http://biopharminternational.findpharma.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. 2009-11-21T13:53:22Z http://biopharminternational.findpharma.com/biopharm/News/Manufacturing-Problems-Again-Hold-Up-FDA-Approval-/ArticleStandard/Article/detail/642423?contextCategoryId=435&ref=25 Following a five-week inspection of Genzyme's plant in Allston Landing, MA, the US Food and Drug Administration is still not satisfied with the company?s large-scale manufacturing of Lumizyme. 2009-11-17T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/472009/642423null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Warns-of-Genzyme-Product-Contamination/ArticleStandard/Article/detail/641751?contextCategoryId=435&ref=25 The FDA and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of several Genzyme products: Cerezyme, Fabrazyme, Myozyme, and Thyrogen, which are supplied as lyophilized powders requiring reconstitution before administration; and Aldurazyme, which is supplied as a liquid solution. The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process, and could potentially cause serious adverse events in patients. 2009-11-13T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462009/641751null HTML http://biopharminternational.findpharma.com/biopharm/News/Genzyme-and-to-BBB-Collaborate-on-Brain-Delivery-o/ArticleStandard/Article/detail/640635?contextCategoryId=435&ref=25 Brain drug delivery company to-BBB, (Leiden, The Netherlands) has entered into a research collaboration with Genzyme Corporation (Cambridge, MA) to evaluate to-BBB?s proprietary G-Technology to enhance delivery of biologics for neurodegenerative diseases. 2009-11-12T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462009/640635null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Grants-Priority-Review-for-Shires-velagluceras/ArticleStandard/Article/detail/640661?contextCategoryId=435&ref=25 The US Food and Drug Administration has granted priority review for Shire plc's (Cambridge, MA) New Drug Application (NDA) for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. 2009-11-12T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462009/640661null HTML http://biopharminternational.findpharma.com/biopharm/News/Octapharma-and-Fresenius-Kabi-Enter-Agreement-for-/ArticleStandard/Article/detail/640665?contextCategoryId=435&ref=25 Octapharma Group (Bad Homburg, Germany) and Fresenius Kabi (Lachen, Switzerland) have signed a license, development, and supply agreement for the use of Fresenius Kabi's HESylation technology to develop a HESylated recombinant protein. 2009-11-12T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462009/640665null HTML http://biopharminternational.findpharma.com/biopharm/News/Morphotek-Signs-a-Pact-with-Centocor-for-a-Therape/ArticleStandard/Article/detail/640666?contextCategoryId=435&ref=25 Morphotek, Inc. (Exton, PA), a subsidiary of Eisai, Inc., has entered into a license agreement with Centocor Ortho Biotech, Inc. (Horsham, PA), for the development and commercialization of an antibody that targets a tumor-associated antigen over-expressed in many solid tumors. 2009-11-12T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462009/640666null HTML http://biopharminternational.findpharma.com/biopharm/News/GenVec-and-SAIC-Frederick-to-Develop-HIV-and-Influ/ArticleStandard/Article/detail/640663?contextCategoryId=435&ref=25 SAIC-Frederick, Inc. (Frederick, MD), has signed a contract with GenVec, Inc. (Gaithersburg, MD), for the development of influenza and HIV vaccines in support of the Vaccine Research Center (VRC, Frederick, MD). 2009-11-12T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462009/640663null HTML http://biopharminternational.findpharma.com/biopharm/News/Abraxis-Opens-Biologics-Manufacturing-Facility-in-/ArticleStandard/Article/detail/640628?contextCategoryId=435&ref=25 Abraxis Biosciences, a Los Angeles-based biotechnology company, unveiled a $70-million biopharmaceutical manufacturing plant in Phoenix, to serve as the company's manufacturing site for its pipeline of biologics. 2009-11-12T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462009/640628null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Publishes-Guidance-on-Diagnostic-Tests-for-200/ArticleStandard/Article/detail/640630?contextCategoryId=435&ref=25 FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus 2009-11-12T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462009/640630null HTML http://biopharminternational.findpharma.com/biopharm/News/Genmab-to-Sell-US-Plant-and-Cut-300-Jobs/ArticleStandard/Article/detail/640278?contextCategoryId=435&ref=25 In an attempt to save around $60 million annually, the Danish biopharmaceutical company Genmab is planning to sell its manufacturing facility located in Brooklyn Park, MN, and reduce headcount by approximately 300 positions. 2009-11-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462009/640278null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Grants-Orphan-Drug-Designation-for-TNFerade/ArticleStandard/Article/detail/639387?contextCategoryId=435&ref=25 The US Food and Drug Administration has granted orphan drug designation to GenVec, Inc.'s TNFerade for the treatment of pancreatic cancer. 2009-11-04T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639387null HTML http://biopharminternational.findpharma.com/biopharm/News/Sartorius-Opens-New-Plant-in-India/ArticleStandard/Article/detail/638055?contextCategoryId=435&ref=25 In a ribbon-cutting ceremony held on October 30, 2009, Sartorius (Goettingen, Germany) inaugurated its new plant at the Sartorius Group's location in Bangalore, India. 2009-10-30T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/638055null HTML http://biopharminternational.findpharma.com/biopharm/News/New-Influenza-Vaccine-Manufacturing-Facility-in-In/ArticleStandard/Article/detail/637340?contextCategoryId=435&ref=25 CPL Biologicals Pvt. Ltd. has begun construction of a state-of-the-art manufacturing facility in India that will be used to produce pandemic and seasonal influenza vaccines. 