http://www.pharmtech.com/pharmtech/News/Article/list/35097 The latest business, scientific & regulatory news from the pharmaceutical and biotechnology industries. Trends & international news from global correspondents and breakthroughs in research in Coming Down the Pike. 2013-05-23T01:32:29Z http://www.pharmtech.com/pharmtech/News/Novo-Acquires-Xellia-for-US-700-Million/ArticleStandard/Article/detail/813844?contextCategoryId=35097&ref=25 Novo A/S, the holding company of Denmark's Novo Nordisk, has acquired Xellia Pharmaceuticals and purchased all shares of the group for approximately US$ 700 million. 2013-05-22T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813844null HTML http://www.pharmtech.com/pharmtech/News/Pfizer-Halts-Phase-III-Trial-of-Cancer-Drug-in-NHL/ArticleStandard/Article/detail/813845?contextCategoryId=35097&ref=25 Pfizer has discontinued a Phase III study of its investigational cancer drug, inotuzumab ozogamicin, in relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) after it failed to show benefit in overall survival. 2013-05-22T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813845null HTML http://www.pharmtech.com/pharmtech/News/AbbVie-and-Galapagos-Extend-GLPG0634-Collaboration/ArticleStandard/Article/detail/813711?contextCategoryId=35097&ref=25 AbbVie and Galapagos have extended their collaboration on the clinical development of GLPG0634 to include Crohn's disease. 2013-05-21T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813711null HTML http://www.pharmtech.com/pharmtech/News/USP-Offers-Herbal-Medicines-Compendium/ArticleStandard/Article/detail/813817?contextCategoryId=35097&ref=25 The U.S. Pharmacopeial Convention is offering free online access to public standards to help ensure the quality of the herbal ingredients used in medicinal products. 2013-05-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813817null HTML http://www.pharmtech.com/pharmtech/News/Actavis-to-Acquire-Warner-Chilcott/ArticleStandard/Article/detail/813797?contextCategoryId=35097&ref=25 Actavis Inc. and Warner Chilcott plc have entered into a definitive agreement under which Actavis will acquire Warner Chilcott plc in a stock-for-stock transaction valued at approximately $8.5 billion. 2013-05-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813797null HTML http://www.pharmtech.com/pharmtech/News/AstraZeneca-Provides-Update-on-Oncology-Pipeline/ArticleStandard/Article/detail/813708?contextCategoryId=35097&ref=25 AstraZeneca announced that three of its cancer compounds—moxetumomab pasudotox, olaparib and selumetinib—will be moving forward to Phase III clinical development. Oncology is one of the company's core therapy areas and accelerating the development of a number of new molecular entities in its pipeline is a strategic priority. 2013-05-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813708null HTML http://www.pharmtech.com/pharmtech/News/AbbVie-and-Alvine-Will-Collaborate-on-Celiac-Disea/ArticleStandard/Article/detail/813311?contextCategoryId=35097&ref=25 Program aims to develop a novel oral treatment. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813311null HTML http://www.pharmtech.com/pharmtech/News/Report-Previews-Future-of-US-Biosimilar-Market/ArticleStandard/Article/detail/813821?contextCategoryId=35097&ref=25 Thomson Reuters released a report that provides a view of the challenges facing companies entering the United States biosimilar drug market. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813821null HTML http://www.pharmtech.com/pharmtech/News/Theravance-and-Elan-Enter-1-Billion-Royalty-Partic/ArticleStandard/Article/detail/813310?contextCategoryId=35097&ref=25 Elan will purchase interest in four respiratory programs. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813310null HTML http://www.pharmtech.com/pharmtech/News/FDA-Issues-Pharmacoepidemiologic-Safety-Study-Guid/ArticleStandard/Article/detail/813184?contextCategoryId=35097&ref=25 FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies. 2013-05-14T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813184null HTML http://www.pharmtech.com/pharmtech/News/Lillys-Enzastaurin-Disappoints-in-Phase-III-Trial/ArticleStandard/Article/detail/812961?contextCategoryId=35097&ref=25 Eli Lilly reported that enzastaurin did not meet the primary endpoint in a Phase III study, which evaluated the agent as a monotherapy for the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). 2013-05-13T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/812961null HTML http://www.pharmtech.com/pharmtech/Online+Only/Amgen-Forms-New-Joint-Venture-to-Commercialize-Vec/ArticleStandard/Article/detail/812960?