http://www.biopharminternational.com/biopharm/News/Article/list/435 Peer-reviewed technical articles, multimedia, and news on bioprocessing methods, regulatory compliance, and business strategies related to the development and manufacture of biotechnology-based drugs. 2013-05-23T15:53:57Z http://www.biopharminternational.com/biopharm/News/Moscow-Hosts-IFPMA-Biosimilars-Conference/ArticleStandard/Article/detail/813568?contextCategoryId=435&ref=25 Representatives of national health regulatory authorities from around the world convened in Moscow to discuss ways to harmonize regulatory standards for biotherapeutic medicines. 2013-05-17T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813568null HTML http://www.biopharminternational.com/biopharm/Online+Only/AbbVie-and-Alvine-Will-Collaborate-on-Celiac-Disea/ArticleStandard/Article/detail/813312?contextCategoryId=435&ref=25 Program aims to develop a novel oral treatment. 2013-05-15T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813312null HTML http://www.biopharminternational.com/biopharm/News/FDA-Issues-Pharmacoepidemiologic-Safety-Study-Guid/ArticleStandard/Article/detail/813185?contextCategoryId=435&ref=25 FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies. 2013-05-14T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813185null HTML http://www.biopharminternational.com/biopharm/News/USP-Launches-Initiative-to-Fight-Counterfeit-Drugs/ArticleStandard/Article/detail/813067?contextCategoryId=435&ref=25 New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries. 2013-05-13T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813067null HTML http://www.biopharminternational.com/biopharm/Online+Only/Amgen-Forms-New-Joint-Venture-to-Commercialize-Vec/ArticleStandard/Article/detail/813590?contextCategoryId=435&ref=25 Amgen and Zhejiang Beta Pharma have signed an agreement to form a joint venture to commercialize Amgen's Vectibix (panitumumab) in the Chinese market. The aim is to quickly and efficiently deliver Vectibix to patients in China. Vectibix is a fully human anti-epidermal growth factor receptor (EGFR) antibody approved by FDA for the treatment of metastatic colorectal cancer. 2013-05-13T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/202013/813590null HTML http://www.biopharminternational.com/biopharm/News/ATMI-Offers-Helium-Integrity-Testing-System/ArticleStandard/Article/detail/812850?contextCategoryId=435&ref=25 Evaluation system for single-use bags and assemblies is now available for onsite testing. 2013-05-10T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/192013/812850null HTML http://www.biopharminternational.com/biopharm/News/EMA-Revises-Draft-Guideline-on-Biosimilars/ArticleStandard/Article/detail/812700?contextCategoryId=435&ref=25 EMA clarifies biosimilars guidelines. 2013-05-08T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/192013/812700null HTML http://www.biopharminternational.com/biopharm/News/FDA-Accepts-BLA-for-Mercks-Allergy-Immunotherapy-T/ArticleStandard/Article/detail/812908?contextCategoryId=435&ref=25 The FDA has accepted for review Merck's Biologics License Application for its investigational ragweed pollen sublingual allergy immunotherapy tablet. 2013-05-08T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/192013/812908null HTML http://www.biopharminternational.com/biopharm/News/Actemra-Receives-FDA-Approval-for-Polyarticular-Ju/ArticleStandard/Article/detail/812034?contextCategoryId=435&ref=25 Genentech announced that FDA has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in children aged two years and older. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/812034null HTML http://www.biopharminternational.com/biopharm/News/Pharmaco-Kinesis-Corporation-Develops-First-Nanodr/ArticleStandard/Article/detail/812035?contextCategoryId=435&ref=25 Pharmaco-Kinesis Corporation (PKC) announced that it is developing the first nanodrug combination of Merck's temozolomide and Celgene's thalidomide (in a 50:50 ratio) for the treatment of gliomas and other cancers. PKC will collaborate with the University of California, San Diego's department of nano-engineering at the Moores cancer centre to develop the nanodroplet formulation. 2013-05-01T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/812035null HTML http://www.biopharminternational.com/biopharm/News/Bayer-to-Acquire-Conceptus-for-US11-Billion/ArticleStandard/Article/detail/812033?contextCategoryId=435&ref=25 Bayer announced that it has signed a merger agreement with US-based birth-control specialist Conceptus. 2013-04-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/812033null HTML http://www.biopharminternational.com/biopharm/News/Uhlmann-Group-Spins-Off-visiotec-GmbH/ArticleStandard/Article/detail/811916?contextCategoryId=435&ref=25 New company will focus on inspection, monitoring, and control systems for automated pharmaceutical manufacturing processes. 2013-04-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/811916null HTML http://www.biopharminternational.com/biopharm/Online+Only/PerkinElmer-Announces-Collaboration-with-Chinas-Na/ArticleStandard/Article/detail/811917?contextCategoryId=435&ref=25 A personalized drug research and development platform will validate biomarkers for individualized disease treatment for Chinese patients. 