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Rx Drugs

August 07, 2019 | Daily News

Hospitals that administer the expensive new CAR-T gene therapy are not required to participate in a clinical registry or study aimed at determining whether real-world results mirror those from clinical trials used to get the cancer drugs approved, according to the national coverage determination CMS published Wednesday (Aug. 7).

August 07, 2019 | Daily News

Novartis CEO Vasant Narasimhan said his company did the right thing by not informing FDA of data manipulation in the development process of its drug Zolgensma until after the company had completed an investigation of the issue.

August 07, 2019 | Daily News

The majority of postmarketing requirements and postmarketing commitment studies for fiscal 2018 were successfully completed by industry or are on their way to being completed on time, with few studies delayed, Acting FDA Commissioner Ned Sharpless said Tuesday (Aug. 6).

August 06, 2019 | Daily News

FDA on Tuesday (Aug. 6) announced that it was investigating a report from drug-maker AveXis Inc. in late June of data manipulation regarding the manufacturing process of the recently approved gene replacement therapy Zolgensma.

August 06, 2019 | Daily News

CMS will increase the add-on payments hospitals receive for CAR-T cancer treatments, but the agency didn’t make what industry sources say are easy changes to the reimbursement system that would have allowed CMS to know the true price of chimeric antigen receptor T-cells.

August 06, 2019 | Daily News

FDA issued its first-ever draft guidance focused on development of drugs for newborn babies, particularly for those born prematurely, to help address gaps in pediatric labeling information.

August 05, 2019 | Daily News

AARP spent at least $700,000 on prescription drug pricing-related television ads in five states that span the territory of Senate Majority Leader Mitch McConnell and of a handful of GOP senators who face competitive 2020 re-election races.

August 01, 2019 | Daily News

Pfizer and GlaxoSmithKline have combined their respective consumer health care businesses as part of a joint venture to create what Pfizer described Thursday (Aug. 1) as “the world’s largest over-the-counter (OTC) business with robust iconic brands.”

August 01, 2019 | Daily News

FDA updated 2014 draft guidance on the rare pediatric disease priority review voucher program to bring its recommendations in line with 2016 laws that made changes to the program, including the definition of rare pediatric disease.

August 01, 2019 | Daily News

FDA released final guidance meant to encourage drug makers to develop medication that keeps kidney transplant patients from developing delayed graft function (DGF), where the transplant doesn’t work as expected after surgery and the patient must go back on dialysis.

August 01, 2019 | Daily News

A recently issued final FDA guidance clarifies key industry questions about how combination product makers should comply with postmarket safety reporting requirements (PMSR), but an industry lawyer said some of the finer points, such as details to be included in foreign event reports and the number of constituent parts in a safety report, will have to be hashed out in practice.

July 31, 2019 | Daily News

In light of a deadly pig disease sweeping across China, bipartisan leaders of the House Energy & Commerce Committee want FDA to brief lawmakers on the potential threat to the U.S. supply of heparin, the only anticoagulant drug used in the United States for open-heart surgeries and kidney dialysis.

July 31, 2019 | Daily News

The Trump administration’s newly unveiled two-track plan to allow drug importation was touted as a precedent-setting move by HHS officials, but some health policy experts said it could slow up state importation efforts through unnecessary rulemaking and do little to lower drug costs under the voluntary, industry-driven track.

July 30, 2019 | Daily News

Public Citizen wants the Federal Trade Commission (FTC) to block the merger between Mylan and Pfizer’s Upjohn, which the companies announced Monday (July 29).

July 30, 2019 | Daily News

The leaders of the Senate Finance and health committees met Tuesday (July 30) to begin cross-committee talks on drug pricing, the chairmen said.

July 29, 2019 | Daily News

Drug makers would pay a significantly larger share of costs in Medicare Part D under the Senate Finance Committee’s new drug-pricing plan, according to Senate Finance Chair Chuck Grassley’s (R-IA) office.

July 26, 2019 | Daily News

Senate Finance Chair Chuck Grassley (R-IA) on Thursday (July 25) warned fellow GOP senators that the drug pricing bill he negotiated with ranking Democrat Ron Wyden (OR) is moderate compared to policies being considered by the Trump administration and House Democrats.

July 25, 2019 | Daily News

Freedom Caucus Chair Mark Meadows (R-NC) said Thursday (July 25) it is “very likely” the Trump administration will take its own steps to lower drug prices in Part D, though the details are in flux. Meadows said he attended a drug-pricing meeting Wednesday between President Donald Trump and drug lobbyists that was first reported by Politico.

July 25, 2019 | Daily News

Thirteen Republican senators and one Democrat voted Thursday (July 25) to kill President Donald Trump’s plan to connect Medicare payment for physician-administered drugs to foreign drug prices in a rebuke of one of the administration’s last remaining drug-pricing policies.

July 25, 2019 | Daily News

In a tie vote, an amendment to repeal a key measure of the Senate Finance Committee’s drug-pricing bill failed Thursday (July 25).

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