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/812960null HTML http://www.pharmtech.com/pharmtech/News/USP-Launches-Initiative-to-Fight-Counterfeit-Drugs/ArticleStandard/Article/detail/813066?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813066null HTML http://www.pharmtech.com/pharmtech/News/Biotage-Responds-to-CEM-Corporation-Patent-Dispute/ArticleStandard/Article/detail/813296?contextCategoryId=35097&ref=25 Biotage issued a statement in response to a recent announcement from CEM Corporation about a patent issue with Biotage. 2013-05-13T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813296null HTML http://www.pharmtech.com/pharmtech/News/Takeda-to-Acquire-Inviragen-for-up-to-250-Million/ArticleStandard/Article/detail/812838?contextCategoryId=35097&ref=25 Takeda and US vaccines maker Inviragen jointly announced that they have entered into a definitive agreement for Takeda to acquire Inviragen for an upfront payment of US$35 million and future payments of up to US$215 million upon achievement of key commercial milestones, linked to the progress of clinical development. 2013-05-10T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812838null HTML http://www.pharmtech.com/pharmtech/News/GSK-Announces-Plans-to-Share-Clinical-Trial-Data/ArticleStandard/Article/detail/812739?contextCategoryId=35097&ref=25 In its commitment to transparency, GlaxoSmithKline (GSK) has outlined plans to share detailed data from its clinical trials. GSK is to establish a new online system that will enable researchers to request access to anonymised patient level data. 2013-05-09T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812739null HTML http://www.pharmtech.com/pharmtech/Online+Only/USP-Workshop-Addresses-Moisture-Permeation-Into-Pa/ArticleStandard/Article/detail/812718?contextCategoryId=35097&ref=25 The workshop will cover a proposed new method for measuring moisture vapor transmission rate. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812718null HTML http://www.pharmtech.com/pharmtech/News/European-Medicines-Agency-Changes-Procedures-for-O/ArticleStandard/Article/detail/812698?contextCategoryId=35097&ref=25 EMA streamlines orphan drug application procedure. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812698null HTML http://www.pharmtech.com/pharmtech/Most+Viewed+Articles/Pfizer-Opens-Online-Pharmacy-to-Fight-Counterfeit-/ArticleStandard/Article/detail/812543?contextCategoryId=35097&ref=25 Pfizer has launched a prescription-fulfillment website for Viagra tablets in an effort to combat the online sale of counterfeited medicine. 2013-05-06T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812543null HTML http://www.pharmtech.com/pharmtech/News/Pharmaco-Kinesis-Corporation-Develops-First-Nanodr/ArticleStandard/Article/detail/812032?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812032null HTML http://www.pharmtech.com/pharmtech/News/Actemra-Receives-FDA-Approval-for-Polyarticular-Ju/ArticleStandard/Article/detail/812031?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812031null HTML http://www.pharmtech.com/pharmtech/News/Bayer-to-Acquire-Conceptus-for-US11-Billion/ArticleStandard/Article/detail/812030?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812030null HTML http://www.pharmtech.com/pharmtech/News/Pharmaceutical-Technology-and-DampB-Launch-Busines/ArticleStandard/Article/detail/811687?contextCategoryId=35097&ref=25 Pharmaceutical Technology has joined with Dun & Bradstreet Credibility Corp. to launch the Pharmaceutical Technology and BioPharm International Marketplace. 2013-04-26T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811687null HTML http://www.pharmtech.com/pharmtech/News/Catalent-Biologics-Opens-New-Single-Use-Biomanufac/ArticleStandard/Article/detail/811649?contextCategoryId=35097&ref=25 Catalent Pharma Solutions, a provider of drug and biologic development services, delivery technologies and supply solutions, has officially opened a new biomanufacturing center of excellence in Madison. The facility, which was constructed in response to customer demand, is expected to quadruple Catalent's current biologics manufacturing capacity and extensively utilise single-use technology for greater flexibility and efficiency. It will allow the company to extend its offerings in the biologics sector while enhancing the efficiency and output of its proprietary GPEx cell line engineering technology as well as other mammalian cell lines. 