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The Courts

October 30, 2015 | Daily News

Amarin Pharma Inc. and FDA asked a federal judge Friday (Oct. 30) to give them more time to reach a settlement in the off-label promotion case filed by the drug maker against the agency. In a filing with the Federal District Court for the Southern District of New York, an attorney for Amarin asked the judge to extend a stay in the case until Dec. 17.

October 30, 2015 | Daily News

FDA recently pulled from its website an off-label promotion warning letter to Pacira Pharmaceuticals Inc. that was the basis of a lawsuit against the agency, as court records indicate the two are working towards a settlement in the case filed by the company in September.

October 29, 2015 | Daily News

In the wake of a Supreme Court ruling earlier this year that providers cannot sue states over inadequate Medicaid pay rates, CMS on Thursday (Oct. 29) finalized a long-awaited rule from 2011 laying out requirements for states to provide information that would help CMS ensure changes to provider pay rates don't hurt beneficiaries' access to care.

October 23, 2015 | Daily News

Industry attorneys are heralding a recent step by FDA to quietly change the intended use regulation as a small but meaningful and long overdue action.

October 22, 2015 | Daily News

Texas, Kansas, and Louisiana are suing the federal government over an Obamacare health insurer fee levied against companies that manage state Medicaid and CHIP programs.

October 19, 2015 | Daily News

A federal judge on Monday (Oct. 19) rejected the Obama administration's request for an immediate appeal of the court's Sept. 9 decision that the House has standing to proceed with its lawsuit charging the administration illegally spent money on the Affordable Care Act's cost-sharing reduction, or CSR, program.

October 16, 2015 | Daily News

The Federal Circuit appeals court shot down requests by Amgen and Sandoz for the full court to hear a high-profile biosimilars case on the Biologic Price Competition and Innovation Act's patent dance provisions.

October 09, 2015 | Daily News

The Center for Science in the Public Interest sued FDA Thursday (Oct. 9) demanding the agency respond to the group's 2005 citizen petition calling for stricter controls over salt levels in food.

September 23, 2015 | Daily News

A federal district court has given HHS until Oct. 1 to meet with hospitals to come up with a time table to re-issue a Medicare rule that contained a controversial two-midnights hospital inpatient admissions policy in order to give hospitals more opportunity to comment, according to the American Hospital Association.

September 11, 2015 | Daily News

A number of industry stakeholders have filed briefs weighing in on appeals by Amgen and Sandoz for an en banc federal appeals court hearing of their litigation concerning the biosimilar pathway, with many fellow biosimilar companies siding with Sandoz in its push for a reversal of the court's ruling that the law's 180-day marketing notice is only effective after licensure.

September 09, 2015 | Daily News

The U.S. House of Representatives' lawsuit claiming the Obama administration illegally disbursed cost-sharing reduction payments to health insurers without congressional approval can go forward, a federal district court ruled in House v. Burwell on Wednesday (Sept. 9).

September 09, 2015 | Daily News

Pacira Pharmaceuticals Inc. filed suit against FDA in federal district court Tuesday (Sept. 8) alleging the agency has violated the Administrative Procedure Act, its own guidance and the First and Fifth Amendments by not allowing the company to promote its post-surgical analgesia product Exparel for its approved indications.

August 31, 2015 | Daily News

Sandoz pushed back against Amgen's “emergency motion” to block the biosimilar sponsor from bringing its filgrastim product Zarxio to market on Sept. 3, saying in court documents Monday (Aug. 31) that a further marketing delay would cause cancer patients significant harm.

August 31, 2015 | Daily News

A federal circuit court judge agreed Monday (Aug. 31) to give Amarin Pharma Inc. and FDA until the end of October to come up with a settlement in a high-profile case that gave the manufacturer wide latitude to promote its triglyceride-lowering drug Vascepa off-label.

August 28, 2015 | Daily News

Lawyers on both sides of U.S. House of Representatives v. Burwell are sparring over whether federal district court Judge Rosemary Collyer should grant a motion to strike what the plaintiffs believe was an “unauthorized” response from defendants to their notice of new supplemental authority filed June 30.

August 18, 2015 | Daily News

The Pharmaceutical Care Management Association, which represents pharmacy benefit managers, is suing Arkansas in a bid to stop implementation of a law the group says would guarantee pharmacies make a profit on every generic drug they dispense.

August 14, 2015 | Daily News

Public Citizen worries that a federal district court judge's ruling last week allowing Amarin Pharma Inc. to promote its triglyceride-lowering drug Vascepa off-label will undermine FDA's regulatory authority to ensure the safety and efficacy of prescription drugs.

August 07, 2015 | Daily News

A federal district court judge ruled Friday (Aug. 7) in a closely watched off-label promotion case that Amarin Pharma Inc. can promote its drug Vascepa to health care professionals for off-label uses as long as the drug maker's statements are truthful and non-misleading.

July 08, 2015 | Daily News

NEW YORK -- U.S. District Court Judge Paul Engelmayer prodded Amarin Pharma, Inc. and FDA Tuesday (June 7) to come to terms on disclaimer language the pharmaceutical company can use if it wants to share information with doctors on off-label use of its Vascepa product, but the parties didn't budge as he heard oral arguments in Amarin’s request for a preliminary injunction shielding the company from criminal prosecution in its suit filed against the agency in May.

July 07, 2015 | Daily News

Several health and employer benefit experts have varying opinions on whether the Supreme Court decision that essentially seals the public exchanges -- and accompanying subsidies -- into the fabric of the health care systems for the foreseeable future will result in more employers opting to push workers to those exchanges.

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