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Biotech/Pharma - Regulatory
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
Newest WikiLeaks Dump of Clinton Emails Exposes Some Biopharma Chatter 10/18/2016
Why Egalet's FDA PDUFA Delay Is No Cause For Panic 10/18/2016
Gramercy Extremity Orthopedics Passes Electromagnetic Compatibility Testing 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
Health Canada Authorizes Use Of Naloxone Nasal Spray 10/4/2016
BioDirection Files Pre-Submission Package With FDA 10/4/2016
Anatara Lifesciences APVMA Submission Major Milestone Achieved 10/4/2016
Heart Test Labs Completes Regulatory Submission For Both FDA 510(K) And CE Mark 10/4/2016
BioPharm Executive: Did the FDA Just Destroy Its Credibility? 10/3/2016
FDA Grants Valencia Technologies IDE Approval For U.S. Pivotal Study Of Bioelectronic Device For Hypertension 10/3/2016
FDA Warns Against The Use Of Homeopathic Teething Tablets And Gels 10/3/2016
Ampio Pharmaceuticals, Inc. (AMPE) Updates Clinical And Regulatory Activity 9/30/2016
Does The FDA Have A High Enough Standard For Drug Approvals? 9/29/2016
Biotechs Leverage Patient Groups In Drug Development 9/29/2016
Serametrix Gains CLIA Certification For MDSC-Based Blood Test For Predicting Response To Immunotherapy In Cancer Patients 9/29/2016
FDA's Clinical Investigator Training Helps Support The Drug Development Process 9/29/2016
GW Pharma (GWPH) Gets Closer To Forcing FDA On Cannabis 9/28/2016
It's a Big Problem When The FDA's Drug Reviewers Keep Leaving To Work For Big Pharma 9/28/2016
Pharma Start Announces Successful Transition Reassessment To The ISO 9001:2015 Standard 9/28/2016
N&N Pharma Release: N-Methanocarbathymidine Granted Orphan Drug Designation In The U.S. 9/27/2016
Minority Inclusion in Clinical Trials: When Diversity Priorities Show 9/27/2016
Clinton, Trump Share Big-Pharma Attack Goals, Andrew Left Says 9/27/2016
New Standards For Forensic Grade Manufacturing Integrated At Promega Corporation 9/27/2016
MDxHealth, Inc. (MXDHF) Announces Independence Blue Cross Rendered Positive Medical Coverage Policy For ConfirmMDx 9/27/2016
Good Pharma Scorecard: Pharma's Worst Fear or Newest Ally? 9/26/2016
Merck & Co. (MRK)’s Keytruda Finds Fast Entry Into China Via Medical-Tourism Push 9/26/2016
Regentis Biomaterials Receives IDE Approval For Pivotal GelrinC Clinical Trial 9/26/2016
Ireland Makes Its Case to Be New Home for the EMA Following Brexit 9/23/2016
GENFIT (ALGFT): Successful Identification Of ROR?t Inverse Agonists As Candidates For Regulatory Pre-IND Studies 9/23/2016
35 U.S. States Sue British Drugmaker Indivior Over Marketing of Opioid 9/23/2016
Levita Magnetics Snags Class II Status for Gallbladder Surgery Device 9/22/2016
Marketpoint Recall Expands To U.S., UK-Based Recall Response Specialist Provides Multilingual Support For U.S. Businesses 9/22/2016
How Big Pharma Pressures States To Pay For Pricey Pills 9/21/2016
AACC Advocates Against Expanded FDA Oversight Of Laboratory Developed Tests To Senate HELP Committee 9/21/2016
Parenteral Drug Association's PAC iAM Task Force Releases Work Plan To Reduce Manufacturing Change Barriers 9/20/2016
Enzo Biochem (ENZ) Announces New York State Health Department Approval Of New Easily Adaptable, Cost Effective Cardiac Assay 9/20/2016
California Life Sciences Association Answers ICER’s Call For Improvements To Its Value Assessment Framework For Evaluating New Therapies 9/19/2016
HHS Issues New Rules To Open Up Data From Clinical Trials 9/19/2016
Big Pharma Spends Millions To Keep Prices High For California Agencies 9/19/2016
Humana, Inc. (HUM) CEO: We Are Using Retail Consumer Behavior Analytics To Personalize Care 9/19/2016
Neogen Corporation (NEOG)'s AccuPoint Advanced Receives AOAC Approval 9/19/2016
Lannett (LCI) Announces Successful FDA Inspections Of Three Facilities 9/19/2016
