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Daily news and top headlines for drug research professionals

Boehringer Ingelheim Announces FDA Approval of COPD Drug

September 25, 2014 1:31 pm | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the FDA approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Read more...


Genzyme to Collaborate on Gene Therapy for Blindness-Causing Disease

September 25, 2014 10:54 am | News | Comments

Genzyme, a Sanofi company announced the establishment of a research collaboration with the University of Florida and the University of Pennsylvania to develop a gene therapy for the treatment of a rare genetic disease that causes childhood blindness. Read more...


Drug for Rigid Muscles Moves Ahead in Clinical Trials

September 25, 2014 10:40 am | News | Comments

A new formulation for a University of Minnesota-developed drug targeted at rare disorders is under development, with the potential to help a small number of Americans each year. Read more...


MedImmune, CRUK Partner to Develop New Cancer Biologics

September 25, 2014 10:22 am | News | Comments

AstraZeneca announced that MedImmune, its global biologics research and development arm, and Cancer Research UK, with its commercial arm, Cancer Research Technology (CRT), have entered into an innovative collaboration to establish a joint laboratory in Cambridge, UK. Read more...


Novartis Psoriatic Arthritis Drug Hits Endpoints in Two Phase 3 Trials

September 25, 2014 10:06 am | News | Comments

Novartis announced that two pivotal Phase 3 studies (FUTURE 1 and FUTURE 2) of AIN457 (secukinumab) in psoriatic arthritis (PsA) met primary and key secondary endpoints. Read more...


Valeant Pitches Potential Eye Drug, Research Focus

September 25, 2014 9:46 am | by Tom Murphy, AP Business Writer | News | Comments

Valeant Pharmaceuticals is drawing attention to a potential glaucoma treatment and its focus on product development, as the Canadian drugmaker continues to build its case to investors for a takeover of Botox-maker Allergan. Read more...


Shire to Pay $56.5M Over False Drug Claims

September 25, 2014 8:30 am | News | Comments

The U.S. Department of Justice said Wednesday that Irish drugmaker Shire will pay $56.5 million to settle allegations it broke the law in promoting five different drugs, including its attention deficit disorder drugs Adderall XR and Vyvanse. Read more...


Anti-Addiction Groups Call for New FDA Chief

September 24, 2014 3:32 pm | by Matthew Perrone, AP Health Writer | News | Comments

Anti-addiction activists are calling for the Food and Drug Administration's top official to step down, saying the agency's policies have contributed to a national epidemic of prescription painkiller abuse. Read more…


FDA Approves New Indication for Celgene's Otezla

September 24, 2014 3:29 pm | News | Comments

Celgene Corp. announced that the FDA has approved Otezla for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Read more...                


Gilead's Investigational HIV Drug Meets Trial Goals

September 24, 2014 3:17 pm | News | Comments

Gilead Sciences Inc. announced that two Phase 3 clinical trials evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide for the treatment of HIV-1 infection in treatment-naïve adults met their primary objectives. Read more...


Acorda to Buy Developer of Parkinson's Treatment

September 24, 2014 3:07 pm | News | Comments

Acorda Therapeutics Inc. plans to buy privately-held Civitas Therapeutics for $525 million in cash as the drugmaker seeks to expand into treatments for Parkinson's disease. Read more…


Inovio Pharma Plans Humans Trials of Ebola Vaccine

September 24, 2014 2:45 pm | News | Comments

Inovio Pharmaceuticals plans to initiate human testing of a DNA-based vaccine for the Ebola virus in the first half of 2015. Read more...                                


New FDA Label Bolsters Safety Case for Chantix

September 24, 2014 2:18 pm | by Matthew Perrone, AP Health Writer | News | Comments

New government-approved labeling on Pfizer's drug Chantix suggests that the anti-smoking medication may not carry the risks of suicidal behavior that first earned it the Food and Drug Administration's strongest warning more than five years ago. Read more...


Gilead Submits Fixed-Dose Hep C Combo NDA in Japan

September 24, 2014 11:09 am | News | Comments

Gilead announced that the company has submitted a NDA to Japan’s PMDA for approval of an investigational once-daily fixed-dose combination  for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in adults. Read more...    


Abraxane Approved in Switzerland for Pancreatic, Breast Cancers

September 24, 2014 11:00 am | News | Comments

Celgene International Sàrl announced that Swissmedic, the regulatory authority for Switzerland, has granted approval for Abraxane as a treatment for metastatic pancreatic cancer (in combination with gemcitabine), and as a treatment for metastatic breast cancer. Read more...



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