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A Solution In Search of A Problem: Streamlining the FDA

02/03/2017

by Craig Klugman, Ph.D.

A professional association for regulatory affairs posted an article on Wednesday reporting Trump’s comments “calling for a massive overhaul of US Food and Drug Administration (FDA) regulations.” Trump issued an executive that called for reducing the number of federal regulations (for each new one created, two must be retired). And he met with the heads of pharmaceutical companies, where he said that he plans to cut taxes, FDA regulations and approval times. He also criticized the companies for selling drugs that were too expensive.…

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02/22/2017
Artificial intelligence grows a nose Science

Now, 22 teams of computer scientists have unveiled a set of algorithms able to predict the odor of different molecules based on their chemical structure. It remains to be seen how broadly useful such programs will be, but one hope is that such algorithms may help fragrancemakers and food producers design new odorants with precisely tailored scents.

02/21/2017
Harvard and M.I.T. Scientists Win Gene-Editing Patent Fight The New York Times

The Broad Institute in Cambridge, Mass., will retain potentially lucrative rights to a powerful gene-editing technique that could lead to major advances in medicine and agriculture, the federal Patent and Trademark Office ruled on Wednesday.

02/17/2017
An old drug gets a new price to fight a rare disease: $89,000 a year Washington Post

An old steroid treatment, long available outside the United States, received approval this week for a rare disease that afflicts about 15,000 Americans. Though not previously approved in the United States, the drug, deflazacort, has for years been available to patients suffering from the devastating and fatal disease Duchenne muscular dystrophy; families can import it from abroad for about $1,200 per year on average. The new list price for the drug? $89,000 a year.

02/16/2017
Speedy drug approvals are risky, but drug companies have another idea that’s just terrible Los Angeles Times

As with Trump’s proposed elimination of consumer safeguards, environmental-protection measures and financial reforms, the reality is that if his administration proceeds with a wholesale deregulation of the drug industry, the public will be largely undefended against the aggressive and potentially dangerous predations of multibillion-dollar conglomerates.