2013-04-30T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/182013/811917null HTML http://www.biopharminternational.com/biopharm/News/BioPharm-International-and-DampB-Launch-Business-M/ArticleStandard/Article/detail/811689?contextCategoryId=435&ref=25 BioPharm International has joined with Dun & Bradstreet Credibility Corp. to launch the Pharmaceutical Technology and BioPharm International Marketplace. 2013-04-26T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/172013/811689null HTML http://www.biopharminternational.com/biopharm/News/BioOutsource-Opens-New-Facility-in-Cambridge-Massa/ArticleStandard/Article/detail/811376?contextCategoryId=435&ref=25 BioOutsource, a contract testing services provider to the biopharmaceutical industry, has opened a new facility in Cambridge, Massachusetts. The facility marks the company's first North American offices, which were opened in response to increasing demand for the company's bioanalytical and biosafety services, particularly in the field of biologic and biosimilar characterisation. 2013-04-24T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/172013/811376null HTML http://www.biopharminternational.com/biopharm/News/FDA-Releases-Draft-Guidance-on-Labeling-Safety/ArticleStandard/Article/detail/811345?contextCategoryId=435&ref=25 FDA issues draft guidance to minimize medication errors. 2013-04-23T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/172013/811345null HTML http://www.biopharminternational.com/biopharm/News/Balanced-Solutions-Voluntarily-Recalls-Sterile-Pro/ArticleStandard/Article/detail/811306?contextCategoryId=435&ref=25 Third compounding pharmacy recalls products due to FDA inspection. 2013-04-23T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/172013/811306null HTML http://www.biopharminternational.com/biopharm/News/AstraZeneca-Seals-Cancer-Nanomedicine-Deal-with-BI/ArticleStandard/Article/detail/811377?contextCategoryId=435&ref=25 AstraZeneca and BIND Therapeutics have formed a strategic collaboration to develop and commercialise BIND's Accurin, a targeted and programmable cancer nanomedicine, based on a molecularly targeted kinase inhibitor developed and owned by AstraZeneca. 2013-04-23T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/172013/811377null HTML http://www.biopharminternational.com/biopharm/Online+Only/Entegris-Acquires-Jetalon-Solutions/ArticleStandard/Article/detail/811213?contextCategoryId=435&ref=25 Unique technology expands Entegris? fluid-sensing and control offering. 2013-04-22T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/172013/811213null HTML http://www.biopharminternational.com/biopharm/News/Sanofi-and-PATH-Launch-Semisynthetic-Artemisinin-P/ArticleStandard/Article/detail/810825?contextCategoryId=435&ref=25 New manufacturing route improves availability of ingredient for malaria treatment. 2013-04-17T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/162013/810825null HTML http://www.biopharminternational.com/biopharm/News/FDA-Releases-Guidance-on-Non-Penicillin-Beta-Lacta/ArticleStandard/Article/detail/810832?contextCategoryId=435&ref=25 FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination. 2013-04-17T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/162013/810832null HTML http://www.biopharminternational.com/biopharm/News/Merck-Opens-New-Manufacturing-Facility-in-China/ArticleStandard/Article/detail/810827?contextCategoryId=435&ref=25 The facility in Hangzhou will package Merck medicines for China and the Asia-Pacific region. 2013-04-17T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/162013/810827null HTML http://www.biopharminternational.com/biopharm/News/Big-Biotech-Outpaces-Big-Pharma-Burrill-Reports/ArticleStandard/Article/detail/810797?contextCategoryId=435&ref=25 Big Biotech companies are demonstrating they are better positioned than their pharmaceutical industry counterparts to meet changing demands. 2013-04-17T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/162013/810797null HTML http://www.biopharminternational.com/biopharm/News/Amgen-to-Pay-249-Million-for-False-Claims-Act-Viol/ArticleStandard/Article/detail/810764?contextCategoryId=435&ref=25 Amgen Inc. has agreed to pay the United States $24.9 million to settle allegations that it violated the False Claims Act. 2013-04-16T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/162013/810764null HTML http://www.biopharminternational.com/biopharm/News/Compounding-Pharmacies-Recall-Products/ArticleStandard/Article/detail/810755?contextCategoryId=435&ref=25 FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls. 2013-04-16T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/162013/810755null HTML http://www.biopharminternational.com/biopharm/News/Thermo-Fisher-Scientific-to-Acquire-Life-Technolog/ArticleStandard/Article/detail/810760?contextCategoryId=435&ref=25 $13.6 billion deal strengthens Thermo?s leading role. 2013-04-16T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/162013/810760null HTML http://www.biopharminternational.com/biopharm/News/GE-Healthcare-Awarded-Contract-to-Design-New-Plant/ArticleStandard/Article/detail/810643?contextCategoryId=435&ref=25 New facility for Bio-Manguinhos will use plant-based protein expression technology. 