  | Today's Top Story |  |  | | - FDA might issue guidance on follow-on biologics earlier than expected
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, hinted that the agency finished crafting guidance for seeking approval of generic copies of biotech drugs and could issue it soon, rather than by year-end, said Janice Soreth, deputy director of the FDA's European office. Minutes of a meeting between the biotech industry and the FDA indicate that a "tentative agreement" was reached regarding user fees needed to support an approval process for follow-on biologics. Reuters (9/23)        | Earn 2X rewards points on gasoline purchases with The New Business Gold Rewards Card from American Express OPEN. Designed to earn Membership Rewards® points faster:
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  - Experts launch efforts to analyze huge amounts of DNA data
The number of people whose entire genomes are being sequenced is expected to increase from 2,700 in 2010 to about 30,000 this year, driven by rapid advances in DNA sequencing technologies, according to estimates published in Nature magazine. Some experts say that because of the rapid adoption of DNA sequencing, there is also an immense increase in sequenced DNA data that need to be analyzed and interpreted. Meanwhile, the industry is launching programs to address the problem, including a plan to create standards that would facilitate the analysis of genetic data and aggregation of multiple data sets to enable scientists to access such data, said Clifford Reid, Complete Genomics' CEO. MIT Technology Review online (9/23) - Experts link 5 new genes to cardiac disease
Researchers reported in the journal PLoS Genetics that they discovered five genes that appear to be responsible for increasing the risk of heart attack and coronary artery disease. They also found that people of South Asian descent carry many of the genes linked to CAD that are also present in European Caucasians. They said the findings could help predict the risk of heart disease and pave the way for new treatments. HealthDay News (9/23)  | How will IM, video, telephony and other elements of UC change in the coming year? This set of products provides a consistent unified user interface and experience and is poised to become more widespread in the enterprise. Get insight from Focus Experts as they share their predictions for Unified Communications in this free guide. |
 - Isis sues Santaris regarding discovery of antisense drugs
Santaris Pharma was sued by Isis Pharmaceuticals for allegedly violating intellectual property related to modified oligonucleotide chemistry used to develop antisense drugs. Worldwide, Isis owns 1,550 patents covering such gene-based therapy. Santaris thinks there is no merit to the allegation, said General Counsel and Vice President Bolette Wildt. San Diego Union-Tribune (9/23) - Roche's Boniva is as good as radiotherapy for cancer pain in study
In a Phase III trial, Roche Holding's IV bisphosphonate drug Boniva was comparable to single-dose radiotherapy for long-term pain management in men whose prostate cancer had spread to the bone. Researchers could not draw a conclusion from Boniva's impact on survival because of uncertainty about "the optimal timing and scheduling of treatment for these patients," said Peter Hoskin, who presented the study at the European Multidisciplinary Cancer Congress. Reuters (9/25)  | Kickstart your business’ marketing with FedEx Office! Save big on posters, postcards and brochures, with up to 40% off on select print products. Go to FedEx Office to take advantage of the Look Good On Paper Print Sale to get discounts on all your business printing needs. |
 
| Hot Topics | | | | Top five news stories selected by BIO SmartBrief readers in the past week. - Results based on number of times each story was clicked by readers.
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