The Dish’s Weekly News Wrap Up – January 25, 2013

This week’s headlines include, news on FDA’s final rule for combination products, vaccine news, healthcare predictions for the future, Avastin’s expanded use and new route for biosimilars.


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“FDA Issues Final Rule on cGMP Requirements for Combination Products, Draft Guidance,” Bloomberg BNA

“The Food and Drug Administration is issuing a final rule on the current good manufacturing practice (cGMP) requirements for combination drug-device products, according to a notice published Jan. 22 in the Federal Register (78 Fed. Reg. 4307). The agency also is releasing a draft guidance for industry on submissions for post-approval modifications to a combination product approved under a new drug application (NDA), biologics license application (BLA), or premarket approval application (PMA). A notice announcing the draft guidance also appeared in the Jan. 22 Federal Register (78 Fed. Reg. 4417).”

If you like this story, please see our blog titled “The Number of FDA Drug Approvals for the 2012 Fiscal Year Remains High”


“10 Predictions that will Transform Healthcare,” Genetic Engineering News

“With all the new developments taking place in biopharma right now, it often feels like we’re living in the future—but the future holds even more promise. GEN has already offered its predictions for what’s to come this year in biotech; below are 10 trends we think are likely to reshape biopharma in the coming years—if not starting in 2013—based on a spot-check of recent journal articles, public Announcements, news reports, and commentaries in GEN and elsewhere.”

If you like this story, please see our blog titled “Part II – Innovative Products Featured at the ASCB Conference”


“Augmenta Vaccine Technology Wins US Patent,” Pharmaceutical Business Review

“Augmenta Biologicals has obtained the first US patent for the technology designed to improve vaccines. The new patent provides protection for the company’s universal flu vaccine target, M2e, which is a viral peptide common in all flu strains. Augmenta founder, president and CSO Dr. Paul Simon said the researchers knew that the red blood cells can increase antigen effectiveness. “We have developed an injectable approach to harness this natural pathway, employing a versatile plug-and-play coupling method to turbo-charge antigens and elicit powerful, durable and protective immunity,” Dr. Simon added. The technology is designed to enhance the immune response towards a vaccine at the same time decreasing the vaccine dose, finally reducing the costs.”

If you like this story, please see our blog titled “A First – Cell Culture Based Seasonal Influenza Vaccine Approved by the FDA”


“Roche: FDA Backs New Avastin Use for Colorectal Cancer,” Fox Business

“Roche Holding AG (ROG.VX) Thursday said the U.S. Food and Drug Administration approved a new use of Avastin in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer. The new indication will allow people who received Avastin plus an irinotecan or oxaliplatin containing chemotherapy as an initial treatment (first-line) for mCRC to continue to receive Avastin plus a different irinotecan or oxaliplatin containing chemotherapy after their cancer worsens (second-line treatment).”

If you like this story, please see our blog titled Tumor Cell Panels Help Researchers Develop New Cancer Treatments”


“U.N. Excludes Vaccine Preservative From Mercury Treaty,” Fierce Vaccines

“The United Nations backed down from a ban on a vaccine preservative that could have driven up prices and required a complex network of cold storage facilities. Scientists and vaccine manufacturers have added the organic mercury compound thimerosal to multidose vaccines since the 1930s, a mainstay for the developing world. And despite groups of experts–including the Institute of Medicine, the American Academy of Pediatrics, the U.K.’s Committee on Safety of Medicines and the European Agency for the Evaluation of Medicinal Products–concluding that the compound is safe and effective, the United Nations Environment Program still considered adding the product to a treaty on the release of mercury into the environment.”

If you like this story, please see our blog titled “New Vaccines Coming Soon to a Doctor’s Office Near You”


“Never Mind FDA, States are Crafting Biosimilar Laws,” Pharmalot

“The FDA may not have approved a biosimilar yet or decided whether a biosimilar is interchangeable with a brand-name biologic, but this is not stopping some state legislatures from considering bills that would allow substitution. So far, six states have legislation in the works and such efforts may gain momentum this year, according to the FDA Law blog.”

If you like this story, please see our blog titled Comments on Biosimilar Guidance Indicate Discontent on Both Sides of the Issues”


“Scientists Announce They’re Poised to Resume Controversial Research with Lab-bred Bird Flu,” The Washington Post

“International scientists who last year halted controversial research with the deadly bird flu say they are resuming their work as countries adopt new rules to ensure safety. The outcry erupted when two labs — in the Netherlands and the U.S. — reported they had created easier-to-spread versions of bird flu. Amid fierce debate about the oversight of such research and whether it might aid terrorists, those scientists voluntarily halted further work last January — and more than three dozen of the world’s leading flu researchers signed on as well.”

If you like this story, please see our blog titled “Cell Culture Based Optiflu on List of Top Selling Flu Vaccines”


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