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Daily news and top headlines for drug research professionals

FDA Fast Tracks Edison's New Friedreich's Ataxia Drug

March 17, 2014 10:53 am | News | Comments

Edison Pharmaceuticals announced that the FDA granted Fast Track designation to EPI-743, the company's lead drug, for the treatment of Friedreich's ataxia. Read more...                       

Medivir Presents New Phase 3 Simeprevir Data

March 17, 2014 10:39 am | News | Comments

Medivir AB announced that new Phase 3 data for the once-daily protease inhibitor simeprevir have been presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL) in Brisbane, Australia. Read more...      

Shire Recalls VPRIV Batch for Particulate Matter

March 17, 2014 10:29 am | News | Comments

Shire Pharmaceuticals announced today the initiation of a voluntary recall in the United States of one batch, packaged into three lots, of VPRIV due to the presence of visible particulate matter, identified as stainless steel and barium sulfate. Read more...

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Daiichi Sankyo Files NDA in Japan for Toxic Blood Drug

March 16, 2014 9:21 pm | by Daiichi Sankyo | News | Comments

Daiichi Sankyo Co. Ltd. announced that it has filed an NDA for the manufacture and marketing in Japan of the methaemoglobinaemia injection Methylene Blue (INN: Methylthioninium chloride). Read more...               

Purdue Taking Drug Discoveries from 'Bench Top to the Bedside'

March 14, 2014 2:52 pm | News | Comments

Purdue University and Houston Methodist Research Institute plan to collaborate on research and educational initiatives, including clinical trials of drugs developed at Purdue. Read more...                   

Merck’s Noxafil Approved at New Dose for Intravenous Use

March 14, 2014 2:47 pm | News | Comments

Merck announced that the FDA has approved a new formulation of Noxafil (posaconazole) injection for intravenous (IV) use. Merck now provides an IV formulation and two oral formulations of Noxafil for prophylaxis against invasive Aspergillus and Candida infections. Read more...

FDA Approves New Blood Clot Use for Eliquis

March 14, 2014 2:22 pm | News | Comments

Bristol-Myers Squibb and Pfizer announced that the FDA approved a Supplemental New Drug Application for Eliquis for the prophylaxis of DVT, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery. Read more...

New Personalized Cancer Treatment Trial Begins in UK

March 14, 2014 11:07 am | News | Comments

The first human trial of a pioneering personalized cancer treatment developed at Oxford University will begin this week, with the potential to tackle a wide range of late-stage cancers. Read more...               

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Novo Nordisk Invests in $100M Purification Plant

March 14, 2014 11:00 am | News | Comments

Novo Nordisk is increasing its drug development capacity by investing 550 million Danish kroner ($100 million) in a new research and development facility in Bagsværd, Denmark. Read more...                  

Bayer Kicks Off Phase 3b Riociguat Trial in PAH Patients

March 14, 2014 10:53 am | News | Comments

Bayer HealthCare announced the enrollment of the first patient in a Phase 3b pilot study, RESPITE, designed to evaluate the clinical effects of riociguat in patients with pulmonary arterial hypertension who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors. Read more...

Alexza, Ferrer Launch Adasuve Agitation Drug in Romania

March 14, 2014 10:40 am | News | Comments

Alexza Pharmaceuticals Inc. and Ferrer announced that Adasuve inhalation powder, inhalation therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder, is now available in Romania. Read more...

Charles River to Acquire CRO Services from Galapagos

March 14, 2014 10:22 am | News | Comments

Charles River Laboratories International Inc. announced that it has entered into a definitive agreement to acquire the CRO services division of Galapagos NV, which includes both Argenta and BioFocus. Read more...           

Novartis Meningitis B Vaccine Gets Recommendation in Australia

March 14, 2014 10:08 am | News | Comments

Novartis announced that Australia has joined the growing number of countries where Bexsero (Meningococcal Group B Vaccine) has received a clinical recommendation for the vaccine's routine use to help protect against meningitis B. Read more...

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FDA Accepts NDA for Kidney Transplant Rejection Drug

March 13, 2014 3:21 pm | News | Comments

Veloxis Pharmaceuticals A/S announced the FDA accepted for standard review the company's New Drug Application (NDA) for Envarsus for the prevention of organ rejection in adult kidney transplant patients. Read more...         

Committee Recommends Roche HPV Test as Primary Cervical Cancer Screening Tool

March 13, 2014 2:55 pm | News | Comments

Roche announced that the FDA Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas HPV Test as a first-line primary screening tool in women to assess their risk of cervical cancer outweigh the risks. Read more...

FDA Chief Defends Zohydro Approval

March 13, 2014 2:08 pm | News | Comments

The head of the Food and Drug Administration said Thursday that the much-debated painkiller Zohydro fills an "important and unique niche" for treating pain. Read more...                       

Pfizer Will Appeal Celebrex Patent Ruling

March 13, 2014 1:59 pm | News | Comments

A U.S. court on Wednesday invalidated the key patent for one of Pfizer's most lucrative medicines, potentially opening the door for cheaper generic versions 18 months sooner than expected and cutting into the drugmaker's profit. Read more...    

GSK Completes Recruitment in New COPD Study

March 13, 2014 9:17 am | News | Comments

GlaxoSmithKline plc and Theravance Inc. announced that recruitment of patients into the “Study to Understand Mortality and MorbidITy,” known as SUMMIT, has completed enrollment. Read more...                 

Actavis Confirms Win in Generic Celebrex Suit

March 13, 2014 9:10 am | News | Comments

Actavis plc confirmed that the United States District Court for the Eastern District of Virginia has ruled that United States Patent No. RE44,048 is invalid. Read more...                       

Perrigo Launches Generic Neptazane for Ocular Conditions

March 13, 2014 9:06 am | News | Comments

Perrigo Co. announced that it has launched, through a distribution and supply agreement, methazolamide tablets, the generic equivalent to Neptazane tablets. Read more...                       

Online Forum to Offer Global Discussion on Counterfeit Drug Regulations

March 13, 2014 9:00 am | News | Comments

Pharma IQ has announced their first Global Pharmaceutical Serialization and Track & Trace Open House will commence on the March 18. Read more...                             

Astellas Secures Isavuconazole Commercialization Rights in the U.S., Canada

March 13, 2014 2:25 am | by Astellas Pharma Inc. | News | Comments

Astellas Pharma Inc. announced that the company has amended the licensing agreement on isavuconazole under co-development with Basilea Pharmaceutica Ltd. Astellas will now be responsible for all regulatory filings and will exclusively commercialize isavuconazole in the U.S. and Canada. Read more...

Pfizer Trial Shows Drug Prevents Community-Acquired Pneumonia

March 12, 2014 3:17 pm | News | Comments

Pfizer Inc. presented detailed results of CAPiTA, demonstrating that Prevenar 13 prevented a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older, the study’s primary objective. Read more...    

Chimerix Gets OK for Brincidofovir Pilot Trial, Gives Drug to Sick Boy

March 12, 2014 3:00 pm | News | Comments

Chimerix Inc. announced that it has reached agreement with the FDA for the immediate initiation of a pilot trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients. Josh Hardy, whose story brought public attention to adenovirus infection, will be the first person enrolled. Read more...

FDA Halts Geron's Imetelstat Development

March 12, 2014 1:46 pm | News | Comments

Geron Corp. announced that its Investigational New Drug (IND) application for imetelstat has been placed on full clinical hold by the FDA, affecting all ongoing company-sponsored clinical trials. Read more...            

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