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Rx Drugs

July 11, 2019 | Daily News

A bipartisan group of senators, including Sens. Chuck Grassley (R-IA) and Dianne Feinstein (D-CA), has introduced a bill that aims to encourage scientific and medical research on marijuana in part by streamlining development of FDA-approved drugs that use cannabidiol (CBD) and marijuana.

July 11, 2019 | Daily News

President Donald Trump has decided to withdraw a proposed rule to eliminate rebates in Medicare Part D and Medicaid managed care because of concerns the rule would raise premiums for Part D beneficiaries, an administration official told Inside Drug Pricing.

July 10, 2019 | Daily News

President Donald Trump calls for steps to encourage the development of wearable or implantable artificial kidneys as part of an executive order he unveiled Wednesday (July 10) to improve American kidney health.

July 10, 2019 | Daily News

FDA took steps Wednesday (July 10) to reduce waiting periods in the generic drug approval process by encouraging industry to propose revisions to United States Pharmacopeia (USP) monographs while applications are pending agency approval.

July 10, 2019 | Daily News

Senate Finance Committee Chair Chuck Grassley told Inside Drug Pricing he wants Congress to require that drug makers disclose list prices for prescription drugs in television ads, coming a day after a federal court on Monday (July 8) ruled the Trump administration lacks authority under current law to regulate drug makers’ television ads.

July 10, 2019 | Daily News

Many dual-eligible beneficiaries are disenrolled from Medicaid even though they likely remain eligible for that coverage, according to a new study, as they are still eligible for Medicare’s low-income drug coverage subsidies.

July 09, 2019 | Daily News

Senate Finance Committee Republicans huddled with HHS Secretary Alex Azar and White House Domestic Policy Council head Joe Grogan Tuesday (July 9) to discuss the panel’s emerging drug-pricing package, but the group did not reach an agreement.

July 09, 2019 | Daily News

FDA updated guidance on Tuesday (July 9) that explains how drug and biologic sponsors should submit modifications to risk mitigation plans, but did not give into a number of suggestions from both the brand and generic drug industries.

July 08, 2019 | Daily News

A federal court on Monday (July 8) threw out the Trump administration’s rule requiring drug makers to disclose list prices in television advertisements because the judge found regulating television ads for prescription drugs is outside CMS’ authority.

July 08, 2019 | Daily News

FDA is expediting review of all generic drug applications for overdose-reversal drugs, including naloxone nasal spray, injection and auto-injector, and nalmefene injection, the agency announced Monday (July 8).

July 08, 2019 | Daily News

FDA on Friday (July 5) announced that it is lifting its ban on the bulk drug substance oxitriptan so that licensed pharmacists can compound oral drugs for patients with BH4 deficiencies on a prescription-by-prescription basis.

July 05, 2019 | Daily News

President Donald Trump is writing an executive order to ensure the United States pays no more than any other country for prescription drugs, he said Friday (July 5).

July 03, 2019 | Daily News

FDA, in its bid to tap real-world evidence to speed approvals of new drugs, is holding discussions with CMS to carve out each agency’s jurisdiction, FDA Principal Deputy Commissioner Amy Abernethy said.

July 03, 2019 | Daily News

FDA unveiled two new guides Monday (July 1) on prescription drug and biologics labeling: One focuses on labeling of drugs and biologics that have potential for abuse and dependence, and the other addresses the content and format for the instructions for use section of labeling for drugs and biologics, and drug-device or biologic-device combination products.

July 02, 2019 | Daily News

Senate Finance Committee members are scheduled to meet next Tuesday (July 9) to discuss drug-pricing legislation that Chair Chuck Grassley (R-IA) and ranking Democrat Ron Wyden (OR) have been negotiating, according to sources following the talks.

July 02, 2019 | Daily News

Sen. Elizabeth Warren (D-MA), a contender for the 2020 Democratic presidential nomination, is calling on former FDA Commissioner Scott Gottlieb to step down from his recently announced board of directors position with the pharmaceutical giant Pfizer.

July 02, 2019 | Daily News

FDA on Monday (July 1) eliminated postmarket requirements that makers of HIV prevention drug Truvada and its generics provide training materials to health care professionals and educational information to consumers, due to evidence that most providers and at-risk individuals are aware of the risks of the drug and know how to use it properly.

June 27, 2019 | Daily News

The Senate health committee on Wednesday (June 26) passed, 20 to 3, bipartisan legislation to lower health care costs that includes drug-pricing provisions.

June 27, 2019 | Daily News

Sen. Ron Wyden (D-OR) wants to reverse a Trump-era drug-pricing policy by putting biosimilars in common billing codes to drive down prices of biosimilars, sources following Senate Finance Committee negotiations say.

June 27, 2019 | Daily News

A coalition of patient advocates, provider groups and drug makers is criticizing the Institute for Clinical and Economic Review for using a metric they say discriminates against people with disabilities and chronic illness.

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