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Biotech/Pharma - Regulatory
Thermo Fisher Scientific (TMO) Release: ISO 17025 Accreditation For Microbiology Manufacturing Site Offers Increased Confidence To Microbiology Testing Laboratories 1/23/2017
4 Key Strategies on How Pharma Can Successfully Negotiate Drug Prices With President Trump 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
Why Donald Trump's Putative FDA Pick Could Scare Pharma 12/9/2016
Here’s 2017 Biopharma Sales Projections, But Trump Might Have Other Plans 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
Pharma Needs To Have A Sense Of Urgency 11/30/2016
Congress Poised To Pass Sweeping Law Covering FDA And NIH 11/30/2016
Gutsy Anti-Vaccine Activists Spot An Ally In The Oval Office 11/30/2016
Why FDA Delay on Brodalumab is Actually Great News For Valeant (VRX) 11/30/2016
Biological Industries Announces FDA Drug Master File Acceptance For Nutristem hPSC XF Medium 11/30/2016
New Vetter Data Processing Center Is Officially Certified 11/30/2016
Even If Donald Trump Changed The FDA Drug Approval Process, Patients Wouldn't Benefit 11/29/2016
Trump Presidency Impact On Biotechnology 11/29/2016
Will Trump Make Biotech ETFs Great Again? 11/29/2016
Warren Slams Cures Bill As Handout To "Big Pharma" 11/29/2016
Axim Biotech Files IP Application On Propietary Method To Extract High-Purity THC 11/29/2016
CombiMatrix (CBMX)’s Pre-Implantation Genetic Screening By Next Generation Sequencing Granted Conditional Approval From New York State Department Of Health 11/29/2016
Audentes (BOLD) Announces Initiation Of Large-Scale cGMP Production At Its Gene Therapy Manufacturing Facility 11/29/2016
How Malpractice Reform Affects Medical Device Innovation 11/29/2016
StemGenex Comments On FDA Docket To Support Stem Cell Therapy 11/29/2016
Anuva Manufacturing Services Awarded ISO-13485:2003 Certification 11/29/2016
Neovasc (NVC) Receives Regulatory Approval To Initiate TIARA II CE Mark Study 11/28/2016
MMJ PhytoTech United Greeneries Receives Cannabis Seed Import Permit 11/28/2016
Easton Pharmaceuticals (OP: EAPH) Announces Negotiations For The Filing Of A Medical Marijuana Application In Jamaica Toward Exporting Medicinal Marijuana Into Various Countries Including Canada, Mexico, And Brazil 11/28/2016
Adapt Pharma Welcomes FDA Consumer Update Regarding Opioids 11/23/2016
Successful AAALAC Accreditation For Envigo Facilities In Barcelona, Spain 11/23/2016
Smith & Nephew Inc. (SNN) Release: New WHO Guidelines Recommend The Use Of NPWT To Help Reduce The Risk Of Surgical Site Infection 11/22/2016
Do CRISPR And Biotech Advances Pose A National Security Threat? 11/21/2016
UK Biotechs Struggle To Cope With Brexit 11/21/2016
WHO Declares Zika Public Health Emergency Over, Though Threat Remains 11/21/2016
GlaxoSmithKline (GSK) Files Regulatory Submission In U.S. For Once-Daily Closed Triple Combination Therapy FF/UMEC/VI For Patients With COPD 11/21/2016
Newt Gingrich Could Be Medical Science's Unlikely Champion During Trump's Presidency 11/18/2016
FDA Confirms A 510(K) De Novo Path For EyeGate Pharma’s Device, The Ocular Bandage Gel, Following Pre-Submission Meeting 11/18/2016
Renexxion Achieves Positive FDA Guidance For Phase 3-Ready GI Drug Naronapride 11/17/2016
Why Trump Should Be Good Medicine For The Pharma Industry 11/16/2016
Boehringer Ingelheim Welcomes Central Role Of LAMA/LABA Therapy Within 2017 GOLD Strategy For COPD 11/16/2016
Marrone Bio Innovations, Inc Receives California Approval For MAJESTENE Bionematicide 11/16/2016
Pfizer Canada Release: National Advisory Committee On Immunization (NACI) Gives Prevnar 13 Grade A Recommendation 11/16/2016
Nutra Pharma Corp. (NPHC) Announces Infomercial Campaign For Pet Pain-Away 11/16/2016
10 Twitter Experts To Help You Navigate Trump’s Health And Science Policy 11/15/2016
