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The Courts

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 11, 2017 | Daily News

Clinical laboratories on Monday (Dec. 11) sued the government over the fee schedule for tests.

December 11, 2017 | Daily News

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

November 28, 2017 | Daily News

The U.S. Supreme Court heard oral arguments Monday (Nov. 27) in a highly watched case set to determine whether the inter partes review process commonly used by generic drug stakeholders to clear the way for generic competition is unconstitutional given such cases are not subject to the same guardrails placed on federal courts.

November 28, 2017 | Daily News

In the wake of arguments over whether the inter partes review process is constitutional, the Supreme Court also heard Monday (Nov. 27) another IPR case that one justice claimed is an attempt to get around precedent that bars parties from challenging the Patent Trial and Appeal Board's non-institution decisions, and counsel for the government argued could be used to stall district court patent litigation -- although one attorney cautioned that this may have less of an effect in Hatch-Waxman cases.

November 13, 2017 | Daily News

Hospitals are asking the federal D.C. district court to make CMS scrap its hospital reimbursement cuts for 340B drugs or at least suspend the cuts until the providers' lawsuit is resolved.

November 10, 2017 | Daily News

A group of Democratic attorneys general are asking a federal judge to block implementation of the Trump administration's new regulations that broaden the ability of employers to end no-cost coverage of birth control, saying the regulations are arbitrary, violate Constitutional protections and will increase costs to states thus causing irreparable harm.

October 30, 2017 | Daily News

The Trump administration and House GOP are asking the DC federal appeals court to keep a high-profile case over the ACA's cost-sharing reduction payments on ice as they actively discuss a resolution, but a coalition of Democratic attorneys general, upset by the Trump administration's decision to stop the payments, want the court to proceed with the case -- now called House v Hargan.

October 27, 2017 | Daily News

Endo Pharmaceuticals and subsidy Par Sterile Products are suing FDA to block the agency's current interim policy on compounding of bulk substances by outsourcers, which they argue ignores congressional intent under the Drug Quality and Security Act (DQSA) and violates drug law by allowing copies of FDA-approved drugs to be compounded in bulk while bypassing the FDA approval process

October 27, 2017 | Daily News

Endo Pharmaceuticals and subsidy Par Sterile Products are suing FDA to block the agency's current interim policy on compounding of bulk substances by outsourcers, which they argue ignores congressional intent under the Drug Quality and Security Act (DQSA) and violates drug law by allowing copies of FDA-approved drugs to be compounded in bulk while bypassing the FDA approval process

October 25, 2017 | Daily News

The federal U.S. District Court of Northern California Wednesday (Oct. 25) rejected a coalition of state Democratic attorneys' general request to issue a temporary restraining order that would force the administration to continue paying out the cost-sharing reductions, and the judge says that issuers' moves to protect themselves from the loss of CSRs means that stopping the money would not cause “irreparable harm.”

October 25, 2017 | Daily News

The federal U.S. District Court of Northern California Wednesday (Oct. 25) rejected a coalition of state Democratic attorneys' general request to issue a temporary restraining order that would force the administration to continue paying out the cost-sharing reductions, and the judge says that issuers' moves to protect themselves from the loss of CSRs means that stopping the money would not cause “irreparable harm.”

October 25, 2017 | Daily News

The Trump administration told the Northern California federal district court that issuers in the majority of states priced their insurance products to reflect the loss of cost-sharing reduction payments either prior to HHS' official announcement that they would end, or in one-time rating changes allowed after the decision.

October 20, 2017 | Daily News

The Department of Justice on Friday (Oct. 20) asked the federal district court in Northern California to deny a request by Democratic attorneys general for an emergency injunction to stop the administration from ending cost-sharing reduction payments.

October 19, 2017 | Daily News

The U.S. District Court of Northern California ordered the Trump administration to justify its decision to stop paying the cost-sharing reduction subsidies and defend its position against insurers who could sue the government for breach of contract under the Tucker Act.

October 18, 2017 | Daily News

A coalition of Democratic attorneys general are seeking a temporary restraining order that would force the administration to continue paying out the cost-sharing reduction payments, arguing the coalition is likely to succeed on the merits of their case and failure to take action would cause irreparable harm to residents.

October 17, 2017 | Daily News

The American Civil Liberties Union (ACLU) Foundation and ACLU of Hawaii Foundation, representing a medical professional and other health organizations, have sued HHS and FDA for what the plaintiffs say are inappropriate and unnecessary Risk Evaluation and Mitigation Strategies (REMS) restrictions on Danco Laboratories' Mifeprex -- also known as the “abortion pill” -- that limit patient access.

October 16, 2017 | Daily News

Watchdog group Democracy Forward sued the White House Office of Management and Budget for information on the role OMB Associate Director of Health Programs Joseph Grogan played in the delays of the Obama administration's 340B drug ceiling price and manufacturer penalty rule.

October 13, 2017 | Daily News

The suit that more than a dozen Democratic attorneys general filed Friday (Oct. 13) to block President Donald Trump from cutting off the Affordable Care Act's cost-sharing reduction payments argues that the law requires the government to pay those subsidies.

October 12, 2017 | Daily News

A federal circuit judge has reversed a lower court's recent controversial decision to order a biologic cholesterol medication to be taken off the market in response to a patent challenge.

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