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Citizen petition requests biopharmaceutical names and information be disclosed by FDA
Ronald A. Rader, Biotechnology Information Institute
09.05.13
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Velesco Expands with Center for Innovation
New Quincy, MA site boosts early-phase CMC capabilities
Gil Roth
08.12.13
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Oncobiologics, inVentiv in Biosimilars Alliance
inVentiv to provide clinical development for Oncobiologic's pipeline
08.07.13
Preparing the CMC Section for NDAs-CTDs-INDs
...
07.23.13
Clinical Trials
3 Merck & Co., Inc.
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07.17.13
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Methods Validation For Comparators
Stability testing for a licensed compound
07.17.13
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Frontage Labs Appoints Global CMC Services Head
Li to lead strategic expansion efforts
07.16.13
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Alexza Names Global Supply Chain VP
Holfinger brings two decades of manufacturing experience
06.25.13
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Characterizing the Cost of Non-Clinical Development Activity
Understanding a critical R&D segment
Stella Stergiopoulos, Jennifer Kim, Kenneth Getz, Tufts CSDD
06.05.13
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Valeant To Buy Bausch & Lomb
Receives complete response letter from FDA for efinaconazole
Gil Roth
05.28.13
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NextPharma Adds Executive
Cuiné joins the management team
05.16.13
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CMC Biologics, RuiYi in MAb Development Pact
CMC will use CHEF1 system for cell line development
05.14.13
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Bio-CMO Industry Trends
The market continues its upswing
William Downey and Jennifer Hartigan, HighTech Business Decisions
04.03.13
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Labrys Biologics Makes Executive Appointments
Adds expertise in neurology, biologics and clinical research
03.18.13
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Spinnovation To Provide Analytical Services at Pivot Park
Gains access to advanced facilities and instrumentation
03.11.13
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Parenteral Facility Brought Under Irvine Brand
Avrio move aligns service portfolio to streamline processes
01.23.13
Analytical Services
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Clinical Trials
Outsourcing Consolidation Report
Reviewing 2012’s M&A activity
Michael A. Martorelli, Contributing Editor
01.22.13
Drug Development
Pharma-Resolutions
Plus: Blame the media!
Gil Roth, Contract Pharma
01.22.13
Preparing the CMC Section for NDAs-CTDs-INDs
...
01.07.13
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Agility Clinical Expands Consulting Services
To aid small and virtual biopharma and device companies
11.09.12
Biosimilars
Biosimilars: The Race to Market Continues…
Going for the Gold
Fiona Greer, SGS Life Science Services
10.09.12
Contractor/Client Perception Gap
CROs and CMOs can leverage pharma experience in customer-facing processes to improve the “gap” in client perception
Joe Taylor, Actuate Consulting
10.09.12
Drug Development
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CMC and Regulatory Affairs
See the forest and the trees
Edward A. Narke, DS InPharmatics
09.06.12
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CMC Biologics Names GM
Massera to head Copenhagen ops
08.31.12
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CMC Acquires XOMA Manufacturing Site
Berkeley site includes bioreactors, purification suites
Gil Roth
07.31.12
cGMP Manufacture
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Drug Development
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Validation
Chatting With CMC
Conversation at BIO 2012
Mak Jawadekar, Contributing Editor
07.18.12
Breaking News
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Affymax Names CMC VP
Holfinger brings 20 years of experience
07.09.12
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Catalent, Bend in Formulation Pact
Will focus on complex CR products
Gil Roth
06.21.12
Bio News
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CMC Biologics Passes PAI
MHRA issues GMP certification
Gil Roth
06.18.12
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ASI Becomes Tergus Pharma
Expands services in dermatology development
06.13.12
Breaking News
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Drug Development
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Promotions & Moves
DSI Appoints BD Director
Savoy brings more than 20 years of pharma experience
05.31.12
Analytical Services
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Vials
Building Flexibility
A new business model for a volatile industry
Kuljit S. Bhatia, DPT Laboratories
05.30.12
Bioassay Development
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Cold Chain Management
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CRO Outlook & Opportunities
e-Clinical solutions fuel advances
Kristin Brooks, Contract Pharma
05.30.12
Analytical Services
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Chemistry
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R&D
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Validation
Resizing the Global Contract R&D Services Market
A new study revises estimates of the market
Kenneth Getz, Mary Jo Lamberti, Adam Mathias, Stella Stergiopoulos, Tufts CSDD
05.30.12
Breaking News
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Celsion, Hisun in ThermoDox Supply Pact
Partnership establishes product supply in China
05.07.12
Analytical Services
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Aseptic Processing
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Bioanalytical Services
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Bioassay Development
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Biologics, Proteins, Vaccines
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Biosimilars
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Capsules
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Clinical Trials
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Serialization
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Toxicology
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Validation
Biosimilar Outsourcing Update
FDA’s draft guidance leads to new opportunities
Gil Roth, Contract Pharma
05.04.12
Drug Development
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Formulation Development
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Process Development
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Regulatory Affairs
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Validation
DPT Laboratories names Kuljit Bhatia Vice President of Research & Development
...
