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Biotech/Pharma - Regulatory
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
NIH Budget Cuts: It's Not Just The Money 6/1/2017
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
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
NPPA Asks Medtechs To Submit Data Of All 19 Devices Notified As Drugs On Prescribed Format To Prevent Overcharging 5/23/2017
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
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
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
Rich Pharma' Division Canncodex Releases List Of Conditional Use Permits Issued In California To Medicinal Cannabis Businesses 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
If The NIH's Budget Gets Slashed, Don't Expect Biopharma To Make Up The Difference 4/27/2017
Abbott (ABT), Medtronic (MDT) Can't Pull Stents Out, Says Indian Regulator 4/27/2017
PURE Bioscience (PURE) Receives USDA Permission Letter And FDA FCN Acknowledgement Letter 4/27/2017
BioCorp’s Value Chain Excellence Strengthened Through The Extension Of International Quality Certifications 4/27/2017
INC Research (INCR) Is The First CRO To Obtain IAOCR’s Silver Workforce Quality Accreditation Status 4/26/2017
Personalis Receives Approval From The New York State Department Of Health For Clinical Tests Based On The ACE Exome 4/25/2017
FDA Takes Action Against 14 Companies For Selling Illegal Cancer Treatments 4/25/2017
Schulman IRB’s Institutional Biosafety Committee (IBC) Service To Launch In May 4/25/2017
Portal Instruments Receives ISO 13485:2012 Certification From NSAI 4/24/2017
Onxeo Receives The EnterNext Tech 40 Label 4/21/2017
Propanc CEO James Nathanielsz's FDA Policy Proposals Published In Pharma Trade Media 4/20/2017
Center Point Clinical Services LLC Announces New Consensus Guidelines Drafted By KOL Industry Leaders for the Modern Clinical Study Including the Siteless CRO and In-home Clinical Trial 4/19/2017
Atomwise Opens Applications for Historic AI Drug Discovery Awards 4/19/2017
Emmaus Life Sciences Announces FDA Advisory Committee Meeting For Endari For Sickle Cell Disease 4/18/2017
CDISC Announces New Standard For Major Depressive Disorder To Foster Development Of New Treatments 4/18/2017
GlaxoSmithKline (GSK) Release: Togo Becomes First Country In Africa To Validate The Elimination Of Lymphatic Filariasis As A Public Health Problem 4/18/2017
Immune Therapeutics Clears Critical Regulatory Hurdle For Lodonal In Kenya 4/17/2017
Abbott (ABT)'s St. Jude Medical (STJ) Unit Hit with FDA Warning Letter on Fortify, Unify, Assura Defibrillators 4/13/2017
Mylan (MYL)'s Shares Drop After FDA Lashes Out at Drugmaker for Drug Quality Control at HIV Drug Facility 4/12/2017
NEO Tech Adds ISO 13485 Medical Certification At Its Chatsworth, CA Location 4/12/2017
Craft Technologies Certified By CDC For Measurement Of Estradiol 4/11/2017
Kimberly-Clark Corporation (KMB) To Challenge Verdict In Microcool Class Action Lawsuit 4/10/2017
Swalwell Leads Call For FDA To Help Life-Science Start-Ups Navigate Regulatory Process 4/10/2017
Align Biopharma Announces New Identity Management Standard Available For Life Sciences Industry Input 4/10/2017
One of the Most Controversial Drug Companies in America Is Out of the Industry's Lobby 4/7/2017
Intralytix Receives FDA Regulatory Clearance For Phage-Based Shigella Technology 4/7/2017
Ferring Pharma Highlights Progress On Social And Environmental Goals In Corporate Social Responsibility (CSR) Review 2015-2016 4/6/2017
Rainin’s Pipette Service Puts The Customer First 4/6/2017
Slam FDA Nominee Gottlieb As Being Too 'Cozy' With Big Pharma To Combat Opioid Epidemic 4/5/2017
Innovus Pharma Announces Receipt Of Notification To Commercialize Zestra Glide In The European Union 4/5/2017
Before We Act Impulsively on Drug Prices We Should Make Precision Policies 4/4/2017
PreventionGenetics LLC Receives New York License For Genetic Tests 4/4/2017
Neotherma Oncology Announces FDA Granted Its Vectron Thermal Device For Treatment Of Pancreatic Cancer Breakthrough Device Designation Within Expedited Access Pathway 4/4/2017
Novogene NGS Medical Lab Receives CAP Accreditation 4/4/2017
