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Study: U.S. Biosimilar Approvals Poised to Grow, But Market Uptake Faces Several Challenges

March 5, 2015 3:32 pm | News | Comments

Biosimilar approvals in the United States are expected to increase during the next five years, but safety concerns among physicians and the need for greater regulatory clarity concerning therapeutic interchangeability could hinder market uptake, according to a study recently completed by the Tufts Center for the Study of Drug Development.

UPM Pharmaceuticals to Manufacture Sprout Pharmaceuticals' Flibanserin Tablets

March 4, 2015 11:14 pm | News | Comments

UPM Pharmaceuticals, a division of Gregory Pharmaceutical Holdings, Inc., has reached an...

Johnson & Johnson Innovation Announces New Startup Campus

March 3, 2015 2:17 pm | by Andy Szal, Digital Reporter | News | Comments

The venture capital arm of the New Jersey consumer products giant officially unveiled its JLABS@...

Blueprint Medicines Announces $265M Strategic Collaboration with Alexion

March 3, 2015 1:48 pm | News | Comments

Blueprint Medicines has announced a strategic collaboration with Alexion to discover, develop...

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Catalent Expands European Clinical Packaging Capabilities

February 26, 2015 3:01 pm | News | Comments

Catalent Pharma Solutions has announced several expanded capabilities within its European Clinical Supply Services network. The expansions have been implemented in response to increased customer demand for specialty clinical packaging, where the proportion of highly-potent or temperature-sensitive investigational medical products continues to increase.

Huntingdon Life Sciences and Harlan Laboratories to Operate Under New Brand and Name

February 24, 2015 11:11 am | News | Comments

Huntingdon Life Sciences (HLS) and Harlan Laboratories have announced that the two companies will be rebranded to reflect the new integrated management structure that has been put in place and the broader product and service offerings of the combined organizations.

Jacobs to Design Ireland Biologic Facility for BMS

February 24, 2015 8:03 am | News | Comments

Jacobs Engineering Group has received a contract from Bristol-Myers Squibb Company to provide architectural and engineering services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland.

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NGM and Merck Announce Agreement to Discover, Develop and Commercialize Novel Biologic Therapeutics

February 23, 2015 8:17 am | News | Comments

NGM Biopharmaceuticals, Inc., a privately-held biotechnology company and Merck announced they have entered into a multi-year collaboration to research, discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas.

Packaging Entrepreneurs: Legacy Pharmaceutical Packaging

February 20, 2015 10:17 am | by Mike Auerbach, Editor-In-Chief | Articles | Comments

Legacy Pharmaceutical Packaging, in St. Louis, Missouri is proud of its entrepreneurial spirit, its operational flexibility and technological expertise, and the breadth of packaging services it offers to its customers in a wide variety of segments of the healthcare industry.

McKesson Corp. Revealed as the Clear Lake, Iowa Mystery Company

February 19, 2015 2:24 pm | News | Comments

Officials said Thursday that San Francisco-based McKesson Corp. would occupy a new 340,000-square-foot distribution center in Clear Lake, ending a nearly yearlong mystery about the company's identity.

NewLink Announces Clinical Development Milestone Achieved With Merck for Ebola Vaccine Candidate

February 19, 2015 8:51 am | News | Comments

Under the terms of the agreement, NewLink Genetics will receive a payment of $20 million in connection with the achievement of the milestone. The milestone pertains to the initiation of a key clinical trial for the vaccine.

Kite Pharma Establishes Manufacturing Capabilities to Support Cancer Immunotherapy Products

February 19, 2015 8:25 am | News | Comments

Kite Pharma has entered into a lease agreement for a commercial manufacturing facility in El Segundo, California, which is adjacent to Los Angeles International Airport.

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Bayer Announces Reorganization as ‘Pure Life-Sciences Company’

February 12, 2015 10:39 am | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

The company announced the overhaul of its HealthCare, CropScience and other operations in a letter sent to employees Wednesday, though it indicated specific decisions on what the company will look like next January haven't yet been made.

Johnson & Johnson Projects Aim to Spot Who Will Get a Disease

February 12, 2015 8:05 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

This isn't a science fiction tale. It's the ambitious goal of three research projects just launched by Johnson & Johnson's pharmaceutical research arm, Janssen Research & Development, that the company says are aimed at redefining health care.

Voyager Therapeutics and Genzyme to Develop Gene Therapies for Patients with CNS Disorders

February 11, 2015 8:30 am | News | Comments

The collaboration will leverage Genzyme’s long-standing commitment and scientific leadership in the field of adeno-associated virus (AAV) gene therapy and Voyager’s industry-leading AAV product engine to develop breakthrough therapies for patients suffering from severe CNS disorders.

Repligen Completes Expansion of U.S. Facility

February 10, 2015 8:49 am | News | Comments

Repligen Corporation announced today that it has completed an 11,000 square foot expansion of its U.S. manufacturing facility. The expansion includes a dedicated space for the production and assembly of Repligen's Alternating Tangential Flow System, the most recent addition to the company's upstream bioprocessing product portfolio.

Enteris BioPharma Launches Contract Manufacturing

February 10, 2015 8:02 am | News | Comments

Enteris BioPharma has announced the launch of contract manufacturing located within its 32,000 square foot, FDA inspected and cGMP compliant facility in Boonton, NJ. Equipped to ensure cost-effective, high-quality production of API using microbial expression systems, Enteris BioPharma offers pharmaceutical companies a full array of services to meet their manufacturing needs, from pre-clinical to commercial scale.

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EMD Millipore and Precision Biologics to Provide Upstream Process Development Services

February 3, 2015 1:09 pm | News | Comments

EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, has announced an agreement for providing upstream process development services for Precision Biologics, Inc., a Texas-based clinical-stage biotechnology company, to advance a preclinical monoclonal antibody.

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 pharmaceutical companies and contract research organizations, according to drug industry R&D executives participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development.

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) extensive expertise in creating new gene therapy strategies and developing them from the bench to bedside with Biogen Idec’s deep understanding of hematology to potentially treat the underlying causes of hemophilia A and B.

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 Agreement with Perrigo for the large-scale production of the active pharmaceutical ingredient of Galmed's product candidate, aramchol.     

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.

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.          

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