Here's How Rare Diseases Are Becoming Too Common 9/19/2016
FDA Takes Back Special Protocol Assessment for Active Biotech (BTPC)'s Laquinimod 9/19/2016
BIO Statement On Biosimilar User Fee Act Goals Letter 9/19/2016
Kerecis Wound-Treatment Product With Omega3 Fish Skin Now Eligible For Medicare Reimbursement In 45 States 9/19/2016
Biotalent Canada To Assist Ontario Biotech Companies With Accessibility-Compliance Reporting 9/19/2016
Seattle Biotechs Still Hurting From Election Season "Witch Hunt" 9/16/2016
Acclarent: FDA Permits Marketing Of Balloon Device To Treat Persistent Eustachian Tube Dysfunction 9/16/2016
Government Hypocrisy Over EpiPen: The Pot Calling The Kettle Black 9/15/2016
Centene Corporation Expands Marketplace Offering In Arizona 9/15/2016
MiMedx Urges FDA To Reconsider Draft Guidances During Hearing 9/15/2016
PCI Synthesis Obtains DEA Registration For Controlled Substance Development And Manufacturing 9/15/2016
Bone Therapeutics Receives Positive Ruling On Belgian Patent Income Deduction 9/15/2016
What The DEA's Plan To Schedule 1 Kratom Will Mean For Millions 9/14/2016
The Candidates' Views On America's Top 20 Science, Engineering, Tech, Health & Environmental Issues In 2016 9/14/2016
Will FDA’s Scrutiny of Pfizer (PFE)’s Chantix Trial Go Up in Smoke? 9/13/2016
FDA Approves The Cleveland Cord Blood Center's CLEVECORD For Stem Cell Transplants 9/13/2016
Organogenesis Release: Nation's Leading Developer Of Advanced Wound Care Technologies Urges FDA To Finalize Regulatory Guidance To Ensure Safety And Efficacy Of Section 361 HCT/Ps 9/13/2016
Johnson & Johnson (JNJ) Announces WHO Will Review Ebola Vaccine Regimen For Emergency Use Assessment And Listing (EUAL) 9/13/2016
The Alliance for Regenerative Medicine (ARM) Submits Comments In Response To FDA Draft Guidances On The Regulation Of Human Cells, Tissues Or Cellular Or Tissue-Based Products 9/13/2016
Sparta Systems, Inc. Partners With Navitas To Provide Comprehensive Solution For IDMP Compliance 9/13/2016
FDA CONSUMER HEALTH INFORMATION: FDA Facilitates Research On Earlier Stages Of Alzheimer's Disease 9/13/2016
The Theranos Debacle: Why We Should Have Less Regulation Of Everything, Not More 9/12/2016
Akari Therapeutics Announces Receipt Of Orphan Drug Designation For Coversin From The FDA For Treatment Of Paroxysmal Nocturnal Hemoglobinuria 9/12/2016
Bavarian Nordic (BAVA.CO) Announces That Janssen Has Completed A Submission For Emergency Use Assessment And Listing For Its Ebola Vaccine Regimen To WHO 9/12/2016
FDA Expands Emergency Use Authorization For Hologic (HOLX)'s Aptima Zika Virus Assay To Include Use With Urine Samples 9/9/2016
Are Geneticists Who Work For Corporations Really Less Ethical Than University Researchers? 9/9/2016
European Chemicals Agency Supports Novartis AG (NVS) Over Use of Toxic Chemical in Drugs 9/9/2016
QIAGEN N.V. (QGEN) Welcomes U.S. Guidance For Latent TB Testing In Primary Care 9/9/2016
Cancer Cures Could Already Exist In Big Data 9/8/2016
Apple (AAPL) Raises Explicit Guidelines for Mobile Medical and Health App Developers 9/8/2016
Embracing Technology Produces Good Regulatory Practice in Pharmaceutical Lifecycle Maintenance 9/8/2016
Anatara Lifesciences Successful Completion of Target Safety Study 9/8/2016
FDA Grants Special Designation To TAXIS Pharma Experimental Antibiotic 9/7/2016
Eppendorf Striving To Ensure All Labs Are Smart, Safe, And Stress-Free, With Eppendorf Advantage 9/6/2016
Alzheimer’s Research UK Release: Loss Of Research Funding Is Top Brexit Fear For Dementia Scientists 9/6/2016
Thermo Fisher Scientific (TMO) Pledges To Verify Specificity Of Antibodies In Accordance With New Antibody Validation Recommendations 9/6/2016
Aerotel Medical Systems's HeartLine ECG Monitors Win Colombian INVIMA Certification 9/6/2016
iuvo Bioscience Announces ISO 17025 Accreditation 9/2/2016
