All
Debiopharm and MSM to Collaborate on Novel Oncology Biologic
August 12th 2009Debiopharm 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.
Sartorius Stedim and SAFC Collaborate to Combine Upstream and Downstream Expertise
August 6th 2009Sartorius 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.
House Committee Supports 12-Year Data Exclusivity Period for Biologics
August 3rd 2009The 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).
Senate Committee Approves Healthcare Bill with 12-Year Data Exclusivity for Innovator Biologics
July 16th 2009The 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.
Prolor Biotech Receives Patents for Longer-Acting hGH and EPO
July 10th 2009Prolor 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.
OctoPlus Opens New GMP Manufacturing Facility
July 10th 2009Netherlands-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.
Vetter Installs Six Automatic Packaging Lines at its New Facility
July 10th 2009Vetter 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.
Biotechs Consider Sites Outside the Industry Hubs
July 10th 2009These 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?
Three Shared Audit Models Tested at Rx-360 Consortium's Launch Meeting
July 10th 2009The 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.
Protalix's Gaucher Drug May Fill Gap Left from Genzyme Plant Closure
July 10th 2009Protalix 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.
BIO Seeking to Round Up Support for 12-Years Data Exclusivity
July 10th 2009In 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.
Novasep Acquires Bioprocess Development Specialist Henogen
July 9th 2009Novasep (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.
Novavax Licenses VLP Vaccine Technology to Spanish Company ROVI
July 9th 2009Novavax (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.
Companies Race to Apply Cell Culture to Swine Flu Vaccines
July 9th 2009Although 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.
Crucell Purchases Xcellerex Bioproduction Line for Vaccine, MAb Manufacturing Facility
July 9th 2009Crucell 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.