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Biotech/Pharma - Regulatory (World)
FDA Priority Review Voucher Scheme Under Fire 11/26/2014
Beximco Pharmaceuticals Becomes First Bangladeshi Company To Receive GMP Approval From Health Canada 11/24/2014
Servier Release: European Medicines Agency Recommends Measures To Reduce Risk Of Heart Problems With Corlentor/Procoralan (Ivabradine) 11/21/2014
Yabao Pharmaceuticals In-licenses China Rights To Parkinson's Drug Technology 11/21/2014
National Institute for Clinical Excellence (NICE) Requests More Info On Novartis AG (NVS)'s Xolair To Treat Chronic Hives 11/20/2014
Endo Pharmaceuticals (ENDP) Announces Early Termination Of HSR Act Waiting Period In Connection With Its Proposed Acquisition Of Auxilium Pharmaceuticals (AUXL) 11/19/2014
Cell Source's Megadose Drug Combination Receives Regulatory Approval In Italy To Commence Human Clinical Trials 11/13/2014
U.S. FDA Sends Warning Letter To Cadila Pharmaceuticals 11/12/2014
Cardiome Pharma Corp. (COM.TO) Submits BRINAVESS® Reimbursement Dossier To Italian Authorities To Support Market Access 11/10/2014
Actavis (ACT) And Durata Therapeutics, Inc.  (DRTX) Receive U.S. FTC Clearance For Actavis' Proposed Acquisition Of Durata 11/3/2014
Veloxis Pharmaceuticals A/S (VELO) Announces Tentative Approval Of Envarsus® XR 10/31/2014
Tianyin Pharmaceutical Co, Inc.'s QLF Updates On Its GMP Certification Progress 10/23/2014
Clanotech AB Receives Orphan Drug Designation In The EU 10/20/2014
Health Canada Issues Notice Of Compliance For Gilead Sciences, Inc. (GILD)'s Harvoni™ (ledipasvir/sofosbuvir), The First Once-Daily Single Tablet Regimen For The Treatment Of Genotype 1 Chronic Hepatitis C 10/17/2014
China Biologic Products Receives Approval For Commercial Manufacturing Of Human Prothrombin Complex Concentrate At Shandong Taibang Facility 10/17/2014
Health Canada Release: Safety Information On The Risk Of Blood Clots With Immunoglobulin Products 10/13/2014
National Institute for Clinical Excellence (NICE) Rejects Another Roche (RHHBY) Leukemia Drug Citing Data Uncertainties 10/6/2014
Rare Cancers Europe Calls For New Criteria To Be Used In Clinical Trials On Rare Cancer Treatments 10/2/2014
Information Update - Health Canada Takes Action To Stop Import Of Products From Three Sites In India 10/1/2014
U.S. Patent and Trademark Office Issues Can-Fite BioPharma (CFBI) Patent For CF102 In The Treatment Of Liver Regeneration And Function Following Surgery 9/30/2014
Tianyin Pharmaceutical Co, Inc.'s QLF Completes GMP Site Inspection By CFDA 9/29/2014
Information Update - Health Canada Requests Quarantine Of Products For Canadian Market From Apotex Inc. Facility In Bangalore, India 9/25/2014
Medunik Canada Announces Health Canada Priority Review Of PHEBURANE® Indicated For The Treatment Of Urea Cycle Disorders (UCD) 9/24/2014
KemPharm, Inc. Receives Health Canada Approval To Begin KP201 Clinical Trials In Canada 9/23/2014
OxThera, Inc. Release: Oxabact® Granted European Medicines Agency Orphan Drug Designation For Treatment Of SBS 9/23/2014
Natco Pharma Limited, Orchid Chemicals Hit With A Strong Dose Of FDA Medicine 9/19/2014
GlaxoSmithKline (GSK) Resolves Violation Issue At Montana Facility 9/18/2014
Novartis AG (NVS), Roche (RHHBY) Cry Foul On New Swiss Pricing System 9/16/2014
