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Biotech/Pharma - Regulatory
SkylineDx Receives CE-IVD Mark For MMprofiler -- Its Innovative Gene Signature-Based Test For Multiple Myeloma 11/25/2015
Medibio’s Study With Johns Hopkins University School of Medicine Receives IRB Approval 11/24/2015
ADM Tronics (ADMT) Withdraws FDA App for Angiodroid CO2 Injector for Angiography 11/23/2015
Ash Stevens Approved As The API Manufacturer For Ixazomib Citrate 11/23/2015
CFDA Issues New Drug/Clinical Trial Approval Regulations 11/20/2015
Hikma (HIK.L) Announces Successful Resolution To FDA Warning Letter At Its Portugal Facility 11/18/2015
Anavex (AVXL) Announces Preparation Of Regulatory Filings Based On Guidance From FDA 11/18/2015
Enzo Biochem (ENZ) Announces New York State Approval Of Its First Assay Based On Ampiprobetm Platform Aimed At Providing Affordable Molecular Diagnostics In Light Of Reimbursement Pressure 11/17/2015
Symphony Clinical Research Earns WBENC-Certified Women’s Business Enterprise Distinction For Second Consecutive Year 11/17/2015
Diatherix Receives Accreditation From College of American Pathologists 11/16/2015
Stock Slides as Boston Scientific (BSX)'s Watchman Hit by Restrictive CMS Coverage Decision 11/12/2015
Opko Health (OPK) 4Kscore Test Receives Category I CPT Code Approval 11/12/2015
Amedica Corporation Submits 24-Month Clinical Data To FDA For Clearance Of Composite Interbody Spinal Device 11/11/2015
NeuroMetrix (NURO)’ Quell Wearable Pain Relief Device Receives American Podiatric Medical Association (APMA) Seal Of Approval 11/11/2015
ScinoPharm Changshu Site Completed US FDA Inspection 11/9/2015
Alere (ALR)'s SD BIOLINE HIV/Syphilis Duo Is First Dual Test To Receive WHO Prequalification 11/9/2015
PTS Diagnostics ' Patent Enforcement Against Jant Pharmacal Gains Momentum 11/6/2015
Albright Technologies Completes ISO 13485:2003 Certification Audit 11/6/2015
FDA Requests Further Data For Approval Of Epigenomics AG' Blood Based Colorectal Cancer Screening Test 11/5/2015
European Medicines Agency Validates Bristol-Myers Squibb (BMY)’s Type II Variation Application For Opdivo (Nivolumab) In Previously Treated Advanced Renal Cell Carcinoma 11/5/2015
FDA Draft Guidance May Have Caught MiMedx Off-Guard 11/4/2015
ALung Receives Expedited Access Pathway Designation From FDA For Hemolung Respiratory Assist System 11/4/2015
NovImmune SA's New Rheumatoid Arthritis Drug Clears Regulatory Hurdles 11/3/2015
NovImmune SA’s New Rheumatoid Arthritis Drug Clears Regulatory Hurdles 11/2/2015
China Cord Blood Corporation Guangdong Subsidiary Has Been Accredited By American Association Of Blood Banks 10/30/2015
BioPharm Executive: From Bad to Worse: Biotech's Next Political Headache? 10/29/2015
Sientra (SIEN) Provides Business Update 10/29/2015
Imprimis (immy) Announces Plans To Register Its Texas Pharmacy With The FDA As An Outsourcing Facility 10/29/2015
EDP Biotech Achieves ISO 13485 Certification 10/28/2015
Bavarian Nordic (BAVA.CO) Announces Expansion Of IMVAMUNE Orders From Canadian Government 10/28/2015
Cynosure (CYNO) Receives Health Canada Authorization To Market MonaLisa Touch For Genitourinary Syndrome Of Menopause 10/28/2015
InDevR Receives ISO 13485:2003 Certification For Assays, Instrumentation And IVD Products 10/27/2015
Amsel Medical Announces Filing Of 2nd 510(K) Pre-Marketing Notification With The US Food And Drug Administration For The Amsel Occluder Device 10/27/2015
PixarBio Corporation Announces FDA OPD Submission Of Neurorelease TN For Orphan Drug Designation For Trigeminal Neuralgia 10/26/2015
