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Novartis Recognizes Rare Disease Day
Novartis calls for more research to understand and find treatments for rare disease.
FDA Releases Guidance on CMC Post-approval Changes
New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.
Waters Marks Ten Years of ACQUITY UPLC With the Introduction of New Products
Waters celebrates ten&$45;year anniversary of the ACQUITY UPLC System.
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.
UC Santa Barbara Students Get Bexsero to Treat Meningitis B
Novartis provides its second US university with Bexsero for the treatment of meningitis B.
FDA Issues Draft Guidance on NCE Exclusivity Determinations
FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.
Elanco to Acquire Lohmann Animal Health
Elanco acquires Germany-based Lohmann Animal Health.
FDA Updates Analytical Validation Guidance
FDA provides recommendations for submitting analytical procedures and methods validation data.
FDA and EMA Collaborate on Pharmacovigilance
FDA and EMA set up regular meetings to harmonize drug safety actions.
FDA Initiates Secure Supply Chain Pilot Program
Thirteen companies are accepted for participation in the supply chain program.
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.
BDP Week Covers Bioprocessing Methods
Conference sessions, keynote events, exhibits, and poster sessions cover different aspects of bioprocessing.
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.
New European Program Targets Novel Antibiotics
Innovative Medicines Initiative will develop novel antibiotics against gram-negative pathogens in a project called ENABLE.
Agilent Technologies, Cell Line Genetics Collaborate
Agilent Technologies and Cell Line Genetics will collaborate on services for regenerative medicine and cancer research.
Debiopharm Group to Acquire Affinium Antibiotic Clinical Assets
Debiopharm acquires Affinium's clinical and preclinical assets and its technology platform.
Nearly 200 New Medicines in Development for Diabetes
New medicines in development include treatments for type 1 and type 2 diabetes.
European Medicines Agency Updates Seasonal Flu Vaccine Guidance
EMA releases an update on its flu vaccine guidance.
EMA Clarifies New Variation Classification Categories
EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.
GMP Certification Extended for Cobra Biologics
Cobra Biologics' GMP Compliance Certification has been extended to include QC testing.
Shimadzu Opens New Solution Center in Maryland
Shimadzu's new Solution Center features additional research space.
Cytovance Biologics Expands GMP Warehouse and Manufacturing Operations
Cytovance Biologics continues to work on the expansion of a manufacturing operations and GMP warehousing facility in Oklahoma.
Mylan Launches First Trastuzumab Biosimilar in India
Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.
Aesica Appoints Commercial Managing Director
Aesica appoints Ian Muir to the newly created position of commercial managing director.
Sartorius Appoints New Head of Lab Products & Services Division
Sartorius appoints Michael Melingo to head marketing, sales, and services of the Lab Products & Services Division.
FDA Outlines Agenda for New Guidances in 2014
FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.
NIH, Biopharmaceutical Companies, Non-profits Work to Speed Validation of Disease Targets
NIH, 10 biopharmaceutical companies, and several nonprofit organizations form a partnership to develop new treatments earlier for Alzheimer's, type 2 diabetes, and autoimmune disorders.
