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FDA Grants Priority Review to Mallinckrodt's MNK-795
Depomed, Inc. announced that FDA has accepted for filing a new drug application (NDA) from Mallinckrodt for MNK-795.
Aesica Appoints Chris Gowland as Chief Operating Officer
Aesica has appointed Chris Gowland as Chief Operating Officer, a new position created to further enhance the company's operational performance in APIs and formulated product manufacturing services.
Scientists Discover New Targets for Breast Cancer
Scientists at A*STAR's Genome Institute of Singapore (GIS) have identified genes that could be potential targets for anticancer agents in the treatment of aggressive breast cancer.
Kemwell Biopharma Acquires Cirrus Pharmaceuticals Inc.
Kemwell Biopharma announced that it has acquired Cirrus Pharmaceuticals Inc., a contract development services company based in Research Triangle Park, N.C.
New Manufacturing Method Improves Drug Delivery of Asthma Inhalers
Australian team develops method for making ultrafine particles for more efficient drug delivery.
Adaptimmune Initiates Phase I/IIa Clinical Trial in Ovarian Cancer
Adaptimmune has opened a Phase I/IIa ovarian cancer trial to evaluate its genetically engineered T cell treatment, with enhanced antitumor activity.
CPhI Pharma Insights: Formulation and Ingredients Report
The report highlights a need for greater third party certification to ensure GMP vigilance.
Muller AG Cleaning Solutions Appoints Dr Christian Heuer As New Managing Director
The Muller Group has appointed Dr Christian Heuer as new chief operating officer of Müller AG Cleaning Solutions.
Maurizio Denaro Named General Manager of The Aptuit Center for Discovery & Development
Aptuit has announced that Maurizio Denaro has assumed responsibilities as general manager of The Aptuit Center for Discovery & Development in Verona, Italy.
Galectin Therapeutics Submits Fast Track Application
Galectin Therapeutics has submitted a Fast Track application to the FDA to help expedite its clinical development program.
New Clinical Trial Partners to Expand Laboratory Sciences Clinical Sample Analysis Groups
Charles River has established partnerships with Target Health Inc. and Theorem Clinical Research Inc.
Zeiss Acquires Xradia
Zeiss announced the acquisition of U.S.-based Xradia, Inc.
FDA Completes Re-inspection of AMRI Burlington Facility
FDA conducted a general inspection of operations and quality systems of Albany Molecular Research Inc (AMRI) in Burlington, Mass.
Abbott Reports Second-Quarter 2013 Results
Abbott announces earnings per share above previous guidance range and notes increased sales in emerging markets.
Breathing New Life Into Old Drugs
Acquisition database helps extend product lifecycle by seeking new applications for drugs.
Life Technologies Stockholders to Meeting on Thermo Fisher Scientific Acquisition
Life Technologies Corporation has filed a definitive proxy statement with the US Securities and Exchange Commission regarding Thermo Fisher Scientific Inc.
UK Government Seeks Pharmaceutical Sector's Views on Regulation Enforcement
UK government review will look for unnecessary regulatory burdens and inconsistencies and at guidance clarity.
Aesica Recruits Technical Director and Two New Business Development Managers
Bashir Hansraj appointed as Global Technical Director, and David Ross and Sven Thomas appointed as business development managers
Solving Common Problems in Warehouse Management
Warehouse layout and personnel training are crucial to successfully implementing a warehouse management solution.
Clinical Manufacturing Site Approved for Molecular Profiles
Molecular Profiles has opened a new clinical manufacturing facility following a successful inspection from the Medicines and Healthcare products Regulatory Agency.
Penn Pharma Invests in Manufacturing Capacity
Penn Pharma has announced plans to invest in additional tablet manufacturing and coating capacity.
CPhI and CPhI Pharma Evolution Announce Expert Industry Panel
13 full members with expertise across the entire pharmaceutical supply chain.
Almac Adds Contained Drug Handling Capabilities
Almac's Clinical Services business unit has expanded its service offering for dispensing and bottling solid dosage products.
MHRA Recalls Medicines Made at Wockhardt's Waluj Site
The precautionary recall follows manufacturing deficiencies identified at the site in India.
Vetter Offers Sterile Water for Injection Syringes with Five Years Stability Data
Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.
Molecular Profiles' New Site Receives MHRA Approval
Molecular Profiles has opened a new facility in the UK following official approval from MHRA.
Domino Introduces Fast-Drying Ink for High-Speed Coding
The new ink takes less a second to dry and is four times more fade resistant than inks that are typically used in retail packaging.
EMD Millipore Opens New R&D Center
The facility, which includes state-of-the-art formulation, analytical and synthetic laboratories as well as a customer training center, will focus on bioavailability enhancement and oral dosage formulations.
Pharma News in Global Health and Sustainability
A roundup of developments in global health and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.
Catalent Launches New Business Unit
The new unit aligns existing modified-release and medication-delivery businesses of the company.