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Biotech/Pharma - Regulatory
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
Ireland Makes Its Case to Be New Home for the EMA Following Brexit 9/23/2016
Levita Magnetics Snags Class II Status for Gallbladder Surgery Device 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
MMJ PhytoTech Ltd Health Canada Instates Task Force For The Legalization Of Recreational Marijuana 7/5/2016
Health Canada Release: Government Of Canada Proposes Stronger Rules For Antimicrobial Drugs 7/1/2016
Cepheid (CPHD) Release: FDA Supports Expanded Claims For Xpert Carba-R Test For "Superbugs" 7/1/2016
California Life Sciences Association Disappointed By Assembly Health Committee’s Action To Advance SB 1010 6/30/2016
Brexit Creates Difficulties And Opportunities For UK Pharma And Medical Device Industries 6/30/2016
Health Canada Release: Mandatory Reporting Of Drugs Shortages And Discontinuances On Track For Spring 2017 Implementation 6/30/2016
MMJ PhytoTech Ltd Granted Licence By Health Canada To Produce Medical Cannabis 6/30/2016
Biocept, Inc. (BIOC) Comments On Reimbursement Provisions In CMS' Final PAMA Rule 6/29/2016
CareDx (CDNA) Responds To CMS Proposal To Cut AlloMap Pricing By 74% 6/29/2016
CXR Biosciences Gains GLP Accreditation, Launches In-Vitro Dermal Absorption Service Following Industry Demand 6/29/2016
Cytori Therapeutics (CYTX) Cell Therapy Receives Limited Approval For Osteoarthritis In Japan 6/27/2016
Chinese Authorities Issued Operating Approval To Siegfried Nantong 6/27/2016
Ferring Pharma Announces Approval Of New Tailored Dosing Regimen In The PICOPREP (Sodium Picosulfate, Magnesium Oxide, Citric Acid) Label In MRP Countries In Europe 6/27/2016
British Trade Group Suspends Astellas (ALPMY) After Drugmaker Disguised the True Purpose of a Meeting Held for Doctors 6/27/2016
CDC Advisory Committee On Immunization Practices Votes To Recommend Vaxchora, PaxVax, Inc.’s Single-Dose Oral Cholera Vaccine 6/23/2016
iCAD, Inc. (ICAD) Commends Final USPSTF Recommendations For Colorectal Cancer Screening Including Computed Tomography Colonography (CTC) 6/22/2016
Newly Issued USPSTF Guidelines For Colorectal Cancer Include Complete Line Of Products From Polymedco 6/22/2016
PCMA: CREATES Act To Increase Access To Generic Drugs 6/22/2016
TransCelerate BioPharma’s SQT Initiative Reaches Target Outcomes 6/22/2016
3 Big Data Risks Pharma Should Fear 6/22/2016
Rosetta Genomics (ROSG) Receives Approval From New York State For HEME FISH-Based Assays 6/21/2016
FDA Grants Emergency Use Authorization For Hologic (HOLX)'s Aptima Zika Virus Assay 6/20/2016
Veracyte (VCYT) Releases Statement On CMS's Final PAMA Rule 6/20/2016
Schulman IRB To Exhibit At DIA Annual Meeting 6/17/2016
EXACT Sciences (EXAS)' Cologuard Included In Final USPSTF Colorectal Cancer Screening Recommendations 6/16/2016
China Begins Marketing Authorization Holder Pilot Program 6/16/2016
Exactech (EXAC) Statement Regarding Pending USPSTF Colorectal Cancer Screening Guidelines 6/16/2016
FDA's Cancer Leader Sends The Wrong Message On Immuno-Oncology Drug Research 6/15/2016
Amplyx Announces Qualified Infectious Disease Product Designation For APX001 In Three Life-threatening Fungal Infections 6/15/2016
National Institute For Health And Care Excellence Provides Positive Guidance For Use Of Boston Scientific (BSX) GreenLight XPS Laser Therapy System In The Treatment Of BPH 6/15/2016
BioPhotas Announces Attainment Of ISO 13485:2003 Certification 6/15/2016
Shire (SHPG) Announces Completion Of Decentralized Procedure In Europe For Immunoglobulin Treatment Cuvitru 6/13/2016
Arena (ARNA) Announces USAN Approval Of Nonproprietary Name "Etrasimod" ForIts Drug Candidate APD334 6/13/2016
FDA Lifts All Remaining Shipping Restrictions At Terumo Cardiovascular Systems' Ann Arbor Facility 6/10/2016
Successful Inspection By FDA Of Almac Clinical Services North Carolina Facility 6/10/2016
Heart Test Labs Achieves Significant Milestone With ISO 13485 Certification 6/9/2016