Breaking News
|
Drug Delivery
|
Drug Development
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Industry News
Patheon Adds Consultant Service
Veteran team to help address CMC questions
04.18.12
Breaking News
|
CRO News
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Drug Development
|
Toxicology
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Trials & Filings
Frontage To Launch Study for China Firm
Will initiate statin trial for Zhejian Hisun
04.05.12
Regulatory Submission Support
...
Biologics, Proteins, Vaccines
|
Biosimilars
|
Chemistry
|
GMPs/GCPs
|
Inspections
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Laboratory Testing
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Regulatory Affairs
Biosimilar Milestone
FDA provides draft guidance on biosimilar product development
Heather Banuelos
04.04.12
Partnering with Your CDMO for CMC Preparation
...
Bioassay Development
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Biologics, Proteins, Vaccines
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Biosimilars
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Chemistry
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Clinical Trials
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Drug Development
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Methods Development
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Focus on Biologics Development
Oncobiologics: a case study
Mak Jawadekar, Contributing Editor
03.07.12
Chemistry
CMC
...
02.27.12
Chemistry
Chemistry, Manufacturing, and Controls (CMC)
...
02.27.12
Breaking News
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Formulation Development
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Process Development
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R&D
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Validation
DPT Labs Appoints R&D VP
Bhatia to oversee R&D CoE in San Antonio
02.21.12
Breaking News
|
Chemistry
|
Promotions & Moves
Argenta Appoints BD Leader
Myer to guide U.S. and New Zealand Ops
01.26.12
Breaking News
|
Chemistry
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Clinical Trial Materials
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Industry News
|
Inspections
Frontage Labs Achieves CMC Milestone
FDA completes review with no 483 citations
01.20.12
Bioassay Development
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Breaking News
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Capsules
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Collaborations & Alliances
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Drug Discovery
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Toxicology
AMRI in Preferred Provider Pact with BioPontis
AMRI will anchor small molecule discovery, CMC services
01.05.12
Breaking News
AVI Bio Appoints Ops SVP, Cuts 28% of Workforce
Aphale responsible for all internal and outsourced manufacturing
12.09.11
Breaking News
ExcellGene, Cytovance Partner to Advance Biologics Development and Manufacture
Selvita Completes Acquisition of PozLab
BioVersys, GSK Expand Strategic TB Collaboration
Cellipont Bioservices, Adva Biotechnology Partner to Optimize Cell Therapy Mfg.
ARTBIO, Nucleus RadioPharma Enter Manufacturing & Supply Pact
View Breaking News >
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Navigating Global CDMO Trends
Weight-loss Drug Packaging
Clinical Supply CDMOs
Industry Experts Weigh in on Oral Solid Dosage
Newsmakers Q&A: Almac Group
Economical Mobile Workstations for Lower-Grade Cleanrooms
Pharmaceutical Manufacturing Equipment & Trends
Insight Into Obesity-Related Clinical Research
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