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Daily news and top headlines for drug research professionals

Lupin Launches Zaxine in Canada

April 21, 2015 3:08 pm | News | Comments

The agreement grants Lupin exclusive rights to promote, distribute and market Zaxine in Canada. Read more...

Teva Offers to Buy Mylan in $40.1B Cash and Stock Deal

April 21, 2015 2:49 pm | by Linda A. Johnson, AP Business Writer | News | Comments

Generic drug giant Teva formally offered to buy fellow drugmaker Mylan about $40.1 billion in cash and stock on Tuesday. Read more...

Pfizer: FDA Breakthrough Therapy Designation for Lung Cancer Drug

April 21, 2015 11:57 am | News | Comments

Pfizer Inc. announced today that Xalkori (crizotinib) received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). Read more...

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Perrigo Launches Generic Nasal Spray

April 20, 2015 8:27 am | News | Comments

Perrigo Company plc announced that it has received final Federal Drug Administration approval for Triamcinolone Acetonide Topical Aerosol, the generic version of Sun Pharma's Kenalog nasal spray. Read more...

Actelion Advances Clinical Development of its Specialty Immunology Pipeline Compounds

April 17, 2015 8:12 am | News | Comments

Actelion announced that it is accelerating its clinical development efforts in the field of immunological disorders. Read more...

Pfizer Breast Cancer Drug Shows Promising Results

April 16, 2015 2:19 pm | by Stephanie Guzowski, Editor | News | Comments

Pfizer said on Wednesday a late-stage trial of its treatment for advanced breast cancer, Ibrance, was stopped early after it met its primary goal of delaying disease progression. Read more...

Abbot Receives FDA Clearance for New Blood Glucose Meter

April 16, 2015 10:38 am | News | Comments

The cost of insurance premiums and employee medical claims continues to rise in the United States, which is especially challenging for people living with chronic conditions such as diabetes. Read more...

Abbvie's Chronic Hepatitis C Treatment Granted Priority Review in Japan

April 16, 2015 10:31 am | News | Comments

AbbVie today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for its investigational, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir. Read more...

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FDA Approves New Type of Heart Failure Drug From Amgen

April 16, 2015 10:12 am | by Linda Johnson, AP Business Writer | News | Comments

Patients with chronic heart failure, a disabling, deadly disease that worsens as the heart gradually pumps less efficiently, are getting a much-needed new option with U.S. approval Wednesday of a novel drug from Amgen Inc. Read more...

Melanoma Treatment Market Value to More than Quadruple to $5.64 Billion by 2023

April 16, 2015 8:26 am | by Fenix Leung, DPhil, GlobalData’s Oncology and Hematology Analyst | Articles | Comments

The global treatment market for melanoma will expand more than fourfold in value from $1.34 billion in 2013 to reach an estimated $5.64 billion by 2023. Read more...

Global Duchenne Muscular Dystrophy Treatment Market to See Spectacular Growth by 2019

April 15, 2015 8:22 am | by Nikhilesh Sanyal, Ph.D., GlobalData's Immunology Analyst | Articles | Comments

GlobalData’s latest report states that this growth will occur across six major markets. Read more...

Soligenix: FDA Clearance of Phase 3 Pediatric Crohn's Study

April 14, 2015 10:31 am | News | Comments

Soligenix, Inc. announced today that agreement has been reached with the US Food and Drug Administration (FDA) on the design of a pivotal, Phase 3 clinical trial evaluating its product, SGX203 (oral beclomethasone 17,21-dipropionate or BDP), in the treatment of pediatric Crohn's disease. Read more...

Actavis, Medicines360 Announce U.S. Availability of Liletta

April 13, 2015 12:16 pm | News | Comments

Actavis plc, a leading global pharmaceutical company and leader in women's health care, and Medicines360, a nonprofit women's health pharmaceutical company, announced today that Liletta (levonorgestrel-releasing intrauterine system) 52 mg is now available in the U.S. for use by women to prevent pregnancy for up to three years.

