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Daily news and top headlines for drug research professionals

Lilly Provides Update on Evacetrapib Phase 3 Trial

February 20, 2015 12:25 pm | News | Comments

Eli Lilly and Company has accepted the recommendation of the ACCELERATE study academic executive committee, based on emerging science in the cardiovascular field, to extend the Phase 3 trial of the investigational medicine evacetrapib by approximately six months. Read more....

FDA Expands Indications for Revlimid

February 18, 2015 10:40 am | by Associated Press | News | Comments

Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma (NDMM). Read more..

Lupin, Celon: Development, Licensing for Generic Advair Diskus

February 17, 2015 10:02 am | News | Comments

​Pharma Major Lupin Limited (Lupin) and Celon Pharma S.A. (Celon) announced that they have entered into a definitive agreement under which the companies will jointly develop a fluticasone/salmeterol dry powder inhaler (DPI) product which is a generic version of GlaxoSmithKline's Advair Diskus. Read more...

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Drug Abuse in Iran Rising Despite Executions, Police Raids

February 13, 2015 10:34 am | by Ali Akbar Dareini - Associated Press | News | Comments

Officials say methamphetamine production and abuse of hard drugs are skyrocketing in the country despite potentially lethal criminal penalties for users if they are caught. Read more...            

Closing the Knowledge Gap on Cancer Drug Toxicity

February 12, 2015 3:59 pm | by David Jackson, Ph.D., Chief Innovation Officer, MolecularHealth | Articles | Comments

There is a dangerous knowledge gap in the use of cancer medications that needs to be closed, immediately. Read more...                                                          

Science is Afire With Plans to Help Smokers Quit

February 12, 2015 12:25 pm | by Cynthia Fox, Science Editor | Articles | Comments

All types of scientists are at work, on all kinds of quit-smoking aids, from an anti-smoking vaccine to a biomarker test. Read more...                                         

Eisai's Thyroid Cancer Drug: Phase 3 Trial

February 12, 2015 11:38 am | News | Comments

Results from the pivotal Phase 3 SELECT (Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid) trial evaluating the use of investigational agent lenvatinib in the treatment of progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC) were published online in the New England Journal of Medicine (NEJM). Read more..

Cumberland Pharmaceuticals: Pipeline Expansion with AERD Drug

February 12, 2015 11:10 am | News | Comments

Cumberland Pharmaceuticals Inc. announced an expansion of its pipeline with a new Phase II development program. The Company has initiated the clinical development of Boxaban (ifetroban) oral capsule for the treatment of aspirin exacerbated respiratory disease (AERD). Read more..

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CDK4/6 Inhibitor: Promising Results for Treating Breast Cancer

February 9, 2015 1:06 pm | by Drug Discovery & Development staff | Articles | Comments

The words “exciting,” “breakthrough,” and “standard-of-care-changing” are being used with regard to cyclin-dependent kinase (CDK) 4 and 6 inhibitors and metastatic breast cancer. Read more...                                       

Achillion Shares Soar Following Hepatitis C Drug Update

February 9, 2015 11:57 am | by Associated Press | News | Comments

Shares of Achillion Pharmaceuticals Inc. jumped Monday morning after the drug developer said a small group of patients who took its experimental hepatitis C treatment combination remained free of the liver-destroying virus three months after they stopped taking doses. Read more...

Theravance Biopharma, Mylan to Develop COPD Compound

February 2, 2015 10:14 am | by Theravance Biopharma | News | Comments

Theravance Biopharma, Inc. and Mylan Inc. announced that the two companies will partner on the development and, subject to FDA approval, commercialization of TD-4208, a novel investigational once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD) and other respiratory diseases. Read more...

AbbVie: Top-line Results from Phase 3 Hepatitis C Treatment

February 2, 2015 10:04 am | by AbbVie | News | Comments

AbbVie released top-line Phase 3 results for its investigational, all-oral, ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection in Japan. Read more...

