Biotechnology Companies in the News
Editor’s Note: The home page of the BioNJ Web site provides an up-to-the-minute headline service where readers can access press releases issued by New Jersey-based biotechnology companies. Go to the “New Jersey Biotechnology Company News” section on the BioNJ home page (www.BioNJ.org) to read the latest news. Companies wishing to appear in the BioLines Biotechnology Companies in the News section are encouraged to send their news releases to BioNJ via e-mail at [email protected].
November 4 Merck’s Investigational 9-valent HPV Vaccine, V503, Prevented 97 Percent of Cervical, Vaginal and Vulvar Pre-cancers Caused by Five Additional HPV Types, in Phase III Study http://www.mercknewsroom.com/news-release/research-and-development-news/mercks- investigational-9-valent-hpv-vaccine-v503-prevente
Antares Pharma Appoints Dr. Bruce Freundlich as Senior Vice President http://www.businesswire.com/news/home/20131104005132/en/Antares-Pharma-Appoints-Dr.- Bruce-Freundlich-Senior
ADMA Biologics Completes Enrollment of Phase III Study for RI-002 http://www.businesswire.com/news/home/20131104005564/en/ADMA-Biologics-Completes- Enrollment-Phase-III-Study
Alliance Life Sciences Participates as Event Sponsor at ISPOR 16th Annual European Congress, Presents Examination of Biotech Industry’s Performance on the Stock Market http://www.bioportfolio.com/news/article/1705865/Alliance-Life-Sciences-Participates-as-Event- Sponsor-at-ISPOR-16th-Annual-European.html
November 2 BMS Submits First All-Oral, Interferon-Free and Ribavirin-Free Treatment Regimen for Regulatory Review in Japan for Patients with Chronic Hepatitis C Infection http://news.bms.com/press-release/bms-submits-first-all-oral-interferon-free-and-ribavirin-free- treatment-regimen-regula
Merck Announces Presentation of Interim Data from Study of Investigational Combination of HCV Therapies MK-5172 and MK-8742 at the 2013 American Association for the Study of Liver Diseases (AASLD) Annual Meeting http://www.mercknewsroom.com/news-release/research-and-development-news/merck- announces-presentation-interim-data-study-investiga
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October 31 Edge Therapeutics Enrolls First Patient in Phase 1/2 NEWTON Study of EG-1962 for Prevention of Delayed Cerebral Ischemia http://finance.yahoo.com/news/edge-therapeutics-enrolls-first-patient-103000583.html
Antares Pharma to Host Third Quarter 2013 Operating and Financial Results Conference Call http://finance.yahoo.com/news/antares-pharma-host-third-quarter-110000991.html
Protalex Initiates Enrollment of Final Cohort in Phase 1b Trial of PRTX-100 in Active Rheumatoid Arthritis Patients http://www.businesswire.com/news/home/20131031005799/en/Protalex-Initiates-Enrollment- Final-Cohort-Phase-1b electroCore's clinical trial program into non invasive vagus nerve stimulation therapy gathers momentum http://www.businesswire.com/news/home/20131031005886/en/electroCores-clinical-trial- program-invasive-vagus-nerve
Soligenix Submits NIAID Contract Proposal for Development of a Thermostable Ricin Vaccine http://www.soligenix.com/news.aspx?titleId=436
October 30 IMS Health Identifies Opportunities for Mobile Healthcare Apps to Drive Patient Engagement, Enhance Delivery of Care http://www.businesswire.com/news/home/20131030005221/en/IMS-Health-Identifies- Opportunities-Mobile-Healthcare-Apps
Celgene Corporation to Webcast at Upcoming Investor Conferences and Medical Congress http://newsroom.celgene.com/press-release/corporate/celgene-corporation-webcast-upcoming- investor-conferences-and-medical-congre
Dr. Greg Koski, Head of ACRES Global Clinical Research Network, Elected to SAFE- BioPharma Board of Directors http://finance.yahoo.com/news/dr-greg-koski-head-acres-124300194.html
Darren Alkins Picked to Head Alvogen Americas http://www.businesswire.com/news/home/20131030005121/en/Darren-Alkins-Picked-Head- Alvogen-Americas
Phyxius Pharma in Conjunction with Oxygen Biotherapeutics Announces New Evidence That Levosimendan Can Reduce Mortality in Heart Surgery Patients http://www.businesswire.com/news/home/20131030005494/en/Phyxius-Pharma-Conjunction- Oxygen-Biotherapeutics-Announces-Evidence
Agano Solutions and Auditgraph Announce Advisory Board http://www.businesswire.com/news/home/20131030006147/en/Agano-Solutions-Auditgraph- Announce-Advisory-Board
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STENTYS Self-Apposing Stent Performs Well in New Coronary Indications http://www.businesswire.com/news/home/20131030006059/en/STENTYS-Self-Apposing-Stent- Performs-Coronary-Indications
Photocure provides update on Visonac®http://finance.yahoo.com/news/lutonix-six- month-results-presented-201100672.html http://www.photocure.com/Pressmedia/News/Visonac-agreement/
Lutonix Six-Month Results Presented on First IDE Trial for Drug-Coated Balloons http://finance.yahoo.com/news/lutonix-six-month-results-presented-201100672.html
The Medicines Company's EUROMAX Trial of Angiox(R) (Bivalirudin) in Heart Attack Meets All Prespecified Endpoints http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol- newsArticle&ID=1870307&highlight=
October 29 RSV Vaccines for the World 2013 Conference Presentation Highlights Data from ADMA Biologics’ Human and Animal Study Experience http://www.businesswire.com/news/home/20131029005742/en/RSV-Vaccines-World-2013- Conference-Presentation-Highlights
Vention Medical Acquires Fast Forward Medical http://www.businesswire.com/news/home/20131029005983/en/Vention-Medical-Acquires-Fast- Medical
STENTYS Sirolimus-Eluting Stent Demonstrates Faster Arterial Healing Than Conventional Drug-Eluting Stent http://www.businesswire.com/news/home/20131029006580/en/STENTYS-Sirolimus-Eluting- Stent-Demonstrates-Faster-Arterial-Healing
