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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.

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.

FDA Acting Commissioner Margaret Hamburg outlined six steps to improve FDA enforcement in a speech given on August 6, eight weeks into her tenure.

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.

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?

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."

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.

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.

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.

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).