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This issue focuses on antibody engineering and manufacturing. The stylized image of antibodies is by Jacque Deshaies and is entitled "Deshaies 99—Antibody #1 to #4" (original 4: 28 x 36 cm, acrylic on paper) http://www.JacquesDeshaies.com
While the FDA waits for someone to come up with a plan to improve the accelerated approval program, some argue that as it is, drugs are not getting to the people who need them.
As new drug approval rates drop in Europe compared to the US, the EU Commission plans to spur innovation by doubling financial support for the biotech industry.
Mexico's genomic researchers believe a mestizo “hapmap” might reveal a genetic basis for some of the nation's health problems, although they are mindful of the potential for the misuse of personal genetic information.
The Indian biotechnology industry is trying to get beyond being a service industry, but the cost of materials and of getting regulatory approval could confound such efforts.
Seizing upon a favorable business climate in Europe, US businesswoman Lisa Drakeman has blended goal-oriented American culture with a European focus on team effort to move her firm's antibodies closer to the market.
Industry hopes to build on recent successes of monoclonal antibodies in oncology and inflammatory disease. But evidence is mounting that the exquisite selectivity and binding capacity of these therapeutics can have unwanted side effects, particularly in autoimmune disease. Christopher Thomas Scott investigates.
Academic ownership of intellectual property facilitated wide dissemination and commercialization of antibody technology. Moves at the University of Cambridge to reclaim institutional IP rights should thus be treated with caution.
At the end of next month, the European Medicines Agency (EMEA) will implement a new legislative framework and several provisions that seek to provide incentives and streamline regulatory oversight of certain monoclonal antibodies and other biologic products.
Ensuring adequate manufacturing capacity for recombinant and monoclonal antibodies is one of the greatest challenges facing the biotech industry. The following factors should be taken into account when designing product development and production strategies.
In responding to future influenza pandemics and other infectious agents, plasmid DNA overcomes many of the limitations of conventional vaccine production approaches.
The current generation of antibodies has done more than make a few companies rich. It has laid the groundwork for ambitious companies to move to maturity.
Most monoclonal antibodies in clinical trials are owned by small biotech companies. But with blockbuster-sized revenues and approval rates higher than those for small-molecule drugs, that all may be set to change.
The failure of many bio-ontologies to follow international standards for ontology design and description is hampering their application and threatens to restrict their future use.
India's thriving biotechnology industry is threatened by a change in the law. Will the current high levels of investment be enough to secure its future?