2009-10-28T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637340null HTML http://biopharminternational.findpharma.com/biopharm/News/Letter-to-the-Editor-Re-Diminutive-Bacteria-Useful/ArticleStandard/Article/detail/635704?contextCategoryId=435&ref=25 2009-10-22T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/432009/635704null HTML http://biopharminternational.findpharma.com/biopharm/News/Letter-to-the-Editor-Re-Diminutive-Bacteria-Useful/ArticleStandard/Article/detail/635419?contextCategoryId=435&ref=25 2009-10-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/432009/635419null HTML http://biopharminternational.findpharma.com/biopharm/News/DASGIP-Adds-to-iPhone-Offerings-for-Scientists/ArticleStandard/Article/detail/634399?contextCategoryId=435&ref=25 In keeping with the growing trend of iPhone applications for every conceivable convenience, DASGIP AG (Juelich, Germany), a provider of parallel bioreactor systems at benchtop scale, has launched an iPhone application for accessing bioprocesses online. 2009-10-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/634399null HTML http://biopharminternational.findpharma.com/biopharm/News/SAFC-Pharma-Expands-Facility-to-Bolster-Biologics-/ArticleStandard/Article/detail/634326?contextCategoryId=435&ref=25 SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics. 2009-10-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/634326null HTML http://biopharminternational.findpharma.com/biopharm/News/Celltrion-and-Hospira-to-Comarket-Celltrions-Biosi/ArticleStandard/Article/detail/633260?contextCategoryId=435&ref=25 The Korean CMO Celltrion and Hospira, a small-molecule injectable generics and drug delivery company based in Lake Forest, IL, agree to co-market biosimilars developed by Celltrion. 2009-10-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633260null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Diminutive-Bacteria-Useful-for-02-mum-Filter-Studi/ArticleStandard/Article/detail/632189?contextCategoryId=435&ref=25 Diminutive bacteria with the right geometry (i.e. very thin) may be useful for research and development work on sterilizing-grade and other 0.2 uM filters, said Kurt Brorson, PhD, a staff scientist for the FDA/CDER's Division of Monoclonal Antibodies. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632189null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Florida-Biologix-Enters-Manufacturing-Agreement-wi/ArticleStandard/Article/detail/632219?contextCategoryId=435&ref=25 Florida Biologix (Alachua, FL) has signed a development and manufacturing contract with America Stem Cell (Helotes, TX) for a Phase 1 cell therapy product, ASC-101. ASC-101 is a human recombinant enzyme technology that increases the efficiency of engraftment in transplantation of cord blood derived stem cells. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632219null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Baxter-Receives-EMEA-Marketing-Authorization-for-C/ArticleStandard/Article/detail/632208?contextCategoryId=435&ref=25 Baxter International Inc. (Deerfield, IL) has been granted marketing authorization for Celvapan H1N1 pandemic vaccine using Baxter's Vero cell technology by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632208null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/GSKs-Adjuvanted-Cervical-Cancer-Vaccine-Receives-F/ArticleStandard/Article/detail/632197?contextCategoryId=435&ref=25 The US Food and Drug Administration?s Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix, GlaxoSmithKline?s (GSK, Middlesex, UK) candidate cervical cancer vaccine. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632197null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/New-USP-Standards-for-Heparin-Includes-New-Identit/ArticleStandard/Article/detail/632194?contextCategoryId=435&ref=25 New heparin standards recently adopted by the United States Pharmacopeia (USP) include new tests to ensure the quality of the drug. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632194null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Laureate-Pharma-to-Manufacture-Neoprobes-MAb-Produ/ArticleStandard/Article/detail/632220?contextCategoryId=435&ref=25 Neoprobe Corporation (Dublin, OH) and Laureate Pharma, Inc. (Princeton, NJ) have entered into a Biopharmaceutical Development and Manufacturing Agreement. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632220null HTML http://biopharminternational.findpharma.com/biopharm/News/InVitria-Launches-Animal-Origin-Free-Transferrin/ArticleStandard/Article/detail/627496?contextCategoryId=435&ref=25 Colorado-based InVitria, a division of the biopharmaceutical company Ventria Bioscience, has launched an animal-free recombinant transferrin for use in mammalian cell culture. 2009-09-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/627496null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-H1N1-Flu-Vaccines-Produced-in-Eggs/ArticleStandard/Article/detail/626935?contextCategoryId=435&ref=25 The US Food and Drug Administration announced yesterday that it has approved four vaccines against the 2009(A)H1N1 (?swine?) influenza virus. 2009-09-16T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/626935null HTML http://biopharminternational.findpharma.com/biopharm/News/Lonza-Building-Cell-Therapy-Facility-in-Singapore/ArticleStandard/Article/detail/625957?contextCategoryId=435&ref=25 Lonza (Basel, Switzerland), broke ground earlier this week on a new cell therapy manufacturing facility in Tuas Biomedical Park, Singapore, adjacent to Lonza?s large-scale mammalian manufacturing facility. 