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The Lead

BioNano Buys Genome Mapping System

July 31, 2014 2:21 pm | News | Comments

BioNano Genomics announced the purchase of an Irys System by BGI, the world's largest genomics organization. BGI selected BioNano's platform to enable comprehensive exploration of human structural variation and to provide vastly improved assemblies for various organisms of interest, including those where no reference exists. Read more...

Illinois Medicaid Restricts Sovaldi Use

July 31, 2014 9:10 am | by Carla L. Johnson, AP Medical Writer | News | Comments

Facing ballooning costs for a $1,000 pill to treat hepatitis C, Illinois' Medicaid program is...

France is 17th Country to Allow Patient Enrollment in Head, Neck Cancer Trial

July 31, 2014 8:44 am | News | Comments

CEL-SCI Corp. announced that the French Agency for the Safety of Health Products has cleared the...

CHMP Has More Issues with Weight Loss Drug

July 31, 2014 8:34 am | News | Comments

Orexigen Therapeutics Inc. announced it has received the Day 180 List of Outstanding Issues from...

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FDA Approves Eylea for Third Indication

July 30, 2014 2:34 pm | News | Comments

Regeneron Pharmaceuticals Inc. announced that the FDA has approved Eylea (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). Read more...                          

Pfizer Buying Two Baxter Vaccines for $635M

July 30, 2014 1:26 pm | News | Comments

Pfizer will spend $635 million on two vaccines owned by Baxter International that are sold in a number of European countries and other locations outside of the U.S. Read more...                     

Sage Licenses Gene Editing Tool from the Broad Institute

July 30, 2014 11:06 am | News | Comments

Sage Labs Inc., a leading provider of products, services and technologies in the field of genome engineering, announced that they have licensed CRISPR/Cas9 technology from the Broad Institute enabling them to use the CRISPR/Cas9 system to engineer cell and animal models for their clients as well as distribute validated CRISPR reagents. Read more...

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Diabetes Drugs Get Positive CHMP Opinions for CV Safety Updates

July 30, 2014 10:58 am | News | Comments

Takeda Pharmaceuticals International GmbH announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued positive opinions for updates to the Summary of Product Characteristics for Vipidia and the fixed-dose combination therapies Vipdomet and Incresync. Read more...

AstraZeneca, Kyowa Hakko Kirin Partner on Immuno-Oncology Study

July 30, 2014 10:48 am | News | Comments

AstraZeneca announced that it has entered into a clinical study collaboration with Kyowa Hakko Kirin for a Phase 1/1b immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumors. Read more...

European Commission Approves Eliquis for DVT, PE

July 30, 2014 10:37 am | News | Comments

Bristol-Myers Squibb Co. and Pfizer Inc. announced that the European Commission has approved Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults. Read more...

Amgen Laying Off at Least 2,400

July 30, 2014 10:20 am | by Linda A. Johnson, AP Business Writer | News | Comments

Biologic drugmaker Amgen said Tuesday that it will lay off 12 to 15% of its worldwide workforce and close four sites, even as it reported stellar second-quarter results trouncing Wall Street expectations and raised forecasts for its 2014 profit and revenue, driving up shares. Read more...

Impax Labs Slumps After Problems with FDA Inspection

July 30, 2014 8:28 am | News | Comments

Shares of Impax Labs sank Tuesday after an FDA inspection uncovered potential problems at a facility where the company will make its experimental Parkinson's disease drug Rytary. Read more...                  

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FDA Approves Expanded Use of Imbruvica

July 29, 2014 2:43 pm | News | Comments

The FDA has approved the supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Read more...        

$1,000 Sovaldi Now Choice Hep C Treatment

July 29, 2014 12:28 pm | by Ricardo Alonso-Zaldivar | News | Comments

The price may be high but so is demand. A new $1,000-per-pill drug has become the treatment of choice for Americans with hepatitis C, a liver-wasting disease that affects more than 3 million. Read more...             

Glaucoma Drug Gets EU Approval

July 29, 2014 11:18 am | News | Comments

Alcon, the global leader in eye care and a division of Novartis, announced that Simbrinza eye drops suspension has been approved by the European Commission to decrease elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction. Read more...

