Food and Drug Administrator Dr. Scott Gottlieb will resign, the Trump administration confirmed Tuesday.
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Why Abbvie May Have A Tough Time Defending Humira’s Price Before Congress
Drug maker Abbvie may have to defend the price of its Humira treatment before the U.S. Senate Finance Committee today.
Shutdown’s Latest Victim: Hundreds Of Delayed Life-Saving Medical Devices
The government shutdown is creating a backlog of hundreds of medical device applications awaiting review at the Food and Drug Administration, triggering a cascade of delays for medical technology, The Advanced Medical Technology Association (AdvaMed) s…
Should You Bet On Transdermal Drug Delivery?
Delivering drugs through a patch sounds good. But can you make money investing in it? Not likely. But a Quebec company is working with Tilray to get you a Cannabis high via oral film.
2018 New Drugs Approvals: An All-Time Record, And A Watershed
2018 stands out not only for the sheer volume of new drug approvals, but also for their quality, and the affirmation of several important trends that make it a watershed. There is every reason to believe that pharmaceutical innovation is shifting into …
No Matter What The FDA Decides, New Diabetes Drugs Will Still Require CV Outcomes Trials
CVOTs for diabetes drugs are here to stay.
Questions Raised About Invokana Label Expansion For CV Risk Reduction
Experts are raising questions about FDA’s decision to expand the label of the diabetes drug Invokana to reduce the risk of cardiovascular events.
Medical Device Makers Shut Out Of Value-Based Care Without Kickback Rule Change
Medical device makers are pushing for a change in the federal anti-kickback statute to allow companies to fully participate in the shift away from fee-for-service medicine to value-based care.
Opioid Lawsuits On Par To Become Largest Civil Litigation Agreement In U.S. History
Recent months have seen a surge in opioid-related lawsuits against pharmaceutical companies and individual leadership of pharma, as well as retail pharmacies and dispensaries. Interestingly, they are being filed by cities, counties, state’s attorneys g…
As Trump’s Trade War Grows, China Hits Medical Device Makers
China’s latest retaliatory tariffs have hit $4.7 billion in U.S. medical technology exports, the Advanced Medical Technology Association (AdvaMed) said.
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