Evonik Industries Birmingham Laboratories Receives Renewal Of GMP Certification 9/2/2016
Becton, Dickinson and Company (BDX) Release: Mayo Clinic Proceedings Publishes New Insulin Injection And Infusion Recommendations 9/1/2016
FDA Requires Strong Warnings For Opioid Analgesics, Prescription Opioid Cough Products, And Benzodiazepine Labeling Related To Serious Risks And Death From Combined Use 9/1/2016
Another Reason Why Medical Device Class Actions Don’t Work 8/31/2016
Evonik Birmingham Laboratories Receives Renewal Of GMP Certification 8/31/2016
PBOA Statement On Reauthorization Of The Generic Drug User Fee Amendments 8/31/2016
Health Canada Moving Quickly To Control Chemicals Used To Make Fentanyl 8/31/2016
PhRMA Release: Improving FDA's Combination Product Review Process Could Increase Epinephrine Auto-Injector Competition 8/30/2016
Cerus (CERS) Release: FDA's New Recommendation For Universal Zika Risk Reduction Of Blood Components Includes Use Of Pathogen Reduction 8/29/2016
Agena Biosciences Names Genelex Corporation As Certified Service Provider For Targeted Genetic Analysis 8/29/2016
Embattled Theranos Plans to Appeal to Re-Open Its Lab in Newark, California 8/26/2016
Most Experts Who Develop Cancer Treatment Guidelines Have Ties To Industry 8/26/2016
PharmAthene, Inc. (PIP) Withdraws Protest Against HHS Over Anthrax Vaccine Bidding Process 8/26/2016
FDA Advises Testing For Zika Virus In All Donated Blood And Blood Components In The US 8/26/2016
Bioness Inc. Vector Gait And Safety System Receives Expanded UL Certification 8/25/2016
Drugmakers And Medtechs Pay Thousands Of Docs With Disciplinary Records 8/24/2016
Singulex Granted ISO 13485:2012 Certification 8/24/2016
10 Disruptive Technologies And The Regulatory Implications 8/24/2016
FDA Allows Marketing Of First-Of-Kind Computerized Cognitive Tests To Help Assess Cognitive Skills After A Head Injury 8/23/2016
Perrigo (PRGO) Announces Tentative FDA Approval For Generic Version Of Suprep Oral Solution And Confirms Patent Challenge For Generic Version Of Mirvaso Gel 8/23/2016
Clinical Trials Doctors Demand Ownership Of Patients' Data 8/22/2016
Edwards Lifesciences Corporation (EW) SAPIEN 3 Transcatheter Heart Valve Receives Expanded Indication From FDA 8/19/2016
Shuwen Biotech Release: Chinese FDA Grants MammaTyper Innovative Product Status For Expedited Approval 8/19/2016
BeiGene (BGNE) OK'd To Test PARP Inhibitor In China 8/19/2016
International Society for Cellular Therapy Calls For Changes To Proposed U.S. REGROW Act On Cell Therapies 8/18/2016
EMD Serono Receives CEO Cancer Gold Standard Re-Accreditation 8/18/2016
Cancer Genetics (CGIX) Strengthens Position As A Leader In Myeloid Cancer Diagnosis And Management Receiving New York State Approval For Focus: Myeloid, A Targeted NGS Panel For Improved Diagnosis, Risk Stratification, And Therapy Selection Of Patients With Myeloid Cancers 8/17/2016
Agena Biosciences Expands ISO Accreditation For Genetic Testing 8/16/2016
ChromaDex, Inc. Release: U.S. FDA Issues GRAS No Objection Letter For NIAGEN 8/16/2016
WuXi AppTec's STA Subsidiary Passed Third U.S. FDA Inspection 8/15/2016
CFDA Will Require Pharmas To Self-Report Any Drug Manufacturing Changes 8/15/2016
EXACT Sciences (EXAS) Release: Cologuard Coverage Expands With Updated Policies From HCSC And Florida Blue 8/11/2016
Magellan Diagnostics Receives CFDA Clearance For LeadCare II In China 8/10/2016
ArcherDX NGS Assays Receive Conditional Approval By New York State 8/9/2016
Wockhardt (WOCKHARDT.BO) Plunges On U.S. Ban On Third Drug-Making Factory 8/8/2016
Bracco Diagnostics Release: Virtual Colonoscopy Receives Highest Grade In The New U.S. Preventive Services Task Force Recommendation For Colorectal Cancer Screening 8/5/2016
Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent ARYMO ER (Morphine Sulfate) and Reports Second Quarter 2016 Financial Results 8/5/2016