2009-09-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/625957null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Grants-Orphan-Status-to-Protalixs-Gaucher-Dise/ArticleStandard/Article/detail/625455?contextCategoryId=435&ref=25 Protalix BioTherapeutics, Inc. (Carmiel, Israel) gained orphan drug status from the US FDA for prGCD, a development drug for Gaucher?s disease, on September 9. The orphan drug designation for prGCD was granted by the FDA?s Office of Orphan Products Development and comes less than a month after the drug received fast-track designation from the FDA. 2009-09-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/625455null HTML http://biopharminternational.findpharma.com/biopharm/News/Shire-Completes-NDA-for-Gauchers-Disease-Treatment/ArticleStandard/Article/detail/624341?contextCategoryId=435&ref=25 Shire plc (Cambridge, MA) has completed its submission of a new drug application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the US Food and Drug Administration. 2009-09-04T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/362009/624341null HTML http://biopharminternational.findpharma.com/biopharm/News/Novavax-Achieves-Good-Results-for-Vaccines-Against/ArticleStandard/Article/detail/623742?contextCategoryId=435&ref=25 Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu. 2009-09-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/362009/623742null HTML http://biopharminternational.findpharma.com/biopharm/News/Pfizer-Unveils-214-Million-Biotech-Facility-in-Swe/ArticleStandard/Article/detail/622127?contextCategoryId=435&ref=25 Pharmaceutical giant Pfizer, Inc., (New York, NY) has opened a new 64,600-square-foot biotech plant in Strangnas, Sweden. 2009-08-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352009/622127null HTML http://biopharminternational.findpharma.com/biopharm/News/GSK-and-Fiocruz-Join-for-RampD-and-Greater-Vaccine/ArticleStandard/Article/detail/621740?contextCategoryId=435&ref=25 GlaxoSmithKline has partnered with Brazil?s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health problems in Brazil. 2009-08-26T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352009/621740null HTML http://biopharminternational.findpharma.com/biopharm/News/Protalix-Receives-Fast-Track-Designation-for-Gauch/ArticleStandard/Article/detail/621782?contextCategoryId=435&ref=25 Protalix BioTherapeutics received "fast track" designation from the US FDA yesterday for prGCD, a development drug for Gaucher's disease. 2009-08-26T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352009/621782null HTML http://biopharminternational.findpharma.com/biopharm/News/Accelerated-Approval-of-GSKs-Hiberix-Boosts-Vaccin/ArticleStandard/Article/detail/620781?contextCategoryId=435&ref=25 London-based GlaxoSmithKline?s Hiberix, a haemophilus influenzae Type b (Hib) vaccine, was approved by the US Food and Drug Administration. 2009-08-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342009/620781null HTML http://biopharminternational.findpharma.com/biopharm/News/Gaucher-Patients-Can-Be-Treated-with-Protalixs-Dru/ArticleStandard/Article/detail/620549?contextCategoryId=435&ref=25 Protalix BioTherapeutics received approval from the US FDA on August 17 to proceed with its treatment protocol for prGCD, a development drug for Gaucher's disease. 2009-08-20T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342009/620549null HTML http://biopharminternational.findpharma.com/biopharm/News/Vaccine-Manufactured-in-Tobacco-Plants/ArticleStandard/Article/detail/620635?contextCategoryId=435&ref=25 A new vaccine for norovirus has been produced in tobacco plants, a scientist reported on August 18 at the national meeting of the American Chemical Society in Washington DC. 2009-08-20T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342009/620635null HTML http://biopharminternational.findpharma.com/biopharm/News/ImmuneRegen-Confirms-Homsperas-Anti-Influenza-Effe/ArticleStandard/Article/detail/618438?contextCategoryId=435&ref=25 Preliminary evidence has shown that ImmuneRegen BioSciences' selective Neurokinin 1-receptor agonist Homspera is active on oral administration and provides therapeutic effects against the current pandemic H1N1 virus infection. 2009-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332009/618438null HTML http://biopharminternational.findpharma.com/biopharm/News/Baxter-Completes-Production-of-First-Commercial-Ba/ArticleStandard/Article/detail/618437?contextCategoryId=435&ref=25 Baxter International, Inc. has completed production of its first commercial batches of Celvapan A/H1N1 pandemic vaccine in late July and is discussing plans for distribution with national health authorities, subject to obtaining appropriate authorizations. 2009-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332009/618437null HTML http://biopharminternational.findpharma.com/biopharm/News/Debiopharm-and-MSM-to-Collaborate-on-Novel-Oncolog/ArticleStandard/Article/detail/618415?contextCategoryId=435&ref=25 Debiopharm Group (Lausanne, Switzerland) and MSM Protein Technologies (MSM, Boston, MA) have entered into an exclusive agreement for the development and commercialization of Debio 0929, an antibody targeting a G protein-coupled receptor (GPCR), to be developed into a new oncology therapeutic drug. 2009-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332009/618415null HTML http://biopharminternational.findpharma.com/biopharm/News/Millipore-Sues-WL-Gore-amp-Associates-for-Patent-I/ArticleStandard/Article/detail/618417?contextCategoryId=435&ref=25 Millipore Corporation (Billerica, MA) has filed a lawsuit in the US District Court for the District of Massachusetts against W.L. Gore & Associates for infringement of Millipore's patent rights under US Patent No. 7,293,477, "Disposable, Pre-Sterilized Fluid Receptacle Sampling Device." 