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Biotech/Pharma - Regulatory
CDC Release: 5 African Countries Approach Control Of Their HIV Epidemics As U.S. Government Launches Bold Strategy To Accelerate Progress 9/19/2017
HumanWell PuraCap Pharmaceutical Announces Second Successful FDA Inspection Of China Manufacturing Facility 9/18/2017
HTG Molecular Diagnostics (HTGM) Receives ISO 13485 Certification For Health Canada CMDCAS Requirements 9/18/2017
Invivotek Maintains Full AAALAC Accreditation For Excellence In Animal Care And Use 9/15/2017
Precision ADM Receives ISO 13485 Medical Device Manufacturing Certification 9/15/2017
Hologic (HOLX) Release: New USPSTF Draft Cervical Cancer Screening Recommendations Are A Step Back For Women's Health, Would Put Lives At Risk 9/14/2017
BIO Statement On California’s Drug Price Reporting & Transparency Bill 9/14/2017
How FDA Commissioner Gottlieb Plans To Seal An Orphan Drug Loophole 9/13/2017
Caprion Biosciences Receives College Of American Pathologists (CAP) Accreditation & Clinical Laboratory Improvement Amendments (CLIA) Certification 9/13/2017
Queensland Bauxite Ltd MDL Work Programme Approved 9/13/2017
BTG plc (BTG.L) Release: Vistogard And Voraxaze Added To Revised Guidelines For Stocking Of Antidotes In U.S. Hospitals 9/13/2017
The Art Of Clinical Trial Design: Generating Real World Evidence That Satisfies Regulators And Payers 9/12/2017
Rise In Unsuccessful Serialization Implementations Prompts Pharmaceutical Companies To Replace Competitive Offerings With TraceLink, Inc. Solutions 9/12/2017
Analogic (ALOG)'s CT Checkpoint Screening Solution, ConneCT, Achieves U.S. TSA Certification 9/12/2017
Easton Pharmaceuticals (OP: EAPH) Announces That Its Partner Windsor Pharma Has Received Regulatory Approvals For Products VS-Sense And AL-Sense For Central America And The Caribbean 9/12/2017
Guerbet (GBT) Statement Following FDA Medical Imaging Drugs Advisory Committee September 8, 2017 9/11/2017
T2 Biosystems (TTOO) Submits 510(K) Application To The FDA For Review Of T2Bacteria Panel 9/11/2017
EDAP TMS (EDAP) Announces Filing Of New 510(K) Application For Focal One Device 9/11/2017
Pharming Group (PHGUF.PK) Announces Conclusion Of FDA End Of Phase II Interactions On RUCONEST For Prophylaxis Of HAE 9/11/2017
HTG Provides Regulatory Update For Its HTG Edgeseq ALKPlus Assay 9/11/2017
Ministry Of Health & Prevention Confirms The Safety And Good Quality Of Brufen, An Anti-Inflammatory, Pain Killer And Antipyretic For Children 9/11/2017
Millennium Dental Technologies Release: Case Western Dental School Adds Regenerative LANAP Protocol 9/11/2017
Henry Schein (HSIC) MicroMD EMR Earns ONC-Health IT Certification From Drummond Group LLC 9/8/2017
Queensland Bauxite Ltd Approval Of Environmental Authority For The MDL Work Program 9/8/2017
Tauriga (TAUG). Confirms The Timely Submission Of Its Expert Report To Federal District Court New Jersey; Report Opines That Tauriga Suffered Losses Of $3,995,000 USD At Minimum 9/7/2017
Picarro Introduces A Hydrogen Peroxide Gas Concentration Analyzer For GMP Pharmaceutical Manufacturing Applications 9/7/2017
TiGenix Obtains Commercial Production License For Expanded Manufacturing Facility 9/5/2017
Yield10 Bioscience Obtains Confirmation Of Nonregulated Status From USDA-APHIS For Its Genome-Edited Camelina Lin 9/5/2017
Biotricity FDA Submission Update 9/5/2017
Kymeta Receives Commercial Authorization From FCC And Ofcom 9/5/2017