2013-04-15T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/162013/810643null HTML http://www.biopharminternational.com/biopharm/News/Vetters-New-Commercial-Line-Validated-for-cGMP-Fil/ArticleStandard/Article/detail/810458?contextCategoryId=435&ref=25 Prefilled-syringe line features automation and novel disinfection techniques. 2013-04-12T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810458null HTML http://www.biopharminternational.com/biopharm/News/FDA-Requests-Almost-5-Billion-for-2014-Budget/ArticleStandard/Article/detail/810468?contextCategoryId=435&ref=25 FDA's FY 2014 budget includes more than $10 million above the 2012 budget for inspections of products and ingredients manufactured in China. 2013-04-12T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810468null HTML http://www.biopharminternational.com/biopharm/News/Accelrys-Adds-Laboratory-Information-Management-Sy/ArticleStandard/Article/detail/810462?contextCategoryId=435&ref=25 The process-driven system reduces total cost of ownership. 2013-04-12T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810462null HTML http://www.biopharminternational.com/biopharm/News/FDA-Commissioner-Claims-Resistance-to-Compounding-/ArticleStandard/Article/detail/810485?contextCategoryId=435&ref=25 FDA inspections of compounding pharmacies result in FDA-483 citations. 2013-04-12T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810485null HTML http://www.biopharminternational.com/biopharm/News/Bristol-Myers-Squibb-Plans-Expansion-of-Massachuse/ArticleStandard/Article/detail/810461?contextCategoryId=435&ref=25 The company expands to add process-development and clinical-manufacturing capabilities at its large-scale bulk biologics facility. 2013-04-12T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810461null HTML http://www.biopharminternational.com/biopharm/News/Roche-Will-Use-Technology-From-Isis-To-Develop-Bra/ArticleStandard/Article/detail/810459?contextCategoryId=435&ref=25 The alliance will develop treatments based on Isis? antisense technology. 2013-04-12T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810459null HTML http://www.biopharminternational.com/biopharm/News/State-Legislatures-Become-Battlegrounds-for-Biosim/ArticleStandard/Article/detail/810417?contextCategoryId=435&ref=25 Maryland is the latest state to consider whether to include additional requirements for substitution of biological products. 2013-04-11T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810417null HTML http://www.biopharminternational.com/biopharm/News/Catalent-Biologics-Expands-Into-ADCs/ArticleStandard/Article/detail/810420?contextCategoryId=435&ref=25 Catalent Pharma Solutions has acquired a license to market Redwood Bioscience 's proprietary SMARTag precision protein-chemical engineering technology. 2013-04-11T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810420null HTML http://www.biopharminternational.com/biopharm/News/Pfizer-Issued-Warning-Letter-for-Italian-Manufactu/ArticleStandard/Article/detail/810423?contextCategoryId=435&ref=25 Company is notified of GMP violations at facility in Catania, Italy. 2013-04-11T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810423null HTML http://www.biopharminternational.com/biopharm/News/Dr-Reddys-to-Relocate-North-America-HQ/ArticleStandard/Article/detail/810266?contextCategoryId=435&ref=25 Dr. Reddy's Laboratories has announced plans to relocate its North America headquarters and establish a R&D facility in Princeton, New Jersey. 2013-04-10T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810266null HTML http://www.biopharminternational.com/biopharm/News/Pfizer-Voluntarily-Recalls-Levoxyl/ArticleStandard/Article/detail/810052?contextCategoryId=435&ref=25 Company issues voluntary recall after learning of complaints of an uncharacteristic odor coming from Levoxyl bottles. 2013-04-08T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810052null HTML http://www.biopharminternational.com/biopharm/Online+Only/Eli-Lilly-Considers-Investment-in-US-Insulin-Manuf/ArticleStandard/Article/detail/810049?contextCategoryId=435&ref=25 Company considers investment in insulin cartridge-filling and insulin API manufacturing capacity in the US. 2013-04-08T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810049null HTML http://www.biopharminternational.com/biopharm/News/Regeneron-Expands-and-Creates-400-New-Jobs-in-West/ArticleStandard/Article/detail/809981?contextCategoryId=435&ref=25 Regeneron, a biopharmaceutical company based in New York, has announced plans to expand its corporate headquarters and laboratories in Westchester. This expansion will create more than 400 new highly skilled jobs and further cement Hudson Valley's reputation as an emerging epicenter for biopharmaceutical growth. 