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.
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).
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.
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.
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).
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.
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.
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.
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.
Roche (Basel, Switzerland) will acquire 100% of Innovatis, AG (Bielefeld, Germany).
Covance Inc. (Princeton, NJ) has completed an additional 8,000-sq. ft. to its biotechnology services facility in Harrogate, UK.
SAFC Biosciences (Lenexa, KS) has completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, KS to animal component free (ACF) status. This is the first of several similar conversions planned by SAFC Biosciences to support growing customer requirements for ACF manufacturing.
The US Food and Drug Administration has released a new draft guidance on somatic cell therapies that are designed to advance the treatment of heart disease through the regeneration of cardiac tissues.
ImClone Systems, Inc. (Branchburg, NJ), and Bristol-Myers Squibb (BMS, New York, NY) voluntarily recalled 13 lots of their cancer drug Erbitux (cetuximab) after a report from a doctor?s office about a leaking cap on a vial of the biologic.
