Network of Paediatric Research Workshop
EMA opens registration for it's sixth annual workshop on pediatric drug research and development.
FDA and EMA Join Forces on Treatment of Gaucher Disease in Children
FDA and EMA release a draft joint proposal on the development of new drugs to treat Gaucher disease in children.
Boehringer Ingelheim to Make Clinical Trial Data Available
Boehringer Ingelheim announced that it is working on a program to make clinical trial data and other related documents more widely accessible for approved products and drug-development programs that have been terminated.
EMA and European Chemicals Agency Strengthen Collaboration
EMA and ECHA sign agreement to share information and work together on risk assessments.
Hilary Clinton to Deliver Keynote at BIO International Convention
Hillary Clinton will deliver a keynote address at the 2014 BIO International Convention in San Diego.
Novasep Commissions Plant Extension for Highly Potent APIs
New manufacturing capacity at the Le Mans, France facility is being used to scale up antibody drug conjugates.
Merck Sells Ophthalmology Business in Japan to Santen Pharmaceutical
Santen will purchase Merck's ophthalmology products business in Japan and key markets in Europe and Asia Pacific.
AstraZeneca and MRC Laboratory of Molecular Biology Launch Joint Research Fund
AstraZeneca will collaborate with the Medical Research Council Laboratory of Molecular Biology to fund a range of pre-clinical research projects.
FDA Releases Draft Guidance on Biosimilarity
Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.
FDA Releases Q&A on ANDAs and Stability Testing
FDA clarifies stability data recommendations for abbreviated new drug applications.
System Improves Vial Drying and Handling
Garvey's vial-drying system and pressure-less accumulator reduces drying time and decreases the risk of vial damage.
Eurofins to Acquire ViraCor-IBT Laboratories
Eurofins Scientific will acquire ViraCor-IBT Laboratories for $255 million.
KBI Biopharma Acquires Merck's Biologics Operations
KBI Biopharma acquires Merck's microbial process development and manufacturing operations in Colorado.
Shire Acquires Lumena Pharmaceuticals
Shire expands rare disease portfolio with acquisition of Lumena Pharmaceuticals.
FDA Approves Omega-3 Therapy for High Triglycerides
AstraZeneca's Epanova is the first FDA-approved prescription omega-3 in free fatty acid form.
National Institutes of Health Sets New Goals for Global Health Research and Training
The Fogarty International Center, a component of the US NIH, calls for a focus on noncommunicable diseases and implementing science in low-resource settings.
New York Genome Center and Sohn Conference Foundation Collaborate on Pediatric Cancer Research
A multi-institutional effort will fight pediatric leukemia and neuroblastoma.
FDA Revises Guidance on HABP and VABP Drugs
FDA releases draft guidance on the development of drugs to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia.
BIO and ViS Research Help Streamline Pediatric Clinical Trials
The Pediatric Clinical Research Group initiative expands to include pediatric research sites.
Bayer to Increase Position in Consumer Care Business
Bayer will acquire the consumer care business of Merck & Co., and enter a co-commercialization agreement in the field of sGC modulators.
New Translational Imaging Center Opens
MPI Research, inviCRO, and 3D Imaging open its new Translational Imaging Center in Michigan.
Ash Stevens Receives 2014 Lilly Global Supplier Award
Ash Stevens receives the 2014 Lilly Global Supplier Award.
Pharmatek Launches New API Manufacturing Program
Pharmatek develops two new cGMP manufacturing suites for API-in-capsule productions.
Janssen Pharmaceutical Collaborates with Stiching International Dispensary Association
Janssen Pharmaceutical collaborates with Stop TB Partnership's Global Drug Facility to increase access to anti-TB compound.
AstraZeneca Board Rejects Latest Pfizer Offer
AstraZeneca rejects $106 billion offer; Pfizer states its case for the merger with British government.