2013-04-08T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/809981null HTML http://www.biopharminternational.com/biopharm/News/Teva-and-Lonza-Review-Biosimilars-Opportunity/ArticleStandard/Article/detail/809982?contextCategoryId=435&ref=25 Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars. 2013-04-08T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/809982null HTML http://www.biopharminternational.com/biopharm/News/BIO-Announces-Presenters-for-Annual-Convention/ArticleStandard/Article/detail/810144?contextCategoryId=435&ref=25 The Biotechnology Industry Organization (BIO) announced the companies confirmed to present at the 2013 BIO International Convention. 2013-04-05T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810144null HTML http://www.biopharminternational.com/biopharm/News/Ajinomoto-Completes-Acquisition-of-Althea-Technolo/ArticleStandard/Article/detail/810143?contextCategoryId=435&ref=25 Ajinomoto Co. Inc. reported the completion of a previously announced acquisition of Althea Technologies. 2013-04-05T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/152013/810143null HTML http://www.biopharminternational.com/biopharm/News/Novartis-Suffers-Setback-in-Indian-Patent-Case-for/ArticleStandard/Article/detail/809077?contextCategoryId=435&ref=25 Novartis loses an appeal in seeking patent protection in India for its anticancer drug. 2013-04-02T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/142013/809077null HTML http://www.biopharminternational.com/biopharm/News/Shire-to-Acquire-SARcode-for-160-Million/ArticleStandard/Article/detail/808905?contextCategoryId=435&ref=25 Shire has announced plans to acquire dry eye specialist SARcode Bioscience with the aim of expanding its ophthalmics portfolio. Under the terms of the agreement, Shire will pay $160 million upfront and SARcode shareholders will receive additional undisclosed payments upon achievement of certain clinical, regulatory and/or commercial milestones. 2013-03-27T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/132013/808905null HTML http://www.biopharminternational.com/biopharm/News/AstraZeneca-Announces-an-Additional-2300-Layoffs/ArticleStandard/Article/detail/808816?contextCategoryId=435&ref=25 AstraZeneca announced further downsizing in response to an expected period of declining revenues in the face of patent expirations. The company will eliminate 2300 positions in sales and general administration. 2013-03-22T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/122013/808816null HTML http://www.biopharminternational.com/biopharm/News/IPEC-Releases-Revised-Excipient-Information-Packag/ArticleStandard/Article/detail/808799?contextCategoryId=435&ref=25 The 2013 Excipient Information Package (EIP) User Guide is now available for free download from the International Pharmaceutical Excipients Council (IPEC)-Americas. 2013-03-21T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/122013/808799null HTML http://www.biopharminternational.com/biopharm/News/Metrohm-and-FOSS-Enter-Strategic-Alliance/ArticleStandard/Article/detail/808798?contextCategoryId=435&ref=25 Metrohm and FOSS have entered into a strategic alliance in which Metrohm will become the sole global distributor of FOSS NIR instruments for the pharmaceutical sector. 2013-03-21T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/122013/808798null HTML http://www.biopharminternational.com/biopharm/News/Mettler-Toledo-Introduces-Mechanical-Analyzer/ArticleStandard/Article/detail/808797?contextCategoryId=435&ref=25 The Excellence Dynamic Mechanical Analyzer DMA 1, introduced by Mettler Toledo offers six different deformation modes to gauge materials performance. 2013-03-21T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/122013/808797null HTML http://www.biopharminternational.com/biopharm/News/Bruker-Introduces-Mass-Spectrometers-NMR-Modules/ArticleStandard/Article/detail/808800?contextCategoryId=435&ref=25 At Pittcon 2013, Bruker introduced a range of instruments and software updates including two LC-triple quadrupole (LC-TQ) mass spectrometers. 2013-03-21T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/122013/808800null HTML http://www.biopharminternational.com/biopharm/News/Rigaku-Raman-Upgrades-Handheld-Analyzer/ArticleStandard/Article/detail/808978?contextCategoryId=435&ref=25 Rigaku Raman Technologies announced an updated version of the FirstGuard handheld Raman analyzer at Pittcon 2013. 2013-03-21T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/132013/808978null HTML http://www.biopharminternational.com/biopharm/News/FDA-Investigates-Med-Prep-Consulting-for-Contamina/ArticleStandard/Article/detail/808602?contextCategoryId=435&ref=25 The New Jersey-licensed specialty pharmacy recalls magnesium sulfate products and halts all production operations. 2013-03-21T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/122013/808602null HTML http://www.biopharminternational.com/biopharm/News/Shimadzu-Scientific-Instruments-Adds-Chromatograph/ArticleStandard/Article/detail/808361?contextCategoryId=435&ref=25 Shimadzu Scientific Instruments introduced several new products at Pittcon 2013. 