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The Lead

Bayer Selects Cardinal Health as U.S. Based Contract Manufacturer for Xofigo Injection

December 18, 2014 1:20 pm | News | Comments

Bayer HealthCare and Cardinal Health have signed a 15-year agreement for the contract manufacturing of Xofigo.  As part of the agreement, Cardinal Health will build a state-of-the art, 64,000 square foot facility in Indianapolis, which will be dedicated exclusively to the manufacturing of Xofigo.

PCI Synthesis Sponsors New England CRO/CMO Council

December 17, 2014 8:54 am | News | Comments

The non-profit New England CRO/CMO Council is open to CROs and CMOs operating in and around...

PPD and ERT to Partner on Drug Development

December 16, 2014 9:10 am | News | Comments

Pharmaceutical Product Development and ERT today announced a strategic partnership to facilitate...

Scilabs Nutraceuticals Responds to FDA Consent Decree

December 15, 2014 8:18 am | News | Comments

Scilabs Nutraceuticals Inc.™, a contract manufacturer of nutraceuticals based in Irvine,...

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Vetter Opens Third Cleanroom for Clinical Syringe Projects

December 11, 2014 9:59 am | News | Comments

Vetter has announced that its U.S. early-stage development site located at the Illinois Science + Technology Park in suburban Chicago, has completed the next step of its expansion with the addition of a third cleanroom. Clinical syringe projects are now being accepted at the facility, which can handle preclinical through phase II projects.

Avid Bioservices to Expand cGMP Manufacturing Capacity

December 10, 2014 8:49 am | News | Comments

Avid Bioservices, the contract manufacturing subsidiary of Peregrine Pharmaceuticals, has initiated an expansion of its biomanufacturing capacity. The new production facility will more than double Avid Bioservices' current manufacturing capacity in a state-of-the-art facility design.

Meda to End Penicillin Contract with Recipharm; Layoffs Forecast

December 4, 2014 1:44 pm | News | Comments

Meda, a Recipharm’s customer, announced that they will transfer supply of their mainly Swedish penicillin products and manufacture offshore with other suppliers. The manufacturing contract with Recipharm Strängnäs will therefore be terminated as of December 31, 2015.

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Catalent and Sellas to Collaborate on Therapeutic Reprofiling of Zolpidem

December 4, 2014 10:00 am | News | Comments

Catalent Pharma Solutions has reached an exclusive development and licensing agreement with Swiss-based development-stage biopharmaceutical company SELLAS Life Sciences Group, to support the development and therapeutic reprofiling of zolpidem using Catalent’s OSDrC® OptiDose™ drug delivery technology.

Noble Life Sciences Acquires Spring Valley Laboratories

December 3, 2014 10:38 am | News | Comments

Noble Life Sciences, a provider of preclinical drug development services, has announced the acquisition of Spring Valley Laboratories, a full service, GLP-compliant, preclinical contract research organization for the development of drugs, vaccines, and medical devices.

Catalent and Valerion Therapeutics to Develop New Treatments for Orphan Genetic Disorders

December 2, 2014 3:23 pm | News | Comments

The collaboration will focus on the delivery of muscle-protein fusions, and treatment of multiple indications, in the fields of muscular dystrophies, glycogen storage diseases, myopathies and enzyme-deficiency disorders.     

Vetter Adds Flexible Serialization Services

December 2, 2014 11:51 am | News | Comments

Vetter, a contract development and manufacturing organization (CDMO), now offers the option of clearly identifying packaging used for drugs. Vetter's comprehensive and flexible serialization service is in response to stricter guidelines from the regulatory authorities of many countries aimed at combatting counterfeit drugs.

Johnson Matthey Acquires Pharmaceutical Manufacturing Capacity in Scotland, UK

December 2, 2014 11:43 am | News | Comments

Johnson Matthey, a provider of pharmaceutical services, APIs and catalyst technologies, has announced completion of an acquisition of pharmaceutical manufacturing capacity in Scotland, U.K. The 109,000 sq. meter site was acquired to meet increasing demand for custom pharmaceutical services and active ingredients utilising enhanced manufacturing capabilities.

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FDA Issues Additional Guidance for Outsourcing Facilities That Compound Sterile Human Drugs

November 24, 2014 1:18 pm | News | Comments

The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the DQSA, which was enacted in November 2013.

Anthera and Patheon Sign Manufacturing Agreement for Liprotamase Phase III Registration Trial

November 20, 2014 11:23 am | News | Comments

Anthera Pharmaceuticals has signed a manufacturing and supply agreement with the Patheon division of DPx Holdings B.V.  The contract provides for Patheon to support the production of the Sollpura clinical drug product for Anthera's Phase III registration trial.

