Orphan Medical Lawsuit

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FDA’s Overview of Catalyst Pharms., Inc. v. Becerra | FDA

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/fdas-overview-catalyst-pharms-inc-v-becerra

Specifically, the court held that under the statute, ODE blocks approval of another company’s application for the same drug for the entire disease or condition for …

Recent US Court Decision Threatens Orphan Exclusivity …

https://www.arnoldporter.com/en/perspectives/advisories/2022/02/recent-decision-threatens-orphan-exclusivity

Under the orphan drug provisions of the Federal Food, Drug and Cosmetic Act (FDCA), a drug that is designated for a rare disease or condition and then …

Appeals court rules FDA 'capriciously' approved rare …

https://www.statnews.com/pharmalot/2021/09/30/fda-catalyst-jacobus-lems-rare-disease-orphan-drug/

The lawsuit was filed by Catalyst Pharmaceuticals ( CPRX ), which accused the agency of violating federal law two years ago when it unexpectedly approved a …

List of off-label promotion pharmaceutical settlements

https://en.wikipedia.org/wiki/List_of_off-label_promotion_pharmaceutical_settlements

Maker of Narcolepsy Drug Pleads Guilty in U.S. Case

https://www.nytimes.com/2007/07/14/business/14jazz.html

Jazz and the subsidiary, Orphan Medical, agreed to pay $20 million in fines and restitution to the federal government and private insurers. Jazz will also cooperate …

Pharma sues feds, again, over 340B hospital orphan …

https://www.healthcaredive.com/news/pharma-sues-feds-again-over-340b-hospital-orphan-drug-discount-rule/320497/

The Pharmaceutical Research and Manufacturers of America ( PhRMA) trade organization has filed another lawsuit against the U.S. Department of Health and Human …

Humira Lawsuits | 2022 Lawsuit Update

https://www.millerandzois.com/products-liability/drugs/other-drug-cases/humira/

Humira Lawsuits. Humira lawsuits have been talked about for more than ten years. Over those same ten years, lawyers have increasingly filed mass tort lawsuits claiming a drug …

Federal Investigation Into Spine Surgeries Uses Mob …

https://khn.org/news/article/federal-investigation-spine-surgeries-racketeering-law-health-care-fraud/

One of the first health care fraud prosecutions under the Travel Act took place in Texas and led to convictions on bribery and kickback charges of 14 people, including six doctors, associated with...

PhRMA Sues HRSA Over Orphan Drug Interpretative Rule

https://www.americanhealthcare.com/LatestNews/DNNArticleDetailView/tabid/179/ArticleId/56/PhRMA-Sues-HRSA-Over-Orphan-Drug-Interpretative-Rule.aspx

SNHPA STATEMENT ON PHRMA'S NEW LAWSUIT ON ORPHAN DRUGS October 9, 2014— Safety Net Hospitals for Pharmaceutical Access is disappointed that …

Three Pharmaceutical Companies Agree to Pay a Total …

https://www.justice.gov/opa/pr/three-pharmaceutical-companies-agree-pay-total-over-122-million-resolve-allegations-they-paid

The Department of Justice today announced that three pharmaceutical companies – Jazz Pharmaceuticals plc (Jazz), Lundbeck LLC (Lundbeck), and Alexion …

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