Artes, Burnet Institute Partner on Malaria Vaccine

July 29, 2014 11:13 am | by Catherine Somerville | News | Comments

Artes Biotechnology and Burnet Institute have joined forces to develop a new type of malaria vaccine in a project funded by the PATH Malaria Vaccine Initiative (MVI), which will produce purified vaccine antigens as virus-like particles, a type of nano-particle, for testing in laboratory studies. Read more...

European Commission Approves Leukemia Drug

July 29, 2014 11:04 am | News | Comments

Roche announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Read more...

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China to Put GSK Investigators on “Public Trial”

July 29, 2014 10:54 am | News | Comments

A Shanghai court said American and British investigators who worked for drug maker GlaxoSmithKline will stand trial - which now will be public - Aug. 8 on charges of illegally obtaining information on Chinese citizens. Read more...    

FDA Rejects Zalviso Pain Treatment System

July 28, 2014 12:45 pm | News | Comments

AcelRx Pharmaceuticals Inc. announced that the FDA has issued a Complete Response Letter (CRL) for the company's NDA for Zalviso. The CRL contains requests for additional information on the system to ensure proper use of the device. Read more... 

MedImmune Fights Pediatricians' New Advice

July 28, 2014 12:13 pm | by Lindsey Tanner, AP Medical Writer | News | Comments

A costly drug given mostly to premature babies is at the center of a clash between the manufacturer and the nation's leading pediatrician's group, which recommends scaling back use of the medicine. Read more...            

FDA Clears IND for Lorus Blood Cancer Drug

July 28, 2014 10:53 am | News | Comments

Lorus Therapeutics Inc. announced that the FDA completed its review and cleared the company's IND application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukemia, high-risk myelodysplastic syndromes, lymphomas and multiple myeloma. Read more...

Veloxis Gets EU Marketing Authorization for Transplant Drug

July 28, 2014 10:47 am | News | Comments

Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. announced that the European Commission (EC) has granted marketing authorization for Envarsus for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU). Read more...

AstraZeneca, Roche Collaborate on Companion Diagnostic Test

July 28, 2014 10:41 am | News | Comments

AstraZeneca announced it has entered into collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small-cell lung cancer (NSCLC). Read more...

Emulate to Commercialize Organs-on-Chips Platform

July 28, 2014 10:25 am | News | Comments

Emulate Inc. announced the company’s launch with a $12 million Series A financing to commercialize a first-in-kind, automated ‘Organs-on-Chips’ platform that mimics human physiology and diseases, while permitting real-time elucidation of molecular mechanisms of action and toxicity. Read more...

Panel Backs Extended Use of Allergan's DME Treatment

July 25, 2014 2:53 pm | News | Comments

Allergan announced that the European Union's Committee for Medicinal Products for Human Use has recommended extending the Marketing Authorization for Ozurdex to treat adult patients with vision loss due to diabetic macular edema. Read more...   

CHMP Recommends MA for Diabetes Drug

July 25, 2014 11:24 am | News | Comments

Novo Nordisk announced that the Committee for Medicinal Products for Human Use under the European Medicines Agency adopted a positive opinion, recommending marketing authorization for Xultophy for the treatment of type 2 diabetes mellitus in adults. Read more...

FDA Reviews What Could Be First Biosimilar

July 25, 2014 11:20 am | News | Comments

The Food and Drug Administration is reviewing research data on what could become the first U.S.-approved "biosimilar" drug, a cheaper, sort-of generic version of a biologic drug, nearly five years after Congress passed a law enabling future approval of biosimilars. Read more...

Pfizer’s Attempted AstraZeneca Deal Gets Obama’s Attention

July 25, 2014 10:42 am | News | Comments

Staking out a populist stand ahead of the midterm elections, President Barack Obama on Thursday demanded "economic patriotism" from U.S. corporations that use legal means to avoid U.S. taxes through overseas mergers, declaring "I don't care if it's legal. It's wrong." Read more...

FDA Approves Combo Painkiller from OxyContin Maker

July 24, 2014 2:59 pm | News | Comments

The Food and Drug Administration has approved a new combination pain pill from the maker of OxyContin that is designed to discourage abuse by painkiller addicts. Read more...                     

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