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Review in Biological Technology

New Drug Application for Exenatide Once Weekly Accepted for Review by FDA

SAN DIEGO, INDIANAPOLIS and CAMBRIDGE, Mass., July 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ) and Alkermes, Inc. (Nasdaq: ALKS ) today announced that the New Drug Application (NDA) for exenatide once weekly has been accepte...

Kuvan Receives Priority Review Status From Health Canada

NOVATO, Calif., June 10 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN ) announced today that it has received notice of priority review status for Kuvan(R) (sapropterin dihydrochloride) as an oral treatment for patients with phenylketonuria (PKU) from Health Canada. Priori...

Cardium Announces Conference Call and Webcast to Review Recent Developments and Future Plans for the Excellarate(TM) Clinical Development Program

SAN DIEGO, May 12 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM ) today announced that the Company will hold a conference call and webcast to discuss recent developments and future plans for its Excellarate(TM) clinical development program. (Logo: http://www.newscom.com/c...

Savient Announces New Date for FDA Arthritis Advisory Panel Review of KRYSTEXXA(TM) for Treatment Failure Gout

EAST BRUNSWICK, N.J., May 7 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT ) today announced that its biologics license application (BLA) for KRYSTEXXA (TM) (pegloticase), a novel biological drug for treatment failure gout (TFG) patients, will be reviewed by the Arthritis...

BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for XIAFLEX(TM) for the Treatment of Dupuytren's Disease

LYNBROOK, N.Y., April 28 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC ), a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (B...

BioMS Medical's pivotal international multiple sclerosis trial receives positive review from Data Safety Monitoring Board

Toronto Stock Exchange Symbol: MS EDMONTON, April 21 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's pivotal phase III MAESTRO-01...

APS Healthcare and Thomson Reuters to Manage New York State's Medicaid Clinical Best Practices Review Program

Health Analytics and Utilization Review Services to Improve Safety and Quality of Care WHITE PLAINS, N.Y., April 16 /PRNewswire/ -- APS Healthcare, a leading provider of specialty healthcare solutions, and Thomson Reuters, a global business information company, have been selected by the New Y...

BioMS Medical's phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board

Toronto Stock Exchange Symbol: MS EDMONTON, April 14 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's U.S. pivotal phase III MAEST...

Sirion Therapeutics Supplemental New Drug Application for Durezol(TM) to Treat Uveitis is Accepted for Review by the FDA

Application Includes Data from a Comparative Trial in Anterior Uveitis TAMPA, Fla., March 16 /PRNewswire/ -- Sirion Therapeutics, Inc. announced today that its supplemental New Drug Application (sNDA) submitted to the U.S. Food and Drug Administration (FDA) seeking market approval of Durezol(...

FDA Provides A Positive Review of InNexus Biotechnology Development Plan for Lead Product

- Agency Supports Company's Production and Clinical and Preclinical Plans for DXL625 - - Live Teleconference Scheduled with Leadership and Scientific Team for March 04, 2009 - BRITISH COLUMBIA, Canada March 3 /PRNewswire-FirstCall/ -- InNexus Biotechnology Inc. (Toronto Stock Exchange: ...

Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee

CHICAGO, Feb. 27 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee (AIDAC) is tentatively scheduled to meet on Jun...

Quest PharmaTech Announces a Review of Strategic Alternatives to Enhance Shareholder Value

TSX Venture: QPT EDMONTON, Feb. 2 /PRNewswire-FirstCall/ - Quest PharmaTech Inc. (TSX-V: QPT) ("Quest" or the "Company"), a pharmaceutical company developing and commercializing products for the treatment of cancer and dermatological conditions, announces that it has entered into an agreement...

Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes

TAMPA, Fla., Jan. 26 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. Food and Drug Administration (FDA). Sir...

Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo(R)

FDA to review Intermezzo(R) (zolpidem tartrate sublingual lozenge) as the first sleep aid specifically designed for the treatment of middle-of-the-night awakenings PT. RICHMOND, Calif., Dec. 16 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical comp...