Merck Announces Presentation of Interim Data from Phase 1B Study of MK-3475, Investigational anti-PD-1 Immunotherapy, in Previously-Treated Patients with Non-Small Cell Lung Cancer (NSCLC) at 15th World Conference on Lung Cancer http://www.mercknewsroom.com/news-release/research-and-development-news/merck- announces-presentation-interim-data-phase-1b-study-
Second Annual Leadership Summit for Interventional Cardiologists Held in San Francisco http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol- newsArticle&ID=1869687&highlight=
October 28 Advaxis Appoints Gregory T. Mayes as Chief Operating Officer http://finance.yahoo.com/news/advaxis-appoints-gregory-t-mayes-120000645.html
KCI Completes Acquisition of Systagenix http://finance.yahoo.com/news/kci-completes-acquisition-systagenix-145400492.html
NPS Pharmaceuticals to Report Third Quarter 2013 Financial Results http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1869295
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Soligenix to Host Conference Call and Webcast Discussion on Oral Mucositis http://www.soligenix.com/news.aspx?titleId=435
Promising Phase IIb Data On Clazakizumab In Patients With Moderate-To-Severe Rheumatoid Arthritis To Be Presented At The 2013 Annual Meeting Of The American College Of Rheumatology http://news.bms.com/press-release/financial-news/promising-phase-iib-data-clazakizumab- patients-moderate-severe-rheumato
Howie Mandel Challenges People To Learn The Fibs And Facts About Atrial Fibrillation And Its Associated Increased Stroke Risk http://news.bms.com/press-release/partnering-news/howie-mandel-challenges-people-learn- fibs-and-facts-about-atrial-fibri
Merck Announces Third-Quarter 2013 Financial Results http://www.mercknewsroom.com/news-release/corporate-news/merck-announces-third-quarter- 2013-financial-results
October 25 Epratuzumab’s Mechanism of Action Featured in Blood, Official Journal of The American Society of Hematology http://finance.yahoo.com/news/epratuzumabs-mechanism-action-featured-blood- 123000489.html
GE Healthcare Announces FDA Approval of Vizamyl™ (Flutemetamol F18 Injection) for Detection of Beta Amyloid http://www.businesswire.com/news/home/20131025005773/en/GE-Healthcare-Announces- FDA-Approval-Vizamyl%E2%84%A2-Flutemetamol
Additional Survival Data on Nivolumab, an Investigational PD-1 Immune Checkpoint Inhibitor, from Lung Cancer Cohort of a Phase 1 Study Presented at 15th World Conference on Lung Cancer http://news.bms.com/press-release/rd-news/additional-survival-data-nivolumab-investigational- pd-1-immune-checkpoint-inhi
October 24 Merck Provides Update on Investigational 9-valent HPV Vaccine V503 to U.S. Advisory Committee on Immunization Practices http://www.mercknewsroom.com/news-release/research-and-development-news/merck- provides-update-investigational-9-valent-hpv-vaccin
Celgene Reports Strong Third Quarter 2013 Operating and Financial Results http://finance.yahoo.com/news/celgene-reports-strong-third-quarter-113100186.html
NPS Pharmaceuticals Submits Biologic License Application to the U.S. Food and Drug Administration for Natpara® in Hypoparathyroidism http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1868017
Bristol-Myers Squibb Prices $1.5 Billion of Senior Notes http://news.bms.com/press-release/financial-news/bristol-myers-squibb-prices-15-billion-senior- notes
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October 23 Results for the third quarter and the first nine months 2013 http://www.photocure.com/Pressmedia/News/2Q13-Report-/
Bristol-Myers Squibb Reports Third Quarter 2013 Financial Results http://news.bms.com/press-release/financial-news/bristol-myers-squibb-reports-third-quarter- 2013-financial-results
ZOSTAVAX® (Zoster Vaccine Live) Awarded Prix Galien USA 2013 Best Biotechnology Product http://www.mercknewsroom.com/news-release/prescription-medicine-news/zostavax-zoster- vaccine-live-awarded-prix-galien-usa-2013-be
The Merck Manual Go-To Home Guide for Symptoms Helps Patients Assess When to Worry and When to Wait, Determine Next Steps http://www.mercknewsroom.com/news-release/merck/merck-manual-go-home-guide- symptoms-helps-patients-assess-when-worry-and-when-wai
Senesco Opens New Clinical Trial Site at Seattle Cancer Care Alliance and is Treating the First West Coast Patient http://www.businesswire.com/news/home/20131023005290/en/Senesco-Opens-Clinical-Trial- Site-Seattle-Cancer
Advaxis Announces First Patient Dosed with ADXS-HPV in Head and Neck Cancer Study http://www.businesswire.com/news/home/20131023005585/en/Advaxis-Announces-Patient- Dosed-ADXS-HPV-Head-Neck
October 22 Spectra Laboratories Enters Acquisition Agreement with Shiel Medical Laboratory http://www.businesswire.com/news/home/20131022005129/en/Spectra-Laboratories-Enters- Acquisition-Agreement-Shiel-Medical
Immunomedics Reports Multiple Objective Responses in Solid Cancers With IMMU-132 http://finance.yahoo.com/news/immunomedics-reports-multiple-objective-responses- 163000395.html
Immunomedics Develops Dendritic-Cell Vaccine Technology for Lymphomas and Leukemias http://finance.yahoo.com/news/immunomedics-develops-dendritic-cell-vaccine-203000454.html
Bristol-Myers Squibb to Present Data on Rheumatoid Arthritis Assets at American College of Rheumatology (ACR) 2013 Annual Meeting http://news.bms.com/press-release/bristol-myers-squibb-present-data-rheumatoid-arthritis- assets-american-college-rheumat
Bard Announces Third Quarter Results http://www.businesswire.com/news/home/20131022006626/en/Bard-Announces-Quarter- Results
ADMA Biologics, Inc. Announces Closing of Initial Public Offering http://finance.yahoo.com/news/adma-biologics-inc-announces-closing-201500299.html
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Merck Receives Breakthrough Therapy Designation for MK-5172/MK-8742, an Investigational Oral Combination Regimen for the Treatment of Chronic Hepatitis C Virus (HCV) Infection http://www.mercknewsroom.com/news-release/research-and-development-news/merck- receives-breakthrough-therapy-designation-mk-5172mk