Alchem International Commits To Tropane Alkaloid Apis And Extends Production And Regulatory Support To Resolve Supply Gap 9/15/2014
FDA's Surprise Visit To Sun Pharmaceutical Industries Ltd (SUNPHARMA.NS)'s Pressures Stock 9/12/2014
Tianyin Pharmaceutical Co, Inc. Release: JCM Applies For Azithromycin API Import Certificate At India 9/9/2014
Exco Intouch Achieves Quality Milestone With Iso9001:2008 Certification 8/21/2014
FDA Finds Falsified Data, Serious Mold, And Decaying Frogs At Amanta (Formerly Known As Marck Biosciences) 8/21/2014
WuXi PharmaTech Co., Ltd. Facility Passes FDA Inspection For Manufacture Of API 8/18/2014
Tianyin Pharmaceutical Co, Inc. Release: Qionglai Facility (QLF) Schedules September For GMP Examination 8/18/2014
Protein Sciences Corporation And Liomont Announce Licensing Of Proprietary Influenza Vaccines For The Mexico Market 8/12/2014
Easton Pharmaceuticals (OP: EAPH) Announces Medical Marijuana Site Facility Visit And Inspection 8/12/2014
ZAI Lab Of Shanghai In-Licenses Two Respiratory Drugs From Sanofi 8/12/2014
Cardiome Pharma Corp. (COM.TO) Submits BRINAVESS Dossier To French Authorities To Support Market Access 8/7/2014
Israel's Ministry Of Health Approves Pluristem Therapeutics (PSTI)'s Commercial-Scale 3D Cell Manufacturing Process Used At Its New Haifa Facility 7/31/2014
Successful FDA Inspection At Hovione's API Manufacturing Plant In Cork, Ireland 7/31/2014
FDA Concern Over Drug Production Process At India's Cadila 7/31/2014
FDA Performs Inspection Of IMPAX Laboratories, Inc. (IPXL)'s Taiwan Facility 7/29/2014
India's Ipca Laboratories Halts Shipments To U.S. From Local Plant After FDA Concerns 7/24/2014
Agenus (AGEN) Release: First Vaccine Candidate for Malaria is Accepted for EU Regulatory Review 7/24/2014
Novartis AG (NVS) Plant To Fall Under GlaxoSmithKline (GSK) Control 7/18/2014
Federal Trade Commission Urged To Probe Shire, Sanofi (France) (SAN.PA) & Icahn Med School Over A "Conspiracy" 7/16/2014
Bial And moksha8 Announce Exclusive License For The Commercialization Of Eslicarbazepine Acetate (Zebinix® / Exalief®) In Brazil And Mexico 7/15/2014
Beximco Pharmaceuticals Becomes First Bangladeshi Company To Receive GMP Approval From Taiwan Food and Drug Administration (TFDA) 7/7/2014
Teva Pharmaceutical Industries Limited (TEVA) Tries Out A New Tactic In Battle For Generic MS Drug 7/7/2014
Recordati S.p.A : Carbaglu® Receives Orphan Drug Designation In The U.S. For Organic Acidemias 7/3/2014
FDA Slaps GlaxoSmithKline (GSK) With Warning For Plant Quality Violations, Orders Company To Review Manufacturing Worldwide 6/26/2014
Cellectis (ALCLS)’ UCART19 Receives Advanced-Therapy Medicinal Product Classification From European Medicines Agency 6/23/2014
WuXi PharmaTech Co., Ltd. Tech Toxicology Facility In Suzhou Passes FDA Inspection 6/20/2014
AstraZeneca PLC (AZN) Release: FDA Adcom Recommends No CV Trial For PAMORA Class 6/13/2014
EffRx Receives U.S. Orphan Drug Designation For EX404 For Treatment Of Pediatric Polycystic Ovary Syndrome 6/10/2014
Europeans, U.S. Disagree Over Safety Of Ranbaxy Laboratories (RANBAXY.BO) Facility 6/6/2014
PCI Given The Green Light In Anvisa Audit 6/4/2014
FDA Cites Manufacturing Concerns At Wockhardt (WOCKHARDT.BO)'s U.S. Unit 5/28/2014
Eisai Company, Ltd. (ESALY.PK)'s R&D Subsidiary Kan Research Institute Commences Full-Scale Operation at New Facility 5/26/2014