SHINE Medical Technologies Achieves Major Milestone On Path To Construction Permit Approval 10/26/2015
Cartiva Announces GMP Certification By Brazil's ANVISA 10/26/2015
Bio-Techne (TECH) Certifies Over 1,000 Antibodies For Simple Western 10/26/2015
TSO3 Allowed Expanded Claims For Revolutionary STERIZONE VP4 Sterilizer 10/26/2015
Theranos Continues to Battle Wall Street Journal Critics, Says FDA Made Unannounced Inspections 10/23/2015
AGTC (AGTC) Announces Orphan Drug Designation In The European Union For Gene Therapy To Treat Achromatopsia 10/22/2015
Would Washington’s FDA Fix Cure Patients Or The Drug Industry? 10/21/2015
goBalto, Inc. Release: New European Clinical Trial Regulations Aim To Reduce Administrative Burden And Costs 10/21/2015
China Biologic Products Received Operating Permit For New Branch Collection Facility In Shandong Province 10/20/2015
Gaumard Scientific's Latest UNI Operating System Is Compliant with Newly Released 2015 AHA CPR/ECC Guidelines 10/19/2015
EDAP TMS S.A. (EDAP) Direct De Novo For Ablatherm HIFU Replaced By 510(K) 10/16/2015
Kapa Biosystems Earns ISO 13485:2003 Certification 10/15/2015
Alere (ALR) Receives U.S. HHS Approval To Electronically Process Drug Tests For Department Of Transportation-Regulated Employees 10/15/2015
Redwood Scientific Technologies Announces TBX-FREE Completes FDA Registration 10/14/2015
Gensignia Receives CLIA Certification Of Its San Diego Laboratory 10/13/2015
Thermo Fisher Scientific (TMO) Manufacturing Site First In Forensic Industry To Meet Proposed Guidelines For ISO 18385 Certification 10/13/2015
TearLab (TEAR) Release: Medical Necessity Of Tear Osmolarity Testing In The Diagnosis And Management Of Dry Eye Disease Confirmed In Recently Published Medicare Local Coverage Determination 10/9/2015
Salix (SLXP) Release: FDA Grants RUCONEST (C1 Esterase Inhibitor [Recombinant]) Twelve-Year Reference Product Exclusivity 10/8/2015
AcelRx (ACRX) Provides Regulatory Update On Zalviso 10/8/2015
Avant Diagnostics Receives FDAIRB Approval for OvaDx Ovarian Cancer Validation Test Specimens 10/7/2015
Marathon Pharmaceuticals, LLC Receives Rare Pediatric Disease Designation From FDA For Deflazacort As A Potential Treatment Of Duchenne Muscular Dystrophy 10/7/2015
Akebia Therapeutics, Inc. (AKBA) Reaches Agreement With FDA And European Medicines Agency On Vadadustat Global Phase III Program 10/6/2015
Successful Australian TGA Inspection Of Asymchem's Dunhua Facility 10/5/2015
Sientra (SIEN)'s Silicon Implant Supplier in Brazil Shut Down by Regulators 10/5/2015
INC Research (INCR) Enhances Clinical Trial Efficiency Through iCardiac Site Certification 10/1/2015
FDA Sets New Regulations Affecting Entire AED Market 10/1/2015
Nordion Welcomes 10 Year Operating License Renewal 9/30/2015
Zafgen (ZFGN) Granted Orphan Drug Designation In The European Union For Beloranib, A First-In-Class Metap2 Inhibitor For The Treatment Of Craniopharyngioma 9/30/2015
Helsinn Group Awarded Global CEO Cancer Gold Standard Accreditation 9/30/2015
Telesta (TSX:TST) Announces FDA Advisory Committee Date For MCNA1 9/28/2015
Bruker Corporation’s NMR FoodScreener Laboratory Achieves ISO/IEC 17025 Accreditation 9/25/2015
Xhale Inc. Submits Biomarker Qualification Package To FDA For Medication Adherence Monitoring Tool 9/22/2015
Re-Analysis of GlaxoSmithKline (GSK)’s Seroxat/Paxil Antidepressant Data Shows Lack of Transparency 9/17/2015