How To Work With The New FDA 9/5/2017
Singulex Expands Diagnostics Partnerships, Looks for FDA Approval of Sgx Clarity System Next Year 9/5/2017
HeartFlow Announces Positive Medical Coverage Decisions On Non-Invasive Heartflow FFRct Analysis From Anthem Blue Cross Blue Shield, Blue Shield Of California And Blue Cross And Blue Shield Of Alabama 8/31/2017
CSA Medical Announces Expansion Of truFreeze Label To Include Barrett's Esophagus With Low Grade Dysplasia 8/31/2017
FDA Clarifies Early Feasibility Study Program For Innovative Medical Devices 8/30/2017
FDA Grants ExThera Medical’s Seraph 100 Blood Filter Expedited Access Pathway (EAP) Designation 8/30/2017
Augmenix Release: NICE Announces Interventional Procedure Guidance Supporting Use Of Hydrogel Spacer In Treatment Of Prostate Cancer In The UK 8/30/2017
Medovex Corporation Receives Regulatory Approval From Australia's Therapeutic Goods Administration (TGA) For Its DenerveX System 8/30/2017
What The FDA's New Pre-Certification Program Means For Digital Health And Medical Device Industries 8/28/2017
Innovus Pharma Files Product License Application For The Commercialization Of Its Seasonal Allergic Rhinitis Product In Canada 8/24/2017
Mettler-Toledo (MTD) Presents A New Comprehensive Guide On Thermal Properties 8/22/2017
Avitide Receives ISO 9001:2015 Certification For Its Affinity Resin Manufacturing Facility 8/22/2017
Valeant (VRX)'s Tampa Facility on Track With Getting Clean Bill of Health From the FDA 8/17/2017
Defeating Cyberattacks On 3D Printers, Rutgers University Reveals 8/16/2017
Ganeden Continues Canadian Expansion with New Health Canada Approvals 8/16/2017
Arcadia Biosciences (RKDA) Release: U.S. FDA Publishes Final Rule Amending Food Regulations For Use Of SONOVA GLA Safflower Oil In Dog Food 8/15/2017
ivWatch Achieves ISO 13485 Certification: Provides Foundation For International Distribution 8/15/2017
Mettler-Toledo (MTD) Announces New Library to Help Organizations Implement ISO 9001 Revisions 8/14/2017
Asterias Biotherapeutics Announces Major AST-VAC2 Development Milestone: First cGMP-Compliant Lot Successfully Manufactured to Support First Clinical Study of AST-VAC2 8/14/2017
Co-Diagnostics To Undergo ISO 13485:2016 Audit 8/10/2017
DEA Proposes Further Cuts in Opioid Supply 8/10/2017
AdvaMed Goes Social With Anti-Medtech Tax Ad 8/10/2017
Establishment Labs Announces Leadership For Energy And Environmental Design (LEED) Gold Certification On Its Headquarters In Costa Rica 8/10/2017
Delta Cargo Awarded IATA’s CEIV Pharma Certification 8/9/2017
Inovalon Certified By CMS, Receiving Fee-For-Service Medicare Data For All 50 States And The District Of Columbia 8/9/2017
eClinical Solutions Completes EU – U.S. Privacy Shield And Swiss – U.S. Privacy Shield Certifications 8/9/2017
Kite Pharma (KITE) Files Key FDA Filing for KITE-585 8/8/2017
The ApiFix Spinal Implant Receives TGA Certification 8/8/2017
Kite Pharma (KITE) Gets A Pass From FDA On Axi-cel Panel Review 8/8/2017
Pharma Scores Big Win: Trump to Ink FDA User Fee Bill, Saving 5,000 Jobs 8/7/2017
BIOCOM Commends Senate Passage Of FDA Reauthorization Act 8/4/2017
California Life Sciences Association Applauds Approval Of FDA Reauthorization Act 8/4/2017
BIO: Senate Passage Of FDA User Fee Package Important Victory For Patients, Medical Innovation 8/4/2017
Vizient, Inc. Applauds Senate Passage Of FDA User Fee Authorization Bill 8/4/2017
FDA Issues Emergency Use Authorization for Thermo Fisher Scientific (TMO)'s Zika Virus Assay 8/4/2017
