European Medicines Agency's Management Board Endorses Revised EMA Code of Conduct
6/17/2013
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Swedish Orphan Biovitrum Gets FDA Approval to Manufacture Substance for Kineret® With Partner Boehringer Ingelheim Corporation
6/11/2013
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EU to Fine Lundbeck Inc. (LUN.CO), Others for Blocking Generic Drugs
6/4/2013
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Clinical CRO ICRC-Weyer to Boost Drug Safety Services for Investigator Trials
5/31/2013
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More Trouble for Ranbaxy Laboratories (RANBAXY.BO) as Drug Boycott to Continue
5/29/2013
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What Patient Harm? FDA Slams Shionogi, Inc. for Not Preparing Studies
5/28/2013
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A Boehringer Ingelheim Corporation Shake Up and an FDA Warning Letter Over Production Gaffes
5/23/2013
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Ranbaxy Laboratories (RANBAXY.BO) Highlights Improved Business and Quality Assurance Standards
5/22/2013
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Lonza Inc. Issues Guidance on Infection Control and Global Influenza A (H7N9)
5/22/2013
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Johnson & Johnson (JNJ) Licence Revoked Over Baby Powder Concerns
5/6/2013
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BioIndustry Association Meeting Highlights Benefits of the Patent Box to Life Science Companies
5/2/2013
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FDA Requests $4.7 Million for China Drug Maker Inspections
4/12/2013
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Vetter's Newest Facility Successfully Completes FDA Inspection
3/28/2013
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FDA Lifts Import Alert on Aurobindo Pharma's Hyderabad Facility
3/28/2013
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Vetter's Newest Facility Successfully Completes FDA Inspection
3/27/2013
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Recipharm AB Site in France Approved for Supply of Manufactured Products to Japan
3/26/2013
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Link Technologies Ltd Release: New Cyanine Dyes Reduce Time and Cost of Oligo Labelling
3/20/2013
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Pfizer Inc. (PFE) Criticizes India's Intellectual Property Policies
3/14/2013
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Regulatory Affairs Professionals Society, Singapore to Collaborate on First Medical Device Regulatory Training Program in Southeast Asia
3/14/2013
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SFDA to Monitor Food Safety; Will Remain Part of Ministry of Health
3/13/2013
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China to Give SFDA Responsibility for Food as Well as Drugs
3/5/2013
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GlySure Earns ISO 13485 Certification
3/5/2013
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Biotage AB (BIOTa.ST): Food Contact Notification to FDA
3/4/2013
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Almac Group Receives FDA Inspection Approval
2/20/2013
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Evogene Ltd. Announces Launch of Model Plant Validation System for Monocot Plants
2/13/2013
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Almac Group Launches U.S. Commercial Packaging Operations With Successful FDA Inspection and New Client Partnership
2/6/2013
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GlaxoSmithKline (GSK) Clashes With Pharmaceutical Research and Manufacturers of America (PhRMA) Over Data Disclosure
2/5/2013
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FDA Extends License of the gvk bioSciences Private Limited Biomarker Database
2/4/2013
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Boehringer Ingelheim Corporation Ohio Drug Plant Shut by U.S. on Quality Issues
2/1/2013
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European Commission (EC) Study Finds UK Health Product Benefit Metric Flawed
1/31/2013
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TiGenix Successfully Renews GMP License for Stem Cell Manufacturing Facility in Madrid
1/29/2013
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Sartorius Stedim Biotech's New Manufacturing Facility in Yauco, Puerto Rico, Receives LEED Platinum Certification
1/25/2013
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ChinaBio(R) LLC Release: China Proposes Fast-Track Approvals for Innovative Drugs
1/18/2013
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Genea Stem Cells (GSC): 25 New Disease Specific Pluripotent Stem Cell Lines Placed on the National Institutes of Health (NIH) Registry
1/14/2013
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Melbourn Scientific Awarded Manufacturer's / Importer's Authorisation (MIA)
1/9/2013