CSL Limited (CMXHF.PK) Release: FDA Advisory Panel Recommends Licensure of NVS Influenza Candidate Vaccine for Protection Against Seasonal Influenza in the Elderly 9/16/2015
Marrone Bio Innovations, Inc' GRANDEVO Bioinsecticide Receives Completeness Determination From The Netherlands 9/15/2015
China Issues Rules For Approval Of Stem Cell Clinical Trials 9/11/2015
BioCision, LLC Announces FDA Master File Acceptance For Thawstar Automated Cell Thawing Instrument 9/9/2015
EndoGastric Solutions, Inc. Announces AMA Assignment Of CPT Code And Short Form Descriptor 9/9/2015
IMPAX Labs (IPXL) Announces Resolution Of FDA Warning Letter Related To Its Hayward Manufacturing Facility 9/8/2015
Mabion Begins Pre-Registration Scientific Advice With The European Medicines Agency 9/8/2015
Cynvenio Receives Accreditation From College of American Pathologists 9/8/2015
Medigus (MDGS.TA) Announces American Medical Association's Publication Of New Category I CPT Code 9/8/2015
Mesoblast (MSB.AX) Partner JCR Pharmaceuticals Receives Recommendation For Approval Of Mesenchymal Stem Cell Product In Japan 9/4/2015
Amyris, Inc. Set To Increase Global Growth Of Its Cosmetic Emollients Through ISO 22716 Certification 9/2/2015
HYD Pharma Receives GMP Certification For Deuterium-Depleted Water (DDW) Production Facility 9/2/2015
Bestronics Achieves ISO 13485 Certification 9/1/2015
Great Basin Scientific Submits 510(K) Application To The FDA For Staph ID/R Blood Culture 8/31/2015
CFDA To Start 60-Day Approvals For INDs Of Oncology Drugs 8/28/2015
WuXi PharmaTech (WX)'s STA Subsidiary Receives First Approval From Japanese Regulatory Authorities 8/27/2015
Arcadia Biosciences (RKDA) Release: Verdeca’s HB4 Stress Tolerance Trait Completes FDA Early Food Safety Evaluation 8/26/2015
EDAP TMS S.A. (EDAP) Provides Formal Response To FDA Addressing All Concerns Raised In July 2015 Ablatherm HIFU Letter 8/25/2015
InformedDNA Achieves NCQA Utilization Management Certification 8/25/2015
Sarepta (SRPT) Receives Rare Pediatric Disease Designation From FDA For Eteplirsen For The Potential Treatment Of Duchenne Muscular Dystrophy 8/21/2015
CombiMatrix (CBMX)'s Combisnp Array For Prenatal Diagnosis Test Granted Approval From New York City Department of Health and Mental Hygiene 8/18/2015
Radiant Sage Achieves ISO 9001: 2008 Quality Management System Certification 8/18/2015
PAREXEL International (PRXL) Receives CEO Cancer Gold Standard Accreditation 8/13/2015
SynteractHCR Requalifies As Certified Member Of BVMA, The Federal Association Of CROs In Germany 8/12/2015
Symbiosis Pharmaceutical Services Release: Successful Sterile Inspection For Scottish CMO 8/10/2015
COLA Accreditation Renewed For Moleculera Labs Testing Services For Childhood Autoimmune Conditions Affecting Brain And Behavior 8/6/2015
Agendia BV Release: NCCN Breast Cancer Guidelines Acknowledge MammaPrint’s Ability to Predict Prognosis 7/28/2015
IndiPharm Awarded Bionexus Status By Malaysian Biotechnology Corporation 7/28/2015
Cellular Biomedicine Group (CBMG) Announces Successful New Certifications For Proprietary Cell And Tissue Preservation Media Kits 7/27/2015
HTG Molecular Diagnostics Achieves ISO 13485:2003 Recertification 7/24/2015
Sigma-Aldrich Corporation (SIAL) Meets Evolving Quality and Regulatory Needs with ISO 13485 Expansion, Provides Diagnostic Customers with Reliable Critical Raw Materials 7/23/2015
European Medicines Agency Release: Stimulating The Development Of Medicines For Children 7/23/2015
FDA QIDP Designation for Motif’s Lead Antibiotic Candidate Iclaprim For ABSSSI 7/23/2015
