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Biotech/Pharma - Regulatory (World)
Lonza Inc.'s Facility In Singapore Received Good Manufacturing Practice (GMP) Certification From The HSA 4/17/2014  More...
FDA Moving Slow To Add Drug Inspectors In China 4/8/2014  More...
ChemCon GmbH Successfully Passes Its Fourth FDA Inspection 4/3/2014  More...
AXIS Clinicals Announces Successful Completion Of 13th U.S. FDA Audit 3/27/2014  More...
POLARIS Announces Illumina CSPro Certification For Sequencing 3/14/2014  More...
Aesica Successfully Completes The Validation Of Its High Capacity Manufacturing Facility At Queenborough, UK Site 3/14/2014  More...
Northwest Biotherapeutics (NWBO) Receives Authorization For New Cancer Therapy In Accordance With $4 Billion German Medical Act 3/12/2014  More...
FDA Approves Pluristem Therapeutics (PSTI)'s Commercial Scale Cell Manufacturing Process 3/6/2014  More...
Basilea Pharmaceutica (BSLN.SW) Reports That Isavuconazole Receives Qualified Infectious Disease Product Designation From FDA For The Treatment Of Invasive Mucormycosis 2/27/2014  More...
ChinaBio(R) LLC Release: China Implements 30-Day Review For "Simple" M&A Transactions 2/26/2014  More...
Neurosearch A/S (NEUR.CO) Announces The Danish Business Authority's Decision In The Accounting Control Matter 2/21/2014  More...
Pluristem Therapeutics (PSTI) Submits FDA Orphan Drug Application For Preeclampsia 2/20/2014  More...
Selvita Received A GMP Certificate 2/18/2014  More...
GMP Certification Boost For Cobra Biologics Ltd. 2/11/2014  More...
Ranbaxy Laboratories (RANBAXY.BO) Workers Fudged Test Results: FDA 1/28/2014  More...
Aratana Therapeutics (PETX) Announces Conditional Approval Of Second Canine-Specific Antibody Therapy 1/28/2014  More...
Protalix Biotherapeutics, Inc. (PLX) Announces Successful Manufacturing Facility Evaluation By Health Canada 1/24/2014  More...
Pluristem Therapeutics (PSTI)'s Cell Manufacturing Facility Marks Major Milestone With German Regulatory Approval Of New Scaled-Up 3D Manufacturing Process 1/23/2014  More...
Suven Life Sciences Ltd's Pashamylaram's Unit Receives FDA Acceptance 1/22/2014  More...
Fraunhofer IZI Granted Manufacturing Authorization For Second GMP Facility 1/21/2014  More...
Bayer HealthCare (BAY) Commends AHS And CAPC For Updated Heartworm Guidelines 1/20/2014  More...
Exco InTouch Successfully Completes HIPAA Security Audit 1/20/2014  More...
ChinaBio(R) LLC Release: China Adds Regs To New IPO Process 1/17/2014  More...
Vectura Group plc (VEC.L): Swedish Regulatory Authority Confirm Approval Of Airflusal® Forspiro® 1/14/2014  More...
BASF Received Excipact™ Certification As Pharmaceutical Excipient Supplier 1/8/2014  More...
TaiGen Biotechnology Receives Qualified Infectious Disease Product And Fast Track Designations From The FDA For Nemonoxacin (Taigexyn®) 12/23/2013  More...
Daiichi Sankyo, Inc. (4568.t) To Help Ranbaxy Laboratories (RANBAXY.BO) Meet FDA Norms 12/19/2013  More...
R-Biopharm Rhône Ltd Welcomes Scottish Government Moves To Improve Food Safety Standards 12/12/2013  More...
Reckitt Benckiser Pharmaceuticals Inc. Pharma Unit In The U.S. Is Raided By The Feds 12/9/2013  More...
China Agrees To Allow Ten Additional FDA Inspectors 12/9/2013  More...
Wockhardt (WOCKHARDT.BO) Falls 4%, FDA Says Company Erased Key Trial Data 12/4/2013  More...
ChemCon GmbH Receives Approval To Manufacture Semi-Solid Pharmaceuticals For Human Use 12/3/2013  More...