TxCell Release: Col-Treg Granted Advanced Therapy Medicinal Product (ATMP) Classification By The European Medicines Agency 5/22/2014
FDA Slams Sun Pharmaceutical Industries Ltd (SUNPHARMA.NS) For Continued Violations At Plant 5/22/2014
WuXi PharmaTech Co., Ltd. Toxicology Facility In Suzhou Passes OECD GLP Inspection 5/21/2014
Nordic Nanovector: Betalutin™ Granted Orphan-Drug Designation In The USA 5/20/2014
WuXi PharmaTech Co., Ltd. Facilities For Late- And Commercial-Stage Analytical And Stability Testing And Clinical-Trial Materials Manufacturing Pass FDA Audit 4/30/2014
Flamel Technologies (FLML) Announces Receipt Of Complete Response Letter From FDA Citing Issues At The Facility Of The Supplier Of The Active Ingredient 4/29/2014
Pluristem Therapeutics (PSTI)'s Manufacturing Facility Approved By European Auditors For Phase 3 Trials 4/28/2014
Lonza Inc.'s Facility In Singapore Received Good Manufacturing Practice (GMP) Certification From The HSA 4/17/2014
FDA Moving Slow To Add Drug Inspectors In China 4/8/2014
ChemCon GmbH Successfully Passes Its Fourth FDA Inspection 4/3/2014
AXIS Clinicals Announces Successful Completion Of 13th U.S. FDA Audit 3/27/2014
Aesica Successfully Completes The Validation Of Its High Capacity Manufacturing Facility At Queenborough, UK Site 3/14/2014
POLARIS Announces Illumina CSPro Certification For Sequencing 3/14/2014
Northwest Biotherapeutics (NWBO) Receives Authorization For New Cancer Therapy In Accordance With $4 Billion German Medical Act 3/12/2014
FDA Approves Pluristem Therapeutics (PSTI)'s Commercial Scale Cell Manufacturing Process 3/6/2014
Basilea Pharmaceutica (BSLN.SW) Reports That Isavuconazole Receives Qualified Infectious Disease Product Designation From FDA For The Treatment Of Invasive Mucormycosis 2/27/2014
ChinaBio(R) LLC Release: China Implements 30-Day Review For "Simple" M&A Transactions 2/26/2014
Neurosearch A/S (NEUR.CO) Announces The Danish Business Authority's Decision In The Accounting Control Matter 2/21/2014
Pluristem Therapeutics (PSTI) Submits FDA Orphan Drug Application For Preeclampsia 2/20/2014
Selvita Received A GMP Certificate 2/18/2014
GMP Certification Boost For Cobra Biologics Ltd. 2/11/2014
Aratana Therapeutics (PETX) Announces Conditional Approval Of Second Canine-Specific Antibody Therapy 1/28/2014
Ranbaxy Laboratories (RANBAXY.BO) Workers Fudged Test Results: FDA 1/28/2014
Protalix Biotherapeutics, Inc. (PLX) Announces Successful Manufacturing Facility Evaluation By Health Canada 1/24/2014
Pluristem Therapeutics (PSTI)'s Cell Manufacturing Facility Marks Major Milestone With German Regulatory Approval Of New Scaled-Up 3D Manufacturing Process 1/23/2014
Suven Life Sciences Ltd's Pashamylaram's Unit Receives FDA Acceptance 1/22/2014
Fraunhofer IZI Granted Manufacturing Authorization For Second GMP Facility 1/21/2014
Exco InTouch Successfully Completes HIPAA Security Audit 1/20/2014
Bayer HealthCare (BAY) Commends AHS And CAPC For Updated Heartworm Guidelines 1/20/2014
ChinaBio(R) LLC Release: China Adds Regs To New IPO Process 1/17/2014
Vectura Group plc (VEC.L): Swedish Regulatory Authority Confirm Approval Of Airflusal® Forspiro® 1/14/2014
BASF Received Excipact™ Certification As Pharmaceutical Excipient Supplier 1/8/2014
TaiGen Biotechnology Receives Qualified Infectious Disease Product And Fast Track Designations From The FDA For Nemonoxacin (Taigexyn®) 12/23/2013