Aratana Therapeutics (PETX) Provides Update On Monoclonal Antibody Products 7/22/2015
Konica Minolta Medical Imaging U.S.A, Inc. (KPI1.BE) AeroDR Achieves Compliance With FIPS 140-2 Security Standard For DoD AND VA Facilities 7/21/2015
PPD, Inc. (PPDI) Achieves CEO Cancer Gold Standard Reaccreditation 7/20/2015
NanoString (NSTG) Release: NCCN Clinical Practice Guidelines For Breast Cancer Acknowledge Prosigna/PAM50 As Clinically Validated For Prediction Of Prognosis 7/17/2015
Amerita Receives Full URAC Specialty Pharmacy Accreditation 7/17/2015
NMS Labs Earns Prestigious International Accreditation From The American Society Of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB) 7/16/2015
Roka Bioscience, Inc. (ROKA) Receives AOAC Certification For The Atlas Listeria Environmental Detection Assay 7/15/2015
Vericel (ASTM) Announces Plan To Submit HDE Supplement To The FDA To Revise The Labeled Indications For Use And Add Pediatric Labeling For Epicel 7/14/2015
ASPiRA Labs Receives New York State Permit 7/13/2015
Neogen Corporation (NEOG)'s ANSR For Listeria monocytogenes Receives AOAC Approval 7/10/2015
Indian CRO Quality Questioned, As Quest Life Sciences Warned by WHO for HIV Trial Fraud 7/9/2015
Arrowhead Research Corporation (ARWR) Receives Regulatory Clearance For ARC-AAT Phase 1 In The United Kingdom And New Zealand 7/8/2015
Prima Biomed (PRR.AX) Receives Positive Scientific Advice From European Medicines Agency For Its Lead Product, IMP321 7/7/2015
Esperion Therapeutics (ESPR) Announces Removal Of 240 mg Partial Clinical Hold For ETC-1002 7/7/2015
Mauna Kea Technologies Receives Regulatory Approval For The AQ-Flex 19 Miniprobe In Japan 7/6/2015
BGI Receives Accreditation From The College of American Pathologists 7/6/2015
Innocoll, Inc. (INNL) Announces Qualified Infectious Disease Product (QIDP) Designation For Cogenzia For The Adjunctive Treatment Of Moderate And Severe Diabetic Foot Infection 6/30/2015
ImmunID Receives Accreditation From College of American Pathologists 6/30/2015
Elevance Aria WTP 40 Certified As HX-1 Food-Grade 6/30/2015
Sirona Biochem Appoints Casper Bych To Its Board of Directors 6/29/2015
Information Update - Health Canada Requests Quarantine Of Drugs Linked To Polydrug Laboratories Due To Data Integrity Concerns 6/25/2015
Beximco Pharmaceuticals Receives U.S. FDA Approval 6/24/2015
Protagen AG Achieves Significant Milestone With ISO 13485 Certification 6/24/2015
TOMI Receives EPA Registration For Its Patented BIT Technology 6/24/2015
Thermo Fisher Scientific (TMO) Release: OIE Approves Registration Of BOVIGAM TB Kit In Diagnostics Manual, Boosting Global Effort To Manage Bovine Tuberculosis 6/24/2015
Verdezyne, Inc. Earns USDA Certified Biobased Product Certification And Label 6/24/2015
Arcadia Biosciences (RKDA)’ Gamma-Linolenic Acid Safflower Meal Receives Approval From FDA For Use In Animal Feed 6/23/2015
AOP Orphan Pharmaceuticals AG Strengthens Core CNS Specialty Business With High Promise In Movement Disorder Treatments 6/19/2015
Cleveland Biolabs Inc. (CBLI) Submits Pre-EUA Dossier For Entolimod To FDA 6/16/2015
Intellirod Spine Raises Capital And Obtains ISO Certification 6/16/2015
Ajinomoto Althea Inc. Receives European GMP Certification For Commercial Aseptic Filling And Testing 6/16/2015
Information Update - Health Canada Requests Quarantine Of Drugs Linked To Zhejiang Hisun Pharma Due To Data Integrity Concerns 6/16/2015
Intertek Gains Official Accreditation With Philippine Food And Drug Administration 6/16/2015
