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The Lead

Israel's Ministry of Health Approves Pluristem's Commercial-Scale 3D Cell Manufacturing Process

July 31, 2014 10:58 am | News | Comments

Pluristem Therapeutics has announced that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa.     

The Galien Foundation Announces 2014 Prix Galien USA Nominees

July 31, 2014 10:13 am | News | Comments

The Galien Foundation today announced the 2014 nominees for the eighth annual Prix Galien USA....

AstraZeneca and Kyowa Hakko Kirin Partner on Immuno-Oncology Clinical Study

July 30, 2014 10:02 am | News | Comments

AstraZeneca today announced that it has entered into a clinical study collaboration with Kyowa...

PCI Announces Definitive Agreement to Acquire Penn Pharma

July 30, 2014 8:38 am | News | Comments

Packaging Coordinators has reached a definitive agreement to acquire Penn Pharmaceutical...

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Ortho-Clinical Diagnostics and Astute Medical to Develop Acute Kidney Injury Tests

July 28, 2014 9:06 am | News | Comments

Ortho-Clinical Diagnostics has entered into a strategic partnership with Astute Medical, under which OCD will become the exclusive commercial partner for the distribution of Astute’s NEPHROCHECK ® Test and ASTUTE140 ® Meter in certain markets in Europe and, pending FDA clearance, the United States.

AstraZeneca and QIAGEN to Develop Diagnostic Test for Lung Cancer Patients Suitable for Treatment with IRESSA

July 28, 2014 8:49 am | News | Comments

AstraZeneca today announced that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with IRESSA®.  

AstraZeneca and Roche to Develop Companion Diagnostic Test for AZD9291

July 28, 2014 7:57 am | News | Comments

AstraZeneca today 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).

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Bayer and Onyx Pharmaceuticals’ Phase 3 Trial of NEXAVAR Misses Study Goals

July 25, 2014 8:26 am | News | Comments

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

Novogen and CanTx Appoint Contract Manufacturers to Produce Clinical Batches of Cantrixil

July 25, 2014 8:16 am | News | Comments

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. 

Ten Cities Where the Drug Business Thrives

July 24, 2014 1:54 pm | News | Comments

They've got money, connections and hordes of eager college students. Ten U.S. cities head a new list of best places to develop and distribute drugs...of the legal kind, that is.  The 2014 JLL Global Life Sciences Cluster Report analyzes the top cities where science and pharmaceutical innovation converge.

GSK's CEO and CFO Discuss the Company's Second Quarter Results

July 23, 2014 9:13 am | Videos | Comments

GSK CEO Sir Andrew Witty and CFO Simon Dingemans on the group’s Q2 2014 results and strategy update.                         

Shire Enters Strategic Licensing and Collaboration Agreement with ArmaGen

July 23, 2014 8:02 am | News | Comments

Shire and ArmaGen announced a worldwide licensing and collaboration agreement for AGT-182, an investigational enzyme replacement therapy (ERT) for the potential treatment of both the central nervous system (CNS) and somatic manifestations in patients with Hunter syndrome (MPS II).

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MedImmune and Advaxis Partner on Immuno-Oncology Combination Clinical Trial

July 22, 2014 8:20 am | News | Comments

AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a clinical trial collaboration with Advaxis, Inc., a US-based biotechnology company developing cancer immunotherapies.    

Merz North America to Establish Headquarters in Raleigh, North Carolina

July 16, 2014 3:42 pm | News | Comments

Merz North America will establish its headquarters in Raleigh, North Carolina, officials announced today at a press conference with Gov. Pat McCrory. The global pharmaceutical company – part of the Merz Pharma Group, with affiliates in 18 countries around the world – will move operations from current headquarters in Greensboro and from elsewhere in the U.S.

Like Peanut Butter and Chocolate

July 16, 2014 3:02 pm | by Mike Auerbach, Editor In Chief | Blogs | Comments

Some things just seem to naturally go together – peanut butter and chocolate is one of those combinations – especially in the form of peanut butter cups. Bacon and eggs is another, as is peanut butter and jelly, pizza and beer and numerous other tasty combinations.

Aptuit Names Executive VP, Business Development & Marketing; Enhances Sterile Drug Product Capabilities

July 16, 2014 11:33 am | News | Comments

Aptuit LLC has appointed Paul D. Overton, Ph.D., as Executive Vice President, Business Development and Marketing, making him responsible for all of Aptuit’s sales and marketing activities.           

GSK and Theravance Initiate Phase III Program for COPD Treatment

July 16, 2014 8:53 am | News | Comments

GlaxoSmithKline and Theravance today announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease (COPD).