Daiichi Sankyo, Inc. (4568.t) To Help Ranbaxy Laboratories (RANBAXY.BO) Meet FDA Norms 12/19/2013
R-Biopharm Rhône Ltd Welcomes Scottish Government Moves To Improve Food Safety Standards 12/12/2013
China Agrees To Allow Ten Additional FDA Inspectors 12/9/2013
Reckitt Benckiser Pharmaceuticals Inc. Pharma Unit In The U.S. Is Raided By The Feds 12/9/2013
Wockhardt (WOCKHARDT.BO) Falls 4%, FDA Says Company Erased Key Trial Data 12/4/2013
FDA Approval For SCM Pharma Limited Following BTG plc (BTG.L)'s Drug Approval 12/3/2013
TxCell Obtains Manufacturing Accreditation Status For Its French Cell Therapy Manufacturing Facility 12/3/2013
ChemCon GmbH Receives Approval To Manufacture Semi-Solid Pharmaceuticals For Human Use 12/3/2013
Eisai Company, Ltd. (ESALY.PK) Submits Application For Proton Pump Inhibitor Pariet In Japan 11/28/2013
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
Gentium S.p.A. Receives European Medicines Agency Orphan Drug Designation For Defibrotide For The Prevention Of GvHD 11/19/2013
Amgen (AMGN) and Sanofi (France) (SAN.PA) Drugs Can Reach U.S. Without Long Studies 11/15/2013
Drug Regulator Asks Sun Pharmaceutical Industries Ltd to Halt Clinical Research at Mumbai Laboratory 11/11/2013
Specialised Therapeutics Australia Receives Therapeutic Goods Administration Approval for Brain Tumour Visualisation Drug - Gliolan® 11/11/2013
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
Mesoblast Limited (MSB.AX) Updates Market on Registration Plans for GVHD Cell Product in Japan 10/28/2013
UK Regulator to Withdraw Approval for Wockhardt (WPL)'s Daman Plant 10/22/2013
Novasep's European Custom Manufacturing Passes FDA Inspection 10/22/2013
Cambridge Major Laboratories, Inc. Announces Successful FDA Inspection At Weert Facility 10/21/2013
WuXi PharmaTech Co., Ltd. Receives CLIA Certification for Its Genomics Clinical Laboratory 10/17/2013
Wockhardt (WPL) Falls After U.K. Regulator Action on Factory 10/14/2013
Ranbaxy Laboratories (RANBAXY.BO) Jumps as US Plant Wins FDA Clearance 10/11/2013
Fujifilm Diosynth Biotechnologies' UK Site Receives Renewed Medicines and Healthcare Products Regulatory Agency Manufacturing Licence 10/9/2013
FDA Accuses USV of Fudging Data 9/23/2013
ImmunoGen, Inc. (IMGN) Announces Positive Regulatory Decisions for Roche (RHHBY)'s Kadcyla® in the European Union and Japan 9/20/2013
Failure by Drugmakers, Researchers to Publish Clinical Trial Results Risk Patient Safety: UK Lawmakers 9/17/2013
Medivir AB (MVIRb.F): The Regulatory Process in Japan for Simeprevir 9/17/2013
BioIndustry Association Flagship UK Bioscience Forum is Now CPD-Certified 9/12/2013
NicOx SA (COX.PA) Receives Positive Opinion for European Orphan Drug Designation for Naproxcinod for the Treatment of Duchenne Muscular Dystrophy 9/11/2013
Procognia Limited Announces Receipt of cGMP Certificate for Its Glycosylation Analysis Services 9/3/2013
Lonza Inc. Issues Guidance on Infection Control Regarding Novel Coronaviruses (nCoV), Including the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) 8/29/2013
GH Genhelix Receives GMP Approval 8/6/2013
FDA Approves BioGaia's Request for Orphan Drug Designation 8/6/2013
After Novartis AG (NVS) Scandal, Japan Considers Penalties for False Data 8/6/2013
Urine, Lies and a Wayward Drugmaker: FDA Tells Off Wockhardt 7/24/2013
Oncodesign SA Awarded Accreditation of Its Research Center by International Association, AAALAC 7/18/2013
