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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

Committee pens letter to Mylan demanding EpiPen price info

October 4, 2016 By Sarah Faulkner

Mylan

Members of the U.S. House Committee on Oversight & Government Reform penned a letter to Mylan (NSDQ:MYL) demanding a more complete look at the pricing of its EpiPen epinephrine auto-injector. At a Sept. 21 congressional hearing, Mylan CEO Heather Bresch testified that the company makes a $100 profit per 2-pack of EpiPens. Last week, Mylan […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured Tagged With: Capitol Hill, Mylan

Mylan clarifies $104 profit on $600 EpiPens

September 27, 2016 By Sarah Faulkner

Mylan

Mylan (NSDQ:MYL) acknowledged that the $104 profit it reported to Congress included taxes, after the Wall Street Journal reported that the company applied the statutory U.S. tax rate of 37.5% to calculate its profits for testimony before the Senate, according to Reuters. “Without the tax-related reduction, Mylan’s profits on the EpiPen 2-pack would be closer […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Wall Street Beat Tagged With: Capitol Hill, Mylan

Parents question Mylan’s EpiPen school campaign

September 23, 2016 By Sarah Faulkner

Mylan

Three years ago, Mylan (NSDQ:MYL) began holding summits for food allergy bloggers to learn about its campaign to get its EpiPen epinephrine injector into schools. Many of the bloggers, mothers of children with serious allergies, were eager to help. Some, including Ruth LovettSmith, wrote thousands of posts, providing testimony that some legislators say convinced them […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Mylan

Sancilio withdraws $86m IPO for lipid-based drug delivery

September 19, 2016 By Sarah Faulkner

Sancilio

Sancilio Pharmaceuticals last week withdrew its plans for an initial public offering it hoped would bring in $86 million for its Advanced Lipid Technology drug delivery platform. The Florida-based company registered the IPO in August 2015, but today requested that the SEC consent to its withdrawal, without giving a specific reason. The company’s drug delivery […]

Filed Under: Drug-Device Combinations, Funding Roundup, Initial Public Offering (IPO), Wall Street Beat Tagged With: Mylan, Sancilio Pharmaceuticals, TherapeuticsMD

Minnesota doc creates $50 EpiPen alternative

September 16, 2016 By Sarah Faulkner

AllergyStop

A Minnesota doctor reportedly created a $50 EpiPen alternative and is trying to raise money to bring it to patients. Dr. Douglas McMahon, who has severe food allergies, told CBS Minnesota that he was hesitant to carry his EpiPen because it was so bulky. As a certified allergy specialist, McMahon began constructing an alternative in his […]

Filed Under: Drug-Device Combinations, Research & Development Tagged With: AllergyStop, Mylan

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

Teva plans competitor for Mylan’s EpiPen

September 12, 2016 By Sarah Faulkner

Teva Pharmaceuticals, Mylan

Teva Pharmaceutical (NYSE:TEVA) said last week that it hopes to win U.S. approval for its version of Mylan‘s (NSDQ:MYL) EpiPen by late 2017 or early 2018. Mylan’s EpiPen holds an estimated 94% market share in the U.S.; an alternate device from Teva could threaten the product’s dominance. Teva’s application for its epinephrine injector has been […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Wall Street Beat Tagged With: Mylan, Teva Pharmaceuticals

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