Pipeline

Biodel Announces Name Change for Lead Product Candidate

September 01, 2010

Currently under review by the U.S. Food and Drug Administration
 

Additional Phase III clinical trial with Urocidin(TM) expected to commence in 2010

August 19, 2010

Analysis of data from first Phase III clinical trial nearing completion
 

DUSA Pharmaceuticals Receives Response From FDA on Orphan Drug Designation Status

August 06, 2010

Orphan Drug Designation must target a disease that affects fewer than 200,000 patients in the U.S.
 
 
 

Horizon Pharma, Inc. Announces Results of Phase 3 Study of LODOTRA®

July 23, 2010

Results Demonstrate 12-Month Sustained Efficacy and Safety in Rheumatoid Arthritis
 

Prochymal New Drug Submission Granted Priority Review by Health Canada

July 21, 2010

Health Canada to add first-in-class stem cell therapy to Register of Innovative Drugs providing eight years of market exclusivity
 

FDA Accepts AFREZZA Complete Response Resubmission

July 20, 2010

FDA Sets Target Action Date of December 29, 2010
 

Winston Laboratories, Inc. Submits NDA for CIVANEX® (Civamide Cream) for Treatment of Osteoarthritis

July 07, 2010

Also awaiting approval in the European Union and Canada
 

Genentech Submits Application to FDA for Trastuzumab-DM1 in Previously Treated Advanced HER2-Positive Breast Cancer

July 07, 2010

T-DM1 is the First Antibody-Drug Conjugate in Genentech's Pipeline to Be Submitted to the FDA
 

Dacogen® (Decitabine) for Injection Phase III AML Results Announced

June 30, 2010

sNDA Submission to FDA by Eisai Planned Based on Preliminary Results
 

BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data in Phase III Clinical Program

June 21, 2010

Data Presented at Endocrine (ENDO) Society Meeting
 

Horizon Pharma, Inc. Announces FDA Acceptance of DUEXA(R) New Drug Application for Filing

May 26, 2010

FDA's completed review for DUEXA is expected in the first quarter of 2011
 

Bayer HealthCare Pharmaceuticals, Inc. Announces Results of a Phase 3 Clinical Trial of Gadobutrol

May 21, 2010

Data Presented at the 48th Annual Meeting of the American Society of Neuroradiology (ASNR)
 

Sigma-Tau Pharmaceuticals Cysteamine Eye Drop NDA Accepted for Filing

May 17, 2010

Cystinosis Treatment Granted Priority Review Status
 

Ironwood and Forest Present Positive Linaclotide Results from Two Pivotal Phase 3 Trials in Patients with Chronic Constipation

May 03, 2010

Data Presented at DDW Demonstrate Trials Met Primary and All Secondary Endpoints
 

BioSante Pharmaceuticals Announces Reinitiation of Prostate Cancer Vaccine Development

May 03, 2010

Regulatory steps to lift the GVAX Prostate clinical hold are being taken
 

Bristol-Myers Squibb Receives Complete Response Letter from FDA for Belatacept

May 01, 2010

No new clinical studies have been requested
 

Takeda Submits New Drug Application for Azilsartan Medoxomil in the U.S.

April 27, 2010

An Investigational Compound for the Treatment of Hypertension
 

Pfizer Discontinues Phase 3 Trial of Sutent® in Advanced Hepatocellular Carcinoma

April 22, 2010

Higher incidence of serious adverse events in the SUN 1170 Trial
 

Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON(TM)

April 22, 2010

Classification of Submission and New PDUFA Action Date Expected Within 14 Days, per FDA Guidelines
 

Positive Phase III Diabetes Data with Lixisenatide Announced by Zealand Pharma's Partner sanofi-aventis

April 15, 2010

Once daily Lixisenatide meets Phase III Study Endpoints in Diabetes
 

FDA Approves New Drug Application for PANCREAZE(TM)

April 13, 2010

Pancreatic Enzyme Therapy Approved by FDA to Treat Exocrine Pancreatic Insufficiency
 

Daiichi Sankyo Submits First New Drug Application for Oral Factor Xa Inhibitor, Edoxaban

April 06, 2010

Innovative Once-Daily Oral Factor Xa Inhibitor Submitted for Approval in Japan
 

Cubist Pharmaceuticals to End Development of CB-500,929

March 31, 2010

Decision follows review of Phase 2 top line results
 

CyDex Pharmaceuticals Initiates Dosing for Phase 2A Oncology Drug Trial

March 22, 2010

Trial to Compare Pharmacokinetics of Captisol-Enabled® Melphalan with Alkeran®
 

Simcere Pharmaceutical Group Successfully Completes Endostar Phase IV Clinical Study

March 22, 2010

Combining Endostar with standard chemotherapy regimes can significantly improve the survival of patients with advanced NSCLC
 

Novelos Therapeutics Discontinues Current Development Program for NOV-002 in NSCLC

March 18, 2010

NOV-002 Phase 2 Development Continues in Breast Cancer Indication
 

ABRAXANE Meets Primary Endpoint in Phase 3 Trial for Advanced Non-Small Cell Lung Cancer

March 17, 2010

ABRAXANE, Carboplatin Combination Demonstrated Superiority to Taxol
 

Pfizer Discontinues A Phase 3 Study Of Figitumumab In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

March 11, 2010

Findings will Contribute to Understanding and Future Study of Figitumumab
 

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