Wockhardt Barred From Making Drugs for Europe 7/10/2013
Datamonitor Release: AMNOG May Cause Havoc in German Diabetes Market - Analyst Opinion 7/9/2013
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
India Upholds Cancellation of Johnson & Johnson (JNJ) Plant License 6/25/2013
Ranbaxy Laboratories (RANBAXY.BO), Another Bad FDA Report & the Missing Generic Diovan 6/25/2013
Sanofi (France) (SAN.PA) CEO: EU Open Data Plan Would Hurt Drugmakers 6/24/2013
Total Recall? China Chastises Johnson & Johnson (JNJ) Over Its Product Recall Policy 6/20/2013
SCM Pharma Limited Release: Medicines and Healthcare Products Regulatory Agency Approval for CDMO's Commercial Facility 6/19/2013
European Medicines Agency's Management Board Endorses Revised EMA Code of Conduct 6/17/2013
Swedish Orphan Biovitrum Gets FDA Approval to Manufacture Substance for Kineret® With Partner Boehringer Ingelheim Corporation 6/11/2013
EU to Fine Lundbeck Inc. (LUN.CO), Others for Blocking Generic Drugs 6/4/2013
Clinical CRO ICRC-Weyer to Boost Drug Safety Services for Investigator Trials 5/31/2013
More Trouble for Ranbaxy Laboratories (RANBAXY.BO) as Drug Boycott to Continue 5/29/2013
What Patient Harm? FDA Slams Shionogi, Inc. for Not Preparing Studies 5/28/2013
A Boehringer Ingelheim Corporation Shake Up and an FDA Warning Letter Over Production Gaffes 5/23/2013
Ranbaxy Laboratories (RANBAXY.BO) Highlights Improved Business and Quality Assurance Standards 5/22/2013
Lonza Inc. Issues Guidance on Infection Control and Global Influenza A (H7N9) 5/22/2013
Johnson & Johnson (JNJ) Licence Revoked Over Baby Powder Concerns 5/6/2013
BioIndustry Association Meeting Highlights Benefits of the Patent Box to Life Science Companies 5/2/2013
FDA Requests $4.7 Million for China Drug Maker Inspections 4/12/2013
FDA Lifts Import Alert on Aurobindo Pharma's Hyderabad Facility 3/28/2013
Vetter's Newest Facility Successfully Completes FDA Inspection 3/27/2013
Recipharm AB Site in France Approved for Supply of Manufactured Products to Japan 3/26/2013
Link Technologies Ltd Release: New Cyanine Dyes Reduce Time and Cost of Oligo Labelling 3/20/2013
Pfizer Inc. (PFE) Criticizes India's Intellectual Property Policies 3/14/2013
Regulatory Affairs Professionals Society, Singapore to Collaborate on First Medical Device Regulatory Training Program in Southeast Asia 3/14/2013
SFDA to Monitor Food Safety; Will Remain Part of Ministry of Health 3/13/2013
China to Give SFDA Responsibility for Food as Well as Drugs 3/5/2013
GlySure Earns ISO 13485 Certification 3/5/2013
Biotage AB (BIOTa.ST): Food Contact Notification to FDA 3/4/2013
Almac Group Receives FDA Inspection Approval 2/20/2013
Evogene Ltd. Announces Launch of Model Plant Validation System for Monocot Plants 2/13/2013
Almac Group Launches U.S. Commercial Packaging Operations With Successful FDA Inspection and New Client Partnership 2/6/2013
GlaxoSmithKline (GSK) Clashes With Pharmaceutical Research and Manufacturers of America (PhRMA) Over Data Disclosure 2/5/2013
FDA Extends License of the gvk bioSciences Private Limited Biomarker Database 2/4/2013
Boehringer Ingelheim Corporation Ohio Drug Plant Shut by U.S. on Quality Issues 2/1/2013
European Commission (EC) Study Finds UK Health Product Benefit Metric Flawed 1/31/2013
TiGenix Successfully Renews GMP License for Stem Cell Manufacturing Facility in Madrid 1/29/2013