The U.S. FDA Completed Pre-License Inspection (PLI) Of Wuxi Biologics cGMP Manufacturing Facilities For Production Of TMB-355 (Ibalizumab) 8/3/2017
Maetrics Provides Free Guide And Business Analysis Of MDSAP 8/2/2017
FDA's Plan To Lower Nicotine In Cigarettes To Non-Addictive Levels Shines Spotlight On 22nd Century Group, Inc. 7/31/2017
Innovus Pharma Files Its Product License Application In Canada For The Commercialization Of Its Drug Xyralid 7/31/2017
Tenax Therapeutics (TENX) Provides Regulatory Update On Levosimendan 7/31/2017
Schulman IRB Launches Central Neurology Review (CNR) Service 7/31/2017
The Senate Probe Into Big Pharma's Hand In The Opioid Crisis Just Got Bigger 7/28/2017
Diabetes Crisis Continues To Rage, But Biopharma's Response Is Tepid 7/28/2017
New CDISC Standard Empowers Smarter Research For Diabetic Kidney Disease 7/28/2017
Eagle Pharma (EGRX) Receives Complete Response Letter From FDA On RYANODEX For Exertional Heat Stroke Application 7/27/2017
Envigo Release: Teklad Diets Recertified To New ISO Standard 7/27/2017
Medtronic (MDT) First To Receive Health Canada Licence For MR-Conditional Cardiac Resynchronization Therapy-Defibrillators 7/26/2017
Health Canada Release: Advisory - Important Safety Information For People With Diabetes Using NovoPen Echo Or NovoPen 5 7/26/2017
Eisai Company (ESALY.PK) Submits Simultaneous Applications In The United States And Europe For Lenvatinib In Hepatocellular Carcinoma 7/26/2017
Safety Of Medical Devices Not Often Evaluated By Sex, Age, Or Race, Yale Study Reveals 7/25/2017
Anika Therapeutics (ANIK) Announces Regulatory Approval For MONOVISC In India For The Treatment Of Pain Associated With Osteoarthritis Of All Synovial Joints 7/25/2017
Cytovance Completes Its First FDA General Inspection Of Oklahoma City, Ok Facilities 7/24/2017
Prime Therapeutics Urges Caution On Mandates Of Abuse-Deterrent Formulations Of Opioids Citing Value Concerns 7/21/2017
OraSure Tech (OSUR) Receives World Health Organization Prequalification Of OraQuick HIV Self-Test 7/21/2017
TearLab (TEAR) Announces European Regulatory Clearance For Next-Generation Tearlab Discovery System 7/21/2017
KD&A Release: Meeting Medical Software Regulatory Requirements 7/21/2017
Is The FDA Biotech's Best Friend? 7/20/2017
Science Exchange First & Only R&D Outsourcing Platform To Receive EU-U.S. Privacy Shield Framework Certification 7/20/2017
SC Laboratories Receives ISO Certification For Laboratory Standards 7/20/2017
Arcadia Biosciences (RKDA)’ Water Use Efficiency Trait Completes U.S. FDA Early Food Safety Evaluation 7/19/2017
Statement From FDA Commissioner Scott Gottlieb, M.D., On The Funding Awards To States For FDA Food Safety Modernization Act (FSMA) Produce Safety Implementation 7/19/2017
EDAP TMS (EDAP) Withdraws 510(k) Application for Focal One 7/18/2017
Guided Therapeutics Re-Establishes Communications With U.S. FDA And Discusses Plan For Refiling For Approval Of The Luviva Advanced Cervical Scan 7/18/2017
Noble Life Sciences Inc. Granted Renewal Of Full AAALAC Accreditation Status 7/18/2017
FDA's 60-Day Extension For Medical Device Defects Not Likely Obstructive To Public Health 7/17/2017
Mitra Biotech Submits Myring For European Marketing Approval 7/17/2017
PharmaCentra, LLC Release: Pharmacy Locator Connections Pass 2 Million Mark 7/14/2017
FDA Deal Would Relax Rules On Reporting Medical Device Problems 7/14/2017
BIO Applauds House Passage Of FDA Reauthorization Act (FDARA) 7/13/2017