Aerie (AERI) Receives Positive Feedback From FDA 6/16/2015
PDCLine Pharma Receives Advanced-Therapy Medicinal Product (ATMP) Classification From European Medicines Agency For Its New Class Of Therapeutic Cancer Vaccines (PDCvac) 6/15/2015
Leica Microsystems' Vienna Plant Certified For DIN EN ISO 14001 6/15/2015
FDA Agrees With OncoGenex Pharmaceuticals Inc. (OGXI)' Phase 3 AFFINITY Protocol Amendment 6/10/2015
BioPharma Services Inc. Scores Another Perfect U.S. FDA Audit 6/10/2015
Lyophilization Services Of New England Completes Successful FDA Pre-Approval Inspection For Sterile Drug Product 6/9/2015
Palatin Technologies (PTN) Supports FDA Advisory Committee's Recommendation To Approve The First-Ever Treatment For Hypoactive Sexual Desire Disorder 6/5/2015
MediciNova, Inc. Announces FDA Granted Orphan Drug Designation To MN-166 (Ibudilast) For Krabbe Disease 6/3/2015
AmpliPhi Biosciences Corporation (APHB)’s Bacteriophage Manufacturing Facility Receives cGMP Certification 6/3/2015
The FDA Accepts To Review Theraclion's Submission For Approval Of An Echopulse Pivotal Trial In The U.S. 6/3/2015
China's CFDA Raises Fees For Drug Review 5/28/2015
Colorcon, Inc.’s UK Site Adds EXCiPACT Certification To Support Pharmaceutical Customers To Reduce Growing Regulatory Requirements 5/28/2015
KCR Accomplishes ISO 9001:2008 Certification For All Company Services 5/26/2015
PTC Therapeutics (PTCT) Release: German Federal Joint Committee Issues Positive Medical Benefit Rating For Translarna In Patients With Nonsense Mutation Duchenne Muscular Dystrophy 5/22/2015
Protein Sciences Corporation New York Facility Receives FDA Licensure To Manufacture Flublok 5/14/2015
Sinovac Biotech Ltd. (SVA) Receives Site Inspection Notification For EV71 Vaccine Production Facilities 5/14/2015
Accutest Recently Completed Its 22nd Successful FDA Inspection 5/13/2015
MicroBiome Therapeutics LLC Receives Positive Response From FDA For Use Of Expedited Regulatory Pathway For Diabetes Drug Nm505 5/12/2015
FDA Performs GMP And Pre-Approval Inspections Of IMPAX Labs (IPXL)'s Hayward Facility 5/12/2015
WIRB-Copernicus Group Release: New England IRB Awarded AAHRPP Reaccreditation 5/11/2015
European Medicines Agency And Evidera Release Draft Opinion On Two Patient-Reported Outcome (PRO) Measures For Evaluating New Treatments For COPD 5/11/2015
FutureCeuticals' elevATP Is Non-GMO Project Certified And Verified 5/11/2015
T-Bird Pharma Announces Health Canada License Renewal Including Full Authorization To Sell 5/7/2015
Oncolytics Biotech Inc. (ONC.TO) Announces Receipt Of Orphan Drug Designation From The U.S. FDA For Gastric Cancer 5/6/2015
NSF Approves Flex Pharma (FLKS)’s Proprietary Formulation Under NSF’s Certified For Sport Program 5/4/2015
IDEAL CURES Becomes The First Indian Excipients Company To Receive Excipact Certification 5/4/2015
Integrated Service Solutions, Inc. Successfully Completes ISO Surveillance Audit 5/4/2015
Human Longevity Inc. Receives CLIA Certification 4/29/2015
CannRx Technology Partner Receives ISO 17025 Certification For Its Laboratory 4/28/2015
FDA Grants Orphan Drug Designation For DCR-PH1, Dicerna (DRNA)’s Investigational Therapy For The Treatment Of Primary Hyperoxaluria Type 1 (PH1) 4/24/2015
Emergent BioSolutions (EBS) Completes Investigation And Resumes Biothrax Manufacturing Activities; Re-Affirms Previous Full-Year 2015 Financial Outlook 4/23/2015
Lucideon (Formerly Known As CERAM) Receives ISO 17025 Accreditation For Wear Testing 4/23/2015