TxCell Obtains Manufacturing Accreditation Status For Its French Cell Therapy Manufacturing Facility 12/3/2013  More...
FDA Approval For SCM Pharma Limited Following BTG plc (BTG.L)'s Drug Approval 12/3/2013  More...
Eisai Company, Ltd. (ESALY.PK) Submits Application For Proton Pump Inhibitor Pariet In Japan 11/28/2013  More...
Biogen Idec, Inc. (Massachusetts) (BIIB) Release: CHMP Determines Dimethyl Fumarate In TECFIDERA® To Be A New Active Substance In The European Union 11/22/2013  More...
Gentium S.p.A. Receives European Medicines Agency Orphan Drug Designation For Defibrotide For The Prevention Of GvHD 11/19/2013  More...
Amgen (AMGN) and Sanofi (France) (SAN.PA) Drugs Can Reach U.S. Without Long Studies 11/15/2013  More...
Specialised Therapeutics Australia Receives Therapeutic Goods Administration Approval for Brain Tumour Visualisation Drug - Gliolan® 11/11/2013  More...
Drug Regulator Asks Sun Pharmaceutical Industries Ltd to Halt Clinical Research at Mumbai Laboratory 11/11/2013  More...
Eisai Company, Ltd. (ESALY.PK) Submits Application To Expand Indication Of Anti-Alzheimer's Agent Aricept® As Treatment For Dementia With Lewy Bodies In Japan 10/31/2013  More...
Mesoblast Limited (MSB.AX) Updates Market on Registration Plans for GVHD Cell Product in Japan 10/28/2013  More...
Novasep's European Custom Manufacturing Passes FDA Inspection 10/22/2013  More...
UK Regulator to Withdraw Approval for Wockhardt (WPL)'s Daman Plant 10/22/2013  More...
Cambridge Major Laboratories, Inc. Announces Successful FDA Inspection At Weert Facility 10/21/2013  More...
WuXi PharmaTech Co., Ltd. Receives CLIA Certification for Its Genomics Clinical Laboratory 10/17/2013  More...
Wockhardt (WPL) Falls After U.K. Regulator Action on Factory 10/14/2013  More...
Ranbaxy Laboratories (RANBAXY.BO) Jumps as US Plant Wins FDA Clearance 10/11/2013  More...
Fujifilm Diosynth Biotechnologies' UK Site Receives Renewed Medicines and Healthcare Products Regulatory Agency Manufacturing Licence 10/9/2013  More...
FDA Accuses USV of Fudging Data 9/23/2013  More...
ImmunoGen, Inc. (IMGN) Announces Positive Regulatory Decisions for Roche (RHHBY)'s Kadcyla® in the European Union and Japan 9/20/2013  More...
Medivir AB (MVIRb.F): The Regulatory Process in Japan for Simeprevir 9/17/2013  More...
Failure by Drugmakers, Researchers to Publish Clinical Trial Results Risk Patient Safety: UK Lawmakers 9/17/2013  More...
BioIndustry Association Flagship UK Bioscience Forum is Now CPD-Certified 9/12/2013  More...
NicOx SA (COX.PA) Receives Positive Opinion for European Orphan Drug Designation for Naproxcinod for the Treatment of Duchenne Muscular Dystrophy 9/11/2013  More...
Procognia Limited Announces Receipt of cGMP Certificate for Its Glycosylation Analysis Services 9/3/2013  More...
Lonza Inc. Issues Guidance on Infection Control Regarding Novel Coronaviruses (nCoV), Including the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) 8/29/2013  More...
After Novartis AG (NVS) Scandal, Japan Considers Penalties for False Data 8/6/2013  More...
FDA Approves BioGaia's Request for Orphan Drug Designation 8/6/2013  More...
GH Genhelix Receives GMP Approval 8/6/2013  More...
Urine, Lies and a Wayward Drugmaker: FDA Tells Off Wockhardt 7/24/2013  More...
Oncodesign SA Awarded Accreditation of Its Research Center by International Association, AAALAC 7/18/2013  More...
Wockhardt Barred From Making Drugs for Europe 7/10/2013  More...