OWC Pharmaceutical Research Corp. To Submit Psoriasis Topical Cream IRB Safety Protocol To The Israeli National IRB ("Helsinki") Committee 11/15/2016
FDA Completes Transfer Of Emergency Use Authorization For Reebov Ebola Antigen Rapid Test To Zalgen Labs 11/14/2016
Amnio Technology's PalinGen And ProMatrX Lines Assigned Q Codes For Product Reimbursement 11/14/2016
President Elect Donald Trump And FDA 11/14/2016
ASPiRA LABS' OVA1 Technology Receives "Level B" Recommendation In The Latest ACOG Clinical Management Guidelines For The Management Of Adnexal Masses 11/11/2016
President-Elect Trump Could Deprive Women Of Reproductive Rights — Here's How Some Women Are Responding 11/10/2016
Fearful Of A Trump Administration, Many In Research Call For A "Tutorial" For The President-Elect 11/10/2016
Do Links Count? FDA To Re-Examine Online Drug Ads 11/10/2016
Florida Keys Voters Split On Genetically Modified Mosquito Trial 11/9/2016
Augmenix Announces New Category 1 CPT Code From The American Medical Association For Periprostatic Implantation Of Biodegradable Material 11/9/2016
Secant Group Launches Regenerez Extruded Component 11/9/2016
Galileo Life Sciences, Inc. Files Application With OTC Markets 11/9/2016
R&D Tax Incentives Are Critical To Building Australia's Innovation Economy, So Let's Get It Right 11/8/2016
Californians Still Hate Trump, But Are More Uncertain About Drug Companies 11/7/2016
How The Pharma Industry Is Supporting Republicans 11/7/2016
NeoTract, Inc. Release: UK Government Names Urolift System To Be Fast Track Funded For The NHS As A Strategically Important Product To Improve UK Healthcare 11/7/2016
Dangerous Infusion Errors Top ECRI Institute's Annual Health Technology Hazards List 11/4/2016
Atox Bio Announces Independent Safety Monitoring Committee Recommendation To Continue Phase 3 Study Of AB103 In Necrotizing Soft Tissue Infections 11/3/2016
FDA Granted E-QURE Approval To Initiate Its US Clinical Trial 11/3/2016
Medicines And Healthcare Products Regulatory Agency ("MHRA") Designates VTS-270 As A Promising Innovative Medicine 11/2/2016
What Do Clinton And Trump Think On Biotech Issues? 11/2/2016
EAG Laboratories Expands Pollinator Testing Capabilities To Meet Agrochemical Industry's Need To Comply With Emerging Regulations 11/2/2016
Mettler-Toledo (MTD) Release: New Weighing Guide: Efficient Weighing Workflows In The Pharmaceutical Industry 10/31/2016
Despite Controversies, China Follows Same Bioethical Regulations As The West 10/28/2016
Imprimis (immy) Registers Its New Jersey Facility With The FDA As An Outsourcing Facility 10/28/2016
FDA Clears VITROS Automation Solutions From Ortho Clinical Diagnostics 10/28/2016
After "Female Viagra," Muscular Dystrophy Drug, Will FDA Stand Firmer Against Pressure To Approve? 10/27/2016
Helius Medical Technologies To Receive ISO 13485 Certificate 10/27/2016
Concordia (CXR.TO) Announces Communication With CMA 10/26/2016
Johnson & Johnson (JNJ) to Stop Using Live Animals in Sale Rep Training 10/25/2016
Harvard Experts Fret Over the Fallout From FDA’s OK for Sarepta (SRPT)’s Controversial DMD Drug 10/25/2016
CFDA Addresses "80% of China Trials Are Based On Fraudulent Data" Story 10/25/2016
Fujitsu Announces That Renowned MRI Testing Facility, MAGNETIC RESONANCE SAFETY TESTING SERVICES, Confirms That Fujitsu UHF RFID Linen Tags Are Proven Suitable For Use In MRI Systems 10/25/2016
Soligenix (SNGX) Receives EMA Designation As Small And Medium Enterprise 10/25/2016
FDA Reclassifies Johnson & Johnson (JNJ) Acclarent's Aera Eustachian Tube Balloon to a Class II Device 10/25/2016
In A Tight Race, One Of Pharma's Favorite Senators Gets A Little Help From His Friends 10/25/2016
Sanders Urges Californians To Approve Drug Price Ballot Measure 10/24/2016
Keep Politics Out Of Science? Fugghedaboutit 10/24/2016