Sartorius Stedim Biotech's New Manufacturing Facility in Yauco, Puerto Rico, Receives LEED Platinum Certification 1/25/2013
ChinaBio(R) LLC Release: China Proposes Fast-Track Approvals for Innovative Drugs 1/18/2013
Genea Stem Cells (GSC): 25 New Disease Specific Pluripotent Stem Cell Lines Placed on the National Institutes of Health (NIH) Registry 1/14/2013
Melbourn Scientific Awarded Manufacturer's / Importer's Authorisation (MIA) 1/9/2013
AITbiotech Secured CE-IVD Certification for Its Influenza (Flu) and Mycobacteria Tuberculosis (MTB) Molecular Diagnostic Assays 1/2/2013
European Medicines Agency Documents Are "Secret No Longer" 12/21/2012
Gyros AB Quality Management System Receives ISO 9001:2008 Certification 12/13/2012
Vetter Receives “Known Consignor” Approval From Germany's Federal Aviation Office 12/11/2012
Cellon SA Release: PharmaTainer™ Single Use Bottles and Carboys Now Meet USP 788 12/11/2012
Vetter Receives "Known Consignor" Approval From Germany's Federal Aviation Office 12/11/2012
Next Generation Sequencing of GATC Biotech Accredited by German DAkkS 12/3/2012
Covance Inc. (CVD) Receives SFDA GLP Certification for Its Early Development Facility in Shanghai, China 12/3/2012
Fastest Spent Media Analysis Validated against ICH Guidelines: Spinnovation Biologics' Spedia-NMRTM Meets Stringent Pharma Guidelines 11/20/2012
Ranbaxy Laboratories (RANBAXY.BO) to Get Guidance Soon for Remedial Steps on Dewas Unit 11/12/2012
Regulatory Affairs Professionals Society and China's SFDA to Collaborate on Regulatory Education and Training 11/8/2012
FDA Warns Celltex Therapeutics Corporation Over Violations 10/17/2012
AITbiotech Secured ISO 13485 Certification for Its Genomic Services and MDx Labs in Singapore 10/15/2012
SEC Investigates Pfizer Inc. (PFE) Over Odd Results 10/9/2012
Genetic Immunity Receives GMP Certification for in-House Manufacturing Facility 10/8/2012
China National Biotech Group May Soon Sell Vaccine to International Aid Groups 10/5/2012
Successful MHRA Inspection of Almac Group's Clinical Services UK Facility 9/26/2012
Summit Corporation Receives Regulatory Approval to Commence Phase I Clinical Trial of Selective Antibiotic for the Treatment of C. Difficile Infections 9/25/2012
Recipharm Monts Secures Regulatory Approval From ANSM to Fill Biotech Products 9/17/2012
FDA Lifts Ban on Indian Pharma, Including Sun Pharmaceutical Industries Ltd and Dr. Reddy's Laboratories Ltd. (RDY), After Fixing Problems 9/4/2012
Biocitech SAS Resident OCT Sante Obtains Official Certification for Innovative Thermal Packaging Models for the Transport of Biological Samples 9/4/2012
Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Release: Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori 8/31/2012
MicroConstants China's New Facility Passes OECD GLP Compliance Inspection 8/28/2012
Caraco Pharmaceutical Laboratories, Ltd. (CPD) Gets FDA Nod to Resume U.S. Operations 8/28/2012
Biostar Pharmaceuticals, Inc. (BSPM) Moves Toward Launch of Topical Pain Relief Product 8/22/2012
Inogent Laboratories Clears the Pharmaceuticals and Medical Devices Agency (PMDA), Japan Audit 8/21/2012
Teva Pharmaceutical Industries Limited (TEVA) Subpoenaed Over Foreign Bribes 8/6/2012
gvk bioSciences Private Limited' Ahmedabad Clinical Pharmacology Unit Successfully Clears the FDA Audit 7/30/2012
AXIS Clinicals Announces Successful Completion of FDA Audit 7/30/2012