Datamonitor Release: AMNOG May Cause Havoc in German Diabetes Market - Analyst Opinion 7/9/2013  More...
Genethon, the French AFM-Telethon Laboratory, Becomes the First Not-for-Profit to Obtain Authorization From ANSM to be a Pharmaceutical Manufacturer 7/8/2013  More...
Ranbaxy Laboratories (RANBAXY.BO), Another Bad FDA Report & the Missing Generic Diovan 6/25/2013  More...
India Upholds Cancellation of Johnson & Johnson (JNJ) Plant License 6/25/2013  More...
Sanofi (France) (SAN.PA) CEO: EU Open Data Plan Would Hurt Drugmakers 6/24/2013  More...
Total Recall? China Chastises Johnson & Johnson (JNJ) Over Its Product Recall Policy 6/20/2013  More...
SCM Pharma Limited Release: Medicines and Healthcare Products Regulatory Agency Approval for CDMO's Commercial Facility 6/19/2013  More...
European Medicines Agency's Management Board Endorses Revised EMA Code of Conduct 6/17/2013  More...
Swedish Orphan Biovitrum Gets FDA Approval to Manufacture Substance for Kineret® With Partner Boehringer Ingelheim Corporation 6/11/2013  More...
EU to Fine Lundbeck Inc. (LUN.CO), Others for Blocking Generic Drugs 6/4/2013  More...
Clinical CRO ICRC-Weyer to Boost Drug Safety Services for Investigator Trials 5/31/2013  More...
More Trouble for Ranbaxy Laboratories (RANBAXY.BO) as Drug Boycott to Continue 5/29/2013  More...
What Patient Harm? FDA Slams Shionogi, Inc. for Not Preparing Studies 5/28/2013  More...
A Boehringer Ingelheim Corporation Shake Up and an FDA Warning Letter Over Production Gaffes 5/23/2013  More...
Lonza Inc. Issues Guidance on Infection Control and Global Influenza A (H7N9) 5/22/2013  More...
Ranbaxy Laboratories (RANBAXY.BO) Highlights Improved Business and Quality Assurance Standards 5/22/2013  More...
Johnson & Johnson (JNJ) Licence Revoked Over Baby Powder Concerns 5/6/2013  More...
BioIndustry Association Meeting Highlights Benefits of the Patent Box to Life Science Companies 5/2/2013  More...
FDA Requests $4.7 Million for China Drug Maker Inspections 4/12/2013  More...
FDA Lifts Import Alert on Aurobindo Pharma's Hyderabad Facility 3/28/2013  More...
Vetter's Newest Facility Successfully Completes FDA Inspection 3/27/2013  More...
Recipharm AB Site in France Approved for Supply of Manufactured Products to Japan 3/26/2013  More...
Link Technologies Ltd Release: New Cyanine Dyes Reduce Time and Cost of Oligo Labelling 3/20/2013  More...
Regulatory Affairs Professionals Society, Singapore to Collaborate on First Medical Device Regulatory Training Program in Southeast Asia 3/14/2013  More...
Pfizer Inc. (PFE) Criticizes India's Intellectual Property Policies 3/14/2013  More...
SFDA to Monitor Food Safety; Will Remain Part of Ministry of Health 3/13/2013  More...
GlySure Earns ISO 13485 Certification 3/5/2013  More...
China to Give SFDA Responsibility for Food as Well as Drugs 3/5/2013  More...
Biotage AB (BIOTa.ST): Food Contact Notification to FDA 3/4/2013  More...
Almac Group Receives FDA Inspection Approval 2/20/2013  More...
Evogene Ltd. Announces Launch of Model Plant Validation System for Monocot Plants 2/13/2013  More...
Almac Group Launches U.S. Commercial Packaging Operations With Successful FDA Inspection and New Client Partnership 2/6/2013  More...
GlaxoSmithKline (GSK) Clashes With Pharmaceutical Research and Manufacturers of America (PhRMA) Over Data Disclosure 2/5/2013  More...
FDA Extends License of the gvk bioSciences Private Limited Biomarker Database 2/4/2013  More...
