WTWH Media and MassDevice.com announced today that Scott Whitaker, president and CEO of AdvaMed, will be a featured keynote speaker at DeviceTalks Boston 2019. DeviceTalks Boston, which takes place on June 5-6, 2019 at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices […]
House votes (again) to repeal medical device tax
The House voted 283 to 132 this week to repeal the 2.3% tax levied upon medical devices as part of the Affordable Care Act. The medical device tax, which has long been decried by the industry as a measure that squashes innovation and kills jobs, has been on hold since 2014. The tax’s moratorium was extended […]
Report: Trump to sign controversial law granting patients access to experimental drugs
President Donald Trump is slated to approve legislation this week that will give terminally-ill patients access to experimental drugs that haven’t yet been cleared by the FDA. The “right-to-try” bill has sparked a great deal of controversy among policymakers and patient groups. While some, including the president, describe the effort as offering hope to patients […]
Tribe taking steps to ‘ramp up’ drug patent business
The Native American tribe wrapped up in litigation with generic pharmaceutical companies is trying to prove that its arrangement with Allergan (NYSE:AGN) reflects a legitimate move to boost its economy, according to court documents. The St. Regis Mohawk Tribe of New York found itself it the middle of a controversial deal this year after it agreed […]
Update: Novartis paid more than $1m to consulting company linked to Trump attorney Michael Cohen
Updated 5/9 to include new information about Novartis’ payments to Essential Consultants. Novartis (NYSE:NVS) found itself in the middle of a national scandal today after it was revealed that the drugmaker paid more than $1 million to a consulting firm linked to President Donald Trump’s personal attorney, Michael Cohen. The shell company, Essential Consultants, was used by […]
FDA chief suggests kickback law could be used to rein in drug prices
Drug rebates paid between pharmaceutical companies and pharmacy benefit managers enjoy safe harbor status under federal kickback law, leaving them immune from legal scrutiny. But that could change, FDA chief Dr. Scott Gottlieb suggested yesterday at the FDA Law Institute’s annual meeting. The commissioner reportedly hinted that reinterpreting the law could help lower drug prices. […]
FDA aims to curb ingredient list for drug compounders
The FDA issued draft guidance last week designed to limit the list of pharmaceutical ingredients that drug compounding pharmacies can use to manufacture drugs in bulk that do not undergo the agency’s traditional approval process. The move comes in the wake of a deadly 2012 fungal meningitis outbreak that originated from contaminated drugs made in […]
Report: Senators take aim at pharmacy “gag clauses”
A bipartisan group of senators introduced two bills this week to stop “gag clauses” – conditions that prevent pharmacists from telling customers when they could save money on a prescription if they paid out of pocket rather than using insurance. These clauses are sometimes included in the contracts inked between the various parties that dictate […]
Controversial “right to try” bill fails in the House
A controversial bill that would grant terminal patients access to experimental therapies failed yesterday in the House. Although the “right to try” effort didn’t muster up enough votes to send it to the Senate, majority leader Rep. Kevin McCarthy (R-CA) said in a statement that the fight wasn’t over. “We will try again, pass legislation, […]
Report: Advocacy groups urge Congress to fund diabetes research programs
Advocacy groups have reportedly warned Congress that if lawmakers don’t find permanent funding solutions for diabetes research programs, it could jeopardize important work being done around the country to help people living with diabetes. Politicians on Capitol Hill have provided funding that will support the Special Diabetes Program and the Special Diabetes Program for Indians through […]
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