2009-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332009/618417null HTML http://biopharminternational.findpharma.com/biopharm/News/Amgen-and-GSK-to-Commercialize-Denosumab-in-Europe/ArticleStandard/Article/detail/618418?contextCategoryId=435&ref=25 Amgen (Thousand Oaks, CA) and GlaxoSmithKline (GSK, London, UK) will share commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand, and Mexico once the product is approved in these countries. 2009-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332009/618418null HTML http://biopharminternational.findpharma.com/biopharm/News/SAFC-Develops-First-Chemically-Defined-Hydrolysate/ArticleStandard/Article/detail/618416?contextCategoryId=435&ref=25 SAFC Biosciences (St. Louis, MO) has developed a chemically defined cell culture supplement based on the characterization of hydrolysate components proven to provide cell growth and protein production capabilities equivalent to traditional undefined hydrolysate raw materials. 2009-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332009/618416null HTML http://biopharminternational.findpharma.com/biopharm/News/Six-Steps-to-Improve-FDA-Enforcement/ArticleStandard/Article/detail/618412?contextCategoryId=435&ref=25 FDA Acting Commissioner Margaret Hamburg outlined six steps to improve FDA enforcement in a speech given on August 6, eight weeks into her tenure. 2009-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332009/618412null HTML http://biopharminternational.findpharma.com/biopharm/News/ImmunoVaccine-Technologies-Partners-with-Scancell-/ArticleStandard/Article/detail/618436?contextCategoryId=435&ref=25 ImmunoVaccine Technologies, Inc. (IVT) has formed a research agreement with Scancell, Ltd. to explore the potential of using IVT's DepoVax delivery system for Scancell's ImmunoBody DNA vaccines. 2009-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332009/618436null HTML http://biopharminternational.findpharma.com/biopharm/News/Quality-Risk-Management-Demystified-at-CMC-Strateg/ArticleStandard/Article/detail/618433?contextCategoryId=435&ref=25 The prospect of conducting risk assessments, as part of the quality risk management strategy promoted by the International Conference on Harmonization (ICH) Q9 guideline, tends to evoke blank stares and confusion. It also prompts many questions: Which of the many tools-PHA, HACCP, FMEA, etc.-should we use? 2009-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332009/618433null HTML http://biopharminternational.findpharma.com/biopharm/News/Sartorius-Stedim-and-SAFC-Collaborate-to-Combine-U/ArticleStandard/Article/detail/617145?contextCategoryId=435&ref=25 Sartorius Stedim Biotech (Goettingen, Germany) and SAFC Biosciences (St. Louis, MO), a division of SAFC, have entered into a partnership to share expertise, support each other in developing custom solutions for customers, and generate data on the performance of equipment in different applications. 2009-08-06T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/322009/617145null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-Avastin-for-the-Most-Common-Type-of-K/ArticleStandard/Article/detail/616493?contextCategoryId=435&ref=25 The US FDA has approved Genentech's Avastin (bevacizumab) plus interferon-alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer. 2009-08-04T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/322009/616493null HTML http://biopharminternational.findpharma.com/biopharm/News/House-Committee-Supports-12-Year-Data-Exclusivity-/ArticleStandard/Article/detail/616167?contextCategoryId=435&ref=25 The House Energy and Commerce Committee approved a legislative amendment that would give 12-years data exclusivity to innovator biologics. The amendment was introduced by Reps. Anna Eshoo (D-CA) and Jay Inslee (D-DC). 2009-08-03T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/322009/616167null HTML http://biopharminternational.findpharma.com/biopharm/News/Sanofi-to-Acquire-Shantha-for-784-Million/ArticleStandard/Article/detail/614023?contextCategoryId=435&ref=25 French drug manufacturer Sanofi Aventis will purchase the Indian vaccine company Shantha Biotechnics for $784 million. 2009-07-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312009/614023null HTML http://biopharminternational.findpharma.com/biopharm/News/Bristol-Myers-Squibb-Buys-Medarex-for-24-billion/ArticleStandard/Article/detail/613502?contextCategoryId=435&ref=25 In an effort to boost its biologics pipeline, Bristol-Myers Squibb (BMS, New York, NY) will acquire Medarex (Princeton, NJ) for approximately $2.4 billion. 2009-07-23T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/302009/613502null HTML http://biopharminternational.findpharma.com/biopharm/News/Wyeth-Recalls-One-Lot-of-Prevnar/ArticleStandard/Article/detail/612125?contextCategoryId=435&ref=25 Wyeth has voluntarily recalled one lot of single-dose prefilled syringes of Prevnar, the company?s pneumococcal 7-valent conjugate vaccine. 2009-07-17T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/292009/612125null HTML http://biopharminternational.findpharma.com/biopharm/News/Senate-Committee-Approves-Healthcare-Bill-with-12-/ArticleStandard/Article/detail/611806?contextCategoryId=435&ref=25 The Senate?s Health, Education, Labor, and Pensions Committee yesterday passed The Affordable Health Choices Act, the committee?s healthcare reform legislation that gives 12 years of data exclusivity to innovator biologics. The committee had adopted the 12-year data protection amendment to the healthcare legislation on Monday. 2009-07-16T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/292009/611806null HTML http://biopharminternational.findpharma.com/biopharm/News/Pink-Slips-for-Genentechs-Bay-Area-Employees/ArticleStandard/Article/detail/610494?contextCategoryId=435&ref=25 When Roche bought Genentech in March, layoffs were expected, and now the company has begun downsizing at Genentech?s South San Francisco headquarters. 