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INTERPHEX 2014: New Partners, New Programs
Conference sessions from PDA and PharmTech expand educational opportunities at INTERPHEX 2014.
Separation of Compliance and Performance Under FDASIA
The root cause of drug shortages is mismanagement of variation.
Control Strategies for Synthetic Therapeutic Peptide APIs—Part I: Analytical Consideration
USP evaluates quality attributes for synthetic peptides.
Lilly Diabetes Donates 91 Scholarships to American Diabetes Association's Summer Camp Program
Lilly Diabetes supports the American Diabetes Association for the seventh year in a row.
MedImmune Announces Research Collaboration with UC SanFrancisco
MedImmune and AstraZeneca enter a three-year collaboration with the Clinical and Translational Science Institute at the UC San Francisco.
FDA Reports Recalls Due to Broken Tablets
Discovery of split and broken tablets led to drug recalls.
New Therapies and Screening for Hepatitis C Are Changing Treatment Landscape
Experts note hepatitis C screening is important for getting care early.
Inflammatory Diseases Explained in Artistic Designs
AbbVie launches art initiative designed to explore impact of chronic inflammatory diseases.
Cyclotron Arrival at MPI Research's Translational Imaging Center
The cyclotron is key component of MPI Research's Translational Imaging Center in Mattawan, Michigan.
Report: Branded Biopharms Most Exposed to Biosimilar Competition
Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.
FDA Approves Orphan Drug Myalept
FDA approves the orphan drug Myalept for the treatment of leptin deficiency.
Almac Adds New Blistering Technology
Almac has added new blistering technology at their US packaging facility in Audubon, PA, as a solution to ease the transition between clinical and commercial launch of blister products.
Fluid Imaging Technologies Seeks Submissions for Research Grant
Fluid Imaging Technologies calls for submissions for its Life Sciences & Materials Research Grant.
FDA Issues Draft Guidance on NCE Exclusivity Determinations
FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.
Nuevolution Enters License Agreement with Merck
Nuevolution enters a license agreement with a subsidiary of Merck for small molecule compounds.
Ranbaxy Suspends API Shipments from Two Plants in India
Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.
FDA and EMA Collaborate on Pharmacovigilance
FDA and EMA set up regular meetings to harmonize drug safety actions.
Actavis to Acquire Forest Laboratories
The combined company will create blockbuster product franchises in the central nervous system, gastroenterology, women's health, urology, and cardiovascular therapeutic categories.
Metrics Expands with Fast-Track Development Laboratory
Metrics opens a new laboratory to support fast-track development of pharmaceutical products in North Carolina.
EMD Serono Appoints New Leaders
EMD Serono assigns operational changes.
FDA Updates Analytical Validation Guidance
FDA provides recommendations for submitting analytical procedures and methods validation data.
DIR Technologies Announces Trial with Pfizer for Integrity Inspection System
DIR Technologies will work with Pfizer to perform a three-month trial of the company's packaging integrity testing systems.
Ben Venue Laboratories Issues Voluntary Recall Of Acetylcysteine Solution
Ben Venue issues a voluntary patient level recall of Acetylcysteine Solution 10% due to glass particle in vial.
FDA Initiates Secure Supply Chain Pilot Program
Thirteen companies are accepted for participation in the supply chain program.
Ecolab Rebrands Shield Medicare Division
Ecolab's Shield Medicare division will now be called Ecolab Contamination Control.
Tandem Diabetes Care Expands Recall
Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.
GMP Certification Extended for Cobra Biologics
Cobra Biologics' GMP Compliance Certification has been extended to include QC testing.
NSF International Acquires Auditing Arm of IPEC-Americas
NSF-IPEA now can provide excipient auditing and certification.
Mallinckrodt to Acquire Cadence Pharmaceuticals
Mallinckrodt acquires Cadence Pharmaceuticals for $1.3 million.
European Medicines Agency Updates Seasonal Flu Vaccine Guidance
EMA releases an update on its flu vaccine guidance.