Agilent Technologies Inc. (A) Announces Resolution To U.S. FDA Warning Letter For Dako Denmark 4/22/2015
Integrated DNA Technologies’s San Diego, California, Manufacturing Facility Receives ISO 14001 Certification 4/22/2015
Pernix (PTX) Obtains Six Months U.S. Pediatric Exclusivity For Treximet 4/20/2015
Centene Corporation Release: Nurtur Receives Full URAC Accreditation 4/17/2015
TWi Pharmaceuticals, Inc. USA Announces The Receipt Of State Sales Licenses From All 50 States In The U.S. 4/17/2015
Hospira Slapped Again By the FDA for Plant Problems 4/16/2015
Juniper Pharma Services Obtains Specials Licence 4/16/2015
T-Bird Pharma Inc. Announces Health Canada Submission For Second Production Facility 4/10/2015
FL-Based Biotech, AmnioLife, Completes Product Sterilization Validation 4/8/2015
Shire (SHPGY) Announces Clear Regulatory Path Forward For SHP465, An Investigational Treatment For Adults With ADHD 4/7/2015
Cellular Biomedicine Group (CBMG)'s Shanghai Facility Passes Fourth Consecutive CFDA Inspection 4/6/2015
Subsidiary Of Immunoclin Corporation (IMCL) Receives Controlled Drug License In The United Kingdom 4/2/2015
Sysmex America, Inc. Receives U.S. Department Of Defense Accreditation For WAM Middleware Solution 4/1/2015
Innate Pharma (IPH.PA ) : DSMB Recommends Continuation Of Effikir Trial With Two Arms 3/30/2015
Onyx Scientific Limited Release: CRO To Expand GMP Capability 3/30/2015
European Medicines Agency Release: Gardasil 9 Offers Wider Protection Against Cancers Caused By Human Papillomavirus (HPV) 3/27/2015
TransUnion Approved By SAFE-BioPharma, LLC Trust Framework 3/25/2015
Oncolytics Biotech Inc. (ONC.TO) Announces Receipt Of Orphan Drug Status From The European Medicines Agency For Ovarian Cancer 3/25/2015
Faster FDA Means More Cancer Breakthroughs 3/24/2015
Hemispherx Biopharma Europe N.V./S.A. Receives Positive Opinion On Application For Orphan Designation By The European Medicines Agency Agency For Ampligen To Treat Patients With Ebola Virus Disease (EVD) 3/24/2015
Kemwell Announces Successful FDA Inspection 3/24/2015
InMed Receives Exemption Status From Health Canada 3/23/2015
Pfenex (PFNX) Announces Early HSR Clearance For Collaboration With Hospira 3/23/2015
THERAVECTYS Granted Authorization By The French National Agency For Medicines To Produce Lentiviral Vectors For Clinical Use And CAR-T Cell Therapies Under GMP Standards 3/23/2015
Stempeutics Receives Advanced Therapy Medicinal Product (ATMP) Classification From European Medicines Agency For Its Novel Stem Cell Drug 'Stempeucel' 3/23/2015
Mesoblast Limited (MSB.AX) Selected For Fast Track Access To Potential Investment Incentives In Japan 3/19/2015
Opko Health, Inc. (OPK) Receives Accreditation From College of American Pathologists 3/18/2015
NYU Langone Medical Center Release: Quality Measures Approved For Childhood Sleep Apnea 3/16/2015
WIRB-Copernicus Group Release: Western Institutional Review Board Receives ISO 9001:2008 Certification 3/16/2015
FDA Rates Kitabis Pak As Therapeutic Equivalent Of TOBI 3/16/2015
MedSource National Completes SOC 2 Type II Audit With No Exceptions 3/10/2015
FDA Wants AcelRx (ACRX) to Run Another Trial on Zalviso Drug-Device Combo 3/10/2015
EXCLUSIVE: Experimental Cancer Drug From Oncoceutics Could Be Fast-Tracked, Says Exec 3/6/2015
Axsome Announces FDA Fast Track Designation For AXS-02 For The Treatment Of Pain Associated With Complex Regional Pain Syndrome 3/5/2015
Denovo Biopharma Licenses Late-Stage Neuroscience Drug From Eli Lilly (LLY) For Development As A Personalized Medicine 3/3/2015