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Daiichi Sankyo, Terumo Apply for Manufacturing and Sales Approval of Flu Vaccine in Japan

April 13, 2015 8:22 am | News | Comments

The Vaccine is a pre-filled syringe type, intradermal influenza HA vaccine co-developed by four companies under a February 23, 2012, agreement. Read more...

Prolong Pharmaceuticals' SCD Treatment Gets Orphan Drug Designation

April 9, 2015 12:43 pm | News | Comments

Prolong Pharmaceuticals, LLC, a biopharmaceutical company dedicated to developing products for the treatment of anemias, cancers and their debilitating comorbidities, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its flagship product Sanguinate for the treatment of Sickle Cell Disease (SCD). Read more...

A Patch for Peanut Allergies

April 9, 2015 11:56 am | by Bevin Fletcher, Associate Editor | News | Comments

French biopharmaceutical company DBV Technologies moves closer to bringing its peanut allergy patch to market, receiving Breakthrough Therapy Designation from the U.S. Food and Drug Administration as it prepares to launch its Phase 3 trial. Read more...

Researchers Develop Effective, Single Dose Ebola Vaccine

April 9, 2015 8:41 am | by University of Texas | News | Comments

A team of researchers has developed a quick-acting vaccine that is both safe and effective with a single dose against the Ebola strain that killed thousands of people in West Africa last year. Read more...

Merck's Potential HCV Drug Gets Special FDA Designation

April 8, 2015 12:40 pm | by Associated Press | News | Comments

Merck & Co. said Wednesday that the Food and Drug Administration granted the pharmaceutical company's developing hepatitis C treatment two special designations. Read more...

New Therapeutic Option Available for Select Treatment Resistant Lung Cancer Patients

April 8, 2015 8:22 am | News | Comments

NSCLC can be characterized based on a patient's genetic abnormalities that are causing the cancer growth and researchers have identified over 12 of these genetic abnormalities. Read more...

Shire: Clear Regulatory Path Forward for Investigational ADHD Treatment

April 7, 2015 11:54 am | News | Comments

Shire plc announces that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a clear regulatory path for SHP465 (triple-bead mixed amphetamine salts - MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. Read more..

Experimental Ebola Vaccine Appears Safe, Prompts Immune Response

April 2, 2015 10:35 am | by NIH | News | Comments

An early-stage clinical trial of an experimental Ebola vaccine conducted at the National Institutes of Health (NIH) and the Walter Reed Army Institute of Research (WRAIR) found that the vaccine, called VSV-ZEBOV, was safe and elicited robust antibody responses in all 40 of the healthy adults who received it. Read more...

GeoVax HIV Vaccine Moves Forward

April 1, 2015 1:40 pm | News | Comments

GeoVax Labs, a biotechnology company developing human vaccines for Ebola and HIV, today announced that the HIV Vaccine Trials Network (HVTN) has assigned a trial number, HVTN 114, to the next clinical trial of its clade B preventive HIV vaccine candidate. Read more...

Merck's HPV Vaccine Now Available in Canada

April 1, 2015 10:12 am | News | Comments

Merck, known as MSD outside the United States and Canada, announced that Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck's 9-valent human papillomavirus (HPV) vaccine, is now available in Canada.  

U.S. RA Treatment Market to Reach $9.3B by 2020

April 1, 2015 10:03 am | News | Comments

The US treatment market for Rheumatoid Arthritis (RA) is set to increase in value from $6.4 billion in 2013 to $9.3 billion by 2020, representing a Compound Annual Growth Rate (CAGR) of 5.5%, says business intelligence provider GBI Research. Read more...

BioDelivery Sciences’ Pain Treatment Fails Study

March 30, 2015 3:46 pm | by Stephanie Guzowski, Editor | News | Comments

BioDelivery Sciences International Inc. said on Monday its pain drug for diabetic neuropathy failed to meet the primary goal in a Phase 3 clinical trial. Shares fell nearly 30 percent. Read more...

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