2009-07-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/292009/610494null HTML http://biopharminternational.findpharma.com/biopharm/News/Three-Shared-Audit-Models-Tested-at-Rx-360-Consort/ArticleStandard/Article/detail/610076?contextCategoryId=435&ref=25 The newly formed Rx-360 consortium, an international consortium developed by members of the pharmaceutical and biotech industries aimed at improving global supply chain security, had an impressive turnout of over 125 people at its launch meeting in Washington, DC, on June 5. The objective of the launch meeting was to increase awareness, solicit membership, and pressure-test shared audit models. 2009-07-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610076null HTML http://biopharminternational.findpharma.com/biopharm/News/Biotechs-Consider-Sites-Outside-the-Industry-Hubs/ArticleStandard/Article/detail/610091?contextCategoryId=435&ref=25 These are dismal times for anyone wishing to start a biotech company. The US economy and stock market are in the tank, and venture capital is tight. At least 100 of the publicly traded biotechs this year will fail or be taken over. So why would a entrepreneur want to further disadvantage himself by locating his company miles away from traditional biotech hubs like San Diego, Boston, and Rockville? 2009-07-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610091null HTML http://biopharminternational.findpharma.com/biopharm/News/OctoPlus-Opens-New-GMP-Manufacturing-Facility/ArticleStandard/Article/detail/610085?contextCategoryId=435&ref=25 Netherlands-based biopharmaceutical company OctoPlus N.V. has started pharmaceutical production in its new manufacturing facility in Leiden. The facility has received a license from the Dutch authorities to manufacture pharmaceutical products according to international good manufacturing practice (GMP) guidelines. 2009-07-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610085null HTML http://biopharminternational.findpharma.com/biopharm/News/Prolor-Biotech-Receives-Patents-for-Longer-Acting-/ArticleStandard/Article/detail/610088?contextCategoryId=435&ref=25 Prolor Biotech, Inc. (Nes-Ziona, Israel), formerly Modigene, Inc., has been issued two new patents from the US Patent and Trademark Office for the company's long-acting CTP-enhanced human growth hormone (hGH-CTP) and human erythropoietin (EPO-CTP). The patents cover the composition of Prolor's proprietary pharmaceutical compounds and certain associated methods. 2009-07-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610088null HTML http://biopharminternational.findpharma.com/biopharm/News/BIO-Seeking-to-Round-Up-Support-for-12-Years-Data-/ArticleStandard/Article/detail/610175?contextCategoryId=435&ref=25 In advance of the Senate Health, Education, Labor, and Pensions Committee?s meeting to be held on Friday to consider amendments to the healthcare reform bill, including several amendments related to biosimilars, Biotechnology Industry Organization?s (BIO) President and CEO Jim Greenwood reaffirmed BIO?s support for a 12-year data exclusivity period for biologics. 2009-07-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610175null HTML http://biopharminternational.findpharma.com/biopharm/News/Protalixs-Gaucher-Drug-May-Fill-Gap-Left-from-Genz/ArticleStandard/Article/detail/610072?contextCategoryId=435&ref=25 Protalix BioTherapeutics (Carmiel, Israel) said the US Food and Drug Administration has asked the company to consider submitting a treatment protocol for the use of prGCD, the company's development drug for patients with Gaucher disease, to address an expected shortage of Genzyme's Cerezyme. Genzyme recently halted production of Cerezyme to sanitize its plant in Allston Landing, MA, because of virus contamination of a bioreactor. 2009-07-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610072null HTML http://biopharminternational.findpharma.com/biopharm/News/Vetter-Installs-Six-Automatic-Packaging-Lines-at-i/ArticleStandard/Article/detail/610081?contextCategoryId=435&ref=25 Vetter Pharma International (Ravensburg, Germany), a provider of aseptically pre-filled injection systems, has completed the installation of six automatic packaging lines at Vetter Secondary Packaging (VSP), the company's new packaging services facility. 2009-07-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610081null HTML http://biopharminternational.findpharma.com/biopharm/News/Biogen-Idec-and-Acorda-to-Develop-and-Commercializ/ArticleStandard/Article/detail/610069?contextCategoryId=435&ref=25 Biogen Idec (Cambridge, MA) and Acorda Therapeutics, Inc. (Hawthorne, NY) have entered into an exclusive collaboration and license agreement to develop and commercialize Fampridine-SR, a multiple sclerosis (MS) therapy, in markets outside the United States. Fampridine-SR is a novel, oral sustained-release compound being developed to improve walking ability in people with MS. The companies also have entered into a related supply agreement. The transaction represents a sublicensing of an existing license agreement between Acorda and Elan Pharma International Limited, a subsidiary of Elan Corporation plc (Dublin, Ireland). 2009-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610069null HTML http://biopharminternational.findpharma.com/biopharm/News/Crucell-Purchases-Xcellerex-Bioproduction-Line-for/ArticleStandard/Article/detail/610067?contextCategoryId=435&ref=25 Crucell N.V. (Leiden, the Netherlands) is acquiring a FlexFactory bioproduction line and multiple XDR single-use bioreactors from Xcellerex, Inc. (Marlborough, MA) to expand the capacity and flexibility of its manufacturing capabilities. The project will deliver validated clinical manufacturing capacity at Crucell?s operations during the first quarter of 2010, enabling Crucell to commence production years faster than with conventional technologies. 