2013-03-18T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/122013/808361null HTML http://www.biopharminternational.com/biopharm/News/Thermo-Fisher-Scientific-Introduces-Software-Instr/ArticleStandard/Article/detail/808359?contextCategoryId=435&ref=25 Thermo Fisher Scientific Inc. launched new software, instruments, consumables, and services for analytical applications at Pittcon 2013. 2013-03-18T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/122013/808359null HTML http://www.biopharminternational.com/biopharm/News/Waters-Corp-Updates-Instruments-and-Software/ArticleStandard/Article/detail/808360?contextCategoryId=435&ref=25 At Pittcon 2013, Water Corp. announced improvement to chromatography systems and software. 2013-03-18T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/122013/808360null HTML http://www.biopharminternational.com/biopharm/News/AstraZeneca-to-Cut-1600-Positions-in-RampD-Reorgan/ArticleStandard/Article/detail/808346?contextCategoryId=435&ref=25 AstraZeneca announced that it will consolidate its R&D capabilities into three centers located in Cambridge, UK; Gaithersburg, MD in the US; and M?lndal, Sweden. The reorganization will result in a net loss of 1600 position, mostly in the US and the UK. 2013-03-18T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/122013/808346null HTML http://www.biopharminternational.com/biopharm/News/Analytical-Technology-Introductions-Planned-for-Pi/ArticleStandard/Article/detail/808216?contextCategoryId=435&ref=25 Scientists and instrument manufacturers gather in Philadelphia for Pittcon 2013. 2013-03-15T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/112013/808216null HTML http://www.biopharminternational.com/biopharm/News/INTERPOL-and-Pharma-Collaborate-to-Fight-Counterfe/ArticleStandard/Article/detail/807919?contextCategoryId=435&ref=25 INTERPOL and 29 of the world's largest pharmaceutical companies have joined forces in an initiative to battle counterfeit drugs. 2013-03-12T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/112013/807919null HTML http://www.biopharminternational.com/biopharm/News/More-than-900-Biologics-in-Development/ArticleStandard/Article/detail/807893?contextCategoryId=435&ref=25 America's biopharmaceutical companies are using biological processes to develop 907 medicines and vaccines targeting more than 100 diseases, according to a new report. 2013-03-11T04:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/112013/807893null HTML http://www.biopharminternational.com/biopharm/Online+Only/Daiichi-Sankyo-Condemns-Falsely-represented-Produc/ArticleStandard/Article/detail/807636?contextCategoryId=435&ref=25 Product sold online in Malaysia and Indonesia infringes on the company’s trademark. 2013-03-08T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/102013/807636null HTML http://www.biopharminternational.com/biopharm/News/Roche-and-BioLamina-Collaborate-on-Novel-Cell-Cult/ArticleStandard/Article/detail/807398?contextCategoryId=435&ref=25 Roche and BioLamina have entered into a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research. The collaboration will assess laminin-based in-vitro cell culture matrices that can offer physiological microenvironments for living cells. 2013-03-06T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/102013/807398null HTML http://www.biopharminternational.com/biopharm/News/First-Biologic-Approved-in-the-EU-for-Gouty-Arthri/ArticleStandard/Article/detail/807577?contextCategoryId=435&ref=25 Ilaris (canakinumab), a selective, fully human, monoclonal antibody that inhibits interleukin-1 beta (IL-1 beta), has been approved in the EU for symptomatic pain relief in patients suffering from gouty arthritis whose condition cannot be managed with current treatments. 2013-03-06T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/102013/807577null HTML http://www.biopharminternational.com/biopharm/News/Mylan-Acquires-Generic-Injectables-Unit-From-Strid/ArticleStandard/Article/detail/807290?contextCategoryId=435&ref=25 Mylan announced that it has signed an agreement to acquire the generic injectables unit Agila Specialties from Strides Arcolab for $1.6 billion in cash. 2013-03-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/102013/807290null HTML http://www.biopharminternational.com/biopharm/News/Archie-Cullen-Named-President-of-BioReliance/ArticleStandard/Article/detail/807601?contextCategoryId=435&ref=25 Archie Cullen has been named the new president of BioReliance, SAFC's biologics and early development services business. 2013-03-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/102013/807601null HTML http://www.biopharminternational.com/biopharm/News/INTERPHEX-2013-Announces-Conference-Program/ArticleStandard/Article/detail/807083?contextCategoryId=435&ref=25 INTERPHEX 2013 to be held April 23–25, 2013, at the Javits Center in New York will highlight pharmaceutical regulation QA/QC, product development, facility, process design, manufacturing, packaging, and supply chain programs. 2013-03-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/092013/807083null HTML http://www.biopharminternational.com/biopharm/News/HHS-Awards-Contract-for-Development-of-Novel-Flu-T/ArticleStandard/Article/detail/806978?contextCategoryId=435&ref=25 The HHS has awarded a $44 million contract for the development of Nitazoxanide to treat influenza in adults and teens. 