Boehringer Ingelheim Corporation Ohio Drug Plant Shut by U.S. on Quality Issues 2/1/2013  More...
European Commission (EC) Study Finds UK Health Product Benefit Metric Flawed 1/31/2013  More...
TiGenix Successfully Renews GMP License for Stem Cell Manufacturing Facility in Madrid 1/29/2013  More...
Sartorius Stedim Biotech's New Manufacturing Facility in Yauco, Puerto Rico, Receives LEED Platinum Certification 1/25/2013  More...
ChinaBio(R) LLC Release: China Proposes Fast-Track Approvals for Innovative Drugs 1/18/2013  More...
Genea Stem Cells (GSC): 25 New Disease Specific Pluripotent Stem Cell Lines Placed on the National Institutes of Health (NIH) Registry 1/14/2013  More...
Melbourn Scientific Awarded Manufacturer's / Importer's Authorisation (MIA) 1/9/2013  More...
AITbiotech Secured CE-IVD Certification for Its Influenza (Flu) and Mycobacteria Tuberculosis (MTB) Molecular Diagnostic Assays 1/2/2013  More...
European Medicines Agency Documents Are "Secret No Longer" 12/21/2012  More...
Gyros AB Quality Management System Receives ISO 9001:2008 Certification 12/13/2012  More...
Vetter Receives "Known Consignor" Approval From Germany's Federal Aviation Office 12/11/2012  More...
Cellon SA Release: PharmaTainer™ Single Use Bottles and Carboys Now Meet USP 788 12/11/2012  More...
Vetter Receives “Known Consignor” Approval From Germany's Federal Aviation Office 12/11/2012  More...
Covance Inc. (CVD) Receives SFDA GLP Certification for Its Early Development Facility in Shanghai, China 12/3/2012  More...
Next Generation Sequencing of GATC Biotech Accredited by German DAkkS 12/3/2012  More...
Fastest Spent Media Analysis Validated against ICH Guidelines: Spinnovation Biologics' Spedia-NMRTM Meets Stringent Pharma Guidelines 11/20/2012  More...
Ranbaxy Laboratories (RANBAXY.BO) to Get Guidance Soon for Remedial Steps on Dewas Unit 11/12/2012  More...
Regulatory Affairs Professionals Society and China's SFDA to Collaborate on Regulatory Education and Training 11/8/2012  More...
FDA Warns Celltex Therapeutics Corporation Over Violations 10/17/2012  More...
AITbiotech Secured ISO 13485 Certification for Its Genomic Services and MDx Labs in Singapore 10/15/2012  More...
SEC Investigates Pfizer Inc. (PFE) Over Odd Results 10/9/2012  More...
Genetic Immunity Receives GMP Certification for in-House Manufacturing Facility 10/8/2012  More...
China National Biotech Group May Soon Sell Vaccine to International Aid Groups 10/5/2012  More...
Successful MHRA Inspection of Almac Group's Clinical Services UK Facility 9/26/2012  More...
Summit Corporation Receives Regulatory Approval to Commence Phase I Clinical Trial of Selective Antibiotic for the Treatment of C. Difficile Infections 9/25/2012  More...
Recipharm Monts Secures Regulatory Approval From ANSM to Fill Biotech Products 9/17/2012  More...
Biocitech SAS Resident OCT Sante Obtains Official Certification for Innovative Thermal Packaging Models for the Transport of Biological Samples 9/4/2012  More...
FDA Lifts Ban on Indian Pharma, Including Sun Pharmaceutical Industries Ltd and Dr. Reddy's Laboratories Ltd. (RDY), After Fixing Problems 9/4/2012  More...
Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Release: Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori 8/31/2012  More...
MicroConstants China's New Facility Passes OECD GLP Compliance Inspection 8/28/2012  More...
Caraco Pharmaceutical Laboratories, Ltd. (CPD) Gets FDA Nod to Resume U.S. Operations 8/28/2012  More...
Biostar Pharmaceuticals, Inc. (BSPM) Moves Toward Launch of Topical Pain Relief Product 8/22/2012  More...
