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Daily news and top headlines for drug research professionals

Ipsen Applies for US, EU GEP-NET Drug Marketing Authorizations

July 1, 2014 11:22 am | News | Comments

Ipsen announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Somatuline Depot 120 mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Read more...

GlycoVaxyn Kicks Off Trial of UTI Vaccine

July 1, 2014 11:17 am | News | Comments

GlycoVaxyn AG, a leader in the development of innovative conjugate vaccines, announced the initiation of a Phase 1 clinical trial of a candidate vaccine to prevent infections caused by Extra-intestinal Pathogenic Escherichia coli (ExPEC), such as urinary tract infections (UTIs). Read more...

Amgen’s Leukemia Drug Gets FDA Breakthrough Designation

July 1, 2014 11:10 am | News | Comments

Amgen announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to investigational bispecific T cell engager antibody blinatumomab, for adults with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia, a rapidly progressing cancer of the blood and bone marrow. Read more...

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Actavis Closes $28B Forest Deal

July 1, 2014 11:05 am | News | Comments

Actavis has completed its $28 billion acquisition of fellow drugmaker Forest Laboratories, and the leader of the acquired company - Brenton Saunders - is now the CEO of Actavis, and former Actavis Chairman and CEO Paul Bisaro will become executive chairman. Read more...

Nanoparticles Prevent Bone Cancer, Strengthen Bones

July 1, 2014 10:54 am | News | Comments

A research collaboration between Dana-Farber Cancer Institute and Brigham and Women’s Hospital and has utilized nanomedicine technologies to develop a drug-delivery system that can precisely target and attack cancer cells in the bone, as well as increase bone strength and volume to prevent bone cancer progression. Read more...

Takeda, Sanofi Launch Diabetes Collaboration in Japan

June 30, 2014 10:27 pm | News | Comments

Sanofi K.K. and Takeda Pharmaceutical Co. Ltd. announced that the two companies have entered into an agreement to build a collaborative system within Japan in the field of diabetes awareness and education. Read more...          

Actavis Facing Generic Zubsolv Patent Challenge

June 30, 2014 2:40 pm | News | Comments

Actavis confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval of a generic version of Orexo's Zubsolv, which is a partial opioid agonist indicated for the maintenance treatment of opioid dependence. As a result, Orexo AB and Orexo US Inc. filed suit against Actavis. Read more...

Merck Drug for Chemo-Induced Nausea, Vomiting Excels in Trial

June 30, 2014 2:30 pm | News | Comments

Merck announced results from a global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged six months to 17 years. Read more...

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GSK, Theravance Submit sNDA for Asthma Inhaler

June 30, 2014 2:20 pm | News | Comments

GSK and Theravance announced the submission of a supplemental New Drug Application FDA for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older. Read more...

FDA Weighs in on Allergan Pipeline

June 30, 2014 2:14 pm | News | Comments

Allergan Inc. announced updates on three key R&D pipeline programs, including abicipar pegol (Anti-VEGF DARPin), bimatoprost sustained-release implant for glaucoma and Semprana (dihydroergotamine) inhalation aerosol (formerly referred to as LEVADEX). Read more...

Iluvien Procedure Receives Positive Outcome for 10 More EU Countries

June 30, 2014 11:07 am | News | Comments

Alimera Sciences Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced the positive outcome of the Repeat-Use Procedure for Iluvien for the treatment of chronic diabetic macular edema in an additional 10 European Union countries. Read more...

Taiho Oncology Posts Positive Results in Colorectal Cancer Study

June 30, 2014 11:03 am | News | Comments

Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co. Ltd. (Japan), announced detailed findings from its global Phase 3 RECOURSE trial of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug. Read more...

Allergan, Pershing Square Settle Lawsuit

June 30, 2014 10:57 am | News | Comments

Pershing Square, the investment firm run by activist investor Bill Ackman, said Friday it settled a lawsuit with Allergan, the maker of Botox, related to Allergan's poison pill plan and Pershing's $53 billion offer for the company. Read more...  

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Scientists Reconstruct Life History of a Single Cell

June 30, 2014 10:50 am | News | Comments

Researchers have developed new methods to trace the life history of individual cells back to their origins in the fertilized egg by looking at the copy of the human genome present in healthy cells and building a picture of each cell's development from the early embryo to part of an adult organ. Read more...

FDA Approves Inhalable Diabetes Drug Afrezza

June 30, 2014 10:40 am | News | Comments

The Food and Drug Administration on Friday approved a long-delayed inhalable diabetes medication - Afrezza, an insulin powder, that comes in a single-use cartridge - to help patients control their blood sugar levels during meals. Read more...

Curing Diabetes Takes Guts

June 30, 2014 10:30 am | News | Comments

By switching off a single gene, scientists at Columbia University’s Naomi Berrie Diabetes Center have converted human gastrointestinal cells into insulin-producing cells, demonstrating in principle that a drug could retrain cells inside a person’s GI tract to produce insulin. Read more...

DVT/PE Drug Receives Positive CHMP Opinion

June 27, 2014 2:11 pm | News | Comments

Pfizer and Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending that Eliquis be granted marketing authorization for the treatment of DVT and PE, and the prevention of recurrent DVT and PE, in adults. Read more...

Researchers Block Key Enzyme to Minimize Stroke Injury

June 27, 2014 2:05 pm | News | Comments

A drug that blocks the action of the enzyme Cdk5 could substantially reduce brain damage if administered shortly after a stroke, UT Southwestern Medical Center research suggests, because aberrant Cdk5 activity causes nerve cell death during stroke. Read more...

CHMP Recommends EU Approval of CF Drug

June 27, 2014 1:59 pm | News | Comments

Vertex Pharmaceuticals Inc. announced that the European CHMP has issued a positive opinion recommending the approval of Kalydeco for people with cystic fibrosis ages six and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Read more...

Essentialis Doses First Patient in Prader-Willi Study

June 27, 2014 1:46 pm | News | Comments

Essentialis announced the dosing of the first patient in clinical study PC025, which is designed to evaluate the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome patients. Read more...   

Scientists Use Cancer Drug in Gene Therapy

June 27, 2014 1:28 pm | News | Comments

Scientists working to make gene therapy a reality have solved a major hurdle - how to bypass a blood stem cell’s natural defenses and efficiently insert disease-fighting genes into the cell’s genome - with rapamycin, which is commonly used to slow cancer growth and prevent organ rejection. Read more...

EU Panel OKs Expanded Use of Roche Cancer Drug

June 27, 2014 11:10 am | News | Comments

Roche announced that the EU Committee for Medicinal Products for Human Use recommended that the European Commission approve the use of Avastin in combination with chemotherapy as a treatment for women with ovarian cancer that is resistant to platinum-containing chemotherapy. Read more...

Gilead Submits Sofosbuvir NDA in Japan

June 27, 2014 11:01 am | News | Comments

Gilead announced that the company has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for approval of sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection. Read more...       

CHMP Recommends Bayer Drug for Gastrointestinal Stromal Tumors

June 27, 2014 10:54 am | News | Comments

The oncology compound regorafenib (Stivarga) from Bayer has been recommended for approval by the European Committee for Medicinal Products for Human Use for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors. Read more...

Lilly-BI Compound is First Biosimilar Insulin Backed by CHMP

June 27, 2014 10:41 am | News | Comments

The investigational compound LY2963016, a new insulin glargine product from Eli Lilly and Co. and Boehringer Ingelheim for the treatment of type 1 and type 2 diabetes, is the first biosimilar insulin recommended for approval in the EU. Read more...

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