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FDA approves new therapy to treat cystic fibrosis in patients 12 and older—and it will cost $311,503

October 28, 2019


FDA on Monday announced that it has approved Trikafta, the first-ever triple combination therapy to treat cystic fibrosis (CF) in patients ages 12 and older who have a genetic mutation that affects the vast majority of CF patients.

CMS delays new primary care, kidney care value-based payment models

October 28, 2019


CMS on Thursday announced it is delaying the start of several new voluntary value-based payment models, but it continued to encourage Medicare providers to apply to participate in the payment models.

Verma suggests Trump has a plan if ACA is struck down—but declines to share the details

October 25, 2019


CMS Administrator Seema Verma during a House Energy and Commerce subcommittee hearing on Wednesday declined to provide details on the Trump administration's plans in case a federal appeals court strikes down the Affordable Care Act in a lawsuit challenging the law's constitutionality.

FDA recommends boxed warnings tying breast implants to cancer

October 25, 2019


FDA this week posted draft guidance recommending manufacturers include boxed warnings on breast implants after the agency found a link between certain implants and a sharp increase in cases of and deaths involving a rare cancer.

DEA will accept unwanted vaping devices as mysterious lung illness cases surge

October 25, 2019


The Drug Enforcement Administration has announced that, for the first time, it will accept unwanted electronic vaping devices and cartridges at collection sites across the United States during its National Prescription Drug Take Back Day, which is scheduled to run from 10 a.m. to 2 p.m. Saturday.

Why FTC is asking health systems, insurers for information on mergers

October 25, 2019


The Federal Trade Commission on Monday announced that it has ordered two health systems and five health insurance companies to give the agency information that will help it with an ongoing project examining the effects of certain state regulations on mergers in the industry.

Biogen reverses course and will seek FDA approval for Alzheimer's drug

October 24, 2019


Biogen on Tuesday announced that it will seek FDA approval for aducanumab, an Alzheimer's disease drug that originally had been considered a failure, after the company in March said trials of the drug had not shown clinical benefits.

Final committee OK's Pelosi's Rx drug pricing bill

October 24, 2019


The House Ways & Means Committee on Tuesday voted 24-17 to approve House Speaker Nancy Pelosi's (D-Calif.) bill that aims to reduce prescription drug prices in the United States, sending the measure to the full House for a potential floor vote.

Average premiums for silver-level exchange plans down 4% in 2020, CMS data shows

October 23, 2019


CMS on Tuesday announced that the average premium rate for the most commonly purchased silver-level health plans sold through the Affordable Care Act's federal exchange will be lower for the 2020 coverage year than they were for 2019.

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