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Merck Serono and Quintiles Announce Clinical Development Partnership

May 15, 2013 8:06 am | News | Comments

Merck Serono, a division of Merck, Darmstadt, Germany, and Quintiles, a provider of biopharmaceutical development and commercial outsourcing services, today announced a new, five-year clinical development agreement. This strategic collaboration is the first-of-its-kind between a biopharmaceutical company and a biopharmaceutical services provider.

Merck Serono and Quintiles Announce Clinical Development Partnership

May 15, 2013 8:06 am | News | Comments

Merck Serono, a division of Merck, Darmstadt, Germany, and Quintiles, a provider of...

Merck Serono and Quintiles Announce Clinical Development Partnership

May 15, 2013 8:06 am | News | Comments

Merck Serono, a division of Merck, Darmstadt, Germany, and Quintiles, a provider of...

Encapsulating Service

April 10, 2013 3:58 pm | by Jonnatha Mayberry, Associate Editor | Articles | Comments

Capsules are an important solid...

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Nordion Signs Contract Manufacturing Agreement with Navidea Biopharmaceuticals

May 16, 2013 8:05 am | News | Comments

Nordion Inc., a provider of products and services to the global health science market, today announced it has signed a contract manufacturing agreement with Navidea Biopharmaceuticals, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals.

Under The Almac Umbrella: Almac replicates its success in Ireland with a full range of services in the United States

April 19, 2013 1:17 pm | by Mike Auerbach, Editor in Chief | Articles | Comments

Almac, a CMO with headquarters in Ireland and a growing presence in the United States, can help alleviate many of the stresses and concerns inherent in pharmaceutical manufacturing with a range of services that encompasses everything a sponsor might need to get a drug to market as quickly and efficiently as possible.

Advanced Clinical Announces New Executive Vice President, CRO Operations

April 19, 2013 10:33 am | News | Comments

Advanced Clinical, a provider of clinical research solutions, today announced an addition to its leadership team: Julie A. Ross, has been hired as Executive Vice President, CRO Operations. Julie Ross is a tenured executive leader who has been instrumental in the development and the success of multiple clinical operations divisions.

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Metrics Adds Liquids, Creams, Gels To Manufacturing Capabilities

April 18, 2013 1:36 pm | News | Comments

Metrics Inc. now has the ability to produce non-sterile liquids, creams and gels for a broad range of pharmaceutical applications. The addition of creams, liquids and gels to Metrics’ existing portfolio of formulation and manufacturing capabilities comes as a result of its recent acquisition by Mayne Pharma Group Limited.

JHP Pharmaceuticals to Produce Supplies of Biologic Drug Product for Late-Phase Clinical Trials

April 17, 2013 9:43 am | News | Comments

JHP Pharmaceuticals, a provider of global contract manufacturing services for sterile products has entered into an agreement with an undisclosed biotechnology company to produce clinical supplies of a biologic for late-phase clinical trials.

Catalent Announces Two Senior Appointments to Drive Growth in China

April 16, 2013 11:08 am | News | Comments

Catalent Pharma Solutions today announced that it has made two senior appointments to support its recently established joint ventures in China for its Softgel Technologies and Clinical Supply Solutions businesses. Dr. Weiyan “Jackson” Zhu has joined as Catalent's Country General Manager for China, while Yufeng (Paul) Cao becomes the new Site Operations Director, for the 31,000 sq ft Catalent Clinical Trial Supplies Co., Ltd facility

Vetter’s New Commercial Filling Line Ready for cGMP Filling

April 8, 2013 8:10 am | News | Comments

Vetter, a contract development and manufacturing organization (CDMO), announced today that its new filling line at the company’s Ravensburg Vetter South facility is fully validated and ready for cGMP filling, after successful media-fill completion.

US is Halfway to Obama 5-Year Export-Doubling Goal

April 4, 2013 7:54 am | by TOM RAUM,Associated Press | News | Comments

Suddenly outsourcing is on the way out and insourcing on the way in as the U.S. trudges unevenly toward President Barack Obama's goal of doubling American exports around the world by the start of 2015. So far, export levels are about halfway to his mark.

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Vetter’s Newest Facility Successfully Completes FDA Inspection

March 28, 2013 8:17 am | News | Comments

Vetter, a contract development and manufacturing organization (CDMO), announced today that its new center for visual inspection and logistics passed its first GMP inspection by the U.S. Food and Drug Administration (FDA). The inspection was conducted March 11 through 14 to ensure the facility is in compliance with good manufacturing practices.

BioClinica and CoreLab Partners Merge

March 14, 2013 7:58 am | News | Comments

BioClinica ®, Inc., a global provider of clinical trial management services, announced today that JLL Partners and Ampersand Capital Partners, two leading middle market private equity firms, have completed their acquisition of BioClinica and CoreLab Partners and have combined the two companies under the name BioClinica.

Clondalkin Pharma and Healthcare North America Increases Capacity and Color Capability

March 8, 2013 1:30 pm | News | Comments

Clondalkin Pharma and Healthcare North America has added an 8 color Man Roland 708 perfecting press with in-line foil applicator  to its PS9000 certified  pharmaceutical packaging production facility in Charlotte, North Carolina.

Ajinomoto Co., Inc. Agrees To Acquire Althea Technologies, Inc.