October 21 STENTYS to Present First Results of Sirolimus-Eluting Self-Apposing®Stent at TCT Conference http://www.businesswire.com/news/home/20131021006039/en/STENTYS-Present-Results- Sirolimus-Eluting-Self-Apposing%C2%AE-Stent-TCT
Celldex Therapeutics Announces Upcoming Data Presentations at the Society for Immunotherapy of Cancer and Society of Neuro-Oncology Annual Meetings http://ir.celldextherapeutics.com/releasedetail.cfm?ReleaseID=798722
Soligenix Announces Appointment of Marco Maria Brughera to its Board of Directors http://www.soligenix.com/news.aspx?titleId=434
October 18 Advaxis Announces Full Exercise of Underwriters’ Over-Allotment Option http://finance.yahoo.com/news/advaxis-announces-full-exercise-underwriters-174500010.html
Senesco Announces Reverse Stock Split http://finance.yahoo.com/news/senesco-announces-reverse-stock-split-203000591.html
October 17 Pacira Pharmaceuticals, Inc. Announces Timing for Third Quarter 2013 Financial Results Webcast and Conference Call http://www.businesswire.com/news/home/20131017005022/en/Pacira-Pharmaceuticals- Announces-Timing-Quarter-2013-Financial
ADMA Biologics, Inc. Announces Pricing of Initial Public Offering http://finance.yahoo.com/news/adma-biologics-inc-announces-pricing-131100895.html
Soligenix Announces Formation of International Melioidosis Scientific Advisory Board http://www.soligenix.com/news.aspx?titleId=433
October 16 Antares Announces Podium Presentation of Pivotal OTREXUP™ (methotrexate) Data at American College of Rheumatology Annual Meeting http://www.antarespharma.com/files/6813/8192/8896/OTREXUP_at_ACR.pdf
Merck Presents New Pharmacokinetic Data on ISENTRESS®(raltegravir) at 14th European AIDS Conference http://www.mercknewsroom.com/news-release/prescription-medicine-news/merck-presents- new-pharmacokinetic-data-isentress-raltegravi
Advaxis Announces Pricing of Public Offering of Common Stock and Warrants http://www.businesswire.com/news/home/20131016006664/en/Advaxis-Announces-Pricing- Public-Offering-Common-Stock
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October 14 New Data from STEPS 2 Support the Long Term Use of Gattex® (Teduglutide [rDNA origin]) for Injection in Adult Patients with Short Bowel Syndrome http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1864016
Results of Phase II PRECEDENT Trial for Investigational Folate Receptor Therapy Vintafolide in Patients with Platinum-Resistant Ovarian Cancer Published in Journal of Clinical Oncology http://www.mercknewsroom.com/news-release/research-and-development-news/results-phase- ii-precedent-trial-investigational-folate-r
Otrexup™ (Methotrexate) Injection Approved By FDA A New Treatment For Adults With Rheumatoid Arthritis, Children With Polyarticular Idiopathic Arthritis, And Adults With Psoriasis http://www.antarespharma.com/files/8613/8175/5363/OTREXUP_FDA_Approval.pdf
October 11 Bracco Diagnostics Inc. Makes New Syringe Packs Available for Use with EmpowerCTA® Computed Tomography Contrast Delivery Systems http://www.reuters.com/article/2013/10/11/nj-bracco-diagnostics- idUSnBw115725a+100+BSW20131011
October 10 QPharma Releases Physician Sunshine Act Survey http://www.businesswire.com/news/home/20131010006052/en/QPharma-Releases-Physician- Sunshine-Act-Survey
PTC Therapeutics to Present at the North American Cystic Fibrosis Conference http://ir.ptcbio.com/releasedetail.cfm?ReleaseID=796102
First Patient Enrolled in Phase III Trial Evaluating The Medicines Company's Angiomax(R) (Bivalirudin) in Patients Undergoing Peripheral Endovascular Procedures http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol- newsArticle&ID=1862841&highlight=
October 9 Lexicon Completes Pilot Study of Telotristat Etiprate In Ulcerative Colitis http://finance.yahoo.com/news/lexicon-completes-pilot-study-telotristat-100000797.html
Immunomedics Announces Termination of Agreement and Return of Worldwide Rights to Veltuzumab for All Non-Cancer Indications http://finance.yahoo.com/news/immunomedics-announces-termination-agreement-return- 210000846.html
October 7 New Findings from the REPLACE Study Suggest Natpara Has a Beneficial Effect on Bone Health in Patients with Hypoparathyroidism http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1861915
Natpara Pivotal Study Published in The Lancet Diabetes & Endocrinology http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1861914
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Precision Spine™ Plans to Introduce New Products at North American Spine Society Meeting in New Orleans http://www.businesswire.com/news/home/20131007006189/en/Precision-Spine%E2%84%A2- Plans-Introduce-Products-North-American
Cegedim Relationship Management Joins Boomer Esiason Foundation in Fight against Cystic Fibrosis at Cegedim 2013 Life Sciences Forum: Charity and Customer Collaboration Event http://www.businesswire.com/news/home/20131007005141/en/Cegedim-Relationship- Management-Joins-Boomer-Esiason-Foundation
Report: Medical technology companies need to make radical changes to business models to stay alive http://www.njbiz.com/apps/pbcs.dll/article?AID=/20131007/NJBIZ01/131009844/Report:- Medical-technology-companies-need-to-make-radical-changes-to-business-models-to-stay- alive/&template=printart
Bristol-Myers Squibb to Announce Results for Third Quarter 2013 on October 23 http://news.bms.com/press-release/financial-news/bristol-myers-squibb-announce-results-third- quarter-2013-october-23
October 3 Soligenix Appoints Oreola Donini, PhD, as Vice President of Preclinical Research and Development http://www.soligenix.com/news.aspx?titleId=431
