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Rx Drugs

January 08, 2020 | Daily News

FDA has proposed withdrawing more than 200 generic drug applications because the application holders repeatedly failed to file annual reports.

January 08, 2020 | Daily News

More than half of voters consider out-of-pocket costs for prescription drugs and other aspects of health care as top concerns ahead of the first primaries, according to a recent poll from Morning Consult and Bipartisan Policy Center.

January 08, 2020 | Daily News

New York Gov. Andrew Cuomo (D) will advance legislation this year to place fentanyl analogues on the state’s controlled substances list, according to the governor’s 2020 State of the State agenda unveiled Wednesday (Jan. 8).

January 07, 2020 | Daily News

In light of President Donald Trump’s Medicare executive order, CMS is seeking advice on how to eliminate Medicare regulations that are more stringent than state laws and limit what services certain non-physician practitioners can offer.

January 07, 2020 | Daily News

FDA has extended the comment period for its homeopathic draft guidance to March 23, 2020, the agency announced Tuesday (Jan. 7).

January 06, 2020 | Daily News

CMS on Monday (Jan. 6) proposed for 2021 to speed up the transition to a new Medicare Advantage risk-adjustment model and to increase its reliance on encounter data in the first part of the so-called advance notice and call letter for MA and Part D.

January 06, 2020 | Daily News

The generic drug lobby is appealing a California district court’s decision not to block the state’s pay-for-delay law, which went into effect Jan. 1.

January 03, 2020 | Daily News

Dialysis stakeholders are cheering a California federal judge’s Monday decision blocking the state from implementing a controversial new law that bars patient steering and limits reimbursements for patients who receive charitable help with premiums, and at least one analyst says the move could calm fears that similar legislation might take hold in other states.

January 02, 2020 | Daily News

The new year ushers in continued uncertainty over proposals to lower prescription drug prices, and President Donald Trump is viewed as the wildcard on whether Congress will pass major drug pricing legislation.

January 02, 2020 | Daily News

Colorado Governor Jared Polis (D) recently released wide-ranging recommendations for stemming drug costs that include price controls, patent reforms and an expansion of the state’s plan to import Canadian drugs.

January 02, 2020 | Daily News

Generic drug and biosimilars companies that make and sell FDA-approved versions of their products overseas would not be allowed to import them into the United States under one prong of HHS’ drug importation plan, which was issued through draft guidance on Wednesday (Dec. 18).

December 30, 2019 | Daily News

A major cancer research advocacy organization wants key House lawmakers to include in their upcoming Cures 2.0 package a policy that would give FDA authority to require generic drug labels be updated to reflect new information about the drug and its use.

December 30, 2019 | Daily News

When Inbrija was close to market, Acorda Therapeutics wanted to set the price of Parkinson’s therapy below the specialty tier monthly threshold of $670, but consultants and pharmacy benefit managers made the company set the list price at $950 per box, according to Ron Cohen, who founded Acorda and is the president and CEO of the company.

December 26, 2019 | Daily News

FDA recently released data showing there was a slight increase in the sales and distribution of antimicrobials for food-producing animals in 2018, when compared with data from 2017.

December 26, 2019 | Daily News

FDA on Friday (Dec. 20) finalized a guidance that details how manufacturers can develop dried plasma products and gain approval of devices used to manufacture dried plasma for application beyond the battlefield.

December 24, 2019 | Daily News

FDA and the European Medicines Agency (EMA) are working with officials in India and China to fight antimicrobial resistance (AMR), an EMA official and others involved told Inside Health Policy.

December 24, 2019 | Daily News

Drug makers and distributors say FDA’s proposal to let states import drugs would jeopardize the security of distribution channels, but importation boosters say states would follow existing importation rules and former FDA Commissioner Scott Gottlieb says the regulatory proposal places stringent conditions on the importation of drugs.

December 23, 2019 | Daily News

The House Democrats’ bill that would direct Medicare to negotiate drug prices would increase wages $116 billion over a decade for those with employer-sponsored health insurance, according to the Joint Committee on Taxation.

December 20, 2019 | Daily News

Senate Finance Committee Chair Chuck Grassley (R-IA) was caught by surprise when six of his fellow Republican committee members introduced an alternative to his drug pricing bill on Friday (Dec. 20), a Grassley spokesperson said.

December 20, 2019 | Daily News

FDA advisers on Tuesday (Dec. 17) narrowly backed the risk-benefit profile for AstraZeneca’s Lynparza (olaparib) to treat pancreatic cancer, even though they questioned the company’s use of progression-free survival as a primary endpoint, as they said it may not reflect a clinical benefit.

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