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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.

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.

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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.

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.                  

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          

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PBOA Elects Chairman

October 30, 2014 8:33 am | News | Comments

The Pharma & Biopharma Outsourcing Association (PBOA), a new non-profit trade association devoted to advancing the interests of CMOs, CDMOs and other service providers, has elected Peter Bigelow to serve as Chairman of the Board of Trustees.

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.            

Catalent Appoints New Asia Pacific President

October 28, 2014 9:10 am | News | Comments

Catalent today announced the promotion of Australia Country General Manager, Mark Bisset, to President, Catalent Asia Pacific. He succeeds David Heyens who has announced that he plans to retire from Catalent on December 31st 2014.    

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.

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.        

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WuXi PharmaTech Laboratory Testing Division Acquires XenoBiotic Laboratories

October 1, 2014 8:12 am | News | Comments

WuXi PharmaTech has acquired XenoBiotic Laboratories, Inc., a contract research organization with 27 years of successful operation that provides bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health, and agrochemical industries.

Chiltern Acquires Pacific Clinical Research

September 29, 2014 10:10 am | News | Comments

Chiltern has acquired Pacific Clinical Research, a pan-Asian CRO based in Singapore. The move allows Chiltern to offer integrated services throughout the Asia-Pacific region and strengthens in particular Chiltern's oncology and anti-infective offerings.

Triple Threat

September 24, 2014 2:02 pm | by Mike Auerbach, Editor In Chief | Articles | Comments

Capsugel acquires Bend Research and Encap Drug Delivery to create a comprehensive solid dosage form solutions group.                       

SAFC and Baxter BioPharma Solutions to Collaborate on ADC Offering

September 24, 2014 11:16 am | News | Comments

SAFC will contribute extensive expertise in conjugation and the manufacture of drug linkers, while BioPharma Solutions will offer world-class, sterile fill/finish services for final filling of ADC products.        

AMRI Expands Services to Protein Market

September 4, 2014 9:07 am | News | Comments

AMRI announced today that it has expanded into the protein market, with an initial focus on protein expression and purification. The global revenue of the total proteomics market is anticipated to grow at a compound annual growth rate of about 4.1% to about $9.2 billion by 2018.

MEDA Sells NJ Facility to DPT

September 4, 2014 8:17 am | News | Comments

Meda has signed an agreement to divest the manufacturing unit in Lakewood, New Jersey, to the contract manufacturer DPT. The manufacturing facility is dedicated to global supply of the product MUSE.         

PPD Acquires RCT Logic’s Exclusive License to Patented Clinical Trial Design Technology

September 3, 2014 10:44 am | News | Comments

PPD has acquired RCT Logic’s exclusive license from Massachusetts General Hospital for the portfolio of patents related to its sequential parallel comparison design (SPCD). SPCD is an alternative method for conducting well-controlled clinical trials that substantially decreases the impact on trial outcomes of any placebo effect.

Ajinomoto Althea Receives European GMP Certification

September 3, 2014 9:13 am | News | Comments

Ajinomoto Althea announced today that it has officially received its European GMP certificate issued by the MHRA. The MHRA conducted an on-site inspection on June 19, 2014 that yielded no critical or major observations. This certification provides clearance to Althea to test commercial drug product for the European market.

Particle Sciences Expands Drug Eluting Device Capabilities and Overall Clinical Trial Manufacturing Resources

September 2, 2014 2:39 pm | News | Comments

Particle Sciences, a CDMO for drug eluting devices, has added to its investment in development and manufacturing capabilities with the addition of a new 18mm extruder. The company now has over 6000ft2 of operating cleanroom and cGMP warehouse space including ISO5 (sterile) and two dedicated highly potent suites.

DPx Holdings B.V. Reaches Definitive Agreement to Acquire Gallus BioPharmaceuticals

August 28, 2014 11:55 am | News | Comments

DPx Holdings B.V., privately owned by JLL Partners and Royal DSM, has reached a definitive agreement to acquire all shares of Gallus BioPharmaceuticals, LLC, a contract manufacturing company specializing in biologics and current portfolio company of Ridgemont Equity Partners.

PPD Names New Executive Vice President and Chief Financial Officer

August 26, 2014 9:01 am | News | Comments

Pharmaceutical Product Development, LLC (PPD) today announced the appointment of Robert Hureau as executive vice president and chief financial officer. Hureau brings 25 years of experience and extensive financial expertise spanning the medical technology/life sciences, manufacturing and consumer sectors.

Metrics Contract Service Reveals New Name and Logo

August 8, 2014 8:44 am | News | Comments

Metrics Contract Services, a full-service contract pharmaceutical formulation development and manufacturing organization, has adopted a new and more descriptive name.              

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