2013-02-28T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/092013/806978null HTML http://www.biopharminternational.com/biopharm/News/Ablynx-and-Spirogen-Collaborate-on-Novel-Toxin-Nan/ArticleStandard/Article/detail/806739?contextCategoryId=435&ref=25 Belgium drug developer Ablynx and UK-based Spirogen have entered into a research collaboration to discover and develop novel anticancer drug conjugates combining Spirogen's proprietary cytotoxic drugs, pyrrolobenzodiazepines (PBDs), and the company,s associated linker technology, with nanobodies generated using Ablynx's proprietary technology platform. 2013-02-27T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/092013/806739null HTML http://www.biopharminternational.com/biopharm/News/Sanofis-Six-In-One-Pediatric-Vaccine-Recommended-f/ArticleStandard/Article/detail/806552?contextCategoryId=435&ref=25 The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi's six-in-one pediatric vaccine for marketing authorization. 2013-02-26T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/092013/806552null HTML http://www.biopharminternational.com/biopharm/News/Breakthrough-Prize-in-Life-Sciences-Recipients-Ann/ArticleStandard/Article/detail/806503?contextCategoryId=435&ref=25 The Breakthrough Prize in Life Sciences Foundation, dedicated to celebrating scientists and generating excitement about the pursuit of science as a career announced the initial recipients of the foundation?s awards. 2013-02-25T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/092013/806503null HTML http://www.biopharminternational.com/biopharm/News/Mercks-Cilengitide-Fails-to-Meet-Primary-Endpoint-/ArticleStandard/Article/detail/806555?contextCategoryId=435&ref=25 Merck's investigational integrin inhibitor cilengitide did not meet its primary endpoint in the CENTRIC Phase III trial evaluating if the agent could prolong overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy). 2013-02-25T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/092013/806555null HTML http://www.biopharminternational.com/biopharm/News/Affymax-and-Takeda-Recall-All-Lots-of-OMONTYS-pegi/ArticleStandard/Article/detail/806489?contextCategoryId=435&ref=25 Affymax Inc. and Takeda Pharmaceutical Company Limited have decided to voluntarily recall all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions. 2013-02-25T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/092013/806489null HTML http://www.biopharminternational.com/biopharm/News/Scientists-Find-Surprising-New-Influence-on-Cancer/ArticleStandard/Article/detail/806510?contextCategoryId=435&ref=25 Scripps Research Institute Team Shows How DNA Sequences Long Considered ?Junk? Are Involved in Gene Regulation 2013-02-24T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/092013/806510null HTML http://www.biopharminternational.com/biopharm/News/RocheGenentech-Win-FDA-Approval-for-Antibody-Drug-/ArticleStandard/Article/detail/806413?contextCategoryId=435&ref=25 FDA approved Roche?s antibody-drug conjugate, Kadcyla (trastuzumab emtansine or T-DM1), for the treatment of people with HER2-positive metastatic breast cancer. 2013-02-22T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/082013/806413null HTML http://www.biopharminternational.com/biopharm/News/Report-Explores-Future-of-Opioid-Abuse-Resistant-F/ArticleStandard/Article/detail/806146?contextCategoryId=435&ref=25 A GBI Research report says the opioid market will be driven by development of new products and post-marketing studies designed to reduce abuse risk. 2013-02-21T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/082013/806146null HTML http://www.biopharminternational.com/biopharm/News/Merck-and-Samsung-Bioepis-Form-Biosimilars-Develop/ArticleStandard/Article/detail/806112?contextCategoryId=435&ref=25 Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates. 2013-02-20T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/082013/806112null HTML http://www.biopharminternational.com/biopharm/News/BARDA-Continues-to-Support-Protein-Sciences-Cell-B/ArticleStandard/Article/detail/805999?contextCategoryId=435&ref=25 Protein Sciences announced that the Biomedical Advanced Research and Development Authority (BARDA) will continue to support the company?s influenza vaccines program. 2013-02-19T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/082013/805999null HTML http://www.biopharminternational.com/biopharm/News/Promisemdashand-ProblemsmdashSignal-Mixed-Year-Ahe/ArticleStandard/Article/detail/805953?contextCategoryId=435&ref=25 Biopharmaceuticals—the major source of new medicines and a key knowledge industry for the future—faces another rough year from empowered payers as it makes its slow passage to a renewed product base. This is the main finding from Pharmaceutical Executive magazine's annual survey of trends and issues facing the biopharma world in the year ahead. 