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Rx Drugs

June 07, 2019 | Daily News

Connecticut lawmakers’ effort to pass a sweeping health reform bill collapsed in the state’s senate late Wednesday (June 5), the final day of the session.

June 07, 2019 | Daily News

Opioid maker Insys Therapeutics, which manufacturers fentanyl product Subsys, will plead guilty to five counts of mail fraud, pay millions in fines and pay to settle allegations that it violated the False Claims Act, the Department of Justice (DOJ) announced Wednesday (June 5).

June 07, 2019 | Daily News

Lawyers in the gene therapy field said FDA’s approval of AveXis’ Zolgensma, a new drug for treating spinal muscular atrophy (SMA), lays the groundwork for an expected wave of future gene therapy drug applications.

June 07, 2019 | Daily News

The Biosimilars Forum is scheduled to meet with White House budget officials June 10 to discuss policies that the trade group says would reduce Medicare spending by boosting the use of biosimilars, according to the Office of Management and Budget website.

June 07, 2019 | Daily News

Washington is the fourth state to seek approval from CMS to enter performance-based contracts with drug makers, according to documents obtained by Inside Drug Pricing.

June 07, 2019 | Daily News

CMS Administrator Seema Verma on Thursday (June 6) called out large hospital systems for anti-competitive behavior, and said CMS policies like pay cuts for 340B drugs and site-neutral pay policies -- both of which led to lawsuits over CMS’ authority to enact them -- were put in place to help combat consolidation and physician movement from independent work to hospital employment.

June 06, 2019 | Daily News

Lobbyists for brand drug makers have told Senate Finance Committee staff they’re open to paying a share of seniors’ catastrophic Medicare Part D drug costs in exchange for capping seniors’ out-of-pocket costs and relieving drug makers of the 70% discounts they currently must pay for drugs that beneficiaries take while in the donut hole, according to sources close to the negotiations.

June 06, 2019 | Daily News

As all eyes are on Oklahoma’s trial against drug maker Johnson & Johnson over its role in the opioid epidemic, the number of states filing charges against opioid makers is stacking up.

June 06, 2019 | Daily News

FDA on Monday (June 3) announced a pilot program call center at its oncology office that is meant to serve as an information hub for physicians treating patients with cancer who seek access to unapproved therapies.

June 06, 2019 | Daily News

Just days after FDA held a 10-hour meeting to discuss the science and regulation of cannabis-based products, Americans for Safe Access issued a resource guide for patients, health care providers, consumers and anyone interested in learning more about cannabidiol (CBD).

June 06, 2019 | Daily News

In the absence of federal regulations and amid a patchwork of state regulations for cannabis products, epilepsy patients are using unapproved cannabidiol (CBD) without any clear direction on dosage or any knowledge of what is in their products, stakeholders told FDA at a public meeting Friday (May 31).

June 05, 2019 | Daily News

The bipartisan National Governors Association wants the federal government to let states import drugs and exclude Medicaid coverage of fast-tracked, first-in-class drugs while additional tests are done on them.

June 05, 2019 | Daily News

Proposals to reform the 340B program were excluded from three legislative packages to cut health care cost that have either been recently introduced or publicly disclosed, and Sen. Bill Cassidy (R-LA), an author of 340B legislation, said that’s because Democrats are not on board.

June 05, 2019 | Daily News

Senate Finance Chair Chuck Grassley (R-IA) said Wednesday (June 5) that he wants drug makers to take on a share of costs in the catastrophic phase of Medicare Part D, and health insurance plans to also pay more.

June 04, 2019 | Daily News

The House Appropriations Committee approved a 2020 funding bill on Tuesday (June 4) that would give FDA a $184 million boost over 2019 levels. During the markup, lawmakers voted to restore language featured in previous bills that would prevent the genetic modification of human embryos.

June 04, 2019 | Daily News

White House officials are set to meet with congressional Republicans later this week to talk about prescription drug pricing, Freedom Caucus Chair Mark Meadows (R-NC) said Tuesday (June 4).

June 04, 2019 | Daily News

Sen. Bill Cassidy (R-LA) plans to introduce next week a package of five drug pricing bills that includes measures to help insurers finance expensive drugs, reward insurers that encourage biosimilar adoption, discourage price concessions that pharmacies call unfair, pay pharmacists for managing complicated regimens and stop authorized generics from lowering Medicaid drug rebates.

June 04, 2019 | Daily News

The House on Tuesday (June 4) passed by voice vote the Senate’s pandemic preparedness bill, which does not include a measure to reform FDA’s over-the-counter (OTC) drug regulatory framework that was part of the House’s original pandemic bill.

June 04, 2019 | Daily News

The United States and the United Kingdom will reach a “phenomenal trade deal” covering “everything” -- including the British National Health Service, President Trump said in London on Tuesday (June 4).

June 03, 2019 | Daily News

If a fiscal 2020 agriculture funding bill passes the House Appropriations Committee on Tuesday (June 4), FDA will be one step closer to receiving millions of dollars to support new oversight efforts in its cosmetics, supplements and food import spaces.

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