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West Dedicates Pharmaceutical Manufacturing Plant in India

July 16, 2014 8:41 am | News | Comments

In June 2012, West signed a 99-year lease on 72,800 square meters (approximately 783,600 square feet) of land in Sri City. Sri City offers the advantages of a metropolitan location and was selected primarily on the suitability of land, availability of utilities, labor suitability, logistics and quality of life.

LEO Pharma and KLOX Technologies Strike Global Dermatology Deal

July 15, 2014 8:57 am | News | Comments

LEO Pharma and KLOX Technologies Inc. have entered into a worldwide license and joint venture agreement, excluding Canada, to further develop and commercialize KLOX's BioPhotonic technology platform in dermatology, which includes a CE approved treatment for moderate to severe acne. 

Novartis to Use Google Technology for Eye Care

July 15, 2014 8:51 am | by The Associated Press | News | Comments

The drugmaker said its Alcon eye care division will license Google technology and work with a team from Google to develop a lens that uses microchips and miniaturized electronics.            

Budding Business: Pot Testing Lab Growing in Bend, Oregon

July 14, 2014 8:29 am | by HILLARY BORRUD, The Bulletin | News | Comments

Cascadia Labs is nestled amid ornamental fruit trees in a quiet office park on the north end of Bend. In this lab, employees with backgrounds in the biotechnology and pharmaceutical industries spend their days testing a variety of products with one common ingredient, consumed by thousands of patients across Oregon: medical marijuana.

Astellas Details Pipeline Progress at R&D Meeting

July 11, 2014 8:37 am | News | Comments

Astellas announced progress on the company's efforts to reshape its research framework at its R&D meeting held in Tokyo on July 10. The meeting provided an opportunity for Astellas to present a comprehensive overview of its late-stage clinical programs and corporate strategy.

Neurelis Regains Rights to Intranasal Diazepam Program

July 11, 2014 8:08 am | News | Comments

Neurelis has announced an agreement with Biotie Therapies to end the option held by Biotie to purchase Neurelis, clearing the way for Neurelis to commence further development of NRL-1 for pediatric and adult epilepsy patients who experience acute repetitive seizures.

KBR to Construct Oral Solid Dosage Production Facility for Purdue Pharma in Durham, NC

July 9, 2014 8:52 am | News | Comments

Production areas will feature clean room spaces with epoxy flooring, and epoxy painted walls and ceilings. The building will also house administrative offices, laboratories and associated support areas, such as dining, conference, and training areas.

Lexicon and JDRF Collaborate for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes

July 9, 2014 8:38 am | News | Comments

Lexicon Pharmaceuticals announced today that JDRF, the world's largest non-profit supporter of type 1 diabetes (T1D) research, will provide funding to support a Phase 2, randomized, double-masked, placebo-controlled clinical trial to evaluate the efficacy and safety of LX4211 in a younger population with T1D.

AstraZeneca and Max Planck Institute to Create Satellite Chemistry Unit for Cardiovascular and Metabolic Diseases

July 8, 2014 8:47 am | News | Comments

AstraZeneca today announced an agreement with the Max Planck Institute of Molecular Physiology (MPI), Germany, to establish a ‘satellite unit’ in cardiovascular and metabolic disease (CVMD), linked to AstraZeneca’s CVMD Innovative Medicines unit (iMed) in Mölndal, Sweden, to study new modalities chemistry.

Compugen Discloses Achievement of Milestone in Cancer Immunotherapy Collaboration with Bayer

July 7, 2014 8:03 am | News | Comments

Compugen Ltd. has achieved the initial milestone in the cancer immunotherapy collaboration it entered last year with Bayer HealthCare. The collaboration provides for the development and commercialization of therapeutic antibodies against two checkpoint protein candidates discovered by Compugen.

Zogenix Details Timeframe for New Zohydro Version

July 2, 2014 9:53 am | News | Comments

Zogenix says a harder-to-abuse version of its powerful painkiller Zohydro could be reviewed by regulators this fall and, if approved, might hit the market early next year.             

Pharmaceutical Processing Annual Buying Guide - 2014/2015

July 1, 2014 9:33 am | Digital Editions | Comments

The June issue is our annual Pharmaceutical Supplier Directory. Organized by product category, this complete resource for the pharmaceutical manufacturing industry features detailed listings of the companies that supply products, equipment, systems, and services to the pharmaceutical industry. The 2014/2015 Supplier Directory is a must have for anyone involved in the development, scale-up, and manufacturing and packaging of pharmaceuticals.

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