Jazz Pharma (JAZZ) Release: CMS Grants New Technology Add-On Payment To Defitelio For The Treatment Of Hepatic Veno-Occlusive Disease With Renal Or Pulmonary Dysfunction Following Hematopoietic Stem-Cell Transplantation 8/3/2016
bioMerieux Submits 510(K) Application To The bioMerieux For BacT/ALERT VIRTUO Next Generation Automated Blood Culture System 8/3/2016
FDA-Approved Knock-Offs Of Biotech Drugs Could Safely Save Big Bucks 8/2/2016
Agilis Biotherapeutics Announces FDA Orphan Drug Designation For The Treatment Of Friedreich’s Ataxia (FA) 8/2/2016
REGENXBIO's Gene Therapy for Hunter Syndrome Nabs FDA's 'Rare Pediatric Disease' Status 8/2/2016
Roche (RHHBY) Receives CLIA Waiver For Cobas Influenza A/B & RSV Test For The Cobas Liat 8/1/2016
Sight Sciences Receives Full Investigational Device Exemption (IDE) Approval From The US FDA To Initiate The VISCO360 Versus SLT Glaucoma Trial 7/27/2016
Bayer (BAY) Increases Monsanto (MON) Offer And Provides Certainty On Financing And Regulatory Matters 7/25/2016
Vascular Insights Release: NICE Issues Approval Via Interventional Procedure Guidance IPG557 For Endovenous Mechanochemical Ablation For Varicose Veins In The United Kingdom 7/25/2016
Araim Pharmaeuticals Obtains Fourth Orphan Designation: ARA 290 Obtains US Orphan Drug Designation For Treatment To Increase Survival And Improve Functioning Of Pancreatic Islets Following Transplantation 7/25/2016
India’s Drug Approvals Near Record Despite FDA Inspection Blitz 7/22/2016
Donald Trump And His Take On Drug Companies 7/22/2016
Royal Philips Electronics N.V. (PHG) SimplyGo Mini Portable Oxygen Concentrator Conforms To FAA Standards, Now Available For On Board Aircraft Use 7/21/2016
ViraCor-IBT Laboratories's Zika Virus RT-PCR Test Receives Emergency Use Authorization From The FDA 7/20/2016
Two More Envigo Facilities Earn AAALAC Accreditation 7/20/2016
Intel Custom Foundry Certifies ANSYS, Inc. (ANSS) Simulation Tools For Next-Generation 10nm Tri-Gate Process 7/19/2016
Drugmakers Try New Ways To Attract Patients To Drug Trials 7/19/2016
Exco InTouch Approved Fully Compliant With NIST Guidelines Following Successful Completion Of HIPAA Privacy Audit 7/19/2016
Calgary Scientific Accredited For Web And Mobile Diagnosis Across Asia 7/19/2016
PhRMA Statement On Prescription Drug User Fee Act Reauthorization 7/18/2016
Bayer (BAY) Sweetens Deal to $54.7 Billion for Monsanto (MON) 7/15/2016
Alere (ALR) HIV Combo Test Receives WHO Prequalification 7/14/2016
EXACT Sciences (EXAS) Release: NCQA Proposes Inclusion Of Cologuard In 2017 HEDIS Quality Measures 7/14/2016
Vascular Insights Release: National Institute For Health And Care Excellence (NICE) Issues Approval Via Interventional Procedure Guidance IPG557 For Endovenous Mechanochemical Ablation For Varicose Veins In The United Kingdom 7/14/2016
Cynosure (CYNO) Receives Health Canada Authorization To Market SculpSure 7/13/2016
42Q Announces GAMP 5 And Part 11 Compliance For Cloud-Based Manufacturing Execution System 7/12/2016
Impact Cryotherapy Leads The Industry With FDA Compliance 7/12/2016
HEPATIQ Receives Additional FDA Clearance 7/12/2016
Hemispherx (HEB) Updates The Status Of The Alferon Manufacturing Facility 7/11/2016
PURE Bioscience (PURE) Receives USDA No Objection Letter For Use Of SDC-Based PURE Control Antimicrobial In Poultry Processing For Pre-OLR And Post Chill Applications 7/11/2016
Drug Industry CEOs Lead New Task Force On Brexit's Pharma Fallout 7/8/2016
Health Canada Allowing Immediate Access To Naloxone Nasal Spray 7/7/2016
Illumina (ILMN) Applauds FDA’s Issuance Of Draft Guidances To Advance Precision Medicine Using Next Generation Sequencing 7/7/2016
Thermo Fisher Scientific (TMO) Trial Design Helps Accelerate FDA Clearance Process For B·R·A·H·M·S PCT License Partners 7/7/2016
GenomeDx Biosciences Receives Accreditation From College of American Pathologists 7/6/2016