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Amerigen Pharmaceuticals and Ningbo Menovo Pharmaceutical to Collaborate on Generics

August 27, 2014 12:04 pm | News | Comments

Under the terms of the agreement, Amerigen and Menovo will jointly develop products for Amerigen to commercialize in the United States. Menovo will be responsible for manufacturing API and finished product whereas Amerigen will be responsible for clinical, regulatory and commercial activities in the United States.

EMD Millipore Announces Strategic Alliance with Samsung BioLogics

August 26, 2014 2:34 pm | News | Comments

The alliance is intended to encompass a long-term supply agreement in which EMD Millipore will...

Trends in High Tox Manufacturing

August 26, 2014 2:12 pm | by Mark Butler, Vince Cebular, Sam Halaby, George Petroka, Thomas Woody; Integrated Project Services, Inc. | Articles | Comments

Due to the special containment requirements for manufacturing highly potent active...

Pfizer And Merck to Collaborate On Study Evaluating Novel Anti-Cancer Combination Regimen

August 26, 2014 8:35 am | News | Comments

Pfizer and Merck announced today that they have entered into an agreement to explore the...

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EMD Millipore Expands Biomanufacturing Sciences and Training Center in Japan and Opens New Location in Tokyo

August 26, 2014 8:14 am | News | Comments

EMD Millipore today announced the opening of a new Biomanufacturing Sciences Training Center (BSTC) facility in Tokyo. The facility is designed to help biopharmaceutical companies develop manufacturing processes and find solutions to processing challenges in collaboration with engineers from EMD Millipore.

The Path to Optimized Drug Production

August 14, 2014 8:36 am | by Nancy Berg, President and CEO of the International Society for Pharmaceutical Engineering (ISPE) | Blogs | Comments

Scaling up can be a challenge; know the processes and tools for a successful transition.                                              

Eli Lilly to Close Terre Haute Animal Enzyme Plant

August 14, 2014 8:02 am | News | Comments

Eli Lilly and Co. says it will close its Elanco animal enzyme plant in Terre Haute by early 2016 as part of a consolidation push. Lilly spokesman Ed Sagebiel tells the Tribune-Star the Indianapolis-based company is consolidating all of its animal enzyme manufacturing to a site in Great Britain.

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Rigel’s R348 Misses Endpoints in Phase 2 Dry Eye Study

August 13, 2014 8:22 am | News | Comments

Rigel Pharmaceuticals today announced that R348, its ophthalmic JAK/SYK inhibitor, did not meet the primary or secondary endpoints in a recently completed Phase 2 clinical study in patients with dry eye disease. The endpoints were measured by changes in corneal fluorescein staining, conjunctival staining, tear production and dry eye symptom scores from baseline over 12 weeks of treatment versus placebo.

Pfizer, 23andMe Team Up to Study Bowel Disease

August 12, 2014 11:29 am | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

Pfizer is teaming up with DNA testing company 23andMe to study the possible genetic underpinnings of inflammatory bowel disease, a hard-to-treat ailment that affects an estimated 1.4 million Americans. Under the agreement, Silicon Valley-based 23andMe will map the DNA of 10,000 patients who have forms of the disease, which include Crohn's disease and ulcerative colitis.

Why Fitting a Square Plug in a Round Hole is Profitable for Pharma and Most Likely Will Stay

August 6, 2014 8:50 am | by Girish Malhotra, PE; President, EPCOT International | Blogs | Comments

In 2005 I had raised a question about Batch or a Continuous Process: A Choice. At that time it seemed like a logical question and still is. However, I left part of the question unanswered. Missing was the discussion of components of pharma manufacturing, API manufacture and their formulations.

FDA Inspects Impax's Hayward Facility – Issues Form 483

August 4, 2014 8:46 am | News | Comments

Impax Laboratories today announced FDA performed a re-inspection of the company's Hayward, California manufacturing facility and issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations.   

Allied Minds and BMS Form Enterprise to Advance Discoveries of Biopharmaceutical Innovations

August 4, 2014 8:32 am | News | Comments

Allied Minds and Bristol-Myers Squibb Company today announced the formation of Allied-Bristol Life Sciences LLC, a new jointly owned enterprise created to identify and foster research and pre-clinical development of biopharmaceutical innovations from leading university research institutions across the U.S.

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NanoViricides to Restart its Anti-Ebola Virus Drug Development Program

August 4, 2014 8:23 am | News | Comments

NanoViricides, Inc. reports that it is restarting its drug development program to combat Ebola virus infections. Currently, there are no licensed drugs or vaccines for Ebola, although some vaccines as well as some drug candidates have entered clinical trials.

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. Awards. The Prix Galien Award is considered the biomedical industry's highest accolade and recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines and devices.

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 Hakko Kirin for a Phase I/Ib immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumours.

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 Services Limited. Penn Pharma is headquartered in Tredegar, Wales in the United Kingdom and operates regional offices in New Hope, Pennsylvania and Tokyo, Japan.

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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).

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).

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.           

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