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The Lead

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...

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...

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...

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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.

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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.

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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.              

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.

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. 

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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Chiltern Acquires Ockham - Companies Merge Operations

July 15, 2014 11:45 am | News | Comments

Chiltern and Ockham, two full-service contract research organizations (CROs), today announce that Chiltern has acquired 100% of Ockham and that the companies will merge their operations. The combined company will be called Chiltern. Ockham's management team will join the management of the enlarged group, thus ensuring a seamless continuation of high quality services.

AAIPharma Services and Cambridge Major Laboratories Name New CEO

July 8, 2014 8:54 am | News | Comments

AAIPharma Services Corp., a global provider of pharmaceutical analytical testing, product development and manufacturing services, and Cambridge Major Laboratories, Inc., a provider pharmaceutical API development and manufacturingservices, announced the appointment of Stephan Kutzer, Ph.D. as Chief Executive Officer (CEO), effective August 1, 2014.

Metrics Expands Drug Delivery Options with Spray Dryer Acquisition

June 27, 2014 9:01 am | News | Comments

Metrics Inc. has expanded its already robust options for enhancing drug bioavailability thanks to the recent acquisition of a BÜCHI B-290 Mini Spray Dryer. The dryer’s core capability is rendering powder from a solution, said Brad Gold, Ph.D., vice president of pharmaceutical development.

BASi Names Names New CFO and VP Bioanalytical Operations

June 12, 2014 8:27 am | News | Comments

Bioanalytical Systems, Inc. (BASi) today announced the appointment of Jeffrey Potrzebowski as Chief Financial Officer and James S. Bourdage, Ph.D., as Vice President Bioanalytical Operations.          

Xcelience Opens UK/European Packaging and Distribution Hub

June 10, 2014 11:24 am | News | Comments

Xcelience announced today the opening of a 3,000 square foot facility in Birmingham, UK, making it the first small to mid-sized American CDMO to launch international operations. The new plant will become a gateway for the Florida-based company’s clinical packaging and distribution services in the UK, Europe and abroad.

AMRI to Acquire Oso Biopharmaceuticals Manufacturing

June 2, 2014 9:01 am | News | Comments

AMRI has signed a definitive agreement to acquire all of the outstanding membership interests of Oso Biopharmaceuticals Manufacturing, for $110M in cash. OsoBio is a contract manufacturer of highly complex injectable drug products, including sterile liquid, suspension and lyophilized formulations.

Ben Venue Labs to Sell Assets of Bedford Labs to Hikma Pharmaceuticals

May 28, 2014 8:47 am | News | Comments

Hikma will be acquiring Bedford Laboratories' assets, including a large product portfolio, intellectual property rights, contracts for products marketed under license, raw material inventories, a strong research and development and business development pipeline, and a number of employees across key business functions.

WuXi PharmaTech Begins Operation of New High-Potency API Laboratory

May 28, 2014 8:13 am | News | Comments

WuXi PharmaTech today announced that its manufacturing subsidiary, Syn-The-All Pharmaceutical Co., Ltd. (STA), has begun operation of a high-potency active pharmaceutical ingredient (HPAPI) laboratory in Shanghai, thereby adding HPAPI processing to its portfolio of services.

AMRI Closing Syracuse-Area Lab in July

April 17, 2014 11:33 am | News | Comments

Albany Molecular Research Inc. announced Wednesday that it will close its 12-year-old facility in Cicero on July 15. Some employees will be transferred to Albany, Cedarburg, Wis., England and India.         

OsoBio Appoints Director of Manufacturing

March 31, 2014 10:21 am | News | Comments

OsoBio has appointed Catherine R. Buck director of manufacturing. In her capacity, Buck is responsible for ensuring that OsoBio’s operations comply with current Good Manufacturing Practices (cGMP) as they apply to the manufacturing of injectable sterile liquid, suspension and lyophilized pharmaceutical products.

Quintiles Appoints New Head to Lead Global Risk Management for Real-World & Late Phase Research

March 27, 2014 8:15 am | News | Comments

Quintiles has announced that Stella Blackburn, M.B. B.S., has been appointed as the vice president and global head of Risk Management for its Real-World & Late Phase Research group. In this role, Dr. Blackburn will be responsible for leading the group’s risk management efforts in North America, EU and Asia-Pacific.

AMRI to Acquire Cedarburg Pharmaceuticals

March 24, 2014 7:58 am | News | Comments

AMRI has signed a definitive agreement to acquire all the outstanding shares of Cedarburg Pharmaceuticals, Inc. for $38.2 million in cash. The transaction, including $2.8 million of assumed liabilities, is valued at $41 million.     

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