FDA accepts Mylan, BioCon’s biosimilar trastuzumab BLA

Thursday, January 12, 2017

Mylan and Biocon has announced that the FDA accepted Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.

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Congresswoman DeLauro proposes pharma price legislation

Tuesday, October 18, 2016

Congresswoman Rosa DeLauro (CT-03) has announced the Prescription Drug and Medical Device Review Board Act, new legislation that would create a national review board to stop pharmaceutical corporations from charging consumers excessive prices. According to a recent report released by IMS Health Holdings, annual spending on prescription medications has skyrocketed in the U.S. in recent years, and is projected to increase by 22% over the next five years, climbing to as high as $400 billion by 2020.

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Mylan to launch generic EpiPen for $300

Tuesday, August 30, 2016

Mylan has announced that its U.S. subsidiary will launch the first generic to EpiPen Auto-Injector (epinephrine injection, USP) at a list price of $300 per generic EpiPen two-pack carton, which represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost (WAC), of the branded medicine. [Read More]

Mylan acquires Famy Care businesses

Monday, November 23, 2015

Mylan Laboratories, a subsidiary of Mylan, has successfully completed the acquisition of certain women’s healthcare businesses, now known as Jai Pharma, which were spun off from Famy Care. The transaction brings Mylan a broad women’s care portfolio, strong technical capabilities and dedicated hormone manufacturing, which, when combined with Mylan’s expansive global commercial footprint and supply chain infrastructure, will create a leading women’s healthcare franchise.

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Mylan cleared by FTC to acquire Perrigo

Thursday, November 5, 2015

Mylan has announced the U.S. Federal Trade Commission (FTC) has cleared the company’s proposed transaction to acquire Perrigo subject to Mylan’s divestiture of certain products following the consummation of the offer. The FTC clearance represents the final regulatory clearance needed by Mylan to close its acquisition of Perrigo and represents the last remaining condition that needs to be satisfied for the successful completion of the offer other than the acceptance condition.

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