New Approach to Delay Alzheimer's Onset to Be Tested

January 29, 2015 10:22 am | by Alzheimer's Drug Discovery Foundation | News | Comments

The Alzheimer's Drug Discovery Foundation (ADDF) announced a $900,000 grant to AgeneBio, a pharmaceutical company developing innovative therapies for neurologic and psychiatric diseases. Read more...                       

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Regeneron, Sanofi: FDA Accepts BLA for Hyperchoestrolemia Drug

January 26, 2015 10:20 am | by Sanofi | News | Comments

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for PraluentTM (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015. Read more...

FDA Approves Prestalia's Hypertension Treatment

January 26, 2015 10:00 am | by Prestalia | News | Comments

Symplmed Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Prestalia (perindopril arginine and amlodipine) tablets, licensed from Servier (Suresnes, France), for the treatment of hypertension.           

Meningococcal Vaccine Gets FDA Approval

January 26, 2015 9:44 am | by FDA | News | Comments

The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Read more..                       

FDA Clears Roche's MRSA/SA Test

January 26, 2015 9:32 am | by Roche | News | Comments

Roche announced that the US Food and Drug Administration (FDA) has provided 510(k) clearance for the cobas MRSA/SA Test for the early, simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) directly from nasal specimens. Read more...

FDA Approves Novartis' Psoriasis Drug

January 22, 2015 11:44 am | by Novartis | News | Comments

Novartis announced the US Food and Drug Administration (FDA) has approved Cosentyx™ (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy.                           

Pharmalink: Open IND Application for IgA Nephropathy

January 21, 2015 9:59 am | by Pharmalink | News | Comments

Pharmalink AB, a specialty pharma company focused on orphan and niche products, announces that its IND for Nefecon is now open with the US Food & Drug Administration (FDA). Read more...                                  

Boehringer Ingelheim: Inhalation Spray Available in U.S.

January 21, 2015 9:53 am | by Boehringer Ingelheim | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. announced that Spiriva Respimat(tiotropium bromide) Inhalation Spray is now available by prescription through retail pharmacies across the United States. Read more...                                                         

Bausch + Lomb Introduces New Optical Software

January 21, 2015 9:47 am | by Valeant Pharmaceuticals | News | Comments

Valeant Pharmaceuticals International, Inc. announced that its wholly owned subsidiary, Bausch + Lomb, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an advanced Swept Source OCT (Optical Coherence Tomography) imaging system and updated software for its VICTUS Femtosecond Laser Platform that will provide surgeons with a new, redesigned interface. Read more...

Aetna Picks Gilead Sciences Hepatitis C Drugs Over Abbvie's

January 20, 2015 12:01 pm | by Associated Press | News | Comments

Insurer Aetna has made new hepatitis C drugs from Gilead Sciences Inc. preferred treatments for customers with the liver-destroying virus. Read more...                                    

Mylan Launches Generic Hepatitis B Treatment

January 16, 2015 11:37 am | by Mylan | News | Comments

Mylan Inc. announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's Epivir-HBV. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Read more...

EGFR Inhibitor Extends OS Compared With Chemo

January 13, 2015 11:51 am | by Boehringer Ingelheim | News | Comments

Boehringer Ingelheim announced overall survival (OS) results were published in The Lancet Oncology from two independent Phase 3 clinical trials (LUX-Lung 3 and LUX-Lung 6) in epidermal growth factor receptor (EGFR) mutation-positive patients with metastatic non-small cell lung cancer (NSCLC). Read more...

Clementia Pharmaceuticals: New Site for FOP Trial

January 12, 2015 11:15 am | News | Comments

Clementia Pharmaceuticals, Inc. announced the opening of a new site in Paris, France for the Phase 2 clinical trial of palovarotene, the company's lead product candidate for the treatment of fibrodysplasia ossificans progressiva (FOP).  Read more...      

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