Protext Pharma (TXTM) CEO Discusses South Africa Cannabis License 7/13/2017
Smooth Drug Development Becomes The First BCMS ISO 22301:2012 Certified CRO In Eastern Europe 7/12/2017
Adents Obtains Gateway Provider Certification From European Medicines Verification Organization (EMVO) 7/11/2017
Nephron Pharma 503B License In California 7/11/2017
PAREXEL (PRXL) Receives CEO Cancer Gold Standard Re-Accreditation 7/11/2017
BioIQ Announces The First Unified Solution For Configuring And Managing Population Health Testing Programs 7/11/2017
Roka Bioscience (ROKA) Announces AOAC Certification For 18-Hour Sample Enrichment Using ActeroTM ELITE Listeria Enrichment Media And The Atlas Listeria Environmental Assay 7/11/2017
Innovation In Quality Assurance: New Sysmex America BeyondCareSM Quality Monitor 7/11/2017
Helix CLIA-Certified DNA Sequencing Laboratory Receives College Of American Pathologists (CAP) Accreditation 7/10/2017
BIO Statement On EPA’s Proposed 2018 Renewable Fuel Standards 7/6/2017
Oxitec's Friendly Aedes Mosquito Receives Positive Evaluation For European Standard In Relation To Human Health And The Environment 7/6/2017
Biogen (BIIB)'s SPINRAZA (nusinersen) Receives Notice Of Compliance From Health Canada For The Treatment Of 5q Spinal Muscular Atrophy (SMA) 7/5/2017
Queensland Bauxite Ltd Successful Winter Cannabis Crop Growing 7/5/2017
FDA Unveils Plan To Eliminate Orphan Designation Backlog 6/30/2017
UNITE HERE-Led Pharma Reform Bill Clears California Assembly Health Committee; Latest Win In UNITE HERE’s Nation Wide Healthcare Strategy 6/30/2017
MannKind (MNKD) Receives Accreditation From College Of American Pathologists 6/29/2017
Biologics Earns Prestigious URAC Accreditation For Specialty Pharmacy 6/29/2017
Ministry Of Health & Prevention Shuts Down Erring Medical And Pharmaceutical Facilities 6/28/2017
IHMML Acquires License To Produce Medical Marijuana 6/28/2017
Custom Ultrasonics Receives Resumption Of Manufacturing Letter From FDA 6/27/2017
TraceLink, Inc. Announces End-To-End Administration For Product Track, Alleviating Time-Intensive DSCSA Compliance Tasks For U.S. Hospitals And Pharmacies 6/26/2017
CureVac Expands GMP Production Capacities For RNA Products 6/26/2017
Linguamatics Ltd Announces University of Pennsylvania Health System As Latest Enterprise NLP Client 6/23/2017
Nephure Obtains Self-Affirmed GRAS Notification 6/22/2017
QPharma, Inc. Helping Life Sciences Prepare For Sales Rep License Requirements 6/22/2017
Santhera (SANN.SW)'s Raxone Receives First Positive EAMS Scientific Opinion From UK's MHRA In Duchenne Muscular Dystrophy 6/22/2017
Aspire Bariatrics Announces Aspireassist Receives Australian TGA Approval And First Commercial Cases Performed In Australia 6/22/2017
AMSilk’s Quality Management Receives Certification According To The International Medical Devices Standard DIN EN ISO 13485:2016 6/21/2017
Medizone Release: AsepticSure Receives Full Approval Of International Electrical Safety Standards 6/21/2017
Egalet Receives Complete Response Letter From FDA For Prior Approval Supplement For 10 Mg And 15 Mg Dosage Strengths Of OXAYDO 6/20/2017
Biotricity Receives Ethics Approval To Investigate Mobile Wireless Fetal Monitoring 6/20/2017
Takeda (TKPYY) And TiGenix Announce That Swissmedic Has Accepted For Review The File On Cx601 For The Treatment Of Complex Perianal Fistulas In Crohn's Disease Patients 6/20/2017
