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Biotech/Pharma - Regulatory
WHO Controversy: Is The Cash-Strapped UN Health Agency Splurging On Travel? 5/24/2017
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
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
IGC Launches Phytocannabinoid Development Committee To Secure Preclinical Initiatives For IGC-501, IGC-502 And IGC-504 2/13/2017
29K Medtech Jobs Lost Under Medical Device Tax, AdvaMed Says 2/10/2017
Shire (SHPG) Responds To U.S. FTC Civil Action 2/9/2017
Mitra Biotech Obtains CLIA Certification For Flagship Massachusetts Lab 2/8/2017
Genentech (RHHBY)'s $94,000-a-Year Drug Tarceva: Why Faster FDA Approvals Could Backfire 2/8/2017
OCT Named As One Of The TOP 5 Russian CROs In 2016 2/8/2017
Canon Virginia, Inc. Announces Receipt of ISO 13485 Certification and the Launch of Medical Device Contract Manufacturing Services 2/7/2017
Trump Is Promising A Big Shake-Up At The FDA—Here’s What That Could Mean 2/7/2017
Cerebain Biotech Applauds Congressional Passage Of 21st Century Cures Act 2/7/2017
This Can Be Patheon (PTHN)'s Fate in Trump's Call for Increased Drug Production 2/6/2017
The March For Science In Washington Is Political Whether You Like It Or Not 2/6/2017
Veeva Systems, Inc. Announces Vault Submissions Publishing To Speed Submission Delivery 2/6/2017
World's Scientists Offer Their Labs To Colleagues Stranded By Trump's Immigration Ban 2/6/2017
Week In Review: China To Add 300 Drugs To National Reimbursement Drug List 2/6/2017
Alimera Sciences (ALIM) Announces The Reimbursement Of ILUVIEN In Italy 2/6/2017
MiMedx Comments On FDA Decision Not To Finalize HCT/P Guidance Documents This Year 2/6/2017
ISCT Affirms Its Commitment To The International Cell Therapy Community 2/6/2017
Who Bears The Brunt Of New Quarantine Costs? 2/6/2017
PURE Bioscience (PURE) Receives FDA Interim Safety Determination Authorization To Test Higher Concentrations Of SDC-Based PURE Control Antimicrobial As A Poultry Processing Aid 2/6/2017
U.S. House Panel To Take Up Bill To Spur Generic Drug Development 2/3/2017
Biohacker Wants To Make A Genetic Upgrade To Dalmatians—But The FDA Isn't On Board Just Yet 2/3/2017
Soligenix (SNGX) Announces SGX301 Receives Promising Innovative Medicine Designation From The UK Medicines And Healthcare Products Regulatory Agency 2/2/2017
Zivo Bioscience, Inc. Expands Algae Cultivation For Compliance And Scaling Studies 2/2/2017
Immune Therapeutics Clears Critical Certification Milestone 2/2/2017
7 Important Policy Agenda Items For Biopharma 2/1/2017
Tilray Announces Medical Cannabis Export To Chile 2/1/2017
Trump Wants To Blow Up The FDA. The Drug Industry? Not So Much 2/1/2017
Mettler-Toledo (MTD) Release: New Resource Helps Ensure Weighing Operations Are USP Compliant 1/30/2017
Biotech Execs Slam Trump’s Travel Ban 1/30/2017
How Trump's Federal Hiring Freeze Impacts Biotech and an Already Short-Staffed FDA 1/27/2017
Prime Therapeutics Is Certified For NCQA Utilization Management And Health Information Products - Pharmacy Benefit Information 1/27/2017
Systech International Announces 90-Day Rapid Compliance Program For Pharmaceutical Companies 1/26/2017
Medtronic (MDT) Receives IDE Approval To Initiate Study Of IN.PACT Admiral Drug-Coated Balloon For A New Indication In Patients With End-Stage Renal Disease 1/26/2017
Women Scientists Call on President Trump in Open Letter 1/25/2017
Ropack Release: Company Selects TraceLink, Inc. To Achieve DSCSA Compliance For Its Pharmaceutical Customers 1/25/2017
Keep Politics Out Of Science, Says Departing FDA Chief 1/24/2017
Endo International (ENDP) Release: Pharma Announces Agreement To Resolve FTC Investigation And Litigation 1/24/2017
4 Key Strategies on How Pharma Can Successfully Negotiate Drug Prices With President Trump 1/23/2017
Thermo Fisher Scientific (TMO) Release: ISO 17025 Accreditation For Microbiology Manufacturing Site Offers Increased Confidence To Microbiology Testing Laboratories 1/23/2017
The Future Of Pharma In The Age Of Trump 1/20/2017
Mallinckrodt (MNK) Release: Pharma And FTC Resolve Questcor Pharmaceuticals, Inc. (QCOR) Matter 1/19/2017
Comprehend CRO Release: Company Oversight Solution Addresses Looming ICH E6 Addendum 1/19/2017