This week’s headlines include, FDA drug and device reviews may halt in January, a highly anticipated vaccine fails in trials, innovative stem Cell Therapy developments, and Alzheimer’s drug shows promise.

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Headlines:

“FDA Drug Review Set to Unravel as Fiscal Cliff Looms,” Bloomberg Businessweek

A $6.4 billion accord for U.S. drug and medical-device reviews is set to unravel just three months after taking effect as lawmakers squabble over budget cutbacks. Drug and device reviews, which rely heavily on fees paid by companies, may slow or halt in January because the Food and Drug Administration must receive certain funding from Congress before it can spend any of the industry money, said Karen Riley, an FDA spokeswoman. That appropriations level is at risk as lawmakers bicker over whether to follow through on $1.2 trillion of government-wide budget cuts through 2021.

If you like this story, please see our blog titled “Supreme Court Upholds Affordable Care Act – What it Means for Healthcare”

“Cancer Study Points to Tighter Pairing of Drugs and Patients,” The New York Times The first large and comprehensive study of the genetics of a common lung cancer has found that more than half the tumors from that cancer have mutations that might be treated by new drugs that are already in the pipeline or that could be easily developed.  For the tens of thousands of Americans with that cancer, squamous cell lung cancer, the results are promising because they could foretell a new type of treatment in which drugs are tailored to match the genetic abnormality in each patient, researchers say.

If you like this story, please see our blog titled “Is Personalized Medicine the Future – How Genetic Sequencing is Enabling New Treatments”

“Pluristem: Third Patient Successfully Treated With Its Cells,” The Wall Street Journal

Pluristem Therapeutics Inc. (PSTI) said its placenta-based cells were successfully administered to a third patient in Israel, results the company said suggest that its cells may have significant potential to treat a range of indications of bone marrow disease.  The latest patient, a 45-year-old male, was treated with the company’s Placental eXpanded cells to treat life-threatening complications following his chemotherapy. No side effects were observed and the patient’s general clinical condition and well-being significantly improved, Pluristem said, resulting in his release from the hospital.

If you like this story, please see our blog titled “Part II – Ten Companies with Innovative Stem Cell Therapies in Clinical Trials”

“Roche Ramps up Alzheimer’s Drug Trial as Rivals Stumble,” Reuters

Roche Holding AG believes it has moved into pole position in the race to develop an Alzheimer’s drug that can change the course of the disease after its rivals suffered setbacks in the past month. The Swiss drugmaker has more than doubled the size of a clinical trial of its experimental drug gantenerumab in patients who have yet to develop dementia, putting it in the vanguard of attempts to catch the disease in its early stages.

If you like this story, please see our blog titled “Defined Supplements – The Role of Recombinant Proteins in Biopharmaceutical Manufacturing”

“Sanofi Dengue Vaccine Less Effective Than Hoped,” Reuters

The world’s most advanced vaccine against dengue fever, being developed by French drugmaker Sanofi SA, proved far less effective than hoped in a clinical trial in Thailand, researchers reported on Monday. Overall efficacy was 30.2 percent – statistically insignificant and a far cry from the 70 percent-plus protection that researchers had anticipated at the start of the company-funded trial. The poor outcome was down to the failure of the vaccine to protect against one type of dengue virus, which turned out to be the prevalent one in Thailand at the time of the study.

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

“Human Stem Cells Restore Hearing to Deaf Gerbils in Study,” US News & World Report

Using nerve cells grown from human embryonic stem cells, researchers report that they restored hearing in deaf gerbils. In the study, which is published online in the Sept. 12 issue of Nature, researchers coaxed human embryonic stem cells — which have the potential to grow into any type of cell in the body — into differentiating into otic (ear) progenitor cells. They did this by placing the stem cells into a test tube that contained certain molecules known to be present during fetal development when the ear forms.

If you like this story, please see our blog titled “Technologies for Downstream Processing in Clinical Stem Cell Manufacturing”