2013-04-26T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811649null HTML http://www.pharmtech.com/pharmtech/News/FDA-Creates-Partnership-to-Battle-Anti-Malaria-Cou/ArticleStandard/Article/detail/811487?contextCategoryId=35097&ref=25 FDA will use a new anticounterfeiting tool to detect fake medicines. 2013-04-24T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811487null HTML http://www.pharmtech.com/pharmtech/News/BioOutsource-Opens-New-Facility-in-Cambridge-Massa/ArticleStandard/Article/detail/811375?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811375null HTML http://www.pharmtech.com/pharmtech/News/Lundbeck-Launches-Selincro-as-First-Alcohol-Depend/ArticleStandard/Article/detail/811374?contextCategoryId=35097&ref=25 Lundbeck has launched Selincro in Norway, Finland, Poland and the Baltic countries of Latvia, Lithuania and Estonia for the treatment of alcohol dependence in patients with high-risk drinking levels. According to Lundbeck, the launch marks the first introduction of a new treatment for alcohol dependence in Europe for more than a decade. 2013-04-24T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811374null HTML http://www.pharmtech.com/pharmtech/News/EMA-Upgrades-Database-to-Strengthen-Supply-Chain-S/ArticleStandard/Article/detail/811372?contextCategoryId=35097&ref=25 EMA has upgraded its EudraGMP database to include information on GDP in addition to GMP. The new EudraGMDP database is a key deliverable of the Falsified Medicines Directive (FMD) that came into effect in January 2013. The aim is to increase supply chain security in the EU by making supervision of manufacturing and distribution of medicines more robust to ensure supplier compliance. 2013-04-23T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811372null HTML http://www.pharmtech.com/pharmtech/News/FDA-Releases-Draft-Guidance-on-Labeling-Safety/ArticleStandard/Article/detail/811344?contextCategoryId=35097&ref=25 FDA issues draft guidance to minimize medication errors. 2013-04-23T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811344null HTML http://www.pharmtech.com/pharmtech/News/AstraZeneca-Seals-Cancer-Nanomedicine-Deal-with-BI/ArticleStandard/Article/detail/811373?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811373null HTML http://www.pharmtech.com/pharmtech/News/Balanced-Solutions-Voluntarily-Recalls-Sterile-Pro/ArticleStandard/Article/detail/811304?contextCategoryId=35097&ref=25 Third compounding pharmacy recalls products due to FDA inspection. 2013-04-23T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811304null HTML http://www.pharmtech.com/pharmtech/News/Entegris-Acquires-Jetalon-Solutions/ArticleStandard/Article/detail/811210?contextCategoryId=35097&ref=25 Unique technology expands Entegris? fluid-sensing and control offering. 2013-04-22T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811210null HTML http://www.pharmtech.com/pharmtech/News/Allergan-Receives-Complete-Response-Letter-from-FD/ArticleStandard/Article/detail/811212?contextCategoryId=35097&ref=25 Allergan has addressed FDA?s concerns with canister filling. 2013-04-22T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811212null HTML http://www.pharmtech.com/pharmtech/News/Positive-Phase-III-Results-for-Lillys-Dulaglutide-/ArticleStandard/Article/detail/810850?contextCategoryId=35097&ref=25 Eli Lilly has announced positive top-line results for two of its Phase III trials, AWARD-2 and AWARD-4, which evaluated dulaglutide as a once-weekly treatment in patients with type 2 diabetes. Both trials met the primary efficacy endpoints, demonstrating non-inferiority of dulaglutide compared to insulin glargine, measured by a reduction of hemoglobin A1c (HbA1c) levels at the 1.5 mg dose level. 2013-04-18T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810850null HTML http://www.pharmtech.com/pharmtech/News/Ovals-Innovative-Autoinjector-Enables-Delivery-of-/ArticleStandard/Article/detail/810857?contextCategoryId=35097&ref=25 Oval Medical Technologies, an autoinjector company based in Cambridge, UK, reported that a variety of highly viscous solutions have been successfully delivered through a 25-gauge thin-wall needle, in less than 7 seconds, using its innovative autoinjector. The technology provides solutions to problems in the industry for drug containment and the end user. 2013-04-18T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810857null HTML http://www.pharmtech.com/pharmtech/News/Cipla-Launches-First-Biosimilar-of-Etanercept-in-I/ArticleStandard/Article/detail/810848?contextCategoryId=35097&ref=25 Cipla has launched the first biosimilar of etanercept in India for the treatment of rheumatoid disorders. The product will be marketed under the brand name Etacept. The launch of Etacept marks Cipla's entry into the biologics market, offering a low-cost alternative to Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India. 