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 •  February 9

The U.S. Food and Drug Administration released a statement on Tuesday afternoon from Commissioner Scott Gottlieb, MD, declaring that kratom, a southeast Asian herbal medicine, contains naturally-occurring plant alkaloid chemicals that are predicted by unpublished computer models to be opioids. The agency has also collected 44 fatal adverse reaction...

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 •  January 31

I agree 100% with President Trump that patients with life-threatening illnesses should have the opportunity for access to experimental drugs outside the confines of a clinical trial, also known as 'compassionate use' or by the hashtag #RightToTry. But the U.S. Food and Drug Administration already operates such an expanded access program (EAP) that...

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 •  January 21

Last year, Marathon Pharmaceuticals acquired a European muscular dystrophy drug, secured FDA approval, and jacked up the price 60-fold. Now, another biotech appears poised to use the same strategy. What can – or should – be done to stop it? Superficially, this may look like a no-brainer, with a fairly obvious path forward: close the loopholes that...

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 •  January 4

2017 was an extraordinary year in the history of medicine. It was the year when scientists beat cancer, and U.S. regulators approved the first therapy to fix a faulty gene. It was also a year that kept us enthralled with a quickening drumbeat of breathtaking news detailing spectacular advances – trials seemingly curing patients of hemophilia A and...

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 •  January 3

A new drug, Luxturna, literally allows blind people to see. It does it by using a virus to insert new genes into patients’ eyes. This morning, Luxturna’s maker, Spark Therapeutics, is announcing the cost of this medical miracle: $425,000 per eye, or $850,000 a year for most patients. That figure is actually less than investors and outside experts...

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 •  December 21, 2017

This morning the Food and Drug Administration approved Luxturna, a gene therapy to treat a rare form of blindness in kids and adults that will be sold by Philadelphia-based Spark Therapeutics. "The culmination of decades of research has resulted in three gene therapy approvals this year for patients with serious and rare diseases. I believe gene...

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 •  December 18, 2017

In today’s social and political climate, public opinion and public action can galvanize and turn on an issue in an instant. We’re seeing it right now as the personal misconduct of public figures eviscerates careers and upends personal lives. We saw something similar on the political front happen not too long ago in healthcare when the Affordable...

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 •  December 18, 2017

A November 30, 2017 post discussed the Food and Drug Administration's (FDA) return to third-party courtroom advocacy for national, uniform regulation of products under its authority. In separate amicus briefs, the agency argued that federal law preempted both New York City's enforcement of an expanded menu-labeling ordinance and certain claims in...

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 •  December 13, 2017

The annual meeting of the American Society of Hematology (ASH), now wrapping up in Atlanta, has generated a lot of excitement about immuno-oncology treatments like Bluebird Bio and Celgene’s experimental CAR-T targeting multiple myeloma. Shares of Bluebird soared 18% yesterday to $201.80 after development partner Celgene announced an overall...

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 •  December 5, 2017

Does it seem like you cannot escape prescription drug advertisements – you know, those slick TV commercials with upbeat music, celebrity actors, swinging golf clubs, and lofty treatment promises? That’s because every hour on television, an average of 80 prescription drug ads are aired, and the average American sees more than nine direct-to-consumer...