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The Lead

FDA Clears Drug for Leading Form of Cystic Fibrosis

July 2, 2015 1:54 pm | by Matthew Perrone, AP Health Writer - Associated Press | News | Comments

The Food and Drug Administration cleared the twice-a-day pill from Vertex Pharmaceuticals for a variation of cystic fibrosis that affects about 8,500 people in the U.S. who are 12 years and older. The approval notice was posted to the agency's website Thursday. Read more...

BiondVax Announces Positive Preliminary Phase 2 Results for Universal Flu Vaccine

July 1, 2015 8:29 am | News | Comments

These results support BiondVax’s claim that M-001 provides a broaden and improved coverage...

Novartis to Try Novel Pricing Strategy for Heart Failure Drug

July 1, 2015 8:27 am | by Ryan Bushey, Associate Editor | Articles | Comments

The company is treading carefully in establishing the exact cost per pill. Read more...

Merck: Phase 3 Study of Single-Dose Emend Met Primary Endpoint

June 30, 2015 11:36 am | News | Comments

Merck, known as MSD outside the United States and Canada, today announced results from a Phase 3...

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Regeneron's Retinal Vein Occlusion Treatment Receives Approval in Japan

June 30, 2015 8:39 am | News | Comments

This new indication includes macular edema secondary to branch retinal vein occlusion in addition to the previously-approved indication of macular edema secondary to central retinal vein occlusion. Read more...

Global Biosimilars Market Value Could Hit $55B by 2020

June 30, 2015 8:28 am | by Sumith Ladda, Analyst, GBI Research | Articles | Comments

The 30 percent to 50 percent reduction in biosimilar prices compared with branded biologics could lead to considerable savings in healthcare expenditure. Read more...

Pharmaceutical Trade Association: Greek Medicine Supply May Be At Risk

June 30, 2015 8:17 am | by Ryan Bushey, Associate Editor | Articles | Comments

The organization is calling for the European Union to take emergency action. Read more...

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Novartis Acquires U.S. Biotech Firm Spinifex

June 29, 2015 8:45 am | by The Associated Press | News | Comments

Novartis didn't disclose financial details Monday of the agreement. Read more...

Ascletis Files Clinical Trial Applications for Hepatitis C Drugs in China, Taiwan

June 29, 2015 8:30 am | News | Comments

Ascletis is now the first Chinese company to file clinical trial applications in China for an IFN-free regimen. Read more...

EU Recommends Approval of Roche's Pre-Surgery Breast Cancer Treatment

June 29, 2015 8:29 am | News | Comments

The majority of breast cancer cases are diagnosed at an early stage of the disease, before the cancer has spread to other parts of the body. Read more...

EU Recommends Approval for Alexion's Rare Disease Drugs

June 29, 2015 8:26 am | News | Comments

The drugs are called Strensiq and Kanuma. Read more...

Janssen Schizophrenia Treatment Now Commercially Available

June 26, 2015 10:37 am | News | Comments

The first schizophrenia treatment to be taken just four times a year – with dosing measured in seasons, not days – is now available in the United States. The three-month dosing interval of Invega Trinza (paliperidone palmitate) offers a new paradigm for treating patients with schizophrenia. Read more...

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Global Gene Therapy Deals Sky-Rocketed to Nearly $5B in 2014

June 26, 2015 8:31 am | by Adam Dion, MS, Senior Industry Analyst, GlobalData | Articles | Comments

Nearly $1.5 billion was raised in the gene therapy arena from 2014 to 2015. Read more...

EU Approves Daiichi Sankyo's Lixiana

June 25, 2015 8:52 am | News | Comments

The drug is intended for stroke prevention in nonvalvular atrial fibrillation and for the treatment and prevention of reccurent DVT and PE. Read more...

AbbVie Announces New Phase3b Results for Liver Cirrhosis

June 24, 2015 12:58 pm | News | Comments

AbbVie, a global biopharmaceutical company, today announced TURQUOISE-III study results demonstrating 100 percent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR12) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis. Read more...

FDA Approves Eisai's Antiepileptic Agent Fycompa

June 24, 2015 8:46 am | News | Comments

It will be used as an adjunctive treatment for primary generalized tonic-clonic seizures. Read more...