NSD Bio Group, LLC chosen by U.S.-China Economic & Security Review Commission for Report on China's High Tech Sectors

PHILADELPHIA, Nov. 25 /PRNewswire/ -- NSD Bio Group, LLC -- a North American Advisory firm -- has been tapped by the U.S. China Economic and Security Review Commission, to conduct special analyses on China's continuing developmental efforts in specific high-tech industries, including Biotechnology...

Amgen to Webcast 2008 Business Review Meeting on November 7 From Millennium Hotel in New York

THOUSAND OAKS, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that it will hold its Business Review Meeting on Friday, Nov. 7, 2008 at the Millennium Broadway Hotel, 145 West 44th Street, New York City, beginning at 8 a.m. Eastern Time. Participating in the meeti...

Halozyme Therapeutics Announces Conference Call on November 6 to Review Third Quarter Results

SAN DIEGO, Oct. 30 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO ), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that it plans to report its third quarter financial results on Thursday, November 6...

DURECT's Collaboration With Alpharma Clears HSR Review and Is Effective

CUPERTINO, Calif., Oct. 29 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX ) announced today that the previously announced development and license agreement with Alpharma Ireland Limited, an affiliate of Alpharma Inc. (NYSE: ALO ), granting such party the exclusive worldwide right...

Solos Endoscopy, Inc. Applauds American College of Surgeons Review of Advanced Breast Cancer Detection at 94th Annual Clinical Congress

BOSTON, Oct. 23 /PRNewswire-FirstCall/ -- Solos Endoscopy, Inc. (Pink Sheets: SNDY) is pleased to announce that advanced breast cancer detection through the use of mammary ductoscopy was a featured topic and reviewed in panel discussions at the 94th Annual American College of Surgeons Clinical...

FDA Issues Draft Guidance on Priority Review Vouchers

-BIO Ventures for Global Health to Work with Industry to Educate, Promote PRV Program- WASHINGTON, Oct. 20 /PRNewswire-USNewswire/ -- BIO Ventures for Global Health (BVGH) today announced its support of the US Food and Drug Administration's (FDA) release of Draft Guidance for Industry on Pri...

FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes

OSAKA, Japan, Oct. 10 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be ab...

BioMS Medical's relapsing-remitting multiple sclerosis trial receives positive review from Data Safety Monitoring Board

Toronto Stock Exchange Symbol: MS EDMONTON, Oct. 6 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of ...

BioMS Medical's phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board

Toronto Stock Exchange Symbol: MS EDMONTON, Oct. 3 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's U.S. pivotal phase III MAESTR...

Neurobiological Technologies, Inc. (Nasdaq: NTII) Q4/08 Review Issued by Scimitar Equity, LLC

BOSTON, Sept. 18 /PRNewswire/ -- Scimitar Equity, LLC issues a Q4/08 review of Neurobiological Technologies, Inc. (Nasdaq: NTII ), entitled, "Defining Outcome Scenarios, Probabilities Appear Focused to the Upside and Future Appreciation." This review is available at our website: http://www.s...

Nucletron Announces Market Release of First Commercially Available Software to Review and Share Dicom-Based Treatment Plans for Radiotherapy

VEENENDAAL, Netherlands, September 15 /PRNewswire/ -- - Oncentra(R) RT Viewer* Officially to Launch at ESTRO 2008 in Gothenburg, Sweden, September 14-18 and ASTRO 2008, Boston, USA, September 21-24 Nucletron, a knowledge-based leader in radiation oncology today announced the market release...

Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery

- Clinical data showing unprecedented 89% reduction in risk of GIST relapse with use of Gleevec after surgery are basis for FDA, EMEA, Swissmedic filings - Historically, one in two patients experienced recurrence of GIST after surg...

VioQuest Pharmaceuticals, Inc Q2/08 Review Issued by Scimitar Equity, LLC

BOSTON, Aug. 25 /PRNewswire/ -- Scimitar Equity, LLC issues a review of VioQuest Pharmaceuticals, Inc (OTC Bulletin Board: VOQP), entitled, "Creating Value; Turnaround Leverages Product Opportunities while Expectation Abounds and Losses Decrease." This review is available at website: http:/...

