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.
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.
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).
Single-use technologies can be configured and installed fairly quickly, but are they ready to handle the urgency and scale of a pandemic?
French drug manufacturer Sanofi Aventis will purchase the Indian vaccine company Shantha Biotechnics for $784 million.
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.
Wyeth has voluntarily recalled one lot of single-dose prefilled syringes of Prevnar, the company?s pneumococcal 7-valent conjugate vaccine.
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.
When Roche bought Genentech in March, layoffs were expected, and now the company has begun downsizing at Genentech?s South San Francisco headquarters.
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.
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.
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.
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?
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.
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.