March 6, 2013 7:53 am | News | Comments

Ajinomoto Co., Inc. and Althea Technologies, Inc., announced today that they have entered into a definitive agreement by which Ajinomoto Co. will acquire Althea Technologies, a leading provider of biopharmaceutical development and manufacturing services.

DBV Technologies Enters into a Strategic Manufacturing Agreement with Sanofi

March 5, 2013 8:03 am | News | Comments

DBV Technologies, creator of the Viaskin® allergy treatment, announced today that it entered into a strategic manufacturing agreement with Sanofi to produce Viaskin’s Active Pharmaceutical Ingredients (API), such as the peanut protein extract. Per the agreement, Sanofi will act as DBV’s Contract Manufacturing Organization (CMO).

DSM Signs Master Supply Agreement with Eisai Inc.

March 5, 2013 8:00 am | News | Comments

DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, today announced the signing of a 3 year master supply agreement with Eisai Inc., based in Woodcliff Lake, NJ, USA, for the production of sterile products.  The agreement covers the production of eribulin mesylate as well as other developmental drugs.

Pharmatek Announces Facility Expansion

February 28, 2013 8:00 am | News | Comments

Pharmatek, a contract development and manufacturing organization supporting the pharmaceutical industry, announced plans to expand its GMP facilities The expansion comes at a time when the company is experiencing strong growth and increasing global demand for its services

Cedarburg Hauser Granted DEA Registration for Denver Manufacturing Facility

February 27, 2013 8:33 am | News | Comments

Cedarburg Hauser Pharmaceuticals (CHP), a contract development and manufacturing organization (CDMO), announced today that its Denver, Colorado facility has been granted registration as a manufacturer of schedule II-V controlled substances by the U.S Drug Enforcement Agency (DEA).

CDMO Cedarburg Hauser Pharmaceuticals Carves Its Niche in the Changing API Market.

February 27, 2013 8:25 am | by Jonnatha Mayberry, Associate Editor | Articles | Comments

In the structure of a successful drug, active pharmaceutical ingredients (APIs) serve as the medicine’s foundation. When outsourcing API development, pharmaceutical companies look for a service provider that can deliver a combination of expertise, technique, and flexibility.

Quintiles Files with SEC to Become Public Company

February 19, 2013 8:07 am | News | Comments

Clinical testing company Quintiles Transnational wants to become a public company again after nearly a decade in private hands. The Durham, N.C.-based company said Friday it filed with the U.S. Securities and Exchange Commission for a proposed initial public offering of stock worth up to $600 million.

IGI Laboratories and Juventio Execute Three Year Turnkey Supply Agreement

February 15, 2013 11:12 am | News | Comments

IGI Laboratories, Inc., a New Jersey based generic topical pharmaceutical company, today announced it has entered into a three year agreement with Juventio, LLC to manufacture and supply finished dose forms of certain cosmetic and OTC products and formulations owned and developed by IGI.

Dow Chemical and Cambrex Collaborate to Manufacture Drug-Solubility Solution

February 14, 2013 1:49 pm | News | Comments

Cambrex and The Dow Chemical Company have executed an agreement for Cambrex to contract manufacture Dow Hydroxypropyl Methylcellulose Acetate Succinate (HPMCAS) for Drug Solubility Enhancement. This is the final step in building on the solubilization partnership that Dow and Bend Research announced in October 2012 and it will help Dow to commercially supply solubility enabling excipients.

AMRI Surges Following 4Q Report and Outlook

February 13, 2013 7:52 am | News | Comments

Shares of Albany Molecular Research climbed Tuesday after the drug developer turned a fourth-quarter profit, compared to a loss the year before. It also expects that when one-time items are excluded from its results, it will be more profitable this year. Albany Molecular Research Inc. shares advanced 89 cents, or 16 percent, to close at $6.55.

AMRI Signs Agreement for Exclusive License of its Tubulin Inhibitor Program for Cancer

February 11, 2013 8:14 am | News | Comments

AMRI announced today that it has signed an exclusive license agreement with Chai Therapeutics, LLC for the development of ALB 109564(a), AMRI's novel tubulin inhibitor compound in late Phase I testing for the treatment of cancer. This agreement follows the exercise of an option to license the intellectual property, which was granted in March 2012 by AMRI to Bessor Pharma, LLC, a translational drug development company.

Almac Launches US Commercial Packaging Operations with Successful FDA Inspection and New Client Partnership

February 6, 2013 8:03 am | News | Comments

Almac today announces the successful inspection of its new US Commercial Packaging operations located in Audubon, PA by the Food and Drug Administration (FDA). The inspection took place on the 9 th and 10 th January 2013 from which the regulatory body concluded that the Pennsylvania based site is fully compliant with Good Manufacturing Practices, with no 483 issued.

Pharmaceutical Processing Interviews Howard Teeter, President and Managing Partner, Anteco Pharma

September 17, 2012 7:58 am | Videos | Comments

Pharmaceutical Processing interviews Howard Teeter from Anteco Pharma and takes a tour of his company's facilities.

Tools That Improve Outsourcing Selection

November 2, 2011 10:20 am | by Victor Coker of Nice Insight | Blogs | Comments

With big pharma and biotech companies looking to cut costs and optimize their spending, the methods used in outsourcing partner selection are more relevant to the industry than ever before.

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