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Biotech/Pharma - Regulatory
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
Pulmatrix (PULM) Jumps on News From the FDA 1/18/2017
Exosome Diagnostics Release: Company Obtains ISO 15189 For Its Munich Laboratory 1/18/2017
Pharma Companies Routinely Bend Orphan Drug Rules 1/18/2017
FDA Release: Statement From Commissioner Robert Califf, M.D. Announcing New Draft Guidances On Medical Product Communications 1/18/2017
Castle Biosciences Release: New Laboratory Receives Accreditation From College of American Pathologists 1/17/2017
Remedy Pharmaceuticals, Inc. Release: CIRARA Granted Orphan Drug Designation For Treatment Of Severe Cerebral Edema Caused By Acute Ischemic Stroke 1/17/2017
VWR International, Inc. (VWR) Release: Company Receives EXCiPACT Certifications At Two Chemical Manufacturing Sites In Ohio 1/17/2017
Exco InTouch Release: Company Certified To EU-U.S. Privacy Shield Framework Self-Certification Status 1/17/2017
In His Latest On Drug Prices, Trump Plays The Medicare Negotiations Card 1/16/2017
ASBM Release: Company Statement On Final Guidance For Industry Nonproprietary Naming Of Biological Products 1/16/2017
How Donald Trump Will Be A Disaster For Autistic People 1/13/2017
Braeburn Pharma Release: Company's Probuphine Implant Receives J-Code By Centers for Medicare & Medicaid Services 1/13/2017
SQI Diagnostics Release: Company To Extend Warrant Expiry 1/13/2017
Shuwen Biotech Release: Company Receives EN ISO 13485 Certification 1/13/2017
Kraig Biocraft Laboratories, Inc. Release: Company's Management Completes Meetings With Vietnamese Officials 1/12/2017
University of Pennsylvania Should Rethink Over-Hyped Press Releases 1/11/2017
5 Facts Donald Trump Needs To Know About Vaccines 1/11/2017
Arcadia Biosciences (RKDA) Release: Biotech Obtains FDA GRAS Status For SONOVA GLA Safflower Oil 1/10/2017
DATATRAK International, Inc. (DATA) Release: Company Certifies As Early Adopter of New EU-U.S. Privacy Shield Framework 1/10/2017
6 Major FDA Decisions And Biopharma Catalysts Coming In January And February 1/9/2017
Asterias Biotherapeutics Announces Successful Commencement Of Operations At New GMP Manufacturing Facility For AST-OPC1 1/9/2017
Health Canada Release: Information Update - New Safety Information On Injectable Gadolinium-Based Contrast Agents Used In MRI Scans 1/9/2017
Vermillion Announces Reimbursement Code Updates For Overa And OVA1 1/9/2017
Janssen PMP Release: SANAFOR PO-5 Antimicrobial Technology Receives NSF Certification 1/6/2017
Okogen Secures Ora To Conduct Clinical And Regulatory Development Of OKG-0301 For Adenoviral Conjunctivitis 1/6/2017
Vermillion And ASPiRA LABS Announce Receipt Of Formal FDA Clarification Regarding Ovarian Cancer Screening Alert 1/5/2017
FDA Provides Positive And Encouraging Feedback For 22nd Century Group, Inc.’s Very Low Nicotine MRTPA Filings 1/5/2017
Drop In FDA Approvals (And New Administration) Rekindles Fears For The Future Of Pharma 1/4/2017
Alere (ALR) Laboratory Receives ABFT Accreditation 1/4/2017
Transperfect’s Updated Encompass System Transforms Regulatory Compliance Into Competitive Advantage For Medical Device Manufacturers 1/4/2017
7 Biotech Companies With Key FDA Decisions or Catalysts in January and February 2017 1/3/2017
Is The Warning That Creatine's Not For Teens Getting Through? 1/3/2017
Donald Trump Could Lower The Bar For FDA Drug Approvals, But Payers Will Limit Access 1/3/2017
Recipharm AB Release: Regulatory Approval Received For Acquisition Of Kemwell Indian Operations 12/30/2016
Conflicts of Interest: Scientists Advising U.S. Government on Biotechnology Financially Tied to Outcome 12/30/2016
The U.S. Has Issued Outlines For Connected Medical Device Security 12/30/2016
Obama's Gift To The Biotech Industry 12/30/2016
Serial Testers And Cursory Checks: India's Flawed Generic Drug Trials Business 12/29/2016
Drug Industry Hired Dozens Of Officials From The DEA As The Agency Tried To Curb Opioid Abuse 12/29/2016
Crescendo Bioscience Release: United Rheumatology Issues Clinical Practice Guidelines And Recommends The Vectra DA Test For Adults With Rheumatoid Arthritis 12/27/2016