2009-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610067null HTML http://biopharminternational.findpharma.com/biopharm/News/Companies-Race-to-Apply-Cell-Culture-to-Swine-Flu-/ArticleStandard/Article/detail/610102?contextCategoryId=435&ref=25 Although mammalian cell culture is the standard production platform for recombinant protein products and monoclonal antibodies, its adoption for influenza vaccine production has been slow, and all currently approved seasonal influenza vaccines are still produced in eggs. The current outbreak of the H1N1 swine flu, however, has renewed and accelerated interest in applying cell culture to influenza vaccine production. 2009-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610102null HTML http://biopharminternational.findpharma.com/biopharm/News/Novasep-Acquires-Bioprocess-Development-Specialist/ArticleStandard/Article/detail/610068?contextCategoryId=435&ref=25 Novasep (Pompey, France), a producer of active pharmaceutical ingredients (APIs) and purification technologies for the life sciences industry, has acquired Henogen (Charleroi, Belgium), a contract manufacturing organization (CMO) offering bioprocess development and manufacturing services from the cell bank to the supply of clinical products. The move adds a complementary range of upstream processing capabilities and services to Novasep's downstream processing offering. Financial terms of the transaction were not disclosed. 2009-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610068null HTML http://biopharminternational.findpharma.com/biopharm/News/Novavax-Licenses-VLP-Vaccine-Technology-to-Spanish/ArticleStandard/Article/detail/610098?contextCategoryId=435&ref=25 Novavax (Rockville, MD) has entered into an initial agreement to license its virus-like particle (VLP) vaccine technology to Madrid-based ROVI Pharmaceuticals. Under a 60-million euro program sponsored by the Spanish Ministry of Health and other government agencies, ROVI will use the VLP technology to create a comprehensive influenza vaccine solution for the Spanish government, including an in-border vaccine manufacturing facility. 2009-07-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282009/610098null HTML http://biopharminternational.findpharma.com/biopharm/News/Genzyme-Recalls-Fabrazyme-5-mg/ArticleStandard/Article/detail/607536?contextCategoryId=435&ref=25 Genzyme has voluntarily recalled all remaining stock of Fabrazyme 5 mg (agalsidase beta), with batch numbers A8049H04 and A8060H01. 2009-06-30T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272009/607536null HTML http://biopharminternational.findpharma.com/biopharm/News/OctoPlus-Opens-New-GMP-Manufacturing-Facility/ArticleStandard/Article/detail/606148?contextCategoryId=435&ref=25 OctoPlus has started production in its new manufacturing facility in Leiden. 2009-06-24T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262009/606148null HTML http://biopharminternational.findpharma.com/biopharm/News/Vetter-Installs-Six-Automatic-Packaging-Lines-at-i/ArticleStandard/Article/detail/605103?contextCategoryId=435&ref=25 Vetter Pharma International (Ravensburg, Germany) has completed the installation of six automatic packaging lines at Vetter Secondary Packaging (VSP), the company?s new packaging services facility. 2009-06-19T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/605103null HTML http://biopharminternational.findpharma.com/biopharm/News/Three-Shared-Audit-Models-Tested-at-Rx-360-Consort/ArticleStandard/Article/detail/604363?contextCategoryId=435&ref=25 The newly formed Rx-360 consortium had an impressive turnout of over 125 people at its launch meeting in Washington, DC, on June 5. 2009-06-17T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/604363null HTML http://biopharminternational.findpharma.com/biopharm/News/Genzyme-Detects-Virus-Contamination-of-Bioreactor-/ArticleStandard/Article/detail/604361?contextCategoryId=435&ref=25 Genzyme Corporation has halted production at its manufacturing plant in Allston Landing, MA, because it has detected a virus that impairs cell growth in one of the six bioreactors there. 2009-06-17T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/604361null HTML http://biopharminternational.findpharma.com/biopharm/News/14-Years-of-Market-Exclusivity-Unnecessary-says-FT/ArticleStandard/Article/detail/603355?contextCategoryId=435&ref=25 A new report by FTC, entitled ?Follow-on Biologic Drug Competition,? examines whether the price of biologics is likely to be reduced by competition from FOBs. 2009-06-16T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/603355null HTML http://biopharminternational.findpharma.com/biopharm/News/ImmunoVaccine-Technologies-Partners-with-FIT-Biote/ArticleStandard/Article/detail/602918?contextCategoryId=435&ref=25 ImmunoVaccine Technologies, Inc. (IVT, Halifax, Nova Scotia), a vaccine development company, has formed a research partnership with FIT Biotech (Tampere, Finland), a clinical stage company that develops DNA vaccines. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602918null HTML http://biopharminternational.findpharma.com/biopharm/News/Emerson-Wins-Lonza-Automation-Contract-for-Biophar/ArticleStandard/Article/detail/602923?contextCategoryId=435&ref=25 Emerson Process Management (Austin, TX) has been selected by Lonza Group, Ltd. (Basel, Switzerland) to provide engineering and design services, and digital automation architecture and control technologies for a new Lonza biopharmaceutical plant in Singapore. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602923null HTML http://biopharminternational.findpharma.com/biopharm/News/AFFiRiS-AGs-Atherosclerosis-Vaccine-Development-Re/ArticleStandard/Article/detail/602917?contextCategoryId=435&ref=25 The atherosclerosis vaccine development program by AFFiRiS AG (Vienna, Austria) is receiving financial support from the EU?s EuroTrans-Bio call. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602917null HTML http://biopharminternational.findpharma.com/biopharm/News/SAFC-Pharmas-St-Louis-HPAPI-Conjugates-Facility-Re/ArticleStandard/Article/detail/602913?contextCategoryId=435&ref=25 SAFC Pharma (St. Louis, MO) has received certification by SafeBridge Consultants, Inc., for the safe handling of potent drug substances of its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite, located in St. Louis, MO. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602913null HTML http://biopharminternational.findpharma.com/biopharm/News/Emisphere-Technologies-and-AAIPharma-to-Expand-Use/ArticleStandard/Article/detail/602931?contextCategoryId=435&ref=25 Emisphere Technologies, Inc. (Cedar Knolls, NJ), a biopharmaceutical company that focuses on delivery of therapeutic molecules using its Eligen Technology, and AAIPharma, Inc. (Wilmington, NC), have formed a strategic alliance intended to expand the application of Emisphere' s Eligen Technology and AAIPharma's drug development services. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602931null HTML http://biopharminternational.findpharma.com/biopharm/News/SAFC-and-Cherokee-Pharmaceuticals-Pool-Expertise-a/ArticleStandard/Article/detail/602933?contextCategoryId=435&ref=25 SAFC (St. Louis, MO), a member of the Sigma-Aldrich group, and Cherokee Pharmaceuticals (Riverside, PA), have formed an exclusive strategic partnership that encompasses the sourcing, analytical testing, warehousing, packaging, and distribution of large-scale raw materials for pharmaceutical manufacturing meeting cGMP quality standards. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602933null HTML http://biopharminternational.findpharma.com/biopharm/News/BioPharm-Editor-in-Chief-Laura-Bush-Joins-Interphe/ArticleStandard/Article/detail/602892?contextCategoryId=435&ref=25 Laura Bush, editor in chief of BioPharm International, has joined the 2010 Interphex Conference Advisory Board. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602892null HTML http://biopharminternational.findpharma.com/biopharm/News/Europe-Australia-and-US-Enter-Regulatory-Informati/ArticleStandard/Article/detail/602890?contextCategoryId=435&ref=25 The European Directorate for Quality of Medicines & HealthCare (EDQM) has established bilateral confidentiality agreements with the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA), respectively, to share non-public information regarding inspections of active pharmaceutical ingredients (API) and excipients manufacturers. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602890null HTML http://biopharminternational.findpharma.com/biopharm/News/HHS-Awards-MedImmune-Contract-to-Manufacture-Live-/ArticleStandard/Article/detail/602916?contextCategoryId=435&ref=25 MedImmune (Gaithersburg, MD) has been awarded a US Department of Health and Human Services (HHS) contract to manufacture monovalent (single-strain) live attenuated influenza vaccine for Novel Influenza A (H1N1) to vaccinate priority populations identified by HHS in the National Strategy for Pandemic Influenza. An initial order of $90 million of vaccine has been placed, with the potential for additional orders. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602916null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Makes-Mixed-Progress-on-IT-Improvement/ArticleStandard/Article/detail/602889?contextCategoryId=435&ref=25 The US Food and Drug Administration has made "mixed progress" in information technology (IT) modernization, according to findings from the Government Accountability Office (GAO). 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602889null HTML http://biopharminternational.findpharma.com/biopharm/News/Louisiana-Biotech-Firm-Explores-the-Potential-of-A/ArticleStandard/Article/detail/602899?contextCategoryId=435&ref=25 Nupotential, a small Louisiana biotechnology firm, believes it may have an answer to the ethical concerns and technological challenges involved in turning stem cells into medical therapies. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602899null HTML http://biopharminternational.findpharma.com/biopharm/News/Louisiana-Biotech-Firm-Explores-the-Potential-of-A/ArticleStandard/Article/detail/601973?contextCategoryId=435&ref=25 Nupotential, a small Louisiana biotechnology firm, believes it may have an answer to the ethical concerns and technological challenges involved in turning stem cells into medical therapies. 2009-06-05T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601973null HTML http://biopharminternational.findpharma.com/biopharm/News/New-Legislation-to-Boost-FDAs-Inspection-and-Enfor/ArticleStandard/Article/detail/597954?contextCategoryId=435&ref=25 On April 24, Senators Charles Grassley (R-IA) and Edward Kennedy (D-MA) introduced The Drug and Device Accountability Act of 2009, which would give the FDA more resources for conducting foreign drug plant inspections and the power to issue subpoenas. 2009-05-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597954null HTML http://biopharminternational.findpharma.com/biopharm/News/ImmunoVaccine-Technologies-to-Help-Strengthen-Cana/ArticleStandard/Article/detail/597961?contextCategoryId=435&ref=25 ImmunoVaccine Technologies, Inc. (IVT, Halifax, Nova Scotia), a vaccine development company, has signed a three-year research agreement with Defence Research and Development Canada (DRDC). 2009-05-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597961null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Authorizes-Emergency-Use-of-Tamiflu-and-Relenz/ArticleStandard/Article/detail/597960?contextCategoryId=435&ref=25 In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration has authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597960null HTML http://biopharminternational.findpharma.com/biopharm/News/Manufacturing-Issues-Cause-Surfaxins-Fourth-Failur/ArticleStandard/Article/detail/597956?contextCategoryId=435&ref=25 In its latest setback, Discovery Labs (Warrington, PA) has failed to receive FDA approval for the fourth time for Surfaxin (lucinactant). 