October 2 NPS Pharmaceuticals Reports Gattex STEPS 2 Study to be Presented at American College of Gastroenterology Meeting http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1860848
Precision Spine™ Announces Expanded FDA 510(k) Clearance For the Reform® Pedicle Screw System http://www.businesswire.com/news/home/20131002005151/en/Precision-Spine%E2%84%A2- Announces-Expanded-FDA-510-Clearance
NPS Pharmaceuticals' CEO Presents at Leerink Swann Rare Disease Roundtable Conference (Transcript) http://seekingalpha.com/article/1725942-nps-pharmaceuticals-ceo-presents-at-leerink-swann- rare-disease-roundtable-conference-transcript
October 1 PTC Therapeutics Expands Management Team http://ir.ptcbio.com/ReleaseDetail.cfm?ReleaseID=794031
Merck Announces Global Initiative to Sharpen Commercial and R&D Focus http://www.mercknewsroom.com/news-release/corporate-news/merck-announces-global- initiative-sharpen-commercial-and-rd-focus
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Merck Updates Plans for Headquarters Move in New Jersey http://www.mercknewsroom.com/news-release/corporate-news/merck-updates-plans- headquarters-move-new-jersey
TKL Research Adds Leadership Support for Regulatory Affairs and Scientific Services http://www.businesswire.com/news/home/20131001005058/en/TKL-Research-Adds- Leadership-Support-Regulatory-Affairs
Senesco Announces $1.725 Million Equity Financing http://www.businesswire.com/news/home/20131001005386/en/Senesco-Announces-1.725- Million-Equity-Financing
Celgene Corporation to Announce Third Quarter 2013 Results on October 24, 2013 http://newsroom.celgene.com/press-release/corporate/celgene-corporation-announce-third- quarter-2013-results-october-24-2013
Data from Merck’s Investigational Hepatitis C Treatment Portfolio to be Presented at the 64th American Association for the Study of Liver Diseases Annual Meeting http://www.mercknewsroom.com/news-release/research-and-development-news/data-mercks- investigational-hepatitis-c-treatment-portfol
Interim Data for Merck’s MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Previously Treated Patients with Non-Small Cell Lung Cancer to be Presented at 15th World Conference on Lung Cancer http://www.mercknewsroom.com/news-release/research-and-development-news/interim-data- mercks-mk-3475-investigational-anti-pd-1-imm
Octapharma Supports Victory for Women Program, Presents Coagulation Research at 65th Annual NHF Meeting http://www.businesswire.com/news/home/20131001006288/en/Octapharma-Supports-Victory- Women-Program-Presents-Coagulation
Bristol-Myers Squibb to Present Range of New Hepatitis C Data at the 2013 American Association for the Study of Liver Diseases (AASLD) Annual Meeting http://news.bms.com/press-release/rd-news/bristol-myers-squibb-present-range-new-hepatitis- c-data-2013-american-associat
Bristol-Myers Squibb to Announce Results for Third Quarter 2013 on October 23 http://news.bms.com/press-release/financial-news/bristol-myers-squibb-announce-results-third- quarter-2013-october-23
Pacira Pharmaceuticals, Inc. Announces Partnership to Support Uptake of EXPAREL® Among the Orthopedic Marketplace http://finance.yahoo.com/news/pacira-pharmaceuticals-inc-announces-partnership- 200100676.html
LX4211 Achieves Positive Results In Type 2 Diabetes Patients With Renal Impairment http://www.lexpharma.com/news/press-releases/2298-lx4211-achieves-positive-results-in-type- 2-diabetes-patients-with-renal-impairment.html
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September 30 Amneal Pharmaceuticals to Acquire Four Generic Products http://www.businesswire.com/news/home/20130930005549/en/Amneal-Pharmaceuticals- Acquire-Generic-Products
Protalex Announces Two Posters Accepted for Presentation at 2013 American College of Rheumatology Annual Meeting http://www.businesswire.com/news/home/20130930005160/en/Protalex-Announces-Posters- Accepted-Presentation-2013-American
PTC Therapeutics To Join Russell 2000® Index http://ir.ptcbio.com/ReleaseDetail.cfm?ReleaseID=793728
Immunomedics Confirms Funding of Department of Defense Clinical Trial Grant for Milatuzumab in Lupus http://finance.yahoo.com/news/immunomedics-confirms-funding-department-defense- 160000973.html
Photocure Sponsors symposium at the 29th Congress of the Scandinavian Association of Urology and Urological Nurses http://www.photocure.com/Pressmedia/News/Photocure-Sponsors-symposium-at-the-29th- Congress-of-the-Scandinavian-Association-of-Urology-and-Urological-Nurses/
Cevira® Phase 2b results presented at the annual Colposcopy meeting in Cologne, Germany http://www.photocure.com/Pressmedia/News/Presentation-of-Cevira-results/
Merck Animal Health’s HomeAgain® Announces Finalists for Hero of the Year Award; Voting Begins http://www.mercknewsroom.com/news-release/homeagain/merck-animal-healths-homeagain- announces-finalists-hero-year-award-voting-beg
September 28 Merck Animal Health Proudly Supports Vaccination Programs Targeted at Reducing Disease in Domestic Pets http://www.mercknewsroom.com/news-release/animal-health/merck-animal-health-proudly- supports-vaccination-programs-targeted-reduci
September 27 Merck to Hold Third-Quarter 2013 Sales and Earnings Conference Call on October 28 http://www.mercknewsroom.com/news-release/corporate-news/merck-hold-third-quarter-2013- sales-and-earnings-conference-call-october
Upcoming Presentations Related to the Lutonix Drug-Coated Balloon LEVANT 2 Trial http://finance.yahoo.com/news/upcoming-presentations-related-lutonix-drug-135400604.html
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September 26 New Hypoglycemia and Pancreatitis Subanalyses from the Onglyza®(saxagliptin) SAVOR Cardiovascular Outcomes Trial Presented at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD) http://www.businesswire.com/news/home/20130926005183/en/Hypoglycemia-Pancreatitis- Subanalyses-Onglyza%C2%AE-saxagliptin-SAVOR-Cardiovascular