2013-04-18T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810848null HTML http://www.pharmtech.com/pharmtech/News/Sanofi-and-PATH-Launch-Semisynthetic-Artemisinin-P/ArticleStandard/Article/detail/810823?contextCategoryId=35097&ref=25 New manufacturing route improves availability of ingredient for malaria treatment. 2013-04-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810823null HTML http://www.pharmtech.com/pharmtech/News/Merck-Opens-New-Manufacturing-Facility-in-China/ArticleStandard/Article/detail/810824?contextCategoryId=35097&ref=25 The facility in Hangzhou will package Merck medicines for China and the Asia-Pacific region. 2013-04-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810824null HTML http://www.pharmtech.com/pharmtech/News/FDA-Releases-Guidance-on-Non-Penicillin-Beta-Lacta/ArticleStandard/Article/detail/810831?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810831null HTML http://www.pharmtech.com/pharmtech/News/FDA-Will-Not-Approve-Generics-to-Original-OxyConti/ArticleStandard/Article/detail/810792?contextCategoryId=35097&ref=25 The FDA approved updated labeling for Purdue Pharma L.P.?s reformulated OxyContin tablets, but also determined that it will not approve generic versions of the original OxyContin. 2013-04-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810792null HTML http://www.pharmtech.com/pharmtech/News/Amgen-to-Pay-249-Million-for-False-Claims-Act-Viol/ArticleStandard/Article/detail/810763?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810763null HTML http://www.pharmtech.com/pharmtech/News/Thermo-Fisher-Scientific-to-Acquire-Life-Technolog/ArticleStandard/Article/detail/810759?contextCategoryId=35097&ref=25 $13.6 billion deal strengthens Thermo?s leading role. 2013-04-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810759null HTML http://www.pharmtech.com/pharmtech/News/Compounding-Pharmacies-Recall-Products/ArticleStandard/Article/detail/810753?contextCategoryId=35097&ref=25 FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls. 2013-04-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810753null HTML http://www.pharmtech.com/pharmtech/News/Bristol-Myers-Squibb-Plans-Expansion-of-Massachuse/ArticleStandard/Article/detail/810455?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810455null HTML http://www.pharmtech.com/pharmtech/News/FDA-Commissioner-Claims-Resistance-to-Compounding-/ArticleStandard/Article/detail/810484?contextCategoryId=35097&ref=25 FDA inspections of compounding pharmacies manufacturing sterile products reveal non-sterile conditions. 2013-04-12T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810484null HTML http://www.pharmtech.com/pharmtech/Online+Only/Roche-Will-Use-Technology-From-Isis-To-Develop-Bra/ArticleStandard/Article/detail/810464?contextCategoryId=35097&ref=25 The alliance will develop treatments based on Isis' antisense technology. 2013-04-12T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810464null HTML http://www.pharmtech.com/pharmtech/News/Vetters-New-Commercial-Line-Validated-for-cGMP-Fil/ArticleStandard/Article/detail/810448?contextCategoryId=35097&ref=25 Prefilled-syringe line features automation and novel disinfection techniques. 2013-04-12T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810448null HTML http://www.pharmtech.com/pharmtech/News/FDA-Requests-Almost-5-Billion-for-2014-Budget/ArticleStandard/Article/detail/810466?contextCategoryId=35097&ref=25 FDA's Fiscal Year 2014 budget request includes more than $10 million above the 2012 budget for inspections of products manufactured in China. 2013-04-12T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810466null HTML http://www.pharmtech.com/pharmtech/News/Accelrys-Adds-Laboratory-Information-Management-Sy/ArticleStandard/Article/detail/810465?contextCategoryId=35097&ref=25 The process-driven system reduces total cost of ownership. 2013-04-12T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810465null HTML http://www.pharmtech.com/pharmtech/News/Pfizer-Issued-Warning-Letter-for-Italian-Manufactu/ArticleStandard/Article/detail/810421?contextCategoryId=35097&ref=25 Company is notified of GMP violations at facility in Catania, Italy. 2013-04-11T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810421null HTML http://www.pharmtech.com/pharmtech/News/State-Legislatures-Become-Battlegrounds-for-Biosim/ArticleStandard/Article/detail/810415?