BMS Will Win Big with Melanoma Combination Immunotherapy

June 24, 2015 8:39 am | by Fenix Leung, DPhil, Oncology and Hematology Analyst, GlobalData | Articles | Comments

Data presented at the recent American Society of Clinical Oncology Annual Meeting 2015 by Bristol-Myers Squibb suggests that its Opdivo/Yervoy combination of immunotherapies to treat metastatic melanoma will shape the therapeutic landscape once it is approved. Read more...  

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Pharma R&D Pipeline Value Jumps 18 Percent to $493 Billion

June 23, 2015 12:36 pm | by Stephanie Guzowski, Editor | News | Comments

The pharmaceutical industry charges on across the U.S. and Europe, fueling a projected 5 percent increase in global prescription sales over the next five years, according to the industry report, “World Preview 2015, Outlook to 2020” from market intelligence firm, Evaluate. Read more...

Sandoz Announces U.S. Launch of Glatopa

June 22, 2015 4:25 pm | News | Comments

This is the first generic version of Teva's Copaxone. Read more...

Tekmira Says Ebola Drug Unlikely to Work in Study

June 22, 2015 8:21 am | by The Associated Press | News | Comments

The Canadian company said the mid-stage study reached a statistical futility boundary. Read more...

Phase 3 Data Show Panitumumab Improves OS in Metastatic Colorectal Cancer

June 19, 2015 11:57 am | News | Comments

Amgen today announced that a Phase 3 study evaluating Vectibix® (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone. Read more...

Allergan to Acquire Kythera Biopharmaceuticals

June 17, 2015 8:53 am | News | Comments

This purchase compliments Allergan's existing position in facial aesthetics. Read more...

MERS Not Given Same Vaccine Attention as Ebola, Other Viruses

June 16, 2015 8:50 am | by Seth Augenstein, Digital Reporter | Articles | Comments

Authorities are scrambling to control the spread of the illness, known fully as the Middle East Respiratory Syndrome. Read more...

Axial Spondyloarthritis Treatment Market Value Will Almost Double to $2.9B by 2024

June 15, 2015 8:33 am | by Heather Leach, Ph.D., Immunology Analyst, GlobalData | Articles | Comments

The company’s latest report states that the US will cement its position as the largest of the seven major treatment markets (7MM) for axSpA. Read more...

Pfizer Reports Top Line Results from Phase 3 Study of Pristiq

June 15, 2015 8:22 am | News | Comments

The drug was evaluated for the efficacy, safety, and tolerability in pediatric patients ages 7 to 17 with Major Depressive Disorder. Read more...

Novartis Gains FDA Approval for ITP Treatment

June 12, 2015 12:51 pm | News | Comments

Novartis announced today that the US Food and Drug Administration (FDA) has approved Promacta (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was approved by the FDA in 2008 for use in adult patients with the same condition. Read more...

Amgen to Discuss Repatha (Evolocumab) for Treatment Of High Cholesterol

June 11, 2015 9:42 am | News | Comments

Amgen today announced that the Company will discuss the data supporting the RepathaTM (evolocumab) Biologics License Application (BLA) for the treatment of high cholesterol with the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). Read more...

Lilly Announces Positive Phase 3 Results for Psoriasis Drug

June 10, 2015 1:36 pm | News | Comments

Eli Lilly and Company announced today that detailed results of two pivotal Phase 3 studies for ixekizumab were published by The Lancet. The UNCOVER-2 and UNCOVER-3 clinical studies of more than 2,500 patients found ixekizumab to be statistically superior to etanercept and placebo on all measures of skin clearance. Read more...

FDA Panel Recommends Approval of New Cholesterol-Lowering Drug

June 10, 2015 11:25 am | by Stephanie Guzowski, Editor | News | Comments

A Food and Drug Administration (FDA) advisory panel on Tuesday recommended approval of a new injectable drug, alirocumab (Praluent) from Sanofi SA and Regeneron Pharmaceuticals, to help prevent heart attacks by lowering cholesterol. The new drug may be more powerful and carry fewer side effects than statins. Read more...

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