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Rx Drugs

October 16, 2018 | Daily News

It's not clear how, or if, HHS' proposed drug-price disclosure requirement for TV ads will be enforced, consultants and lawyers say.

October 16, 2018 | Daily News

FDA on Tuesday (Oct. 16) issued a draft guidance in a bid to help drug firms share consumer-friendly efficacy and risk data in their direct-to-consumer (DTC) promotional labeling and advertisements.

October 16, 2018 | Daily News

An FDA advisory committee on Friday (Oct. 12) determined that the benefits of a proposed new sufentanil sublingual tablet support the product's approval, overriding three panel members who disagreed.

October 16, 2018 | Daily News

Michigan has asked CMS for permission to enter into outcomes-based contracts with drug manufacturers under its Medicaid program, Michigan Department of Health and Human Services spokesman Bob Wheaton confirmed Monday (Oct. 15).

October 15, 2018 | Daily News

HHS is relying on Medicare and Medicaid law to require brands to post drug prices in TV ads and is counting on drug companies to sue each other when they don’t, HHS officials said Monday (Oct. 15).

October 15, 2018 | Daily News

FDA Commissioner Scott Gottlieb announced two new guidances Monday (Oct. 15) aimed at guiding industry on how to design clinical trials and medical products that use two new technologies: minimal residual disease (MRD) biomarkers and the tracking of molecular changes that cause diseases.

October 15, 2018 | Daily News

TV drug ads will direct consumers to company websites that include information on drug prices, including list prices and estimated out-of-pocket costs, as part of a voluntary program that all 33 companies in the Pharmaceutical Research and Manufacturers of America have agreed to.

October 15, 2018 | Daily News

Brand drug makers are warning against relying on 340B hospitals to execute Louisiana’s plan to pay a subscription for an unlimited supply of hepatitis C drugs over a fixed period.

October 12, 2018 | Daily News

Pew Charitable Trusts says states could use a subscription-based model to buy hepatitis C drugs without triggering the Medicaid best price law by routing the medications through 340B hospitals.

October 12, 2018 | Daily News

Merck is discontinuing its insulin biosimilar Lusduna, the company announced Thursday (Oct. 11), but, unlike most biologics, insulin is covered by Medicare Part D instead of Part B where biosimilar makers can make a bigger profit, so the Lusduna discontinuation is not seen as a bellwether of biosimilar market erosion, brand drug and analyst sources said.

October 11, 2018 | Daily News

FDA's move toward developing more product-specific guidances rather than establishing policy through citizen petition responses may cause delays in agency policy development and leave industry left with unanswered questions, especially in the combination products space, one industry representative argued at a recent conference.

October 11, 2018 | Daily News

Patient advocates plan to meet with HHS officials in the coming weeks to make their case against what they say is an increasingly common insurance industry practice of preventing drug company financial assistance from counting toward consumers’ deductibles and out-of-pocket spending limits.

October 11, 2018 | Daily News

Newly minted Supreme Court Justice Brett Kavanaugh could play a pivotal role in deciding two key cases related to the pharmaceutical industry in the upcoming term.

October 10, 2018 | Daily News

Industry lawyers say it is not clear whether Congress' expansion of the sunshine law's reporting requirements to include industry payments to health professionals beyond doctors will kick in in 2021 or 2022.

October 10, 2018 | Daily News

The Justice Department on Wednesday (Oct. 10) approved the $69 billion merger of CVS Health Corporation and Aetna, two of the largest companies in the prescription drug market, but Aetna must sell its Medicare Part D plans that cover 1.5 million people to WellCare Health Plans, and Aetna may not sell new Medicare drug plans in 2020.

October 10, 2018 | Daily News

The Justice Department on Wednesday (Oct. 10) approved the $69 billion merger of CVS Health Corporation and Aetna, two of the largest companies in the prescription drug market, but Aetna must sell its Medicare Part D plans that cover 1.5 million people to WellCare Health Plans, and Aetna may not sell new Medicare drug plans in 2020.

October 09, 2018 | Daily News

FDA released a slate of guidance documents on Tuesday (Oct. 9) aimed at advancing development of complex generic drug products, which tend to be more difficult to formulate, manufacture and “genericize” than other generics, FDA Commissioner Scott Gottlieb said Tuesday.

October 05, 2018 | Daily News

CVS next year will offer a Part D plan that shares drug rebates at the point of sale, and the monthly premium for the plan is $80 in the Washington area, compared to the $32.50 national average Part D premium, though the CVS plan offers more generous benefits than basic drug plans.

October 05, 2018 | Daily News

A nonpartisan forum of state policy advisers will hire a consultant next month to help a handful of states create drug price transparency programs, and in turn hopes to develop a plan that other states could use to require price transparency -- an issue likewise central in the national drug-pricing debate.

October 04, 2018 | Daily News

The White House budget office is reviewing the final physician fee schedule and Part B pay rule, with stakeholders bracing for the possible inclusion of controversial drug-pricing measures.

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