Arpida's iclaprim MAA Accepted for Review by EMEA

REINACH, Switzerland, August 21 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) today announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorisation Application (MAA) for intravenous iclaprim. Arpida is seeking approval of intravenous iclaprim in the ...

FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months

HORSHAM, Pa., Aug. 8 /PRNewswire/ -- Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by three months to December 2008. The application, filed...

VioQuest Pharmaceuticals, Inc Valuation Upgrade Review Issued By Scimitar Equity, LLC

BOSTON, July 29 /PRNewswire/ -- Scimitar Equity, LLC issues a review of VioQuest Pharmaceuticals, Inc (OTC Bulletin Board: VOQP), entitled, "510k Application Submitted for Xyfid(TM) and Priority Review Voucher for Lenocta(TM) Focuses Milestones and Share Price Appreciation." This review is a...

BioMS Medical's relapsing-remitting multiple sclerosis trial receives positive review from Data Safety Monitoring Board

Toronto Stock Exchange Symbol: MS EDMONTON, July 17 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of...

Insmed to Request Hearing Before NASDAQ Panel to Review NASDAQ Staff Determination

RICHMOND, Va., June 20 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that it intends to request a hearing before The NASDAQ Listing Qualifications Panel ('the Panel") to appeal an earlier Staff Determination to ...

Scimitar Equity, LLC Initiates Coverage Review of VioQuest Pharmaceuticals, Inc.

BOSTON, June 16 /PRNewswire/ -- Scimitar Equity, LLC issues a review of VioQuest Pharmaceuticals, Inc. (OTC Bulletin Board: VOQP), entitled, "Robust Pipeline of Niche' Cancer Therapies with Billion Dollar Upside." This review is available at website: http://www.scimitarequity.com . VioQue...

BioMS Medical's relapsing-remitting multiple sclerosis trial receives positive review from Data Safety Monitoring Board

Toronto Stock Exchange Symbol: MS EDMONTON, May 27 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MIN...

BioMS Medical's phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board

Toronto Stock Exchange Symbol: MS EDMONTON, April 15 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) has reviewed data from the C...

Chem Rx Corporation Postpones Conference Call to Review Full Year 2007 Financial Results

LONG BEACH, N.Y., March 31 /PRNewswire-FirstCall/ -- Chem Rx Corporation (OTC Bulletin Board: PMQC, PMQCU, PMQCW), a leading provider of institutional pharmacy services, announced today that it has postponed its conference call to review 2007 financial results and discuss 2008 outlook that was...

Chem Rx Corporation Schedules Conference Call to Review Full Year 2007 Financial Results

LONG BEACH, N.Y., March 31 /PRNewswire-FirstCall/ -- Chem Rx Corporation (OTC Bulletin Board: PMQC; PMQCU; PMQCW), a leading provider of institutional pharmacy services, announced today that it will hold a conference call to review 2007 financial results and discuss 2008 outlook on April 1, 20...

IBF/LifeScience Alley MedTech Investing Conference Adds Ashley Boam, Acting Deputy Director for Science and Review Policy, Office of Device Evaluation, Center for Devices and Radiological Health, FDA

Boam to address venture capitalists and venture-backed companies on the present and future FDA regulation of medical devices ST. LOUIS PARK, Minn., and Massapequa, N.Y., March 18 /PRNewswire/ -- Conference organizer International Business Forum (IBF) and LifeScience Alley, a Minneapol...

Neurobiological Technologies, Inc. (Nasdaq: NTII) Q2/08 Review Issued By Scimitar Equity Research, Inc.

BOSTON, Feb. 14 /PRNewswire/ -- Scimitar Equity Research, Inc. (Scimitar) issues a review of Neurobiological Technologies, Inc. (Nasdaq: NTII), entitled, "When You Review Stroke Treatments, Look at One Stroke Drug at a Time; Each One is Different". This review is available at our website: h...

EMEA Accepts for Review Vidaza(R) Marketing Authorization Application for Higher-Risk Myelodysplastic Syndromes

Application to be reviewed under European Accelerated Assessment Procedure BOULDER, Colo., Feb. 7 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM ) today announced that the European Medicines Agency (EMEA) has accepted for review the Company's Marketing Authorization Application (...
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