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AITbiotech Secured CE-IVD Certification for Its Influenza (Flu) and Mycobacteria Tuberculosis (MTB) Molecular Diagnostic Assays
1/2/2013
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European Medicines Agency Documents Are "Secret No Longer"
12/21/2012
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Gyros AB Quality Management System Receives ISO 9001:2008 Certification
12/13/2012
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Vetter Receives “Known Consignor” Approval From Germany's Federal Aviation Office
12/11/2012
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Cellon SA Release: PharmaTainer™ Single Use Bottles and Carboys Now Meet USP 788
12/11/2012
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Vetter Receives "Known Consignor" Approval From Germany's Federal Aviation Office
12/11/2012
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Next Generation Sequencing of GATC Biotech Accredited by German DAkkS
12/3/2012
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Covance Inc. (CVD) Receives SFDA GLP Certification for Its Early Development Facility in Shanghai, China
12/3/2012
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Fastest Spent Media Analysis Validated against ICH Guidelines: Spinnovation Biologics' Spedia-NMRTM Meets Stringent Pharma Guidelines
11/20/2012
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Ranbaxy Laboratories (RANBAXY.BO) to Get Guidance Soon for Remedial Steps on Dewas Unit
11/12/2012
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Regulatory Affairs Professionals Society and China's SFDA to Collaborate on Regulatory Education and Training
11/8/2012
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FDA Warns Celltex Therapeutics Corporation Over Violations
10/17/2012
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AITbiotech Secured ISO 13485 Certification for Its Genomic Services and MDx Labs in Singapore
10/15/2012
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SEC Investigates Pfizer Inc. (PFE) Over Odd Results
10/9/2012
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Genetic Immunity Receives GMP Certification for in-House Manufacturing Facility
10/8/2012
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China National Biotech Group May Soon Sell Vaccine to International Aid Groups
10/5/2012
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Successful MHRA Inspection of Almac Group's Clinical Services UK Facility
9/26/2012
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Summit Corporation Receives Regulatory Approval to Commence Phase I Clinical Trial of Selective Antibiotic for the Treatment of C. Difficile Infections
9/25/2012
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Recipharm Monts Secures Regulatory Approval From ANSM to Fill Biotech Products
9/17/2012
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FDA Lifts Ban on Indian Pharma, Including Sun Pharmaceutical Industries Ltd and Dr. Reddy's Laboratories Ltd. (RDY), After Fixing Problems
9/4/2012
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Biocitech SAS Resident OCT Sante Obtains Official Certification for Innovative Thermal Packaging Models for the Transport of Biological Samples
9/4/2012
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Release: Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori
8/31/2012
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MicroConstants China's New Facility Passes OECD GLP Compliance Inspection
8/28/2012
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Caraco Pharmaceutical Laboratories, Ltd. (CPD) Gets FDA Nod to Resume U.S. Operations
8/28/2012
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Biostar Pharmaceuticals, Inc. (BSPM) Moves Toward Launch of Topical Pain Relief Product
8/22/2012
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Inogent Laboratories Clears the Pharmaceuticals and Medical Devices Agency (PMDA), Japan Audit
8/21/2012
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Teva Pharmaceutical Industries Limited (TEVA) Subpoenaed Over Foreign Bribes
8/6/2012
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gvk bioSciences Private Limited' Ahmedabad Clinical Pharmacology Unit Successfully Clears the FDA Audit
7/30/2012
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AXIS Clinicals Announces Successful Completion of FDA Audit
7/30/2012
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FDA to Meet Sanofi (France) (SAN.PA) Execs Over Violations at Vaccine Plants
7/25/2012
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EU Regulators Charge Lundbeck Inc. (LUN.CO), Others Over Generics
7/25/2012
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BioIndustry Association Welcomes Publication of Proposed EU Regulation on Clinical Trials
7/17/2012
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BioIndustry Association Welcomes Medicines and Healthcare Products Regulatory Agency Early Access to Medicines Scheme Consultation
7/17/2012
