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EMA CHMP issues positive opinion for label updates to Takeda's Vipidia, Vipdomet and Incresync

Takeda Pharmaceuticals International GmbH today 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 (SmPC) for Vipidia (alogliptin) and the fixed-dose combination (FDC) therapies Vipdomet (alogliptin and metformin) and Incresync (alogliptin and pioglitazone).

30 Jul 2014

Glide Pharma licenses prostate cancer diagnostic technology from FScan

Glide Pharmaceutical Technologies Ltd today announced that it has taken an exclusive worldwide licence to an innovative prostate cancer diagnostic technology from FScan Ltd, a Durham University spin-out company.

30 Jul 2014

EMD Serono begins MSB0010718C Phase II study in mMCC patients

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, today announced the initiation of an international Phase II study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1).

29 Jul 2014

EDG Partners announces growth equity investment in MMIS

EDG Partners today announced a growth equity investment in MMIS, Inc., a global technology company that develops and markets compliance and collaboration software solutions for pharmaceutical and medical device companies.

29 Jul 2014

FDA approves EYLEA Injection for treatment of Diabetic Macular Edema

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved EYLEA (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME).

29 Jul 2014

Cloud Pharmaceuticals awarded Phase I grant from NSF SBIR program

Cloud Pharmaceuticals, Inc., a therapeutics company focused on cloud-based drug design and development, announced today that it has been awarded a Phase I grant from the National Science Foundation Small Business Innovation Research program.

29 Jul 2014

First Edition: July 29, 2014

Today's headlines include coverage of the latest Medicare trustee report and the details of the veterans care legislation on Capitol Hill.

29 Jul 2014

Cardioxyl reports positive results from CXL-1427 Phase I trial for treatment of ADHF

Cardioxyl Pharmaceuticals, Inc. announced today the positive results of a clinical trial demonstrating that CXL-1427, a novel potential treatment for acute decompensated heart failure (ADHF), was well tolerated in healthy volunteers.

28 Jul 2014

Envarsus gets marketing authorization from EC for treatment of kidney and liver transplant patients

Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. today 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.

28 Jul 2014

New study in recognition of World Hepatitis Day released on Life Sciences Connect

The Intellectual Property and Science business of Thomson Reuters, the world's leading source of intelligent information for businesses and professionals, today released a new study in recognition of World Hepatitis Day on Life Sciences Connect, a blog exploring the latest news and trends in Life Sciences and updates on the drug pipeline identifying multiple treatments in development that may serve as potential alternatives to Gilead's Sovaldi, currently priced in the United States at $84,000 for 12 weeks of treatment - $1000 per pill.

28 Jul 2014

Research project examines pros and cons of launching multiple products in same therapeutic area

In today's marketplace, launching multiple products for a common therapeutic area is costly and challenging - as is managing a portfolio of products in the same therapeutic area.

26 Jul 2014

Trinidad & Tobago Ministry of Health approves hepatitis C drug telaprevir

The Chemistry, Food & Drugs Division of the Trinidad & Tobago Ministry of Health approved the introduction of Telaprevir to the market, an innovative therapy that significantly increases the cure rate from Hepatitis C, and it is indicated for patients infected with the genotype 1 virus. Telaprevir is available in Trinidad under the trade brand INCIVO®.

26 Jul 2014

Viewpoints: Ryan's 'thoughtful blueprint' to end poverty; GOP challenges after health law ruling

The Republican chairman of the House Budget Committee today released a thoughtful blueprint for overhauling $800 billion worth of U.S. anti-poverty programs.

26 Jul 2014

CanTx, Novogen name two key CMOs to manufacture clinical batches of anti-cancer drug Cantrixil

Oncology drug developer, CanTx Inc., and its parent company, Novogen Ltd., today announced that they have named two key contract manufacturing organizations (CMOs) to produce clinical batches of the experimental anti-cancer drug, Cantrixil.

26 Jul 2014

Eminent doctor explores the science behind flavor perfect food

As a featured speaker at Catersource's Art of Catering Food conference in Atlanta, GA August 4–6 at the Atlanta Convention Center at AmericasMart, Dr Larrian Gillespie, CEO of Culinary Science Investigations of Beverly Hills, CA brings her extensive medical and pharmaceutical background to the culinary world, where she will explore the science behind what makes food delicious.

26 Jul 2014

CPhI South America 2014 to be held in São Paulo from 5 to 7 August 2014

Leading events organizer UBM Live announces that CPhI South America is returning for the seventh year to São Paulo, Brazil from 5th to 7th August 2014.

26 Jul 2014

RI Defeats Hepatitis C project aims to eliminate HCV in Rhode Island

Lynn E. Taylor, M.D., director of The Miriam Hospital's HIV/Viral Hepatitis Coinfection program, states in the July, 2014 Rhode Island Medical Journal special edition, "RI Defeats Hep C" that eliminating hepatitis c virus infection (hep c or HCV) is feasible, can provide economic benefits, enhance capacity to address other health challenges, and improve health care disparities.

26 Jul 2014

Best Practices: Forces of change likely to impact library and information services

Corporate libraries are constantly being faced with a variety of challenges, including understanding new advancements in technology and how to cope with flat or shrinking budgets.

26 Jul 2014

FDA issues Complete Response Letter for AcelRx's Zalviso NDA

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso (sufentanil sublingual tablet system).

26 Jul 2014

Galmed reports net loss of $3.9 million for six months ended June 30, 2014

Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, today announced financial results for the period ended June 30, 2014.

25 Jul 2014

Pharmaceuticals News and Research

EMA CHMP issues positive opinion for label updates to Takeda's Vipidia, Vipdomet and Incresync

Glide Pharma licenses prostate cancer diagnostic technology from FScan

EMD Serono begins MSB0010718C Phase II study in mMCC patients

EDG Partners announces growth equity investment in MMIS

FDA approves EYLEA Injection for treatment of Diabetic Macular Edema

Cloud Pharmaceuticals awarded Phase I grant from NSF SBIR program

First Edition: July 29, 2014

Cardioxyl reports positive results from CXL-1427 Phase I trial for treatment of ADHF

Envarsus gets marketing authorization from EC for treatment of kidney and liver transplant patients

New study in recognition of World Hepatitis Day released on Life Sciences Connect

Research project examines pros and cons of launching multiple products in same therapeutic area

Trinidad & Tobago Ministry of Health approves hepatitis C drug telaprevir

Viewpoints: Ryan's 'thoughtful blueprint' to end poverty; GOP challenges after health law ruling

CanTx, Novogen name two key CMOs to manufacture clinical batches of anti-cancer drug Cantrixil

Eminent doctor explores the science behind flavor perfect food

CPhI South America 2014 to be held in São Paulo from 5 to 7 August 2014

RI Defeats Hepatitis C project aims to eliminate HCV in Rhode Island

Best Practices: Forces of change likely to impact library and information services

FDA issues Complete Response Letter for AcelRx's Zalviso NDA

Galmed reports net loss of $3.9 million for six months ended June 30, 2014

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