Adapt Pharma Acknowledges The U.S. Drug Enforcement Administration (DEA) New Guidance To First Responders On The Hazards Of Exposure To Fentanyl 6/20/2017
Innocrin Granted SME Status Designation By EMA 6/20/2017
Daiichi Sankyo Selects Deloitte's ConvergeHEALTH Safety To Transform And Upgrade Global Drug Safety Platform 6/20/2017
Bavarian Nordic (BAVA.CO) Announces Notification Of Request For Proposal For Freeze-Dried IMVAMUNE 6/16/2017
New FDA Head Lays Out Bold Plan for Digital Health Regulation 6/16/2017
Claritas Genomics Receives New York State (NYS) Approval For Bone Marrow Failure, HLH/MAS, Nephrotic Syndrome, And Mitochondrial DNA Tests 6/14/2017
Acerus (TRLPF) Announces Support Of New Men’s Health Guidelines 6/14/2017
Zimmer Biomet Announces Resolution Of FDA Warning Letter Related To Its Zhejiang, China Manufacturing Facility 6/13/2017
Vertera Spine Receives New CMS ICD-10 Code For Radiolucent Porous Interbody Fusion Devices 6/13/2017
Rich Pharma Announces Institutional Review Board Submission 6/8/2017
Invitation To Review: EAACI Allergen Immunotherapy Guidelines 6/7/2017
PhRMA Release: New Reports Highlight Increasing Global Competition In Biopharmaceutical R&D, Posing Significant Challenges To Future U.S. Standing 6/5/2017
Protalix Biotherapeutics, Inc. (PLX) Announces FDA Approval To Operate Its Current Facility As A Multi-Product Facility 6/1/2017
Successful AAALAC Accreditation For Envigo Facilities In Hyderabad, India 6/1/2017
ASLAN Receives Clinical Trial Authorization To Initiate Pivotal Study Of Varlitinib In Gastric Cancer 6/1/2017
M Pharmaceuticals Announces Successful Pre-IND Meeting Results 6/1/2017
Mylan (MYL) Accused of Overcharging the Government by About $1.27 Billion for EpiPens 6/1/2017
NIH Budget Cuts: It's Not Just The Money 6/1/2017
Pfizer (PFE) Announces Acceptance Of Regulatory Submissions By U.S. FDA And EMA For SUTENT (Sunitinib) For Adjuvant Treatment Of Adult Patients At High Risk Of Recurrent Renal Cell Carcinoma After Surgery 5/31/2017
Veristat Congratulates Tesaro (TSRO) On The FDA Approval Of ZEJULA 5/30/2017
Kinpo Electronics Acquired EU Medical Certificate For Wearable ECG Monitor - BC1 Patch 5/30/2017
FDA Advisory Committee Recommends Approval Of Pfizer (PFE)’s Proposed Biosimilar To Epogen/Procrit Across All Indications 5/26/2017
Puma Biotech (PBYI) Receives FDA Advisory Committee Support For Neratinib 5/26/2017
BioPharma Services Successfully Completes 3 FDA Inspections With ZERO Form 483’s 5/26/2017
The Parenteral Drug Association Connecting Drug Manufacturers, Glass Suppliers To Make Manufacturing Great 5/26/2017
What Should Trigger A CAPA In Medical Device Manufacturing? 5/25/2017
Puma Biotech (PBYI) Receives FDA Advisory Committee Support For Neratinib 5/25/2017
Hepatera: Eligibility To PRIME Scheme Granted To Myrcludex B By The EMA 5/25/2017
TGaS Asks: How Are Market Access Leaders Dealing With Health Policy Uncertainties? 5/25/2017
BioLogics’ Patient Access Services Team Procures More Than $44 Million In Co-Pay Assistance For Cancer Patients In 2016 5/24/2017
PURE Bioscience (PURE) Receives Final FDA Acknowledgement Letter 5/24/2017
WHO Controversy: Is The Cash-Strapped UN Health Agency Splurging On Travel? 5/24/2017
Mithra Pharmaceuticals Receives GMP Approval For Myring Production 5/23/2017
ASCO And College of American Pathologists Invite Comment On Focused Update To HER2 Testing Guideline In Breast Cancer 5/23/2017
NPPA Asks Medtechs To Submit Data Of All 19 Devices Notified As Drugs On Prescribed Format To Prevent Overcharging 5/23/2017
