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.
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.
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.
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.
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.
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.
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).
Genzyme has voluntarily recalled all remaining stock of Fabrazyme 5 mg (agalsidase beta), with batch numbers A8049H04 and A8060H01.
OctoPlus has started production in its new manufacturing facility in Leiden.
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.
The newly formed Rx-360 consortium had an impressive turnout of over 125 people at its launch meeting in Washington, DC, on June 5.
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.
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.
The atherosclerosis vaccine development program by AFFiRiS AG (Vienna, Austria) is receiving financial support from the EU?s EuroTrans-Bio call.
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.
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.
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.
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.
The US Food and Drug Administration has made "mixed progress" in information technology (IT) modernization, according to findings from the Government Accountability Office (GAO).
Laura Bush, editor in chief of BioPharm International, has joined the 2010 Interphex Conference Advisory Board.
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.
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.
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.
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.
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.
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.
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).
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.
In its latest setback, Discovery Labs (Warrington, PA) has failed to receive FDA approval for the fourth time for Surfaxin (lucinactant).