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810415null HTML http://www.pharmtech.com/pharmtech/News/FDA-Releases-Guidance-on-Self-Selections-Studies/ArticleStandard/Article/detail/810255?contextCategoryId=35097&ref=25 FDA Releases Guidance on Self-Selections Studies 2013-04-10T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810255null HTML http://www.pharmtech.com/pharmtech/News/Dr-Reddys-to-Relocate-North-America-HQ/ArticleStandard/Article/detail/810265?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810265null HTML http://www.pharmtech.com/pharmtech/News/Teva-and-Lonza-Review-Biosimilars-Opportunity/ArticleStandard/Article/detail/809976?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/809976null HTML http://www.pharmtech.com/pharmtech/News/Astellas-and-Ambrx-Collaborate-on-Antibody-Drug-Co/ArticleStandard/Article/detail/809979?contextCategoryId=35097&ref=25 Astellas and Ambrx have entered into a collaboration to discover and develop novel antibody drug conjugates (ADCs) for an undisclosed number of targets in oncology. ADCs enable targeted delivery of drugs to the target tissue. 2013-04-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/809979null HTML http://www.pharmtech.com/pharmtech/News/Eli-Lilly-Considers-Investment-in-US-Insulin-Manuf/ArticleStandard/Article/detail/810046?contextCategoryId=35097&ref=25 Company considers investment in insulin cartridge-filling and insulin API manufacturing capacity in the US. 2013-04-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810046null HTML http://www.pharmtech.com/pharmtech/News/Pfizer-Voluntarily-Recalls-Levoxyl/ArticleStandard/Article/detail/810051?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810051null HTML http://www.pharmtech.com/pharmtech/News/Regeneron-Expands-and-Creates-400-New-Jobs-in-West/ArticleStandard/Article/detail/809977?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/809977null HTML http://www.pharmtech.com/pharmtech/News/China-Lab-Joins-USP-Spectral-Libraries-Alliance/ArticleStandard/Article/detail/810148?contextCategoryId=35097&ref=25 USP has inaugurated the first satellite site of the USP Spectral Library Global Laboratory Network in China. 2013-04-05T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152013/810148null HTML http://www.pharmtech.com/pharmtech/News/Novartis-Suffers-Setback-in-Indian-Patent-Case-for/ArticleStandard/Article/detail/809078?contextCategoryId=35097&ref=25 Novartis loses an appeal in seeking patent protection in India for its anticancer drug. 2013-04-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809078null HTML http://www.pharmtech.com/pharmtech/News/FDA-Releases-SUPAC-Guidance/ArticleStandard/Article/detail/809060?contextCategoryId=35097&ref=25 Draft guidance combines and supersedes previous guidance documents. 2013-04-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809060null HTML http://www.pharmtech.com/pharmtech/News/Pharm-Exec-Names-Januvia-Brand-of-the-Year/ArticleStandard/Article/detail/809055?contextCategoryId=35097&ref=25 Merck's Januvia [sitagliptin] was named 2013 Brand of the Year by Pharmaceutical Executive magazine. 2013-03-27T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142013/809055null HTML http://www.pharmtech.com/pharmtech/News/Shire-to-Acquire-SARcode-for-160-Million/ArticleStandard/Article/detail/808904?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/132013/808904null HTML http://www.pharmtech.com/pharmtech/News/Products-Recalled-Due-to-Possible-Filament-Contami/ArticleStandard/Article/detail/808908?contextCategoryId=35097&ref=25 A Massachusetts-based compound pharmacy is voluntarily recalling all sterile compound products dispensed since Jan. 1, 2013 due to possible filament contamination. 2013-03-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/132013/808908null HTML http://www.pharmtech.com/pharmtech/News/AstraZeneca-Announces-an-Additional-2300-Layoffs/ArticleStandard/Article/detail/808815?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808815null HTML http://www.pharmtech.com/pharmtech/News/Mettler-Toledo-Introduces-Mechanical-Analyzer/ArticleStandard/Article/detail/808766?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808766null HTML http://www.pharmtech.com/pharmtech/News/FDA-Investigates-Med-Prep-Consulting-for-Contamina/ArticleStandard/Article/detail/808601?contextCategoryId=35097&ref=25 The New Jersey-licensed specialty pharmacy recalls magnesium sulfate products and halts all production operations. 2013-03-21T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808601null HTML http://www.pharmtech.com/pharmtech/News/Bruker-Introduces-Mass-Spectrometers-NMR-Modules/ArticleStandard/Article/detail/808762?