Cepheid (CPHD) Announces Receipt Of Required Regulatory Clearances In Proposed Acquisition 10/24/2016
Orthofix International NV (OFIX) Announces North American Spine Society Coverage Policy Recommendations For Electrical Bone Growth Stimulators 10/24/2016
Panther Biotechnology Announces Meeting With U.S. FDA 10/24/2016
Allergan (AGN) Release: FDA Advisory Committee Recommends Approval Of SER120 (Desmopressin Nasal Spray) 10/21/2016
Teva (TEVA) Rallies Despite FDA Warning Letter 10/21/2016
FDA Panel Backs Allergan (AGN)'s Drug For Frequent Nightly Urination 10/20/2016
Pharma Reps May Have To Carry Special License In Chicago To Promote Drugs 10/20/2016
Lannett (LCI) Comments On FDA Proposal Regarding Methylphenidate Extended Release Tablets 10/19/2016
Gramercy Extremity Orthopedics Passes Electromagnetic Compatibility Testing 10/18/2016
Why Egalet's FDA PDUFA Delay Is No Cause For Panic 10/18/2016
Newest WikiLeaks Dump of Clinton Emails Exposes Some Biopharma Chatter 10/18/2016
Swinging at Wild Pitches, BioMarin (BMRN) Considering Appealing DMD Drug Rejection 10/17/2016
Pfizer (PFE) Retractions Point To The Need For Better Research Oversight 10/17/2016
Health Canada Release; Information Update - Premature Battery Depletion With Certain St. Jude Medical (STJ) Implantable Defibrillators 10/17/2016
Canadian Generic Pharmaceutical Association Release: New Report: Regulatory Convergence Key To Ensuring Ongoing Supply Of Generic Prescription Medicines In Canada 10/17/2016
Sarepta (SRPT) Lands a Valuable Priority Review Voucher on Exondys 51 OK 10/14/2016
Valeant (VRX) Patient Access And Pricing Committee Comments On Recent Pricing Action Decisions 10/14/2016
Avacen Medical Announces Support For New Initiative 10/13/2016
Certara Corporation Establishes Phoenix PK/PD Centers Of Excellence In China And Japan 10/13/2016
Carestream Health Ultrasound Systems Receive Health Canada License 10/13/2016
Regenicin, Inc. Announces Scheduled Pre-IND Meeting With FDA For Its New Autologous Cultured Skin Substitute, NovaDerm 10/12/2016
FDA Signs CRADA With CluePoints To Explore A Data-Driven Approach To Quality Oversight In Clinical Trials 10/12/2016
Chinese Vendors Openly Offer One Of The Most Lethal Opioids For Worldwide Export 10/11/2016
Syros Pharma Announces Approval Of Investigational Device Exemption (IDE) For Blood Test To Identify Cancer Patients With Proprietary Biomarkers 10/11/2016
BioStable Science & Engineering Completes Direct De Novo Application To FDA For The HAART 300 Aortic Annuloplasty Device 10/11/2016
BioElectronics Corporation Comments On Its U.S. FDA's OTC Market Clearance Application 10/10/2016
MYnd Analytics California Centers Receive CMS Approval 10/10/2016
Biostage Provides Regulatory Update of Cellspan Esophageal Implant 10/7/2016
Centene Corporation's Kansas Subsidiary Awarded Commendable Accreditation Status From NCQA 10/7/2016
Trump And Clinton Are Ignoring Science And Engineering -- A Key Part Of America's Future 10/6/2016
T-Cyte Launches First USDA-Approved Treatment Aid For Canine Osteoarthritis 10/6/2016
Martin Shkreli A Creature Of FDA Regulation, Not Pharma Industry's Greed 10/5/2016
Could Drug Checking Have Prevented Prince's Overdose Death? 10/5/2016
Ascentage Pharma's Lab Passes China National Standards Test 10/5/2016
CFDA: 80% Of China's Drug Applications Rely On Faulty Data 10/5/2016
AstraZeneca Canada (AZN) Release: Canada Denies Public Access To Potentially Life-Prolonging Ovarian Cancer Treatment LYNPARZA (Olaparib) 10/5/2016
Interpace Diagnostics Announces New York State Approval Of ThyGenX For Indeterminate Thyroid Nodules 10/5/2016
Obama Extends Controversial Program For Rare Pediatric Drugs 10/4/2016
Trinity Biotech (TRIB) Cuts Jobs in Shutdown of Swedish Facility, Withdraws Device App With the FDA 10/4/2016
EXACT Sciences (EXAS) Announces Inclusion Of Cologuard In HEDIS Quality Measures 10/4/2016