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Vetter Completes Structural Work on New Multi-Functional Development Service and Information Technology Building

January 29, 2015 10:40 am | News | Comments

Following 16 months of construction, the first phase of a modern, multi-functional building at Vetter’s Ravensburg Schuetzenstrasse site has been completed. Estimated to be fully operational by the beginning of 2016, the new facility will contain high-tech laboratories and workplaces for Vetter Development Service, as well as a highly secure data center and additional office space for a total area of 8,500 sqm.

Study: Sponsors and CROs Implementing New Ways to Better Leverage Investigative Site Relationships

January 29, 2015 9:33 am | News | Comments

Improved investigative site relationship use and effectiveness are top objectives in 2015 for...

Biogen Idec, Fondazione Telethon and Ospedale San Raffaele Announce Global Collaboration to Develop Gene Therapies for Hemophilia

January 29, 2015 8:06 am | News | Comments

The agreement will combine San Raffaele - Telethon Institute for Gene Therapy’s (TIGET)...

Galmed and Perrigo Announced Agreement for Large-Scale Aramchol API Production

January 28, 2015 8:49 am | News | Comments

Galmed Pharmaceuticals announced today that it has entered into a Manufacturing Services...

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PPD Expands Clinical Supplies Facility in Athlone, Ireland

January 28, 2015 8:07 am | News | Comments

Pharmaceutical Product Development, (PPD) has completed an expansion of its clinical supplies facility in Athlone, Ireland, that will enable the company to double its packaging warehousing capabilities and quadruple its distribution services. Those increases are the result of PPD more than tripling the size of the facility as part of its long-term strategy to expand its global depot network.

Report: Single-Use Bioreactors Market to Grow to $471M by 2019

January 28, 2015 8:02 am | News | Comments

The single use bioreactors (SUBs) market is expected to grow at a double digit CAGR of 18.4% to reach $470.9 million by 2019 from $202.5 million in 2014. Developing markets such as China and India are lucrative markets for single-use bioreactors (SUB), owing to the low cost benefits offered by these nations.

GSK Expands Its Asthma and COPD Portfolio in the US

January 26, 2015 10:36 am | News | Comments

GlaxoSmithKline has announced the simultaneous availability of two of its recently approved products for the treatment of asthma and COPD to retail pharmacies in the US. Over the past 15 months, GSK has launched four inhaled respiratory therapies in the US, all delivered in its Ellipta inhaler.

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FDA Approves Octapharma's Second Octagam® 10% Manufacturing Site

January 26, 2015 10:24 am | News | Comments

Octapharma announced that the FDA has approved the company’s manufacturing facility in Vienna, Austria for the production of Octagam 10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation], which became available in the U.S. during October 2014.

Catalent Expands Integrated Softgel Operations Through Coating and Packaging Investment In Eberbach, Germany

January 22, 2015 10:44 am | News | Comments

Catalent Pharma Solutions will adding new coating and blister packaging equipment at its 360,000 sq ft, Eberbach, Germany softgel manufacturing facility, expanding the integrated softgel solutions available.       

PPD Expands GMP Laboratory in Athlone, Ireland

January 21, 2015 9:50 am | News | Comments

Pharmaceutical Product Development, LLC (PPD) has expanded its good manufacturing practices (GMP) operations in Athlone, Ireland, by adding a new, state-of-the-art laboratory for cell-based assays to its existing portfolio of services at the facility.

Catalent Biologics and MGC Pharma Announce Partnership for Biomanufacturing in Asia

January 19, 2015 12:29 pm | News | Comments

Catalent Pharma Solutions and Mitsubishi Gas Chemical Company, Inc. (MGC), have entered into a partnership agreement to co-promote Catalent’s proprietary GPEx® technology in the Asian market.          

AMRI Receives NIH Contract Award

January 19, 2015 9:29 am | News | Comments

AMRI has received a 10-year federal contract award from the NIH for drug development and manufacturing services. This NIH/National Institute of Neurological Disorders and Stroke award will support NIH's Drug Manufacturing and Formulation Program, which is a component of the Blueprint Neurotherapeutics Network. AMRI has supported the NIH BPN since 2011, providing chemistry services and discovery technologies.

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Evotec Achieves Milestones in TargetAD Collaboration With Janssen

January 15, 2015 2:31 pm | News | Comments

Evotec AG has announced the achievement of several small, but very important milestones in its TargetAD collaboration with Janssen Pharmaceuticals, Inc. for the identification and selection of novel targets from Evotec's TargetAD database and for the transition of targets into the drug discovery process.

Moderna and Merck to Develop Messenger RNA-based Antiviral Vaccines and Passive Immunity Therapies

January 15, 2015 1:32 pm | News | Comments

Moderna Therapeutics has announced a license and collaboration agreement with Merck for the discovery and development of vaccines and passive immunity treatments against viral diseases using modified messenger RNA (mRNA).     

Elite Pharmaceuticals Announces First Shipment of Generic Isradipine Capsules

January 15, 2015 11:07 am | News | Comments

Elite Pharmaceuticals has announced the first shipments of generic Isradipine 2.5 mg and 5.0 mg capsules. Isradipine is a calcium channel blocker prescribed for hypertension.             

