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Rx Drugs

August 12, 2019 | Daily News

The controversial inflationary rebate policy in the Senate Finance Committee’s drug-pricing package could incentivize drug makers to raise prices before the bill would take effect in 2022, sources say.

August 12, 2019 | Daily News

Brand drug makers’ return to price hikes this year helped CVS Health’s pharmacy benefit manager make a lot more money from rebates in the second quarter of this year than Wall Street expected, according to the company’s second quarter earnings report.

August 09, 2019 | Daily News

A group of five senators, including 2020 presidential hopefuls Elizabeth Warren (D-MA) and Bernie Sanders (I-VT), pilloried drug-maker AveXis on Friday (Aug. 9) for not telling FDA it had manipulated testing data for its new gene therapy drug, Zolgensma, until after the drug’s approval.

August 08, 2019 | Daily News

Some generic drug stakeholders told Congress’ oversight arm that brand-drug makers are strategically timing labeling changes as a ploy to stall generic drug competition.

August 08, 2019 | Daily News

Proposals with bipartisan support have been left out of the trifecta of Senate drug-pricing bills, including legislation to require that drug makers disclose list prices in television ads and to ban agreements between generic and brand drug makers that delay generic competition.

August 08, 2019 | Daily News

Senate Finance Committee Chair Chuck Grassley (R-IA) is pressing FDA to resume surprise inspections of foreign drug manufacturing facilities as part of the administration’s newly unveiled plan to allow prescription drug imports.

August 08, 2019 | Daily News

Patient advocates and a panel of experts on Wednesday (Aug. 7) laid out a host of concerns with drug maker Gilead’s proposal to allow its already-approved HIV drug Descovy to be used for pre-exposure prophylaxis (PrEP).

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.

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