United Therapeutics (UTHR) Announces Regulatory Delays For Remosynch Implantable Pump 4/3/2017
NIH’s New Embrace Of Preprints Will Be A Boon To Science 3/31/2017
Should Taxpayers Cover The Light Bills At University Medical R&D Labs? Trump Kicks Off A Tense Debate 3/31/2017
The Senator From Ground Zero Of The Opioid Crisis Has No Idea What He's Talking About 3/30/2017
How Much Pain Will Congress Inflict On These Opioid Drugmakers' Stocks? 3/30/2017
BioStem Technologies Announces Issuance Of Prescription Drug Repackager Permit For Qualified Pharma Ingredients Inc. 3/29/2017
Egalet Announces FDA Does Not Object To Egalet's Distribution Of Materials And Communications To Healthcare Professionals Regarding Abuse-Deterrent Properties Of ARYMO ER Via Intranasal Route 3/29/2017
Halozyme (HALO) Release: FDA Advisory Committee Provides Unanimous Recommendation For Subcutaneous Rituximab Coformulated With Halozyme Enhanze Technology 3/29/2017
Here's Who Has The Most To Lose If The Government Starts Negotiating Drug Prices 3/28/2017
Tamarack Biotics Receives Regulatory Approval To Sell Breakthrough Protein Ingredient As Food Substance 3/28/2017
Ipsen (IPN.PA) Joins National Pharmaceutical Council 3/28/2017
Kraig Biocraft Laboratories, Inc. Awarded Investment Certificate In Vietnam 3/27/2017
Avid Bioservices, Inc. Receives Mutliple 2017 CMO Leadership Awards For Quality, Reliability, Capabilties, Expertise And Compatibility 3/24/2017
New Coalition Formed To Save NIH Funding 3/24/2017
Icertis Extends Leadership In Pharmaceutical Market With Update To Clinical Trial Agreement And Budgeting Solution 3/24/2017
Alexion (ALXN) Submits Application In Japan For Soliris (Eculizumab) As A Potential Treatment For Patients With Refractory Generalized Myasthenia Gravis (gMG) 3/23/2017
Cobra Biologics Ltd. Wins "CMO Leadership Award" In Five Categories 3/23/2017
China FDA Proposes New Rules To Speed Foreign Drug Approvals 3/21/2017
How Trump Plans To Gut Health And Medical Research To Make America Great Again 3/20/2017
5 Biotech Products U.S. Regulators Aren’t Ready For, National Academy of Sciences Reveals 3/20/2017
BiCOM Statement In Response To The Administration's Proposed Cuts To Medical Research 3/20/2017
NuVasive (NUVA) Release: New Evidence-Based Recommendation Released From NICE (U.K.) For Lateral Interbody Fusion 3/20/2017
Western IRB Establishes Single-IRB Solution To Help Institutions Comply With New Mandate For NIH-Funded Research 3/20/2017
Trump NIH Cuts Would Be 'Catastrophic Event,' Says Bush-Era NIH Chief 3/17/2017
Lawmakers Question the FDA's "Unusual" Approval of Marathon Pharma's Controversial Old DMD Drug 3/16/2017
FDA Proposes Exempting Hundreds of 337 Class II Devices From 510(K) Requirements 3/16/2017
Recipharm AB Names 2016 International Environmental Award Winner 3/16/2017
GOP Bill Could Force Employees To Undergo DNA Tests Or Pay Huge Fines 3/15/2017
Baxter International (BAX) And The Institute For Safe Medication Practices (ISMP) Address Global Medication Error Prevention 3/15/2017
Altasciences Clinical Research Companies Recognized For Leadership 3/15/2017
Cardiome Pharma Corp. (COM.TO) Receives Notice Of Compliance From Health Canada For Its BRINAVESS NDS 3/15/2017
Maetrics Launches Swiss Seminar Series 3/15/2017
Endo International (ENDP) Statement On FDA Advisory Committees' Vote Related To OPANA ER 3/15/2017
FDA Lifts Ban On Sun Pharma (SUNPHARMA.NS)'s Mohali Plant Exports 3/14/2017
Statement From Health Canada On The Publication Of A White Paper On Public Release Of Clinical Information In Drug Submissions And Medical Device Applications 3/10/2017
Why The FDA Is Doomed No Matter What They Do 3/10/2017
NovaBay (NBY) To Present Features And Benefits Of The Intelli-Case At FDA Public Advisory Meeting 3/9/2017
Opthea Completes FDA Meeting To Inform OPT-302 Wet AMD Clinical Program 3/9/2017
PolyPid Ltd. Announces Receipt Of Qualified Infectious Disease Product (QIDP) Designation From FDA For D-PLEX In Post-Cardiac Surgery Sternal Infection 3/8/2017
Functional Biosciences Achieves CLIA Compliance 3/8/2017
Alere (ALR) Gets FDA CLIA Waiver for Alere i RSV Rapid Molecular Test 3/7/2017
TiGenix Receives Positive Feedback From The FDA On Cx601 Global Phase III Trial Protocol 3/7/2017