PuriCore Successfully Completes Pre-IND Meeting With The FDA On PR022 For Atopic Dermatitis 6/9/2016
Meijer Specialty Pharmaceutical Services Receives National Accreditation 6/9/2016
NN, Inc. Certifies Additive Manufacturing Technology For Medical Devices 6/9/2016
Amarantus Announces cGMP Manufacturing Readiness For Its Engineered Skin Substitute (ESS) Program At Lonza Walkersville 6/8/2016
These Threats Can Take Down a Device Company 6/7/2016
EU Rules on Medical Devices Reached Sooner than We Thought 6/7/2016
Enzo Biochem (ENZ) Announces New York State Approval Of New Women’s Test Based On Proprietary Technology 6/7/2016
Cristalia Obtains Registration For First Biotechnological Pharmaceutical Ingredient 6/7/2016
Test The Right Way At The Right Time: Mettler-Toledo (MTD) Offers Free Standard Operating Procedures For Routine Balance Testing 6/7/2016
TherapeuticsMD, Inc.  (TXMD) Announces New Innovation In Compliance Packaging For Prenatal Vitamins 6/6/2016
St. Jude Medical (STJ) Cardiomems HF System Is Now Guideline Directed Therapy For Heart Failure Patients In Europe 6/6/2016
GlaxoSmithKline (GSK) Release: Regulatory Update On US Filing Plans For Closed Triple Combination Therapy FF/UMEC/VI In Patients With COPD 6/3/2016
BioStem Technologies Announces Issuance Of FDA Drug Establishment Registration Number And FDA Labeler Code To Wholly Owned Subsidiary Biostem Pharmaceuticals, Inc. 6/3/2016
Innovus Pharma To Request Regulatory Guidance For Filing For Its FlutiCare Product In Europe For The Treatment Of Allergic Rhinitis 6/3/2016
Most Scientists Believe There Is A "Crisis" Reproducing Experiments 6/2/2016
Vexos Shenzhen China Facility Achieves ISO 13485:2003 Registration Of Its Quality Management System 6/2/2016
TSO3 (TOS) Responds To U.S. Regulators On Extended Claims And Provides Operations Update 6/2/2016
How Drug Companies Target Kids 6/2/2016
Corbus Release: Non-Deal Road Show Adds Confidence To Our Bullish Thesis 6/2/2016
Aratana Therapeutics (PETX) Receives CMC Technical Section Complete Letter For Post-Operative Pain Therapeutic 6/2/2016
Kite Pharma (KITE) Granted Access To Priority Medicines (PRIME) Regulatory Support For KTE-C19 In The Treatment Of Chemorefractory Diffuse Large B-Cell Lymphoma (DLBCL) 6/2/2016
Janssen Pharmaceutica N.V. Release: New Idylla Ebola Virus Triage Test Granted Emergency Use Authorization by U.S. FDA 6/1/2016
China Announces NDRC Investigation Into Drug/Device Pricing 6/1/2016
Second iCardiac Certified Site For Altasciences Clinical Research 6/1/2016
PharPoint Research Strengthens European Capabilities 6/1/2016
BioVentrix Receives FDA IDE Approval For Its Pivotal Clinical Trial, ALIVE 5/31/2016
Swedish Orphan Biovitrum Initiates Disclosure Of Payments To The Healthcare Industry To Increase Transparency 5/31/2016
Pixium Vision Receives Clinical Trial Approval From UK Regulatory Authority For 150 Electrode IRISII Bionic Vision System 5/31/2016
Independent Data Safety Monitoring Board Recommends Continuation Of CytoSorbents REFRESH I Trial 5/27/2016
Kitov (KTOV) Announces Completion Of Manufacturing Pivotal Batches Of KIT-302 Required For Registration In The U.S. 5/27/2016
Approving Sarepta (SRPT)'s DMD Drug Could Force FDA To Get Creative 5/26/2016
Coalition Asks FDA To Issue Broad Guidance On Acceptable Irritation Test Methods 5/26/2016
DSM Sinochem Pharmaceuticals Supports Fight Against Superbugs And Welcomes The Clear Recommendations Of The AMR Review 5/24/2016
BIO Release: Arizona Governor Ducey Signs Bill Ensuring Patient Access To Interchangeable Biologic Medicines 5/24/2016
Proove Announces Lab Accreditation From College of American Pathologists 5/24/2016
Warwick Analytical 24 Hour ICP Analysis Service 5/23/2016
Rosetta Genomics (ROSG) Receives Approval From New York State For Four PCR-Based Assays 5/23/2016
Intoxalock is Now Certified To Install Ignition Interlock Devices In Florida 5/23/2016
Oxitec CEO To Testify Before Congressional Committee On May 25th 5/23/2016
California Life Sciences Association Release: Patients, Life Sciences Community Announce Opposition To SB 1010; Launch Digital Campaign 5/23/2016