2013-02-19T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/082013/805953null HTML http://www.biopharminternational.com/biopharm/News/Merck-Pays-688-Million-to-Resolve-Vytorin-Lawsuits/ArticleStandard/Article/detail/805816?contextCategoryId=435&ref=25 Merck has agreed in principle to pay $688 million to settle two federal securities class-action lawsuits involving the company's anticholesterol drugs Vytorin and Zocor, thereby avoiding trial. 2013-02-18T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/082013/805816null HTML http://www.biopharminternational.com/biopharm/News/Mylan-Biocon-Form-Pact-to-Develop-and-Commercializ/ArticleStandard/Article/detail/805769?contextCategoryId=435&ref=25 Mylan has entered into a definitive agreement with Biocon Limited for an exclusive collaboration on the development and commercialization of generic versions of three insulin analog products. 2013-02-15T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072013/805769null HTML http://www.biopharminternational.com/biopharm/News/SGS-Expands-Viral-Challenge-Testing-Facility/ArticleStandard/Article/detail/805613?contextCategoryId=435&ref=25 SGS has added a 12-bed, Biosafety Level 2-Q compliant, quarantine facility for viral challenge studies to its clinical pharmacology unit in Antwerp, Belgium. 2013-02-14T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072013/805613null HTML http://www.biopharminternational.com/biopharm/News/Lycera-and-MSD-Collaborate-on-Autoimmune-Therapies/ArticleStandard/Article/detail/805643?contextCategoryId=435&ref=25 The biopharmaceutical company lycera has announced a collaboration agreement with Merck, Sharpe & Dohme (MSD) that will focus on developing and commercializing small-molecule therapies for treating a range of autoimmune diseases. 2013-02-12T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072013/805643null HTML http://www.biopharminternational.com/biopharm/News/Lilly-Discontinues-Phase-III-Rheumatoid-Arthritis-/ArticleStandard/Article/detail/805326?contextCategoryId=435&ref=25 Eli Lilly and Co. announced that it will discontinue its Phase III rheumatoid arthritis program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, because of lack of efficacy. 2013-02-12T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072013/805326null HTML http://www.biopharminternational.com/biopharm/News/Drug-Discovery-Initiative-Launched-in-Europe/ArticleStandard/Article/detail/805132?contextCategoryId=435&ref=25 An international consortium of pharmaceutical companies, academia, research organisations and other related entities have launched a new platform to help enhance drug discovery in Europe. 2013-02-11T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072013/805132null HTML http://www.biopharminternational.com/biopharm/News/Biogen-Acquires-Full-Tysabri-Rights-from-Elan/ArticleStandard/Article/detail/805629?contextCategoryId=435&ref=25 Biogen Idec has agreed to acquire full Tysabri rights from Elan, and will use its existing cash reserves to make a payment of $3.25 billion to Elan upon the closing of the transaction and make future contingent payments to Elan. 2013-02-07T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072013/805629null HTML http://www.biopharminternational.com/biopharm/News/GSK-Announces-Fourth-Quarter-2012-Results-and-2013/ArticleStandard/Article/detail/804939?contextCategoryId=435&ref=25 Group sales were down, but R&D progress points to future growth. 2013-02-07T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062013/804939null HTML http://www.biopharminternational.com/biopharm/News/First-Commercially-Available-Intravenous-Immune-Gl/ArticleStandard/Article/detail/804593?contextCategoryId=435&ref=25 Biotest Pharmaceuticals Corporation announced that Bivigam [immune globulin intravenous (human), 10% liquid] is now available in the pharmaceutical distribution channel for use by physicians, pharmacists and hospitals throughout the US. Bivigam is a sugar-free, glycine stabilized intravenous immune globulin that has been approved by the FDA in December 2012 for the treatment of patients with primary humoral immunodeficiency (PI). 2013-02-06T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062013/804593null HTML http://www.biopharminternational.com/biopharm/News/Shire-to-Resolve-Federal-Investigation-and-Pay-575/ArticleStandard/Article/detail/804594?contextCategoryId=435&ref=25 Shire announced that it has reached an agreement in principle with the US government to resolve the previously disclosed civil investigation into its sales and marketing practices in the US relating to the company?s attention deficit hyperactivity disorder (ADHD) drugs, Adderall XR and Vyvanse as well as the ADHD patch Daytrana. 2013-02-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062013/804594null HTML http://www.biopharminternational.com/biopharm/News/FDA-Lists-Guidance-Documents-Planned-for-2013/ArticleStandard/Article/detail/804549?contextCategoryId=435&ref=25 FDA has released a list of more than 50 guidance documents planned for 2013. 2013-02-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062013/804549null HTML http://www.biopharminternational.com/biopharm/News/FDA-Lists-Guidance-Documents-Planned-for-2013/ArticleStandard/Article/detail/804908?contextCategoryId=435&ref=25 FDA has released a list of more than 50 guidance documents planned for 2013. 