Thermo Fisher Scientific (TMO) Earns the First U.S. EPA ENERGY STAR Certification On Laboratory-Grade Refrigerators 3/7/2017
Why President Trump's View Of The FDA Is Misguided 3/7/2017
PolySkope Labs Announces AOAC PTM Submission of the World's First Comprehensive Multiplex Pathogen Detection Method for Food Safety Industry 3/7/2017
5 Tips To Survive An FDA Inspection 3/6/2017
5 Predictions For The Medical Device Industry 3/6/2017
Lyophilization Services of New England Successfully Completes FDA PAI And General GMP Inspection Of Two Aseptic Manufacturing Plants And QC Laboratory 3/6/2017
Trump Calls The FDA ‘Slow And Burdensome,’ But It’s Faster Than Ever 3/3/2017
Would Trump's FDA Deregulation Create An Age Of Miracles? Don't Bet On It 3/2/2017
Shift To Making Many Drugs Under One Roof Sparks Worries About Shortages 3/2/2017
22nd Century Group, Inc. Granted FDA Guidance Meeting For X-22 Smoking Cessation Aid 3/2/2017
MiMedx Audit Committee Announces Completion Of Its Investigation 3/2/2017
Intercept Pharma (ICPT) Release: NICE Recommends Ocaliva® (Obeticholic Acid) For The Treatment Of Patients With Primary Biliary Cholangitis In England, Wales And Northern Ireland 3/2/2017
FDA Release: Mutual Recognition Promises New Framework For Pharmaceutical Inspections For United States And European Union 3/2/2017
Trump Takes Another Shot at the FDA's 'Slow And Burdensome' Approval Process 3/1/2017
President Trump: Keep Your Peter (Thiel) Out Of Our FDA Politics 3/1/2017
Alnylam (ALNY) Receives EMA PRIME Designation For Accelerated Assessment Of Givosiran, An Investigational Rnai Therapeutic For The Treatment Of Acute Hepatic Porphyrias 3/1/2017
WuXi AppTec Lab Testing Division's Bioanalytical Service Unit Passed FDA Inspection 3/1/2017
22nd Century Group, Inc. Provided With Written Feedback From FDA On The Company’s Modified Risk Tobacco Product Application 2/28/2017
Parenteral Drug Association Adds ISO Class 8 Cleanroom As Part Of Training And Research Institute Enlargement 2/28/2017
Consumer Safety Coalition Urges Justice Department Review Of Proposed Acquisition Of Mead Johnson By Reckitt Benckiser (RB.L) 2/28/2017
Growing Threat Could Kill 10 Million People A Year By 2050 2/24/2017
Senators Introduce A Bill To Overhaul Medical Device Inspections 2/24/2017
Heron (HRTX) Announces Inclusion Of SUSTOL (Granisetron) Extended-Release Injection In NCCN Antiemesis Guidelines 2/24/2017
Is Trump About To Blow Up Medtronic (MDT)'s Tax Avoidance Business Model? 2/24/2017
Accelerate Diagnostics (AXDX) Receives FDA Marketing Authorization For The Accelerate Pheno System And Accelerate PhenoTest BC Kit 2/24/2017
Independent Laboratory Analysis Confirms Cannimed Cannabis Products Free From Pesticides, Fungicides, And Plant Growth Regulators 2/23/2017
BMJ Editors Pen Piece on R&D and Regulation in President Trump's Era 2/23/2017
Certara Corporation Strategic Consulting Awarded Good Laboratory Practices (GLP) Compliant Toxicokinetic Test Site Certification 2/22/2017
Becton, Dickinson and Company (BDX) Veritor System Meets FDA's New Performance Requirements For Rapid Influenza Antigen Detection Tests 2/22/2017
A Call For The FDA To Raise The Bar For Clinical Trials Is Flawed 2/22/2017
SeqGen, Inc. Earns ISO 9001:2015 Certification 2/21/2017
QPharma, Inc. Expands Client Base With Innovative KOL Influence Mapping Solution 2/20/2017
Wound Care Technologies Achieves ISO 13485 Certification 2/17/2017
Imprimis (immy) Begins Dispensing from FDA-Registered 503B Outsourcing Facility 2/16/2017
Genos Biosciences Receives CAP Accreditation For Meeting The Highest Standards In Laboratory Practices 2/16/2017
With All Due Respect President Trump, Drug Companies Don't Want a Deregulated FDA 2/16/2017
Human Embryo Editing Gets The OK—But No Superbabies 2/15/2017
CRO Beaufort Obtains ISO 9001:2015 Certification 2/15/2017
Here Is What Donald Trump's Policies May Mean for Medical Equipment Companies 2/14/2017
Information Update - Health Canada Safety Review Finds Risk Of Serious Skin Burns With Over-The-Counter Topical Pain Relievers Containing Menthol 2/14/2017
ARCexperts Simplifies The Daunting Process Of Achieving Regulatory Compliance 2/14/2017
AEterna Zentaris (AEZS) Announces Plans To Pursue FDA Registration Of Macrilen 2/13/2017