Celldex Therapeutics Announces Upcoming Presentation at the Leerink Swann Rare Disease Roundtable http://ir.celldextherapeutics.com/releasedetail.cfm?ReleaseID=793505
QPharma’s Medical Device Division Offers Guidance on UDI Final Rule http://www.businesswire.com/news/home/20130926006285/en/QPharma%E2%80%99s- Medical-Device-Division-Offers-Guidance-UDI
Hooper Holmes Names Tom Collins as Chief Financial Officer http://www.businesswire.com/news/home/20130926006279/en/Hooper-Holmes-Names-Tom- Collins-Chief-Financial
September25 NPS Pharmaceuticals to Present at Leerink Swann Rare Disease Roundtable http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1857871
Bayer Senior Executive to Lead World Self-Medication Industry: Global Self-Medication Industry Association Elects Bayer HealthCare’s Erica Mann as Incoming Chair http://www.businesswire.com/news/home/20130925005843/en/Bayer-Senior-Executive-Lead- World-Self-Medication-Industry
Soligenix Awarded NIAID Contract Valued up to $6.4 Million for the Development of OrbeShield™ in GI ARS http://www.soligenix.com/news.aspx?titleId=430
OXYTROL® FOR WOMEN, the First Over-the-Counter Treatment for Overactive Bladder in Women, Now Available Nationwide http://www.mercknewsroom.com/news-release/merck/oxytrol-women-first-over-counter- treatment-overactive-bladder-women-now-available
September 24 New Phase III Data Showed Dapagliflozin Significantly Reduced HbA1c Compared to Placebo at 24 Weeks in Patients with Type 2 Diabetes Inadequately Controlled with the Combination of Metformin Plus Sulfonylurea http://www.reuters.com/article/2013/09/24/nj-bristol-myers-squibb- idUSnBw245372a+100+BSW20130924
September 23 Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection http://www.mercknewsroom.com/news-release/research-and-development-news/merck- receives-complete-response-letter-investigational-m
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September 19 Trifecta Clinical and SAFE-BioPharma Form Strategic Partnership to Promote Use of Standards-Based Digital Identities http://finance.yahoo.com/news/trifecta-clinical-safe-biopharma-form-190200625.html
Cyclacel's Sapacitabine Reported to Have Anti-Tumor Activity Against Ovarian Cancer http://investor.cyclacel.com/releasedetail.cfm?ReleaseID=791843
Celator® Pharmaceuticals Announces Start of Clinical Study of CPX-351 in Pediatric, Adolescent and Young Adult Patients with Relapsed or Refractory Hematologic Malignancies http://www.businesswire.com/news/home/20130919006446/en/Celator%C2%AE- Pharmaceuticals-Announces-Start-Clinical-Study-CPX-351
Study Shows EXPAREL® Provided Improved Pain Control, Shorter Length of Hospital Stay and Substantial Cost Savings Following Total Knee Replacement http://www.businesswire.com/news/home/20130919006126/en/Study-Shows- EXPAREL%C2%AE-Improved-Pain-Control-Shorter
Soligenix Awarded BARDA Contract Valued up to $26.3 Million for Advanced Development of OrbeShield™ in GI ARS http://www.soligenix.com/news.aspx?titleId=429
September 18 PTC Therapeutics to Present at European Pediatric Neurology Society Congress http://ir.ptcbio.com/releasedetail.cfm?ReleaseID=791275
September 17 NPS Pharmaceuticals to Present at NewsMakers in the Biotech Industry Conference http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1855374
Bristol-Myers Squibb Announces Dividend http://news.bms.com/press-release/financial-news/bristol-myers-squibb-announces-dividend-17
Vertical Pharmaceuticals, Inc. Announces New Co-promote Agreement for Zonatuss™ (Benzonatate Capsules, USP) http://www.businesswire.com/news/home/20130917005078/en/Vertical-Pharmaceuticals- Announces-Co-promote-Agreement-Zonatuss%E2%84%A2-Benzonatate
Aerie Pharmaceuticals Files Registration Statement for Proposed Initial Public Offering http://finance.yahoo.com/news/aerie-pharmaceuticals-files-registration-statement- 231500318.html
Diavacs Inc. Appoints Chief Medical Officer http://finance.yahoo.com/news/diavacs-inc-appoints-orville-kolterman-120000239.html
Merck Named To 2013 Working Mother 100 Best Companies http://www.mercknewsroom.com/news-release/diversity/merck-named-2013-working-mother- 100-best-companies
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September 16 NJ Governor Chris Christie Visits Zoetis as Company Celebrates Establishing Strong Roots in New Jersey http://finance.yahoo.com/news/nj-governor-chris-christie-visits-140000318.html
Antares Pharma Announces First Patients Dosed in VIBEX™ QS T Study Evaluating Testosterone Deficient Males http://finance.yahoo.com/news/antares-pharma-announces-first-patients-150000125.html
September 13 JBK Associates International Earns Spot on Inc. 500|5000 List of America’s Fastest-Growing Private Companies for Second Consecutive Year http://www.globenewswire.com/news-release/2012/09/04/488737/10003942/en/JBK- Associates-Earns-Spot-on-Inc-500-5000.html
September 12 Senesco Technologies Reports Fiscal Year 2013 Financial Results http://www.businesswire.com/news/home/20130912005346/en/Senesco-Technologies-Reports- Fiscal-Year-2013-Financial
Bristol-Myers Squibb Reports Results for Phase 3 Trial of Yervoy®(Ipilimumab) in Previously-Treated Castration-Resistant Prostate Cancer http://news.bms.com/press-release/rd-news/bristol-myers-squibb-reports-results-phase-3-trial- yervoy-ipilimumab-previousl
Celator® Pharmaceuticals Announces Listing on OTCBB and OTC Link http://www.businesswire.com/news/home/20130912005292/en/Celator%C2%AE- Pharmaceuticals-Announces-Listing-OTCBB-OTC-Link
September 11 Merck and AstraZeneca Enter License Agreement for Investigational Oral WEE1 Kinase Inhibitor Therapy for Cancer http://www.mercknewsroom.com/news-release/research-and-development-news/merck-and- astrazeneca-enter-license-agreement-investigati