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808762null HTML http://www.pharmtech.com/pharmtech/News/Metrohm-and-FOSS-Enter-Strategic-Alliance/ArticleStandard/Article/detail/808765?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808765null HTML http://www.pharmtech.com/pharmtech/News/Rigaku-Raman-Upgrades-Handheld-Analyzer/ArticleStandard/Article/detail/808768?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808768null HTML http://www.pharmtech.com/pharmtech/News/IPEC-Releases-Revised-Excipient-Information-Packag/ArticleStandard/Article/detail/808763?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808763null HTML http://www.pharmtech.com/pharmtech/News/Xceleron-and-JCL-Bioassay-Partner-in-Early-Stage-C/ArticleStandard/Article/detail/808495?contextCategoryId=35097&ref=25 Xceleron and JCL Bioassay have entered into a partnership that will offer drug developers access to a range of sensitive and robust analytical platforms for early clinical development across Asia, Europe, and North America. 2013-03-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808495null HTML http://www.pharmtech.com/pharmtech/News/Jetrea-Granted-EU-Approval-for-Vitreomacular-Tract/ArticleStandard/Article/detail/808364?contextCategoryId=35097&ref=25 ThromboGenics' eye drug, Jetrea (ocriplasmin) has been approved in the EU for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. 2013-03-19T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808364null HTML http://www.pharmtech.com/pharmtech/News/Waters-Corp-Updates-Instruments-and-Software/ArticleStandard/Article/detail/808356?contextCategoryId=35097&ref=25 At Pittcon 2013, Water Corp. announced improvement to chromatography systems and software. 2013-03-18T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808356null HTML http://www.pharmtech.com/pharmtech/News/Thermo-Fisher-Scientific-Introduces-Software-Instr/ArticleStandard/Article/detail/808358?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808358null HTML http://www.pharmtech.com/pharmtech/News/AstraZeneca-to-Cut-1600-Positions-in-RampD-Reorgan/ArticleStandard/Article/detail/808345?contextCategoryId=35097&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 positions, mainly in the UK and the US. 2013-03-18T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808345null HTML http://www.pharmtech.com/pharmtech/News/Shimadzu-Scientific-Instruments-Adds-Chromatograph/ArticleStandard/Article/detail/808355?contextCategoryId=35097&ref=25 Shimadzu Scientific Instruments introduced several new products at Pittcon 2013. 2013-03-18T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/122013/808355null HTML http://www.pharmtech.com/pharmtech/News/Analytical-Technology-Introductions-Planned-for-Pi/ArticleStandard/Article/detail/808214?contextCategoryId=35097&ref=25 Scientists and instrument manufacturers gather in Philadelphia for Pittcon 2013. 2013-03-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/112013/808214null HTML http://www.pharmtech.com/pharmtech/News/INTERPOL-and-Pharma-Collaborate-to-Fight-Counterfe/ArticleStandard/Article/detail/807918?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/112013/807918null HTML http://www.pharmtech.com/pharmtech/News/More-than-900-Biologics-in-Development/ArticleStandard/Article/detail/807813?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/112013/807813null HTML http://www.pharmtech.com/pharmtech/News/Daiichi-Sankyo-Condemns-Falsely-represented-Produc/ArticleStandard/Article/detail/807634?contextCategoryId=35097&ref=25 Product sold online in Malaysia and Indonesia infringes on the company’s trademark. 2013-03-08T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102013/807634null HTML http://www.pharmtech.com/pharmtech/News/European-Patent-Filings-Up-But-Pharma-Stays-Flat/ArticleStandard/Article/detail/807598?contextCategoryId=35097&ref=25 While the number of patent filings at the European Patent Office in 2012 increased by 5.2% over 2011, pharmaceutical-based patents remained flat, and biotechnology patents dropped slightly. 2013-03-07T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102013/807598null HTML http://www.pharmtech.com/pharmtech/News/AstraZenecas-Crestor-Patents-Ruled-Invalid-in-Aust/ArticleStandard/Article/detail/807400?contextCategoryId=35097&ref=25 AstraZeneca's three patents protecting Crestor (rosuvastatin) have been ruled invalid by the Federal Court of Australia. 