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Daily news and top headlines for drug research professionals

FDA Accepts Janssen's Schizoaffective Disorder Drug sNDA

November 14, 2014 12:11 pm | News | Comments

Janssen Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. Read more...

WHO Sees Few Promising Ebola Drugs in Pipeline

November 14, 2014 9:17 am | News | Comments

WHO scientists have proposed lots of experimental interventions but none has been thoroughly evaluated yet.                          

Gilead's Hep C Drug Gets Positive Results

November 11, 2014 10:09 am | News | Comments

Gilead Sciences Inc. announced results from several Phase 2 and Phase 3 studies evaluating investigational uses of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic hepatitis C virus (HCV) infection in patients with limited or no treatment options. Read more...

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Lilly's Injectable Diabetes Drug is Now Available in US Pharmacies

November 10, 2014 1:18 pm | News | Comments

Eli Lilly's new type 2 diabetes drug arrives in US pharmacies today. Read more...                              

FDA Approves Lilly's Gastric Cancer Drug

November 7, 2014 12:46 pm | News | Comments

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Cryamza (ramucirumab) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach). Read more...

Mylan Launches Generic Loestrin 24 Fe

November 7, 2014 12:41 pm | News | Comments

Mylan Inc. announced the U.S. launch of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate, which is the generic version of Warner Chilcott's Loestrin 24 Fe. Read more...

Gilead Submits Application for New HIV Pill to FDA

November 6, 2014 1:38 pm | News | Comments

Gilead submitted a new drug application that focuses on an experimental HIV pill. Read more...                                

FDA Approves Janssen's Hep C Drug

November 6, 2014 9:26 am | News | Comments

Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio(simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients. Read more...

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Astellas' Fungal Treatment Gets Orphan Drug Designation

November 5, 2014 10:43 am | News | Comments

Astellas announced that the FDA granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis. Read more...                     

Pharming, Salix Launch HAE Treatment

November 3, 2014 11:16 am | News | Comments

Pharming Group NV and Salix Pharmaceuticals, Ltd. announced the launch of Ruconest (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg in the United States for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). Read more...

Game Changing Migraine Med to be Available November 2014

October 31, 2014 12:54 pm | News | Comments

Migranade Inc announced the new migraine medication will be available to the 36 million U.S. migraine sufferers November 2014. Read more...                    

FDA Approves Generic Alzheimer's Drug

October 30, 2014 12:52 pm | News | Comments

TWi Pharmaceuticals Inc. announced that it has received final approval from the FDA on its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride Tablets USP, 23 mg, the generic equivalent to Eisai Inc.'s Aricept 23mg. Read more...     

AstraZeneca's Diabetes Treatment Gets FDA Approval

October 30, 2014 12:00 pm | News | Comments

AstraZeneca announced that the FDA has approved once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes. Read more...                 

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Scientists Aim to Simplify Life Saving Drug

October 30, 2014 9:33 am | News | Comments

A research team from the University of British Columbia has set out to make the use of Heparin a lot safer by developing a universal antidote. Read more...                

Pfizer Gains FDA Approval for Meningococcal B Vaccine

October 30, 2014 9:14 am | News | Comments

Pfizer announced that the FDA has granted accelerated approval of a new meningococcal vaccine. Read more...                          

ESMO: Cancer Immunotherapy on the Road

October 29, 2014 12:20 pm | by Neil Canavan | Articles | Comments

Since cancer immunotherapy was declared the Breakthrough of the Year in 2013 by Science magazine the field has been on fire, and its relatively few experts have been on the run– explaining the nascent technology and related data to oncologists at venues from the April meeting of AACR in San Diego, to the June meeting of ASCO in Chicago, to the September meeting of ESMO in Madrid.  Read more...

AstraZeneca's Cancer Drug Gets Positive CHMP Review

October 24, 2014 1:16 pm | News | Comments

AstraZeneca announced that the CHMP of the EMA has adopted a positive opinion recommending the marketing authorisation of Lynparza (olaparib) as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer. Read more...

Arbor Pharmaceuticals Announces FDA New Drug Approval

October 24, 2014 12:40 pm | News | Comments

Arbor Pharmaceuticals announced that the FDA) has approved its New Drug Application (NDA) for Sotylize (sotalol hydrochloride) oral solution. Read more...                                      

Five More Ebola Vaccines To Be Tested in March

October 24, 2014 9:40 am | by Maria Cheng, AP Medical Writer | News | Comments

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready in 2015 and five more experimental vaccines will start being tested in March. Read more...           

Experimental Breast Cancer Drug Has Promise in Combination Therapy

October 23, 2014 1:40 pm | News | Comments

Ewing sarcoma tumors disappeared and did not return in more than 70 percent of mice treated with combination therapy that included drugs from a family of experimental agents developed to fight breast cancer, reported St. Jude Children's Research Hospital scientists.  Read more...

NIH Begins Early Human Clinical Trial of New Ebola Vaccine

October 22, 2014 2:00 pm | News | Comments

Human testing of a second investigational Ebola vaccine candidate is under way at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. Read more...                

UNC Researchers Found New Characters In Cancer Cells

October 22, 2014 1:47 pm | News | Comments

UNC School of Medicine researchers have pinpointed a set of intriguing characteristics in a previously unknown subpopulation of melanoma cancer cells in blood vessels of tumors. Read more...            

Taiho Receives FDA Fast Track for Cancer Treatment

October 22, 2014 1:14 pm | News | Comments

Taiho Oncology Inc. announced that the FDA granted Fast Track designation for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer (mCRC). Read more...

Oramed Gets Positive Data From Oral Insulin Trial

October 22, 2014 10:03 am | News | Comments

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, reported positive top-line clinical results from its Phase 2a clinical trial of ORMD-0801, the company's proprietary oral insulin capsules, to treat type 1 diabetes. Read more...

Lilly's Diabetes Treatment Receives NDA

October 21, 2014 2:19 pm | News | Comments

FDA has accepted the filing of a NDA for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes (T2D). Read more...       

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