Inogent Laboratories Clears the Pharmaceuticals and Medical Devices Agency (PMDA), Japan Audit 8/21/2012  More...
Teva Pharmaceutical Industries Limited (TEVA) Subpoenaed Over Foreign Bribes 8/6/2012  More...
AXIS Clinicals Announces Successful Completion of FDA Audit 7/30/2012  More...
gvk bioSciences Private Limited' Ahmedabad Clinical Pharmacology Unit Successfully Clears the FDA Audit 7/30/2012  More...
EU Regulators Charge Lundbeck Inc. (LUN.CO), Others Over Generics 7/25/2012  More...
FDA to Meet Sanofi (France) (SAN.PA) Execs Over Violations at Vaccine Plants 7/25/2012  More...
BioIndustry Association Welcomes Medicines and Healthcare Products Regulatory Agency Early Access to Medicines Scheme Consultation 7/17/2012  More...
BioIndustry Association Welcomes Publication of Proposed EU Regulation on Clinical Trials 7/17/2012  More...
Aurobindo Pharma and Other Drugmakers Cited for Polluting 7/16/2012  More...
SFDA Issues New Rules for Drug Excipients 7/10/2012  More...
BioIndustry Association Release: Phase I Clinical Trials Insurance Guidance Published 6/27/2012  More...
Link Technologies Ltd Launches New Products for Oligonucleotide Synthesis 6/13/2012  More...
European Medicines Agency Management Board Completes Framework for Conflicts of Interests 6/8/2012  More...
TiGenix: National Reimbursement in the Netherlands Obtained for Breakthrough Cartilage Therapy ChondroCelect(R) 6/8/2012  More...
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  More...
Shanghai Pharmaceutical Co., Ltd. Faces Media Charges of Accounting Fraud 5/24/2012  More...
A Generic Drugmaker Grows in Uganda 5/23/2012  More...
AIDCOC Demands India Ban 33 Drugs 5/21/2012  More...
ISPE, ILF Engage With US and Asian Regulators at Meetings in Japan, China 5/14/2012  More...
New Zealand Drugmakers Deny Plans to Undermine Pharmac 5/14/2012  More...
Metabolon's Shanghai Jiao Tong University School of Medicine Lab Receives Validation 5/11/2012  More...
GlaxoSmithKline (GSK): We Complied With Indian Rules for Drug Approval 5/10/2012  More...
Sigma Pharmaceuticals Warning on Distribution of Medicines 5/10/2012  More...
Novartis AG (NVS) to Probe India Drug Approval Allegations 5/10/2012  More...
U.S. May Lose Chance to Pass National Drug Trace Plan 4/26/2012  More...
TiGenix Obtains Manufacturing License for European Production Facility 4/24/2012  More...
Medgenics, Inc. Files for U.S. Orphan Drug Designation for INFRADURE for the Treatment of Hepatitis D 4/23/2012  More...
Pluristem Therapeutics (PSTI) Receives U.S. FDA Clearance for Phase II Clinical Trial in Intermittent Claudication 4/17/2012  More...
Ampio Pharmaceuticals, Inc. (AMPE) Reaches Agreement With the TGA for the Submission Plan for Zertane in Australia 4/2/2012  More...
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  More...
FDA to Inspect Dr. Reddy's Laboratories Ltd. (RDY)'s Plant in Mexico 3/20/2012  More...
European Medicines Evaluation Agency Wants Two More Drugs Moved From Ben Venue Laboratories Due to Ongoing Manufacturing Practice Concerns 3/20/2012  More...
Meda AB (MEDA-A.ST) Release: Astepro Approved in Europe 3/20/2012  More...
Pfizer Inc. (PFE) Says Europe Undermining Drug Innovation 3/13/2012  More...
Researchers Give Link Technologies Ltd Resounding Endorsement 3/12/2012  More...
Recipharm AB Goes "Green" With Environmental Management 3/9/2012  More...
Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Hid Actos Adverse Effects From Regulators, Suit Says 3/8/2012  More...
Baxter International, Inc. (BAX) Receives Marketing Authorization in European Union for VEPACEL Pre-Pandemic Influenza Vaccine 3/2/2012  More...