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Aurobindo Pharma and Other Drugmakers Cited for Polluting
7/16/2012
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SFDA Issues New Rules for Drug Excipients
7/10/2012
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BioIndustry Association Release: Phase I Clinical Trials Insurance Guidance Published
6/27/2012
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Link Technologies Ltd Launches New Products for Oligonucleotide Synthesis
6/13/2012
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European Medicines Agency Management Board Completes Framework for Conflicts of Interests
6/8/2012
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TiGenix: National Reimbursement in the Netherlands Obtained for Breakthrough Cartilage Therapy ChondroCelect(R)
6/8/2012
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Medivation, Inc. (MDVN) and Astellas Pharma Inc. (YPH.BE) Announce Initiation of Expanded Access Program for Enzalutamide (formerly MDV3100) in the United States
5/30/2012
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Shanghai Pharmaceutical Co., Ltd. Faces Media Charges of Accounting Fraud
5/24/2012
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A Generic Drugmaker Grows in Uganda
5/23/2012
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AIDCOC Demands India Ban 33 Drugs
5/21/2012
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New Zealand Drugmakers Deny Plans to Undermine Pharmac
5/14/2012
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ISPE, ILF Engage With US and Asian Regulators at Meetings in Japan, China
5/14/2012
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Metabolon's Shanghai Jiao Tong University School of Medicine Lab Receives Validation
5/11/2012
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Novartis AG (NVS) to Probe India Drug Approval Allegations
5/10/2012
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Sigma Pharmaceuticals Warning on Distribution of Medicines
5/10/2012
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GlaxoSmithKline (GSK): We Complied With Indian Rules for Drug Approval
5/10/2012
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U.S. May Lose Chance to Pass National Drug Trace Plan
4/26/2012
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TiGenix Obtains Manufacturing License for European Production Facility
4/24/2012
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Medgenics, Inc. Files for U.S. Orphan Drug Designation for INFRADURE for the Treatment of Hepatitis D
4/23/2012
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Pluristem Therapeutics (PSTI) Receives U.S. FDA Clearance for Phase II Clinical Trial in Intermittent Claudication
4/17/2012
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Ampio Pharmaceuticals, Inc. (AMPE) Reaches Agreement With the TGA for the Submission Plan for Zertane in Australia
4/2/2012
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Emerging World Pharma Inc. Release: Ghana Food and Drug Board (FDB) Grants African Global Pharma (AGP) Regulatory Approval for Sale of Atenolol in Ghana
3/22/2012
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Meda AB (MEDA-A.ST) Release: Astepro Approved in Europe
3/20/2012
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European Medicines Evaluation Agency Wants Two More Drugs Moved From Ben Venue Laboratories Due to Ongoing Manufacturing Practice Concerns
3/20/2012
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FDA to Inspect Dr. Reddy's Laboratories Ltd. (RDY)'s Plant in Mexico
3/20/2012
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Pfizer Inc. (PFE) Says Europe Undermining Drug Innovation
3/13/2012
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Researchers Give Link Technologies Ltd Resounding Endorsement
3/12/2012
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Recipharm AB Goes "Green" With Environmental Management
3/9/2012
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Hid Actos Adverse Effects From Regulators, Suit Says
3/8/2012
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Baxter International, Inc. (BAX) Receives Marketing Authorization in European Union for VEPACEL Pre-Pandemic Influenza Vaccine
3/2/2012
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DBV Technologies Release: Clinical Development Program Receives FDA “Fast Track Designation” and Encouraging Phase Ib Safety Results for Viaskin® Peanut
2/28/2012
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Skinvisible, Inc. (SKVI) Formulation Submitted to European Union for Orphan Drug Designation
2/23/2012
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OneWorld Health’s Pioneering VL Treatment PMIM Now Registered in Nepal
2/21/2012
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Genetic Technologies Limited (GTG.AX) Receives CLIA Certificate of Compliance from Centers for Medicare & Medicaid Services, USA
2/16/2012
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TGA Registration for Cellmid Limited's Evolis™ Hair Products