Vizient, Inc. Submits Comments To The FDA About Biosimilar Interchangeability, Looks Forward To Working Toward Lowering Drug Costs 5/22/2017
Cogmedix Successfully Passes ISO 13485:2016 Recertification Audit 5/19/2017
Polyphor Announces Successful End Of Phase II Meeting With FDA For Murepavadin In Nosocomial Pneumonia 5/19/2017
Avita Medical Announces Positive Results From Pivotal Trial 5/18/2017
Innovus Pharma Files Its Product License Application In Canada For The Commercialization Of Vesele As A Natural Health Product To Help Improve Symptoms Of Sexual Dysfunction 5/18/2017
Galapagos (GLPG.BR) Creates New Warrant Plan 5/18/2017
Tenax Therapeutics (TENX) Meets With FDA To Discuss Positive Mortality Data And Potential Levosimendan NDA Submission 5/17/2017
Prolacta Bioscience Applauds New York Gov. Cuomo, Assemblywoman Solages, Senator Hannon & State Lawmakers For Providing Access To An Exclusive Human Milk Diet For Extremely Premature Infants 5/16/2017
BIO Submits Comments To EPA Regulatory Reform Task Force 5/16/2017
Parenteral Drug Association QRM Technical Report And Workshop Advancing Pharma Manufacturing Science 5/16/2017
China's FDA Issues Proposals To Speed Drug Approvals, Improve IP 5/16/2017
Correcting Misconceptions About FDA Design Controls For The Medical Device Industry 5/15/2017
Abivax (ABVX.PA) Announces The Publication Of Its 2016 Registration Document And Highlights The Development Stage Of Its Portfolio 5/12/2017
iX Biopharma Prepares For Waferest Launch 5/12/2017
McKesson Specialty Health Selected By Tesaro (TSRO) To Provide ZEJULA (Niraparib), Approved For The Treatment Of Recurrent Ovarian Cancer 5/12/2017
Alexion (ALXN) Global Headquarters Earns Highest LEED Green Building Certification 5/11/2017
Rich Pharma' Division Canncodex Releases List Of Conditional Use Permits Issued In California To Medicinal Cannabis Businesses 5/10/2017
Does The White House Need Its Own Drug Policy Office? A Former Insider Offers A Resounding ‘Yes’ 5/10/2017
BIO Congratulates Dr. Scott Gottlieb On Confirmation As FDA Commissioner 5/10/2017
Savara Announces Expedited U.S. Molgradex Development Strategy 5/10/2017
Otsuka Pharma Release: Launch Of Alzheimer’s Journey Coordinator Certificate Program 5/10/2017
A Giant Drugmaker Just Set The Strictest Price Increase Caps Of The Industry 5/9/2017
Blockchain: The Missing Link Between Genomics And Privacy? 5/8/2017
Zephyr Health Receives Veeva CRM MyInsights Certification 5/8/2017
Diamond BioPharm's Response to the United Kingdom's Withdrawal from the European Union 5/8/2017
WCCT Global Announces CLIA Certification For Phase I Research Site Laboratory 5/4/2017
Sorrento (SRNE) Announces The Completion Of GMP Manufacturing Plant In Suzhou, China To Support Its Growing Antibody-Drug Conjugate (ADC) Pipeline And Service Business 5/4/2017
BioPharma Services Completes Another Successful Inspection By EMA 5/4/2017
MediWound (MDWD) Announces Successful GMP Manufacturing Audit By The Israeli Ministry Of Health 5/3/2017
Microbix Biosystems Inc. (MBXBF) Consults With FDA Regarding Plans For Kinlytic Urokinase 5/2/2017
Axim Biotech Receives Schedule 1 Permit To Move Forward With Development Of Medchew Rx Pharmaceutical Chewing Gum 5/2/2017
Science Isn’t Dead In Washington. At Least Not Yet 5/1/2017
Invacare (IVC) Reports Completion Of Consent Decree Milestones 4/28/2017
A Heart-To-Heart From The Hackers: Cyber-Vulnerabilities In Cardiac Devices 4/27/2017