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Legal News

West Virginia wants Justice Dept. to nix Mylan settlement

November 3, 2016 By Sarah Faulkner

Mylan

(Reuters) – West Virginia Attorney General Patrick Morrisey on Wednesday blasted a pending $465 million settlement between Mylan NV (NSDQ:MYL) and the U.S. Justice Dept. over the misclassification of the EpiPen, saying it was “woefully deficient.” In a Nov. 2 letter to Attorney General Loretta Lynch, Morrisey said the amount likely fell short of how […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Legal News Tagged With: Mylan

SEC launches probe, investors file suit against Mylan over EpiPen pricing

October 12, 2016 By Sarah Faulkner

Mylan

Despite a $465 million settlement with the U.S. Justice Dept., Mylan (NSDQ:MYL) is still under fire for misclassifying its EpiPen auto-injector with the Centers for Medicare & Medicaid Services. Last week, the Securities & Exchange Commission’s enforcement division launched an investigation into the Canonsburg, Pa.-based company’s history with CMS; yesterday investors filed a purported class […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Legal News Tagged With: Mylan

Mylan settles EpiPen pricing probe with $465m

October 11, 2016 By Sarah Faulkner

Mylan

Mylan (NSDQ:MYL) last week agreed to pay $465 million to settle claims that it underpaid Medicaid for its EpiPen auto-injector by misclassifying the device as a generic. Last week, the Centers for Medicare & Medicaid Services said it spent $797 million on the emergency allergy treatment between 2011 and 2015, including rebates. The Canonsburg, Pa.-based company has […]

Filed Under: Auto-injectors, Featured, Legal News, Regulatory/Compliance, Wall Street Beat Tagged With: Centers for Medicare and Medicaid Services (CMS), Mylan

CMS finds Mylan overcharged Medicaid for EpiPens for years

October 7, 2016 By Sarah Faulkner

Mylan

The Centers for Medicare & Medicaid Services said this week that Mylan Pharmaceuticals (NSDQ:MYL) has been overcharging Medicaid for its EpiPen auto-injector for years, despite being warned that it should have paid bigger rebates. CMS said that between 2011 and 2015, Medicaid spent $797 million on the epinephrine auto-injector after deducting rebates, marking the 1st […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Legal News, Policy Tagged With: Centers for Medicare and Medicaid Services (CMS), Mylan

Sanofi sues Merck over injected insulin

September 19, 2016 By Sarah Faulkner

Sanofi, Merck

Sanofi Aventis (NYSE:SNY) said today that it filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. (NYSE:MRK) over 10 U.S. patents related to its injected insulin device. The Paris-based company said it is seeking an injunction and damages from Merck for filing a new drug application with the FDA that challenged 10 of Sanofi’s patents […]

Filed Under: Diabetes, Drug-Device Combinations, Legal News Tagged With: Merck, Sanofi-Aventis

Mylan CEO to testify before House panel over EpiPen pricing

September 14, 2016 By drugdelivery

Mylan

(Reuters) –Mylan (NSDQ:MYL) Chief Executive Officer Heather Bresch will appear at a Sept. 21 congressional hearing over price increases for its EpiPen emergency allergy treatment, the U.S. House of Representatives Oversight Committee said in a statement on Wednesday. Mylan has been widely criticized, including by U.S. Democratic presidential candidate Hillary Clinton, for sharply raising the price […]

Filed Under: Drug-Device Combinations, Legal News, Wall Street Beat Tagged With: Mylan

Parents file lawsuit against Mylan over EpiPen ‘price-gouging’

September 7, 2016 By Sarah Faulkner

A parent in Ohio reportedly leveled a class-action lawsuit against EpiPen maker Mylan (NSDQ:MYL) over the nearly 500% increase in the cost of the epinephrine injector since Mylan acquired the device in 2007. The suit, filed yesterday in Hamilton County Common Pleas Court, seeks an unspecified amount of damages for its 25 plaintiffs, according to Cincinnati.com. […]

Filed Under: Drug-Device Combinations, Legal News Tagged With: Mylan

Unilife: Ex-CEO Shortall’s shenanigans exposed ‘material weaknesses’

September 2, 2016 By Brad Perriello

Shares in Unilife (NSDQ:UNIS) are off 7% this week after the company said its investigation into former CEO Alan Shortall turned up “material weaknesses” in its bookkeeping procedures that will require it to restate some of its financials. Shortall, who left the company in March along with COO Ramin Mojdeh, was elevated to chairman in 2013. In May, […]

Filed Under: Drug-Device Combinations, Legal News, Wall Street Beat Tagged With: Personnel Moves, Unilife Corp.

J&J’s Acclarent to pay $18m over off-label marketing charges

July 22, 2016 By Fink Densford

Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent will pay $18 million to resolve allegations over false claims submitted to Medicare and other federal health care programs in relation to marketing its Relieva Stratus MicroFlow sinus spacer as a drug-delivery device without FDA clearance. The company won FDA clearance in 2006 to market the Stratus as a […]

Filed Under: Drug-Device Combinations, Legal News Tagged With: Acclarent Inc., johnsonandjohnson

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