2/16/2012
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Merck KGaA (MKGAF.PK) Receives Highly Unusual, Holistic Warning Letter From FDA
2/16/2012
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SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval for Excella Gmbh API Plant Feucht, Germany
2/15/2012
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Mettler-Toledo (MTD) Release: ReactIR™ 247 Receives Ex Certification for Zone 1 Hazardous Environments
2/15/2012
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CARBOGEN AMCIS Announces Successful FDA Audit
2/13/2012
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Eppendorf AG Licenses Technology for Thermal Cyclers to Agilent Technologies Inc. (A)
2/13/2012
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Sanofi (France) (SAN.PA), Bristol-Myers Squibb Company (BMY) Receive Nearly $445 Million From Apotex Inc. Over Generic Plavix
2/9/2012
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BioLineRx Ltd. In-Licenses Second Oral Hepatitis C Treatment
2/6/2012
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Drugmakers Including GlaxoSmithKline (GSK) Scuttle Plan for Approval System Pushed by Biotechs
2/2/2012
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Cell>Point Executes Brazil License with Radiopharmacus for Cancer and Heart Disease Molecular Imaging Drug, EC-G
1/25/2012
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EpiCept Corporation (EPCT) Receives Finalized FDA Guidance for AmiKet™ Phase III CIPN Program and Regulatory Strategy
1/23/2012
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Almac Sciences Celebrates MHRA Audit Successes
1/23/2012
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Biovest International, Inc. Prepares for EU Regulatory Meetings; SME Status Granted Providing European Regulatory Benefits for BiovaxID Personalized Lymphoma Vaccine
1/19/2012
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Ablynx is Granted Extended GMP Certificate for New GMP Unit
1/11/2012
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Quantum Genomics Corp. Gets Approval from the Patients' Protection Committee
1/5/2012
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BioLineRx Ltd. Announces Initiation of CE Mark Registration Trial for BCM (BL-1040), a Novel Medical Device for Prevention of Cardiac Remodeling Following Acute Myocardial Infarction
1/3/2012
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Novo Nordisk A/S (NVO) Files for Regulatory Approval of the Ultra-Long-Acting Insulin Degludec in Japan
12/22/2011
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Eisai Company, Ltd. (ESALY.PK) Submits Application for Partial Change to Label of Egg White Lysozyme Preparation Neuzym
12/22/2011
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EpiCept Corporation (EPCT) Provides Update on Ceplene® Manufacturing at Ben Venue Laboratories
12/21/2011
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National Health Service Publishes Implementation Guidelines for Source BioScience's Automated Cervical Cancer Screening Technology
12/19/2011
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Obama Administration Keeps Limit on Teva Pharmaceutical Industries Limited (TEVA) Morning-After Pill, Marks First Time US Overrules FDA
12/9/2011
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FDA Cites Violations at Three Novartis AG (NVS) Plants
12/7/2011
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Warner Chilcott, PLC (WCRX) Announces Receipt of FDA Response to Citizen Petition
12/2/2011
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World Health Organization Certification a Shot-in-the-Arm for China Vaccine Makers
12/2/2011
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PRC Increases Goals of Healthcare Reform
12/1/2011
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Almac Diagnostics Laboratory Receives Accreditation from College of American Pathologists
11/30/2011
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'Significant' Offenses Cited at Mylan Inc. (MYL) Plant
11/23/2011
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A*STAR Institute of Microelectronics Receives ISO 13485 (Medical Devices Standard) Certification
10/31/2011
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LAB21 Limited Extends CPA Accreditation
10/27/2011
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Emerging World Pharma Inc. Updates on Sunyani, Ghana Manufacturing Facility
10/24/2011
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Sun Pharmaceutical Industries Ltd Resolves Manufacturing Issues With FDA
9/19/2011
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Teva Pharmaceutical Industries Limited (TEVA) Receives FDA Close-Out Letter Over Jerusalem Plant
9/13/2011
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FDA to Review Safety of Popular Bone Drugs like Merck & Co., Inc. (MRK)'s Fosamax and Roche (RHHBY)'s Boniva
9/6/2011