Frank E. Young, Former FDA Commissioner, Joins Braeburn Pharmaceuticals as EVP, Clinical and Regulatory Affairs http://www.businesswire.com/news/home/20130911005913/en/Frank-E.-Young-FDA- Commissioner-Joins-Braeburn
Amicus Therapeutics' CEO John F. Crowley to Advocate for Rare and Orphan Disease Community in Washington, D.C. This Week http://ir.amicustherapeutics.com/releasedetail.cfm?ReleaseID=790047
September 10 Dr. Francois Nader, President and CEO of NPS Pharmaceuticals, Appointed to Biotechnology Industry Organization’s Board of Directors http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1853624
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Edge Therapeutics Elects Robert J. Spiegel, MD To Board of Directors http://www.businesswire.com/news/home/20130910005394/en/Edge-Therapeutics-Elects- Robert-J.-Spiegel-MD
Forest Laboratories Names Brent Saunders CEO and President http://news.frx.com/press-release/corporate-news/forest-laboratories-names-brent-saunders- ceo-and-president
Research and Markets: Osteoarthritis Pain - Pipeline Review, H2 2013 http://www.businesswire.com/news/home/20130910005867/en/Research-Markets- Osteoarthritis-Pain---Pipeline-Review
Amicus Therapeutics Enters Collaboration With Biogen Idec for Parkinson's Disease http://ir.amicustherapeutics.com/releasedetail.cfm?ReleaseID=789756
Phase 3 Data From The Medicines Company's Oritavancin Solo Trials Featured at ICAAC Conference http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol- newsArticle&ID=1853562&highlight=
September 9 Jubilant Clinsys Launches TrialStat eClinical Suite with Cloud Based TrialStat Orbit EDC, TrialStat CTMS and TrialStat Portal http://www.businesswire.com/news/home/20130909006243/en/Jubilant-Clinsys-Launches- TrialStat-eClinical-Suite-Cloud
September 6 Lexicon to Present at the Stifel Nicolaus Healthcare Conference http://www.lexicon-genetics.com/news/press-releases/2295-lexicon-to-present-at-the-stifel- nicolaus-healthcare-conference.html
Celator® Pharmaceuticals to Present at Stifel Healthcare Conference 2013 http://finance.yahoo.com/news/celator-pharmaceuticals-present-stifel-healthcare- 123000562.html
U.S. Food and Drug Administration Approves ABRAXANE®in Combination with Gemcitabine as First-Line Treatment of Patients with Metastatic Pancreatic Cancer http://newsroom.celgene.com/press-release/product/us-food-and-drug-administration-approves- abraxane-combination-gemcitabine-firs
September 5 Results from Phase III Study (MM-003) of Pomalidomide Plus Low-Dose Dexamethasone versus High-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma Patients Published in The Lancet Oncology http://newsroom.celgene.com/press-release/product/results-phase-iii-study-mm-003- pomalidomide-plus-low-dose-dexamethasone-versus
EMA Now Accepts SAFE-BioPharma Digital Signatures on eSubmissions http://finance.yahoo.com/news/ema-now-accepts-safe-biopharma-113800840.html
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Protalex to Present at the Rodman & Renshaw 15th Annual Healthcare Conference http://finance.yahoo.com/news/protalex-present-rodman-renshaw-15th-120000120.html
Advaxis Lead Product Candidate ADXS-HPV in Combination with PD-1 Antibody Significantly Improves Immune and Therapeutic Efficacy in Preclinical Study http://finance.yahoo.com/news/advaxis-lead-product-candidate-adxs-103000674.html
Aerie Pharmaceuticals Elects Dr. Gerald D. Cagle to the Company’s Board of Directors http://finance.yahoo.com/news/aerie-pharmaceuticals-elects-dr-gerald-163900576.html
Soligenix to Present at the 15th Annual Rodman & Renshaw Global Investment Conference in New York City http://www.thestreet.com/story/12027261/1/soligenix-to-present-at-the-15th-annual-rodman- renshaw-global-investment-conference-in-new-york-city.html
Research and Markets: Dystonia - Pipeline Review, H2 2013 Report Features Players such as Addex Pharmaceuticals and QRxPharma Limited http://www.businesswire.com/news/home/20130905006499/en/Research-Markets-Dystonia--- Pipeline-Review-H2
Amicus Therapeutics to Present at Stifel Nicolaus 2013 Healthcare Conference http://ir.amicustherapeutics.com/releasedetail.cfm?ReleaseID=789060
Elusys Therapeutics Presents Efficacy Results and Other Key Findings on Eti-204 Anthrax Anti-Toxin http://www.elusys.com/press_releases13/090513.html
September 4 CR Bard to buy Rochester Medical for $262 million http://www.reuters.com/article/2013/09/04/us-rochestermedical-offer- idUSBRE9830H520130904
Lexicon to Present at the Morgan Stanley Global Healthcare Conference http://www.lexpharma.com/news/press-releases/2294-lexicon-to-present-at-the-morgan-stanley- global-healthcare-conference.html
September 3 Subanalysis of Phase III ARISTOTLE Trial of Eliquis® (apixaban) Demonstrated Consistent Results Versus Warfarin in Patients with Nonvalvular Atrial Fibrillation with or without Valvular Heart Disease http://news.bms.com/press-release/partnering-news/subanalysis-phase-iii-aristotle-trial-eliquis- apixaban-demonstrated-co
Advaxis Announces Three Abstracts Accepted for Presentation at Society for Immunotherapy of Cancer Annual Meeting http://www.businesswire.com/news/home/20130903005542/en/Advaxis-Announces-Abstracts- Accepted-Presentation-Society-Immunotherapy
Immunomedics Appoints Peter P. Pfreundschuh as New Chief Financial Officer http://finance.yahoo.com/news/immunomedics-appoints-peter-p-pfreundschuh-200000345.html
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Totality of Data From Three Phase III Trials of The Medicines Company's Intravenous Cangrelor Presented and Published http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol- newsArticle&ID=1851237&highlight=
September 2 Onglyza® (saxagliptin) Achieves Primary Safety Endpoint, Demonstrating No Increased Risk for Cardiovascular Death, Heart Attack or Stroke in SAVOR Cardiovascular Outcomes Trial http://news.bms.com/press-release/onglyza-saxagliptin-achieves-primary-safety-endpoint- demonstrating-no-increased-risk-c