Boehringer Ingelheim and Sanofi to Collaborate on Manufacturing Biopharmaceuticals

January 15, 2015 8:34 am | News | Comments

Boehringer Ingelheim and Sanofi announced today that they enter into an alliance to extend Sanofi’s manufacturing capacity network for therapeutic monoclonal antibodies.              

Catalent and Sanofi to Collaborate On Smartag™ Antibody-Drug Conjugate Technology With Sanofi’s Proprietary Antibodies

January 15, 2015 8:07 am | News | Comments

Catalent Pharma Solutions has entered into a collaboration with Sanofi-Aventis Recherche & Développement, a Sanofi Company to implement Catalent’s proprietary SMARTag™ technology in the development of next generation Antibody-Drug Conjugates (ADCs).

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SAFC Opens Dry Powder Media Manufacturing Facility in Irvine, Scotland

January 15, 2015 8:02 am | News | Comments

The Irvine expansion, announced in March 2013, was initiated as part of a five-year capital investment plan designed to support SAFC customers with critical products and services across the globe. Now fully validated, the site acts as the European counterpart to the Lenexa, Kansas, Center of Excellence for cell culture media manufacture and supply in the U.S.

Vical and AnGes to Develop Therapy for Ebola Virus

January 14, 2015 8:38 am | News | Comments

Vical Incorporated and AnGes MG announced today that they have entered into collaboration to develop and commercialize an equine polyclonal antibody therapy for patients afflicted with Ebola virus disease. No medicines or vaccines are currently approved for the treatment of Ebola.

SGS Expands Biomarker Services

January 14, 2015 8:28 am | News | Comments

SGS Life Science Services today announced that its laboratory in Poitiers, France, has successfully completed a full analytical validation of the novel Meso Scale Discovery (MSD®) V-PLEX 10-plex Proinflammatory Panel I, for use with human plasma samples.

Roche, Meiji and Fedora to Collaborate on New Antibiotic to Fight Increasing Bacterial Resistance

January 13, 2015 11:26 am | News | Comments

Roche, Meiji Seika Pharma and Fedora have entered into a license agreement for the development and commercialization of OP0595, a beta-lactamase inhibitor in phase I clinical development. Under the agreement, Roche obtains worldwide rights from both companies for development and commercialization with the exception of Japan, where Meiji will retain sole commercialization rights.

Harvard Researchers Bolster Chemical Production by Bacteria

January 13, 2015 8:40 am | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

Their report, published in the journal Proceedings of the National Academy of Sciences, detailed how scientists engineered the common E. coli bacteria to produce desirable chemicals at an output 30 times greater and a rate 1,000 times faster than previously possible.

Merck Races Bristol-Myers Squibb as it Seeks New OK for Cancer Drug

January 13, 2015 8:22 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

Merck is ratcheting up its race with rival Bristol-Myers Squibb Co. for leadership in one of today's hottest research areas, immuno-oncology, which harnesses the immune system to fight cancer.          

Lilly, Merck to Collaborate on Immuno-Oncology Combination Regimens in Multiple Types of Cancer

January 13, 2015 8:17 am | News | Comments

Merck and Eli Lilly announced today an oncology clinical trial collaboration to evaluate the safety, tolerability and efficacy of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Lilly compounds in multiple clinical trials.

2015 Critical Issues

January 12, 2015 3:57 pm | by Mike Auerbach, Editor In Chief | Blogs | Comments

The pharmaceutical industry faces numerous issues on a day-to-day and yearly basis. Manufacturing, quality control, efficiences, budgets and regulations all must be met or exceeded. Here are ten industry critical issues, I feel the industry will be facing in the coming year.

AMRI to Develop and Manufacture Parenteral Products for Genovi Pharmaceuticals

January 12, 2015 8:51 am | News | Comments

AMRI will initially provide cGMP manufacture and analytical support for the registration of five product candidates. AMRI will be reimbursed for technology transfer activities, analytical development and manufacture of regulatory submission batches. In addition, AMRI is eligible to receive additional payments for achieving product delivery milestones.

MedImmune Enters Licensing Agreement with Omnis Pharmaceuticals for Oncolytic Viruses in Immuno-Oncology

January 12, 2015 8:43 am | News | Comments

This agreement will allow MedImmune to combine key agents from its investigational immunotherapy portfolio with Omnis’ lead investigational oncolytic virus program, a genetically engineered strain of vesicular stomatitis virus (VSV).   

Perrigo Partners with Ferrara Candy to Enter Gummy Vitamins And Dietary Supplement Market

January 12, 2015 8:38 am | News | Comments

Perrigo Company and Ferrara Candy Company announced today that Perrigo's Nutritionals division has signed a supply agreement with Ferrara to manufacture store brand gummy vitamins and dietary supplements to be sold at leading retailers across the United States.

Merck Provides Update on Strategic Actions to Transform the Company

January 12, 2015 8:20 am | News | Comments

Merck today will report on the ongoing execution of its multi-year, strategic initiative to sharpen its commercial and research and development (R&D) focus, redesign its operating model and reduce its cost base. In October 2013, Merck launched its global initiative to transform the company into a more competitive and innovative company and to build a platform for sustained future growth.

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