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LI-COR Biosciences Submits Active Substance Master File for IRDye 800CW to European Regulatory Authorities and Registers Drug Master File with US FDA
9/2/2011
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National Institute for Clinical Excellence (NICE) Says No to Bristol-Myers Squibb Company (BMY) for Second-Line Orencia Use
8/25/2011
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SFDA Issues Anti-Counterfeiting Rules for CMOs
8/25/2011
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Simcere Pharmaceutical Group Passes EU-GMP Inspection for OTC Diarrhea Treatment
8/23/2011
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New FDA Plan to Increase Foreign Drugmaker Inspections
8/16/2011
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LGC Genomics GmbH Gains Illumina, Inc. (ILMN) CSPro Certification
8/5/2011
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Ablynx Is Granted GLP Certificate for New GLP Unit
7/27/2011
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National Institute for Clinical Excellence (NICE) Proposes to Disapprove the Use of the Drug Novartis AG's Lucentis; Diabetes Groups Outraged
7/19/2011
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genOway Acquires Worldwide Exclusive License for RMCE Technology From bluebird bio for Genetically Modified Rodents
7/12/2011
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Orchid Chemicals & Pharmaceuticals Ltd. Plant Receives Closure Notice
7/11/2011
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CSL Biotherapies Receives US FDA Warning for GMP Violations at Vaccine Plant
6/28/2011
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Credentis AG Obtains ISO 9001 & ISO 13485 Certificate
6/27/2011
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European Medicines Evaluation Agency Delays Verdict on Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Diabetes Drug to July
6/24/2011
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European Medicines Evaluation Agency Approve New Manufacturing Facility for Shire plc's REPLAGAL(R) (agalsidase alfa)
6/24/2011
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Merck KGaA (MKGAF.PK) Pulls Plug on Cladribine on FDA Feedback
6/23/2011
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Roche (RHHBY) Won't Be Forced to Disclose Ties to Avastin Backers
6/21/2011
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Futura Medical CSD500 CE Mark Certification
6/20/2011
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Oroxcell Granted Good Laboratory Practice (GLP) Certification by Afssaps
6/16/2011
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AusBiotech Ltd. Welcomes Announcement on R&D Tax Credit
6/15/2011
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Allergy Therapeutics plc Regulatory Update
6/8/2011
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Octapharma AG: European Commission Adopts European Medicines Agency's (EMA) Recommendation to Lift the Suspension of the Marketing Authorization of octagam(R) and octagam(R)10%
5/31/2011
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MicroConstants China Receives Endorsement of OECD GLP Compliance
5/26/2011
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BeiGene Makes Key Hires in Clinical Research and Regulatory Affairs
5/25/2011
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Provepharm Obtains European Marketing Authorization for its Methylthioninium Chloride Proveblue
5/24/2011
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Astellas Pharma Inc. (YPH.BE) and Theravance, Inc. (THRX) Receive Positive Opinion From CHMP for European Approval of VIBATIV(TM) for Nosocomial Pneumonia Caused by MRSA
5/20/2011
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BioCentrum Sp. z o.o. Obtains a Certificate of Good Laboratory Practice (GLP)
5/19/2011
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Drug Regulators are Protecting Profits over Patients, Warn Nordic Cochrane Centre Researchers
5/11/2011
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Biogen Idec, Inc. (Massachusetts) (BIIB) and Swedish Orphan Biovitrum Receive Opinion From European Medicines Evaluation Agency on Pediatric Plan for Long-Lasting Hemophilia B Therapy
5/9/2011
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Servier Denies French Allegation of Concealing Mediator Diabetes Drug Risk
5/9/2011
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Vitrolife is the First Company in China to Receive Regulatory Approval for an Entire IVF Culture Media Portfolio
5/5/2011
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UVP, LLC Announces ISO 9001:2008 Certification
4/29/2011
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CARBOGEN AMCIS Announces Containment Performance Validation
4/28/2011
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Vexim Obtains CAN/CSA ISO 13485:2003 in Canada
4/26/2011
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China's Ministry of Health Regulates Antibiotics to Curb Abuse