The Senate Fumbles its First Stab at Pharma Profiteering, Keeping the Issue Front and Center in 2017 12/27/2016
Sinovac Biotech Ltd. (SVA) Responds To Recent Report 12/27/2016
MiMedx Announces Preliminary Investigation Findings 12/27/2016
Sinovac Biotech Ltd. (SVA) CEO Reportedly Bribed Chinese FDA, Buyout Offers Could Be in Jeopardy 12/22/2016
IBBL Takes Center Stage In Microbial Sequencing 12/22/2016
Advanced Accelerator Applications Receives Complete Response Letter From FDA For Lutathera, An Investigational Treatment For Neuroendocrine Tumors 12/21/2016
Vitality Biopharma Receives DEA Approval for Cannabinoid Pharma Development Facility 12/21/2016
Trovita Health Science Announces FDA 510(K) Submission Of New, Fully Closed System For Administration Of Tube Feeding Formulas 12/20/2016
Three Novasep Custom Manufacturing Sites Renew FDA Approval In 2016 12/20/2016
Genmab A/S (GEN.CO) Announces Submission Of Regulatory Application For Daratumumab In Relapsed/Refractory Multiple Myeloma In Japan And Updates Financial Guidance 12/20/2016
Vivex Biomedical Receives Level II HCPCS Q-Code For Cygnus, A Human Amniotic Tissue Allograft 12/20/2016
HematoGenix Receives Accreditation From College of American Pathologists 12/20/2016
White House Kills Plan for Drug Price Cap 12/19/2016
Drug Master File Submitted To FDA For Citius Pharma's Ethanol 12/19/2016
Boehringer Ingelheim And Eli Lilly (LLY) Welcome New Recommendation For Jardiance (Empagliflozin) Tablets In Updated American Diabetes Association's 2017 Standards 12/19/2016
MetaStat Receives Additional State Clinical Laboratory Licenses 12/19/2016
Exclusive: If Trump Skews Science, Researchers Must Raise The Alarm 12/16/2016
FDA's Woodcock Speaks About One Of The Agency's Most Controversial Decisions 12/15/2016
MMJ PhytoTech Canadian Government Submits Report On Cannabis Legalization 12/15/2016
UAE Ministry Of Health & Prevention Receives ISO 9001:2015 Certification For Quality Management Systems 12/15/2016
W. L. Gore & Associates Receives Innovative Technology Designation From Vizient For Gore Synecor Biomaterial 12/15/2016
Eclipse Aesthetics Receives ISO 13485:2003 Certification 12/14/2016
Korean Scientist's Stem Cell Line To Be Registered 12/13/2016
Trump Is Considering A Radical To Lead The FDA. That’s Dangerous For Public Health 12/13/2016
Health Canada Release: Government Of Canada Announces New Comprehensive Drug Strategy Supported By Proposed Legislative Changes 12/13/2016
Akorn, Inc. (AKN) Announces Completion Of FDA Re-Inspection Of Decatur Facility 12/12/2016
Here’s 2017 Biopharma Sales Projections, But Trump Might Have Other Plans 12/9/2016
Why Donald Trump's Putative FDA Pick Could Scare Pharma 12/9/2016
Wake Up And Smell The Coffee Pharma—Trump Is Not Your Savior 12/8/2016
Interpace Diagnostics Announces New Aetna Coverage Policy 12/8/2016
Panther Biotechnology Receives Positive Feedback From The FDA 12/8/2016
California Life Sciences Association Praises Congressional Approval Of 21st Century Cures, Sending Landmark Medical Innovation Bill To President 12/8/2016
Eurofins Genomics Receives Accreditation From CLIA And CAP For New Laboratory In Louisville 12/7/2016
The Amyloidosis Research Consortium, A Patient Led Foundation, Delivers Draft Guidance To FDA For Developing Drugs For AL Amyloidosis 12/7/2016
10 Major Pharma and FDA Catalysts Coming in December 12/6/2016
Paradigm Spine, LLC Announces Publication Of ISASS Guidelines Recommending Coverage Of Interlaminar Stabilization 12/6/2016
Baxter International (BAX) Receives Perfect Score From Human Rights Campaign Foundation 12/5/2016
Here's What Top Pharma Execs Expect Under Donald Trump 12/2/2016
Merck & Co. (MRK) CEO Kenneth Frazier: There Are Ways To "Strengthen And Improve" Obamacare Coverage 12/2/2016
Pharma Execs Weigh In On Possible Changes Under Trump 12/2/2016
CDG Biotech Corporation Is Poised To Enter The Market For Diagnostic Assay Solutions In The Fight Against Allergies And Rare Diseases 12/2/2016
Eisai Company (ESALY.PK) Release: Halaven (Eribulin) Receives Registration In South Africa For Treatment Of Women With Advanced Breast Cancer 12/1/2016