2013-02-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062013/804908null HTML http://www.biopharminternational.com/biopharm/Online+Only/European-Commission-Investigates-JampJ-and-Novarti/ArticleStandard/Article/detail/804923?contextCategoryId=435&ref=25 The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules. 2013-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062013/804923/Magnifying_thumbnail.jpg http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062013/804923null HTML http://www.biopharminternational.com/biopharm/News/Pfizer-Reports-Fourth-Quarter-and-Full-Year-2012-F/ArticleStandard/Article/detail/804399?contextCategoryId=435&ref=25 Pfizer has reported financial results for fourth-quarter and full-year 2012. Fourth-quarter 2012 revenues were $15.1 billion, a decrease of 7% compared with $16.1 billion in the year-ago quarter, which reflects an operational decline of $802 million, or 5%, and the unfavorable impact of foreign exchange of $271 million, or 2%. 2013-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052013/804399null HTML http://www.biopharminternational.com/biopharm/News/US-Pharmacopeial-Convention-Announces-Revised-Offi/ArticleStandard/Article/detail/804263?contextCategoryId=435&ref=25 Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014. 2013-01-31T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052013/804263null HTML http://www.biopharminternational.com/biopharm/News/Endo-Pharmaceuticals-and-GVK-Biosciences-Form-Rese/ArticleStandard/Article/detail/804131?contextCategoryId=435&ref=25 Endo Pharmaceuticals and GVK Biosciences (GVK BIO), a CRO based in India, have entered into an agreement to collaborate on the development of small molecules targeting an undisclosed protein. Using its discovery expertise, GVK BIO will deliver a clinical candidate and Endo will be responsible for the development and commercialization of the product. 2013-01-30T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052013/804131null HTML http://www.biopharminternational.com/biopharm/News/Ben-Venue-Laboratories-Enters-Consent-Decree/ArticleStandard/Article/detail/803932?contextCategoryId=435&ref=25 Ben Venue Laboratories announced that it has voluntarily entered into a consent decree with FDA over violations of cGMP. 2013-01-29T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052013/803932null HTML http://www.biopharminternational.com/biopharm/News/GSK-Announces-Joint-Venture-for-Pediatric-Vaccine/ArticleStandard/Article/detail/803850?contextCategoryId=435&ref=25 GlaxoSmithKline has formed a joint venture with Indian vaccines company Biological E to research and develop a six-in-one combination pediatric vaccine to help protect children in India and other developing countries from certain infectious diseases. 2013-01-28T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052013/803850null HTML http://www.biopharminternational.com/biopharm/News/Actavis-Unveils-Long-Term-Growth-Strategy/ArticleStandard/Article/detail/803762?contextCategoryId=435&ref=25 Following its recent acquisition, Actavis (formerly Watson Pharmaceuticals) unveiled its long-term growth strategy during its investor meeting in New York. 2013-01-25T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/042013/803762null HTML http://www.biopharminternational.com/biopharm/News/FTC-Reports-an-Increase-in-Anticompetitive-Activit/ArticleStandard/Article/detail/803321?contextCategoryId=435&ref=25 According to the Federal Trade Commission, the number of potentially anticompetitive patent dispute settlements between branded and generic drug companies increased between 2011 and 2012. 2013-01-22T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/042013/803321null HTML http://www.biopharminternational.com/biopharm/News/FDA-Approves-New-Influenza-Vaccine-Manufactured-wi/ArticleStandard/Article/detail/803148?contextCategoryId=435&ref=25 FDA has approved Protein Sciences's FluBlok, a seasonal influenza vaccine made with novel technology. FluBlok uses recombinant DNA and a modified baculovirus (a virus that infects insects) to produce a safe and effective human flu vaccine. FDA approved FluBlok for people 18–49 years old. 2013-01-18T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/032013/803148null HTML http://www.biopharminternational.com/biopharm/Online+Only/Rutgers-University-Research-Center-and-Janssen-Dev/ArticleStandard/Article/detail/802922?contextCategoryId=435&ref=25 Rutgers engineers constructed a direct compaction line in collaboration with Janssen. 2013-01-17T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/032013/802922null HTML http://www.biopharminternational.com/biopharm/News/Lonza-Expands-Antibody-Drug-Conjugate-Manufacturin/ArticleStandard/Article/detail/802706?contextCategoryId=435&ref=25 Lonza will invest CHF 14 million ($15.1 million) to double the existing large-scale manufacturing capacity in Visp, Switzerland. 2013-01-15T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/032013/802706null HTML