August 31 New Eliquis® (apixaban) Post-hoc Subanalysis of the Phase III ARISTOTLE trial Demonstrated that within 30 Days of a Procedure, Stroke or Systemic Embolism and Major Bleeding were Uncommon http://news.bms.com/press-release/partnering-news/new-eliquis-apixaban-post-hoc- subanalysis-phase-iii-aristotle-trial-de
August 29 Octapharma USA Announces Octaplas™ Now Available for U.S. Patients http://www.bioportfolio.com/news/article/1614292/Octapharma-USA-Announces-Octaplas-Now- Available-for-U-S-Patients.html
STENTYS Reports H1 2013 Financial Results http://www.dailyfinance.com/2013/08/29/stentys-reports-h1-2013-financial-results/
PTC Therapeutics to Present at Upcoming Investor Conferences http://ir.ptcbio.com/releasedetail.cfm?ReleaseID=787887
Celator® Pharmaceuticals Receives U.S. Patent on Proprietary Liposome Composition http://www.reuters.com/article/2013/08/29/nj-celator-pharma- idUSnBw295926a+100+BSW20130829
Otsuka Receives Complete Response Letter from U.S. Food and Drug Administration for Tolvaptan for Use in Patients with Autosomal Dominant Polycystic Kidney Disease http://www.businesswire.com/news/home/20130829006215/en/Otsuka-Receives-Complete- Response-Letter-U.S.-Food
August 28 NPS Pharmaceuticals to Present at Morgan Stanley Global Healthcare Conference http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1850290
Celgene Corporation to Webcast at Upcoming Investor Conferences http://newsroom.celgene.com/press-release/corporate/celgene-corporation-webcast-upcoming- investor-conferences-0
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August 27 RUCDR Infinite Biologics Selects NuGEN as Corporate Sponsor and Genomic Sample Processing Partner http://www.businesswire.com/news/home/20130827005282/en/RUCDR-Infinite-Biologics- Selects-NuGEN-Corporate-Sponsor
Cancer Genetics, Inc. [CGIX] to Ring The NASDAQ Stock Market Opening Bell http://finance.yahoo.com/news/cancer-genetics-inc-cgix-ring-140000915.html
August 26 New Evidence Published in Muscle and Nerve on Measuring 6-Minute Walk Distance in Duchenne Muscular Dystrophy http://ir.ptcbio.com/ReleaseDetail.cfm?ReleaseID=787023
Genmab Reaches Milestone in DuoBody Platform Collaboration with Janssen http://ir.genmab.com/releasedetail.cfm?ReleaseID=787031
August 22 Results for the second quarter and first half 2013 http://www.photocure.com/Pressmedia/News/Photocure-ASA---Results-for-the-second-quarter- and-first-half-2013/
Immunomedics Announces Fiscal 2013 Results http://finance.yahoo.com/news/immunomedics-announces-fiscal-2013-results-200000249.html
August 21 Exalenz Granted US Patent for Liver Application of Company’s BreathID Platform Technology http://www.businesswire.com/news/home/20130821005415/en/Exalenz-Granted-Patent-Liver- Application-Company%E2%80%99s-BreathID
QPharma’s Medical Device Division Advises Manufacturers to Prepare for UDI Compliance http://www.businesswire.com/news/home/20130821005958/en/QPharma%E2%80%99s- Medical-Device-Division-Advises-Manufacturers-Prepare
August 20 Advaxis Appoints Daniel J. O’Connor President and CEO and Elects Dr. James Patton Non-Executive Chairman of the Board http://www.businesswire.com/news/home/20130820005678/en/Advaxis-Appoints-Daniel-J.- O%E2%80%99Connor-President-CEO
Adimab Announces New Antibody Discovery Collaboration with Celgene Corporation http://www.businesswire.com/news/home/20130820005351/en/Adimab-Announces-Antibody- Discovery-Collaboration-Celgene-Corporation
Sanofi Survey Finds Travel Puts Those with Severe Allergies on High Alert http://sanofi.mediaroom.com/2013-08-20-Sanofi-Survey-Finds-Travel-Puts-Those-with-Severe- Allergies-on-High-Alert
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August 19 Aerie Pharmaceuticals Elects Murray Goldberg to the Company’s Board of Directors http://www.businesswire.com/news/home/20130819006017/en/Aerie-Pharmaceuticals-Elects- Murray-Goldberg-Company%E2%80%99s-Board
August 16 Merck Animal Health Strengthens Commitment to Five Steps to Responsible Beef http://www.mercknewsroom.com/press-release/animal-health/merck-animal-health-strengthens- commitment-five-steps-responsible-beef
August 15 Celator® Announces Business Update and Fiscal Second Quarter 2013 Operational and Financial Results http://www.businesswire.com/news/home/20130815005498/en/Celator%C2%AE-Announces- Business-Update-Fiscal-Quarter-2013
Protalex Announces PRTX-100 Phase I Data Published in The Journal of Clinical Pharmacology http://finance.yahoo.com/news/protalex-announces-prtx-100-phase-175700286.html
August 14 Epratuzumab And Rituximab Produce High Rate and Durable Progression-Free Survival in Previously Untreated Follicular Lymphoma http://www.nasdaq.com/press-release/epratuzumab-and-rituximab-produce-high-rate-and- durable-progression-free-survival-in-previously-untreated-follicular-lymphoma-20130814-00398
Advaxis’ ADXS-HPV Granted Orphan Drug Designation for Treatment of HPV-Associated Anal Cancer http://www.businesswire.com/news/home/20130814005628/en/Advaxis%E2%80%99-ADXS- HPV-Granted-Orphan-Drug-Designation-Treatment
Cyclacel Reports Second Quarter 2013 Financial Results http://investor.cyclacel.com/releasedetail.cfm?ReleaseID=785367
Forest Laboratories and Almirall Decide to Delay NDA Filing for Aclidinium/formoterol Combination http://investor.frx.com/press-release/corporate-news/forest-laboratories-and-almirall-decide- delay-nda-filing-aclidiniumform
August 13 SAFE-BioPharma Elects Four Pharma Executives to Board of Directors http://finance.yahoo.com/news/safe-biopharma-elects-four-pharma-121600561.html
Celator® Pharmaceuticals Announces Start of Clinical Study in Patients with Untreated Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia at High Risk of Treatment- Related Mortality http://www.businesswire.com/news/home/20130813005275/en/Celator%C2%AE- Pharmaceuticals-Announces-Start-Clinical-Study-Patients
