This week’s headlines include, flu season arrives early, new stem cell academic – industry partnership, FDA approvals increase this year, FDA ready to rethink antibiotic clinical requirements, application of stem cells made from blood, and Lilly sees success with antibody for Alzheimer’s.

Headlines:

“FDA Drug Approvals Increase,” The Wall Street Journal

The Food and Drug Administration is on track to approve more than 30 new drugs this year—the most in eight years—partly because the pharmaceutical industry is speeding development of experimental drugs.  As of the end of November, the agency approved 31 new types of drugs for diseases including cancer, multiple sclerosis, rheumatoid arthritis and HIV in addition to the first weight-loss drug approved in more than a decade. A separate FDA report released Wednesday also said that, based on a broader definition of what counts as a new drug, the agency showed 35 new approvals in the fiscal year that ended Sept. 30. The agency still has weeks to add to its calendar year total, but has already approved the most new medicines since 2004, when it approved 36 new drugs.

If you like this story, please see our blog titled “FDA Strives to Provide Faster Approval Time for Drugs by Employing Special Medical Use Category”

“Flu Season Arrives Early and Could be Bad,” ABC News

Flu season arrived early this year. And according to the U.S. Centers for Disease Control and Prevention, it’s shaping up to be a bad one.  CDC director Dr. Thomas Frieden announced today that Tennessee, Mississippi, Alabama, Louisiana and Texas have reported enough seasonal flu cases to officially mark the beginning of the flu season.  “It looks like it’s shaping up to be a bad flu season,” Frieden said, explaining that the predominant flu subtype being passed around — H3N2 — is known to cause more severe illness. H3N2 was the predominant subtype in 2003-2004, the last time the flu season arrived this early.

But there’s some good news: It appears the circulating strains are “a great match” for this year’s vaccine, according to Frieden.   As many as 112 million Americans have already received the annual flu shot, according to Dr. Melinda Wharton, acting director of the CDC’s National Center for Immunization and Respiratory Diseases.

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

“Stem Cell Tech Gets Boost From Academic-Industry Partnership,” Genetic Engineering News

Roche and the Innovative Medicines Initiative (IMI) launched StemBANCC, a new academic–industry partnership that unites ten pharmaceutical companies and 23 academic institutions. Initiated and coordinated by Roche and managed by Oxford University, StemBANCC aims to use human induced pluripotent stem cells as research tools for drug discovery with the goal of using this new technology to develop human disease models and enhance drug development.“The aim of StemBANCC is to generate and characterize 1,500 high quality human induced pluripotent stem cell lines derived from 500 patients that can be used by researchers to study a range of diseases including diabetes and dementia,” explained Martin Graf, head of the stem cell platform and coordinator of the project. “The cell lines will help implement patient models that will facilitate the drug development process thanks to the possibility of reproducing the disease mechanism in vitro.”

If you like this story, please see our blog titled “Employing Innovative Platforms for Large Scale Stem Cell Culture”

“FDA Under Pressure to Relax Drug Rules, Nature”

The latest skirmish in the battle between human and microbe played out on 29 November in a hotel conference room in Silver Spring, Maryland. There, an assembly of scientists and clinicians debated the merits of an experimental antibiotic. For some, the coveted prize was not just an endorsement of the drug itself, but a sign that the US Food and Drug Administration (FDA) is finally ready to rethink its clinical-trial requirements for antibiotics — requirements that the drug industry says are unrealistic. The number of FDA approvals of new antibiotics has dropped even as multi-drug-resistant strains of bacteria have proliferated. FDA advisers at last week’s meeting did recommend approval of telavancin (Vibativ) — a derivative of vanco­mycin — for the treatment of hospital-acquired pneumonia when alternative drugs are not suitable. But that vote came nearly two years after the FDA had rejected the drug for a second time because clinical data did not measure up to the agency’s guidelines.

If you like this story, please see our blog titled “How Stem Cells Can Play a Major Role in Developing New Therapeutics”

“Drug Industry Treading Water on R&D Productivity,” Reuters

Drug companies are becoming more efficient in hunting for new treatments, though this has yet to be reflected in improved investment returns, according to a report on Tuesday. Low productivity in research labs is the biggest single challenge facing the global pharmaceutical industry, which is struggling to replenish its medicine chest after a wave of patient expiries that peaked this year. While companies are getting more compounds into late-stage development – reflecting a smarter and more targeted approach to research and development (R&D) – turning those new products into big commercial winners is an uphill struggle.

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

“Stem Cells Being Made From Blood,” BBC

A patient’s own blood has been used to make personalised stem cells, which doctors hope will eventually be used to treat a range of diseases. The team at the University of Cambridge says this could be one of the easiest and safest sources of stem cells. In a study, published in the journal Stem Cells: Translational Medicine, the cells were used to build blood vessels. However, experts cautioned that the safety of using such stem cells was still unclear.

If you like this story, please see our blog titled “Two Important Developments in Stem Cell Therapy to Treat Heart Failure”

“Lilly Tests Therapy to Rid Brain Plaque in Mice With Alzheimer’s,” Reuters

Drugmaker Eli Lilly & Co said it may have found a way to remove plaque from the brains of forgetful, old mice using an experimental therapy it hopes someday will be used to treat Alzheimer’s disease in humans. Previous animal studies have demonstrated that it is possible to prevent the formation of brain plaques, which are thought to be a hallmark of the progressive memory-robbing disease. But until now, researchers have not been able to remove pre-existing plaques, made of amyloid beta protein, once they have deposited into the brain, Lilly said. These deposited plaques are insoluble, whereas soluble forms of amyloid beta are free-floating around the brain and have been easier to target. Lilly researchers developed a genetically engineered antibody that selectively targets insoluble plaques and was able to cross the blood-brain barrier. The antibody was then able to bind itself to the deposited amyloid beta, and clear roughly 50 percent of pre-existing plaques in the mice without causing damage to tiny vessels in the brain.

If you like this story, please see our blog titled “Best Selling Biologics for 2011 – CHO Still the Top Manufacturing Choice”

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