DBV Technologies Release: Clinical Development Program Receives FDA “Fast Track Designation” and Encouraging Phase Ib Safety Results for Viaskin® Peanut 2/28/2012  More...
Skinvisible, Inc. (SKVI) Formulation Submitted to European Union for Orphan Drug Designation 2/23/2012  More...
OneWorld Health’s Pioneering VL Treatment PMIM Now Registered in Nepal 2/21/2012  More...
Merck KGaA (MKGAF.PK) Receives Highly Unusual, Holistic Warning Letter From FDA 2/16/2012  More...
TGA Registration for Cellmid Limited's Evolis™ Hair Products 2/16/2012  More...
Genetic Technologies Limited (GTG.AX) Receives CLIA Certificate of Compliance from Centers for Medicare & Medicaid Services, USA 2/16/2012  More...
Mettler-Toledo (MTD) Release: ReactIR™ 247 Receives Ex Certification for Zone 1 Hazardous Environments 2/15/2012  More...
SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval for Excella Gmbh API Plant Feucht, Germany 2/15/2012  More...
Eppendorf AG Licenses Technology for Thermal Cyclers to Agilent Technologies Inc. (A) 2/13/2012  More...
CARBOGEN AMCIS Announces Successful FDA Audit 2/13/2012  More...
Sanofi (France) (SAN.PA), Bristol-Myers Squibb Company (BMY) Receive Nearly $445 Million From Apotex Inc. Over Generic Plavix 2/9/2012  More...
BioLineRx Ltd. In-Licenses Second Oral Hepatitis C Treatment 2/6/2012  More...
Drugmakers Including GlaxoSmithKline (GSK) Scuttle Plan for Approval System Pushed by Biotechs 2/2/2012  More...
Cell>Point Executes Brazil License with Radiopharmacus for Cancer and Heart Disease Molecular Imaging Drug, EC-G 1/25/2012  More...
Almac Sciences Celebrates MHRA Audit Successes 1/23/2012  More...
EpiCept Corporation (EPCT) Receives Finalized FDA Guidance for AmiKet™ Phase III CIPN Program and Regulatory Strategy 1/23/2012  More...
Biovest International, Inc. Prepares for EU Regulatory Meetings; SME Status Granted Providing European Regulatory Benefits for BiovaxID Personalized Lymphoma Vaccine 1/19/2012  More...
Ablynx is Granted Extended GMP Certificate for New GMP Unit 1/11/2012  More...
Quantum Genomics Corp. Gets Approval from the Patients' Protection Committee 1/5/2012  More...
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  More...
Eisai Company, Ltd. (ESALY.PK) Submits Application for Partial Change to Label of Egg White Lysozyme Preparation Neuzym 12/22/2011  More...
Novo Nordisk A/S (NVO) Files for Regulatory Approval of the Ultra-Long-Acting Insulin Degludec in Japan 12/22/2011  More...
EpiCept Corporation (EPCT) Provides Update on Ceplene® Manufacturing at Ben Venue Laboratories 12/21/2011  More...
National Health Service Publishes Implementation Guidelines for Source BioScience's Automated Cervical Cancer Screening Technology 12/19/2011  More...
Obama Administration Keeps Limit on Teva Pharmaceutical Industries Limited (TEVA) Morning-After Pill, Marks First Time US Overrules FDA 12/9/2011  More...
FDA Cites Violations at Three Novartis AG (NVS) Plants 12/7/2011  More...
World Health Organization Certification a Shot-in-the-Arm for China Vaccine Makers 12/2/2011  More...
Warner Chilcott, PLC (WCRX) Announces Receipt of FDA Response to Citizen Petition 12/2/2011  More...
PRC Increases Goals of Healthcare Reform 12/1/2011  More...
Almac Diagnostics Laboratory Receives Accreditation from College of American Pathologists 11/30/2011  More...
'Significant' Offenses Cited at Mylan Inc. (MYL) Plant 11/23/2011  More...
A*STAR Institute of Microelectronics Receives ISO 13485 (Medical Devices Standard) Certification 10/31/2011  More...
LAB21 Limited Extends CPA Accreditation 10/27/2011  More...