Vetter Opens Singapore Office to Support Growing Asian Healthcare Market

November 20, 2014 8:42 am | News | Comments

Vetter has announced the opening of a new representative office in Singapore. The announcement was made at a ceremony attended by members of local government agencies and a number of executives of pharmaceutical/biotech companies with a presence in the Asian region, as well as Vetter executives.

Pharmaceutical Processing’s Nov/Dec 2014 Digital Issue

November 13, 2014 11:13 am | Digital Editions | Comments

Pharmaceutical Processing’s Nov/Dec 2014 issue features an in-depth look at SAFC’s recently expanded high-potency API manufacturing facilities in Madison, WI. In addition, our Annual CMO/CSO Survey is included in this issue detailing the trends driving the CMO/CSO market. Other articles take a look at elastomeric closure in parenteral manufacturing, cleanroom energy efficiency, package integrity, deduster design efficiency, and desiccant canister design and feeding options.

Eurofins Acquires SF Analytical Labs

November 6, 2014 2:17 pm | News | Comments

Eurofins Scientific has announced the pending acquisition of SF Analytical (SFA) Laboratories. The transaction will close at the end of November. The acquisition strengthens Eurofins' growing presence in the US, as well as expands the current base of operations in the Midwestern United States.

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GVK BIO to Acquire Vanta Bioscience

November 6, 2014 8:16 am | News | Comments

GVK BIO has announced the signing of a definitive agreement to acquire Vanta Bioscience, a full service preclinical GLP toxicology and safety assessment contract research organization operating out of Chennai, India.      

Catalent Expands Highly Potent and Cytotoxic Clinical Packaging Capabilities

November 3, 2014 7:55 pm | News | Comments

Catalent Pharma Solutions has announced that work has commenced to expand its highly potent and cytotoxic clinical drug packaging capabilities within its 450,000 sq. ft. Kansas City, MO campus.          

LabCorp to Spend $6.1B on Covance

November 3, 2014 7:35 pm | by The Associated Press | News | Comments

LabCorp will pay about $6.1 billion in cash and stock to buy Covance in a tie-up that aims to improve clinical trial research for pharmaceuticals.                  

High Potency, High Reward

October 31, 2014 10:43 am | by Nikita Ernst, Associate Editor | Articles | Comments

SAFC, a global supplier of a a wide range of services to the biopharm and pharmaceutical industry, has recently expanded their Madison, Wisconsin facilities to neighboring Verona to rev up their high-potency API manufacturing capabilities.

Impax Announces R&D Reorganization, Layoffs

October 30, 2014 4:25 pm | News | Comments

Impax Laboratories has announced a reorganization of its research and development (R&D) organizations and a prioritization of the project portfolios within the generic and brand businesses          

Metrics Scientist Awarded Patent For Zero-Order Release Tablet Technology

October 28, 2014 1:35 pm | News | Comments

An expert scientist in pharmaceutical formulation development at Metrics Contract Services has been awarded a patent for intellectual property about controlled release technology.            

Mayne Pharma Appoints New VP of Quality for U.S. Operations

October 22, 2014 11:22 am | News | Comments

Q. Dwight Lewis is responsible for managing all quality-related functions to ensure that Mayne Pharma’s U.S. pharmaceutical operations – which range from laboratories to manufacturing lines – continue to comply with global regulatory agency and industry standards.

Pharmaceutical Processing's October 2014 Issue

October 20, 2014 11:34 am | Digital Editions | Comments

The October issue of Pharmaceutical Processing describes Capsugel’s merger with Bend Research and Encap to create a comprehensive solid dosage form solutions group. The issue also features articles on supply chain trends including how to reduce risk, managing a clinical supply chain,  a look at the best printing and coding solutions, and the move to the fully connected enterprise. Other articles focus on particle size analysis, disposable chromatography technologies, and monitoring potency assays.

Halozyme Receives FDA Approval for Additional Manufacturing Facilities For Hylenex Recombinant

October 20, 2014 9:02 am | News | Comments

The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.

Vetter Announces Personnel Changes in its Development Service Division

October 15, 2014 10:31 am | News | Comments

Vetter, a contract development and manufacturing organization (CDMO), today officially announced a series of adjustments to its Development Service related structures designed to support its customer base.        

LSNE Appoints New Vice President of Quality

October 15, 2014 8:11 am | News | Comments

Lyophilization Services of New England (LSNE), a New Hampshire based contract manufacturing organization, is pleased to announce that Thomas McGrath has been named Vice President of Quality.          

PCI Opens North American Clinical Facility

October 10, 2014 8:27 am | News | Comments

The 97,000 square foot purpose built site was constructed in support of the growth PCI has experienced in its Clinical Trial services business, which includes drug development and manufacturing, laboratory services, packaging and storage services, global logistics, as well as client supporting consultative services for executing global investigational studies.

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