2013-03-06T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102013/807400null HTML http://www.pharmtech.com/pharmtech/News/First-Biologic-Approved-in-the-EU-for-Gouty-Arthri/ArticleStandard/Article/detail/807426?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102013/807426null HTML http://www.pharmtech.com/pharmtech/News/Roche-and-BioLamina-Collaborate-on-Novel-Cell-Cult/ArticleStandard/Article/detail/807396?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102013/807396null HTML http://www.pharmtech.com/pharmtech/News/Roche-Chairman-to-Step-Down-in-2014/ArticleStandard/Article/detail/807349?contextCategoryId=35097&ref=25 Franz B. Humer, chairman of the board of directors of the Roche Group, will not stand for re-election to the Board in 2014. 2013-03-05T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102013/807349null HTML http://www.pharmtech.com/pharmtech/News/Mylan-Acquires-Generic-Injectables-Unit-From-Strid/ArticleStandard/Article/detail/807289?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102013/807289null HTML http://www.pharmtech.com/pharmtech/News/SAFC-Announces-Raw-Materials-Dry-Powder-Media-Manu/ArticleStandard/Article/detail/807641?contextCategoryId=35097&ref=25 SAFC added 20 raw materials to its PharmaGrade portfolio and announced an expansion of its Irvine, Scotland manufacturing plant. 2013-03-05T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102013/807641null HTML http://www.pharmtech.com/pharmtech/News/Russian-Lab-Achieves-ISO-Accreditation/ArticleStandard/Article/detail/807597?contextCategoryId=35097&ref=25 The Rostov-on-Don Medicines Quality Control Laboratory is the first official medicines control laboratory in Russia to have achieved internationally recognized ISO accreditation. 2013-03-05T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/102013/807597null HTML http://www.pharmtech.com/pharmtech/News/Capsugel-Acquires-Encap-Drug-Delivery/ArticleStandard/Article/detail/807056?contextCategoryId=35097&ref=25 Capsugel’s acquisition of Encap Drug Delivery expands its lipid expertise and adds an FDA-inspected commercial manufacturing facility. 2013-03-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092013/807056null HTML http://www.pharmtech.com/pharmtech/News/Sequestration-Threatens-Life-Sciences-Drug-Develop/ArticleStandard/Article/detail/807054?contextCategoryId=35097&ref=25 Mandatory cuts threaten to slow research and patient access to new therapies, Burrill & Company says. 2013-03-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092013/807054null HTML http://www.pharmtech.com/pharmtech/News/INTERPHEX-2013-Announces-Conference-Program/ArticleStandard/Article/detail/807086?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092013/807086null HTML http://www.pharmtech.com/pharmtech/News/European-Commission-Authorizes-First-Therapy-for-A/ArticleStandard/Article/detail/806974?contextCategoryId=35097&ref=25 The European Commission has granted H. Lundbeck A/S marketing authorization for Selincro (nalmefene) for the reduction of alcohol consumption in adult patients with alcohol dependence. 2013-02-28T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092013/806974null HTML http://www.pharmtech.com/pharmtech/News/Ablynx-and-Spirogen-Collaborate-on-Novel-Toxin-Nan/ArticleStandard/Article/detail/806738?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092013/806738null HTML http://www.pharmtech.com/pharmtech/News/Sanofis-Six-In-One-Pediatric-Vaccine-Recommended-f/ArticleStandard/Article/detail/806551?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092013/806551null HTML http://www.pharmtech.com/pharmtech/News/Affymax-and-Takeda-Recall-All-Lots-of-OMONTYS-pegi/ArticleStandard/Article/detail/806487?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092013/806487null HTML http://www.pharmtech.com/pharmtech/News/Mercks-Cilengitide-Fails-to-Meet-Primary-Endpoint-/ArticleStandard/Article/detail/806554?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092013/806554null HTML http://www.pharmtech.com/pharmtech/News/RocheGenentech-Win-FDA-Approval-for-Antibody-Drug-/ArticleStandard/Article/detail/806412?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/082013/806412null HTML http://www.pharmtech.com/pharmtech/Online+Only/Report-Explores-Future-of-Opioid-Abuse-Resistant-F/ArticleStandard/Article/detail/806142?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/082013/806142null HTML http://www.pharmtech.com/pharmtech/News/Merck-and-Samsung-Bioepis-Form-Biosimilars-Develop/ArticleStandard/Article/detail/806113?contextCategoryId=35097&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.pharmtech.com/pharmtech/data/articlestandard/pharmtech/082013/806113null HTML