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NovaDel Announces Completion of the Sale of Substantially All Assets to Suda Ltd. http://finance.yahoo.com/news/novadel-announces-completion-sale-substantially- 200100960.html
Elusys Therapeutics to Present Results on Eti-204 Anthrax Anti-Toxin http://www.elusys.com/press_releases13/081313.html
The Medicines Company Prices Public Offering of Common Stock http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol- newsArticle&ID=1847392&highlight=
August 12 Celldex Announces Expansion of Phase 2 ReACT Study in Recurrent Glioblastoma http://ir.celldextherapeutics.com/releasedetail.cfm?ReleaseID=784514
Immunomedics Advances Solid Tumor Antibody-Drug Conjugate Programs To Phase Ii Clinical Trials http://finance.yahoo.com/news/immunomedics-advances-solid-tumor-antibody-123000554.html
ZRG Partners Global Life Sciences Hiring Index Shows Moderate 3% Growth in Q2 http://finance.yahoo.com/news/zrg-partners-global-life-sciences-143000044.html
ADMA Biologics Reports Second Quarter 2013 Financial and Operational Results http://www.businesswire.com/news/home/20130514006610/en/ADMA-Biologics-Reports- Quarter-2013-Financial-Operational
PTC Therapeutics Reports Second Quarter 2013 Financial and Corporate Results http://ir.ptcbio.com/ReleaseDetail.cfm?ReleaseID=784603
Soligenix Reports Second Quarter 2013 Financial Results, and Highlights Recent Accomplishments http://www.soligenix.com/news.aspx?titleId=426
The Medicines Company Announces Proposed Public Offering of Common Stock http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol- newsArticle&ID=1847003&highlight=
Endo and Metamark Announce Sale of HealthTronics Laboratory Solutions http://phx.corporate-ir.net/phoenix.zhtml?c=231492&p=irol- newsArticle_print&ID=1846977&highlight=
August 9 Oral Anti-Cancer Therapy Pomalidomide Now Approved by European Commission as Treatment for Patients with Relapsed/Refractory Multiple Myeloma – a Rare Form of Blood Cancer http://newsroom.celgene.com/press-release/oral-anti-cancer-therapy-pomalidomide-now- approved-european-commission-treatment-patie
August 8 PTC Therapeutics Announces Achievement of Major Milestone in SMA Collaboration http://ir.ptcbio.com/releasedetail.cfm?ReleaseID=783724
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NPS Pharmaceuticals Reports Second Quarter 2013 Financial Results and Provides Business Update http://www.npsp.com/investors-pr?trxml_v=nrd&trxml_nr_id=1846411
Dendreon Announces Second Quarter 2013 Results http://investor.dendreon.com/releasedetail.cfm?ReleaseID=784045
August 7 Antares Pharma Reports Second Quarter 2013 Operating and Financial Results http://finance.yahoo.com/news/antares-pharma-reports-second-quarter-110000241.html
Insmed to Participate in August Investor Conferences http://investor.insmed.com/releasedetail.cfm?ReleaseID=783480
August 6 Pacira Pharmaceuticals, Inc. to Present at the Wedbush 2013 Life Sciences Management Access Conference http://finance.yahoo.com/news/pacira-pharmaceuticals-inc-present-wedbush-102500895.html
Pacira Pharmaceuticals, Inc. Reports Second Quarter EXPAREL® Revenue of $15.2 Million and Full Second Quarter 2013 Financial Results http://www.businesswire.com/news/home/20130806005345/en/Pacira-Pharmaceuticals- Reports-Quarter-EXPAREL%C2%AE-Revenue-15.2
PTC Therapeutics to Present at Wedbush Conference http://ir.ptcbio.com/releasedetail.cfm?ReleaseID=782898
Oncobiologics and inVentiv Health Form Strategic Partnership around Biosimilars http://www.prnewswire.com/news-releases/oncobiologics-and-inventiv-health-form-strategic- partnership-around-biosimilars-218509731.html
Merck & Co to Halt Production at NJ Plant and Focus on Biologics R&D http://www.in-pharmatechnologist.com/Processing/Merck-Co-to-Halt-Production-at-NJ-Plant- and-Focus-on-Biologics-R-D
Celldex Reports Second Quarter 2013 Financial Results http://ir.celldextherapeutics.com/releasedetail.cfm?ReleaseID=783026
August 5 Derma Sciences to Present at the Canaccord Genuity 33rd Annual Growth Conference http://www.businesswire.com/news/home/20120809006145/en/Derma-Sciences-Present- Canaccord-Genuity-Annual-Growth
Aerie Pharmaceuticals Names Thomas Mitro as President and Chief Operating Officer http://www.businesswire.com/news/home/20130805005846/en/Aerie-Pharmaceuticals-Names- Thomas-Mitro-President-Chief
PTC Therapeutics to Host Second Quarter 2013 Financial Results Conference Call and Webcast http://ir.ptcbio.com/releasedetail.cfm?ReleaseID=782614
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The Medicines Company Announces Positive Phase III Trial Results for Fibrocaps; Completes ProFibrix Acquisition http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol- newsArticle&ID=1844738&highlight=
August 2 Lexicon to Present at the Wedbush PacGrow Life Sciences Management Access Conference http://www.lexpharma.com/news/press-releases/2292-lexicon-to-present-at-the-wedbush- pacgrow-life-sciences-management-access-conference.html
Rutgers Merging Trio of Research Centers to Increase Research on Disease http://www.njbiz.com/article/20130802/NJBIZ01/130809951/Rutgers-merging-trio-of-research- centers-to-increase-research-on-disease
July 31 Elusys Releases New Data on Anthrax Anti-Toxin Administered Via Intramuscular Injection From Three Recent Animal Studies http://www.elusys.com/press_releases13/073113.html
July 26 ADDING MULTIMEDIA: Forest Laboratories and Pierre Fabre Laboratories Announce FDA Approval of FETZIMA™ for the Treatment of Major Depressive Disorder in Adults http://investor.frx.com/press-release/corporate-news/forest-laboratories-and-pierre-fabre- laboratories-announce-fda-approval
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