4/11/2011
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Allergy Therapeutics plc U.S. Regulatory Update
3/28/2011
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Oxford Immunotec Limited: UK’s NICE Recommend Replacing Mantoux with TB Blood Tests for Key Patient Groups
3/25/2011
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Provepharm Receives Favorable European Medicines Evaluation Agency Review of its Methylthioninium Chloride Proveblue
3/11/2011
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China's Vaccine Regulation Passes World Health Organization Test
3/3/2011
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FDA to Outsource More Inspections of Foreign Drug Makers
2/22/2011
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Oxford Gene Technology Ltd. Awarded ISO/IEC 17025:2005 Accreditation, Signifying Technical Expertise
2/15/2011
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Innovotech Inc. (IOTp.V)'s bioFILM PA(TM) Receives Regulatory Approval In Israel
2/3/2011
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Alphalyse Inc. Receives GLP Accreditation to Determine Serum Concentration of Protein Biologics
1/31/2011
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Baxter Healthcare Corporation (BAX) Halts PD Production at Castlebar to Investigate Contamination
1/25/2011
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LFB Biomedicaments Received Additional Regulatory Approval in 15 European Countries for Its World Wide Unique Von Willebrand Factor with Low Factor VIII Content: Willfact(R)
12/22/2010
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Bavarian Nordic (BAVA.CO) Receives Special Protocol Assessment Agreement From The FDA For Phase 3 Trial Of Cancer Vaccine PROSTVAC(R)
12/9/2010
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Selcia Limited Awarded GMP Certificate for Preparation and Carbon-14 Labelling of APIs for Clinical Trials
12/7/2010
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AusBiotech Ltd. and Medicines Australia: the Time to Speak Out on Gene Patents is Now
12/6/2010
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The National Development and Reform Commission (NDRC) Orders Price Cuts on Patented Drugs
12/3/2010
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China Nuokang Bio-Pharmaceutical Inc. (NKBP) Provides Update on Kaitong
12/2/2010
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AFSSAPS and GIPC Renew GLP Certification of CIT
11/29/2010
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curasan AG (DX:CUR) Receives Approval for Cerasorb(R) M ORTHO in Canada
11/17/2010
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Argenta Discovery Inc. Receives CIR (French Research Tax Credit) Accreditation
11/15/2010
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Limitations of Current Chemotherapy Regimes Coupled with Increasing Incidence of Cancer is Driving the Uptake of Cancer Support Therapies, States Frost & Sullivan
11/15/2010
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Guilin Pharmaceutical's Malaria Drug Meets World Health Organization Standards
11/9/2010
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MicroConstants China Receives CNAS (ISO-17025) Accreditation
11/5/2010
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UK's NICE Rejects GlaxoSmithKline (GSK)'s Revolade For Blood Condition
10/27/2010
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Sinovac Biotech Ltd. (SNVBF) Receives Drug Registration Certificate from Hong Kong Department of Health for Seasonal Flu Vaccine Anflu(R)
10/25/2010
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ESHRE Publishes New PGD Guidelines
10/22/2010
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ICON Awarded Phase I Supplementary Accreditation from Medicines and Healthcare Products Regulatory Agency
10/6/2010
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Almac Clinical Technologies Division Undergoes Successful Joint GCP-GMP MHRA Inspection
9/21/2010
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Advanced Biological Laboratories SA (ABL) Announces the Strengthening of Its Patent Estate: Notice of Allowance in Canada, Issuance of a Patent in India, and Issuance of Reexamination Certificates in the United States after Several Patent Reexaminations
9/20/2010
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Eurogentec North America, Inc. Receives Iso 13485:2003 Medical Device Certification for the Production and Sale of Ivd Oligonucleotides
9/10/2010
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Vela Laboratories Announces Renewal of Gmp Certificate For Analytical And Quality Control Laboratories
9/8/2010
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WuXi PharmaTech Co., Ltd. Subsidiary Passes ISO Tests
9/3/2010
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Novozymes Biopharma Announces Master File for Recombinant Albumin
9/1/2010
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