The FDA is seeking public comment on guidance detailing a system for handling postmarket drug safety issues, including drug quality and serious adverse events. The draft guidance establishes a three-tiered system of classifying the severity of problems.
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Reps. Cliff Stearns, R-Fla., and Edolphus Towns, D-N.Y., have introduced a bill that would speed up the commercialization of new drugs for serious diseases. The Faster Access to Specialized Treatments Act would update and systematize the accelerated-approval program of the FDA. BIO President and CEO Jim Greenwood praised the proposal, saying it would allow biotech firms to bring newly developed drugs to those who need them "at the earliest point in time."
Organogenesis has received FDA approval to market Gintuit, its cell-based product designed to replace receding gum tissue during dental gum surgeries. Gintuit is composed of donated skin cells attached to bovine collagen. Organogenesis CEO Geoff MacKay said the decision marks the agency's first approval of a mass-produced cell treatment and its first OK of regenerative tissue for an oral condition.
Foundation Medicine has signed a deal to use its genome sequencing technology to help pinpoint patients who may potentially respond to cancer drugs developed by Array BioPharma. The company has similar agreements with pharmaceutical firms Johnson & Johnson, Novartis, Sanofi and Celgene.
Swedish and American researchers have developed a technique that could be used to turn patients' stem cells into organs and complex tissue. Paolo Macchiarini writes in The Lancet that animal tissue could be used as scaffolds to grow organs, but he cautions that a strong commitment to safety is necessary. Macchiarini has been involved in two trachea transplants using tissue engineered from patients' cells.
Valeant Pharmaceuticals International spent less than $10 million for a 19.9% stake in Pele Nova Biotecnologia, a Brazilian research firm involved in tissue regeneration. The deal entitles Valeant to representation on Pele Nova's board and a lower royalty rate for wound-healing product Regederm. Valeant also gets rights to all of Pele Nova's future products in Brazil and the first right to refuse worldwide product rights.
HemaQuest Pharmaceuticals secured $13 million in an extension of a Series B funding round. The company will use the money for a Phase IIb trial of its lead drug candidate, HQK-1001, in patients with sickle cell disease.
Sanofi and Spain's Center for Genomic Regulation plan to study hereditary and rare disorders through medical genetics, computational biology and epigenetics. The multidisciplinary approach "will bring added value to basic research by offering a better understanding of
disease for pathologies such as tuberculosis and cancer and also by helping to develop new therapeutic solutions for their treatment," according to a joint statement.
BioLineRx was awarded a European patent for BL-1020 and its use as a schizophrenia treatment effective through Sept. 29, 2022. Preclinical and clinical trials showed that BL-1020 has a good safety profile and treats the disease's symptoms.
Spanish scientists have infused the genes that give the Sicilian blood orange its red pigments into biotech Valencia orange seedlings to create an orange "superjuice" that they say could help fight obesity, heart disease and irritable bowel syndrome. The seedlings are being grown at a Spanish research center and are expected to produce oranges this year.
Several biofuel groups are calling on U.S. senators to support an amendment by Sen. Debbie Stabenow, D-Mich., that would renew tax incentives for cellulosic ethanol and biodiesel. "This is about creating good-paying jobs and building up a U.S. energy industry that will help end our dangerous vulnerability to the kinds of oil price spikes we're seeing now," said Anne Steckel, vice president of federal affairs for the National Biodiesel Board.
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