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597956null HTML http://biopharminternational.findpharma.com/biopharm/News/New-Coalition-Aims-to-Improve-Pharmaceutical-Suppl/ArticleStandard/Article/detail/597952?contextCategoryId=435&ref=25 Members of the pharmaceutical and biotech industries have formed a new industry coalition, called "Rx-360," with the goal of improving supply chain safety. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597952null HTML http://biopharminternational.findpharma.com/biopharm/News/Millipore-and-Microbix-to-Develop-a-Novel-Purifica/ArticleStandard/Article/detail/597966?contextCategoryId=435&ref=25 Millipore Corporation (Billerica, MA) and Microbix Biosystems, Inc. (Toronto, Canada), have formed a collaboration to develop a novel purification process for influenza virus vaccine manufacturing. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597966null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Researchers-Contribute-Insights-into-Avian-Flu/ArticleStandard/Article/detail/597963?contextCategoryId=435&ref=25 An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597963null HTML http://biopharminternational.findpharma.com/biopharm/News/Merck-Secures-Rights-to-Two-Novel-Monoclonal-Antib/ArticleStandard/Article/detail/597964?contextCategoryId=435&ref=25 Merck & Co., Inc. (Whitehouse Station, NJ), Medarex, Inc. (Princeton, NJ), and Massachusetts Biologic Laboratories (MBL, Jamaica Plain, MA) of the University of Massachusetts Medical School (UMMS) have signed an exclusive worldwide license agreement for CDA-1 and CDB-1. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597964null HTML http://biopharminternational.findpharma.com/biopharm/News/Small-Vaccine-Company-Ready-to-Play-its-Part-in-Re/ArticleStandard/Article/detail/596504?contextCategoryId=435&ref=25 The current outbreak of the H1N1 influenza strain is exactly the kind of situation the vaccine company Novavax (Rockville, MD) has been preparing for over the last three years. 2009-05-04T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192009/596504null HTML http://biopharminternational.findpharma.com/biopharm/News/Novozymes-Recombinant-Human-Albumins-Comply-with-N/ArticleStandard/Article/detail/596096?contextCategoryId=435&ref=25 A new excipient monograph standard for recombinant human albumin (HSA) became official in the United States Pharmacopeia-National Formulary (USP-NF) today, and Novozymes Biopharma (Nottingham, UK) says that its "Recombumin" and "Albucult" products are the first to comply with the new standard. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596096null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Authorizes-Emergency-Use-of-Tamiflu-Relenza-to/ArticleStandard/Article/detail/595276?contextCategoryId=435&ref=25 In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration yesterday authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu. 2009-04-28T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/595276null HTML http://biopharminternational.findpharma.com/biopharm/News/JampJs-Once-Monthly-Simponi-Approved-for-Three-Rhe/ArticleStandard/Article/detail/595236?contextCategoryId=435&ref=25 Centocor Ortho Biotech (Horsham, PA), a subsidiary of Johnson & Johnson, received approval from the US Food and Drug Administration on April 24 for Simponi (golimumbad), a monthly treatment for moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. 2009-04-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/595236null HTML http://biopharminternational.findpharma.com/biopharm/News/Novavax-Forms-Strategic-Alliance-with-Cadila-Pharm/ArticleStandard/Article/detail/592300?contextCategoryId=435&ref=25 Novavax, Inc. (Rockville, MD), has formed a joint venture with Cadila Pharmaceuticals, Ltd. (Ahmedabad, India), to develop, manufacture, and market vaccines, pharmaceuticals, and diagnostic products in India. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592300null HTML http://biopharminternational.findpharma.com/biopharm/News/Roche-Acquires-Innovatis-AG-for-its-Product-Portfo/ArticleStandard/Article/detail/592312?contextCategoryId=435&ref=25 Roche (Basel, Switzerland) will acquire 100% of Innovatis, AG (Bielefeld, Germany). 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592312null HTML http://biopharminternational.findpharma.com/biopharm/News/QbD-Case-Study-Will-Push-Limits/ArticleStandard/Article/detail/592288?contextCategoryId=435&ref=25 When the final version of the Quality by Design (QbD) case study is made public this summer, it will be an aspirational document, says Ken Seamon, PhD, one of the project?s facilitators. "If the regulatory authorities read our final document and said 'yes, this is all fine,' we will have failed," he said. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592288null HTML http://biopharminternational.findpharma.com/biopharm/News/Novozymes-Biopharma-Joins-with-GE-Healthcare-to-Pr/ArticleStandard/Article/detail/592310?contextCategoryId=435&ref=25 Novozymes Biopharma UK Ltd. (Nottingham, UK) has signed a license agreement with GE Healthcare Life Sciences (Chalfont St. Giles, UK), which enables Novozymes Biopharma to produce and deliver native, animal-free Protein A using GE Healthcare technology. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592310null HTML http://biopharminternational.findpharma.com/biopharm/News/Covance-Receives-cGMP-Manufacturing-License/ArticleStandard/Article/detail/592297?contextCategoryId=435&ref=25 Covance Inc. (Princeton, NJ) has completed an additional 8,000-sq. ft. to its biotechnology services facility in Harrogate, UK. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592297null HTML