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Drug Pricing

December 15, 2017 | Daily News

The Federal Circuit dealt what appears to be the final death blow against Amgen's arguments in the suite of cases between the company and Sandoz over interpretation of the so-called biosimilar patent dance.

December 15, 2017 | Daily News

Congressional Medicaid advisers on Thursday (Dec. 14) debated the merits of policies on the calculation and oversight of drug rebates, including giving CMS more power over classifying drugs as brands for determining rebate amounts.

December 13, 2017 | Daily News

Representatives of the drug-distribution sectors argued over the causes of drug prices at a House Energy & Commerce health subcommittee hearing Wednesday (Dec. 13), but lawmakers were left with unanswered questions and committee Chair Greg Walden (R-OR) said the subcommittee will likely hold another hearing on drug prices early next year.

December 13, 2017 | Daily News

Brand drug companies and industry-supported patient advocacy groups are attempting to use FDA’s reexamination of the Hatch-Waxman drug patent framework to push for greater exclusivity protections, which would further delay potential generic competition.

December 13, 2017 | Daily News

The Association for Accessible Medicines wants FDA to exert greater pressure on brands thought to be manipulating Risk Evaluation and Mitigation Strategies (REMS) to block generic competition.

December 13, 2017 | Daily News

Neither the brand nor the generic drug lobby appear keen on FDA Commissioner Scott Gottlieb’s idea to publish the letters it sends to brand companies explaining that a potential generic competitor has adequate safety protections in place to be sold brand drug samples for the bioequivalence testing required as a prerequisite of generic approval.

December 12, 2017 | Daily News

A bipartisan group of six senators recently urged the upper chamber's leadership to include a provision to prevent a cut to hospital reimbursement for 340B drugs in an end-of-the-year package -- though it is unclear what legislation lawmakers may look to pass once the current continuing resolution runs out Dec. 22.

December 12, 2017 | Daily News

Sen. Rand Paul (R-KY) on Tuesday (Dec. 12) proposed letting drug companies offer varying up-front discounts because doing so would move industry away from rebates that are blamed for obscuring business deals many lobbyists and policy analysts say contribute to price increases.

December 11, 2017 | Daily News

FDA approved Monday (Dec. 11) the first fast-acting insulin to go through the abbreviated 505(b)(2) pathway, Sanofi-Aventis U.S.'s Admelog, a follow on to Lilly's blockbuster Humalog.

December 11, 2017 | Daily News

Brand drug makers on Friday (Dec. 8) challenged the constitutionality of a California drug-price transparency law.

December 06, 2017 | Daily News

A National Academy of Sciences report on ways to cut drug prices -- to be featured at a Senate health committee hearing next Tuesday (Dec. 12) -- includes proposals that run counter to the interests of brand drug makers, pharmacy benefit managers and health plans.

December 01, 2017 | Daily News

FDA has approved Mylan and Biocon’s Ogivri, the first U.S.-licensed biosimilar to Genentech’s Herceptin, and the first biosimilar approved to treat certain breast and stomach cancers.

December 01, 2017 | Daily News

FDA will set out in guidance a policy of allowing complex generics and the brand product they are copying to have different labels so long as those changes reflect solely design differences, Commissioner Scott Gottleib said this week.

December 01, 2017 | Daily News

FDA has fulfilled a promise it first made in 2016 to list patent submissions dates in the Orange Book, making it easier for generic companies to discern whether the patent will trigger certain required Hatch-Waxman steps.

November 29, 2017 | Daily News

HHS Secretary-nominee Alex Azar said Wednesday (Nov. 29) he wants to stop brand drug companies from thwarting generic competition by gaming the patent system and drug-approval policies; he'd consider applying design aspects of Part D to Part B drug coverage; and he opposes gag orders that keep pharmacies from telling customers when drugs are cheaper out of pocket than when bought with insurance.

November 29, 2017 | Daily News

HHS' Office of Inspector General Tuesday (Nov 28) rescinded an advisory opinion that allowed Caring Voice Coalition, a charitable entity that receives donations from the drug industry, to help consumers with drug expenses without violating federal anti-kickback statute after discovering the group apparently allowed its donors greater influence than it had disclosed.

November 28, 2017 | Daily News

Sen. Elizabeth Warren (D-MA) told HHS Secretary-nominee Alex Azar to bone up on drug-reimbursement policy the day before the Senate health committee’s courtesy hearing Wednesday (Nov. 29) on Azar’s nomination.

November 28, 2017 | Daily News

The HHS Inspector General recommends a legislative change that would lower beneficiary spending on drugs and save taxpayers money, but CMS opposes the change because on rare occasion it would make it difficult for doctors to infuse the drug of their choice.

November 22, 2017 | Daily News

As CMS considers testing approaches to curb rising drug prices, the Pharmaceutical Research and Manufacturers of America is trying to stop the agency from turning those pilots into national programs.

November 21, 2017 | Daily News

Patients should be told when co-pays are more than drug cash-prices, according to the American Medical Association.

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