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The Lead

Mylan Offers About $29B For Rival Generic Drugmaker Perrigo

April 8, 2015 2:28 pm | by MARLEY JAY, AP Business Writer | News | Comments

In a deal that would combine two generic drugmakers that recently left the U.S. for Europe, Mylan says it wants to buy Perrigo for $205 per share, or $28.86 billion.

Watchdog Group Seeks US Ban of Antifungal Tablets

February 24, 2015 11:34 am | News | Comments

A consumer safety group is calling on the U.S Food and Drug Administration to pull certain...

Mylan Signs Exclusive Agreement with Gilead Sciences to Distribute Sovaldi and Harvoni in India

February 23, 2015 8:13 am | News | Comments

Mylan announced that its Indian subsidiary, Mylan Pharmaceuticals Private Limited, has entered...

Mylan Buying Women's Health Care Businesses for $750M

February 2, 2015 8:11 am | News | Comments

Mylan is buying some women's health care businesses from Indian health care company Famy Care...

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Mylan Shareholders Approve Abbott Business Purchase

January 29, 2015 1:13 pm | News | Comments

Mylan announced that its shareholders approved its purchase of an Abbott Laboratories business and its tax-reducing move to the Netherlands. The company also said European Union regulators cleared the deal, which Mylan values at about $5.3 billion.

Mylan Launches First Generic Version of Vivelle-DOT

December 29, 2014 2:49 pm | News | Comments

Mylan has announced the U.S. launch of its Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day (Twice Weekly), which is the generic version of Novartis' Vivelle-DOT®.      

FDA Tentatively Approves Mylan’s Pediatric Formulations of Abacavir/Lamivudine for HIV

December 4, 2014 10:22 am | News | Comments

Mylan has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients.

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Mylan and Gilead to Enhance Access to HIV Treatments in Developing Countries

December 1, 2014 8:29 am | News | Comments

Mylan has entered into an agreement with Gilead Sciences under which Mylan has licensed the non-exclusive rights to manufacture and distribute Tenofovir Alafenamide (TAF) as both a single agent product and in combination with other drugs.   

Mylan Files Patent Challenge Relating to BREVIBLOC(R)

November 25, 2014 11:07 am | News | Comments

Mylan has confirmed that it and several subsidiaries have been sued by several Baxter subsidiaries in connection with the filing of an Abbreviated New Drug Application (ANDA) with the FDA for Esmolol HCl in Sodium Chloride Injection.    

Mylan Beats Wall Street Third Quarter Forecasts

October 31, 2014 8:48 am | News | Comments

Mylan has reported earnings of $499.1 million in its third quarter. On a per-share basis, the Canonsburg, Pennsylvania-based company said it had profit of $1.26. Earnings, adjusted for one-time gains and costs, came to $1.16 per share.   

Mylan Recalls Some Lots of Nitroglycerin Spray Used to Treat Angina

October 15, 2014 2:14 pm | by The Canadian Press | News | Comments

Some lots of the product, called Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose, are potentially missing the dip tube, a part of the pump component. A missing dip tube could pose a problem with delivery of nitroglycerin to the patient.  

Mylan Commences Clinical Trials for Generic Versions of Advair Diskus and Insulin Analog to Lantus

September 16, 2014 8:59 am | News | Comments

Mylan today announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's Advair Diskus and its insulin analog to Sanofi's Lantus. In October 2014, Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.

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Mylan to Pay $300M for U.S. Rights to Arixtra Injection

September 10, 2014 7:59 am | News | Comments

Mylan has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra® (fondaparinux sodium) Injection and the authorized generic (AG) of Arixtra from Aspen Global Incorporated.

Mylan Second Quarter Profit Drops 30%

August 7, 2014 7:35 am | by The Associated Press | News | Comments

Mylan reported profit that declined by 30 percent in its second quarter, and missed analysts' expectations. The Canonsburg, Pennsylvania-based company said net income fell to $125.2 million, or 32 cents per share, from $177.7 million, or 46 cents per share.

Mylan to Buy Abbott's Generic Drugs Business in $5.3B Deal

July 14, 2014 8:17 am | News | Comments

Mylan said Monday that the deal will diversify and expand its business outside the U.S. The combined company will be organized in the Netherlands, which will help reduce its tax expenses, while maintaining its headquarters near Pittsburgh.  

Mylan First Quarter Profit up 8%, Eyeing Acquisitions

May 1, 2014 11:34 am | News | Comments

Mylan's first-quarter net income rose about 8 percent, and the generic drugmaker said Thursday that it is still hunting for acquisitions and it expects to pull off a "substantial transaction" this year.        

Meda Rejects Revised Offer from Mylan

April 28, 2014 7:33 am | by The Associated Press | News | Comments

Swedish pharmaceutical company Meda says it has rejected another offer from U.S. generic drugmaker Mylan Inc. Meda says its board decided to reject a revised Mylan proposal because the deal lacks support from Meda's largest shareholder, which the company did not name in a brief statement.

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Mylan Launches Generic ORTHO EVRA Patch

April 17, 2014 8:48 am | News | Comments

Mylan has launched XULANET, the generic version of Janssen Pharmaceuticals Inc.'s ORTHO EVRA (Norelgestromin / Ethinyl Estradiol Transdermal System 150/35 mcg per day).              

Prosonix Licenses Products to Mylan

April 15, 2014 8:45 am | News | Comments

PSX1001 and PSX1050, which are the first products to emerge from Prosonix's innovative and proprietary particle engineering platform, are being developed as generic versions to GlaxoSmithKline's pressurized metered dose inhalers (pMDI) Flixotide® and Flovent®, respectively.

Meda Turns Down Mylan

April 4, 2014 10:57 am | News | Comments

Swedish drug company Meda has rebuffed an approach from generic drug maker Mylan which was looking to combine the two businesses. Meda AB says talks between the two companies have stopped "without further actions."          

Supreme Court Takes Up Drug Company Dispute

March 31, 2014 10:11 am | News | Comments

The justices agreed Monday to hear an appeal from Teva Pharmaceutical Industries Ltd., which claims the U.S. Court of Appeals for the Federal Circuit wrongly overturned five of its patents for the drug Copaxone.      

Mylan Wins Breach of Contract Case Against GSK

March 27, 2014 8:50 am | News | Comments

Mylan has announced that, after a trial in the United States District Court for the District of New Jersey, a jury returned a verdict in favor of Mylan in its breach of contract lawsuit against GSK relating to Paroxetine Hydrochloride Extended-release (ER) Tablets.

Court Upholds Mylan's Patents on Perforomist Inhalation Solution

March 25, 2014 7:26 am | News | Comments

Mylan Inc. has announced the United States District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist (formoterol fumarate) Inhalation Solution.

Mylan Fourth Quarter Profit Jumps 11%

February 27, 2014 9:02 am | News | Comments

Shares of Mylan Inc. jumped in premarket trading Thursday as the generic drugmaker reported an 11 percent increase in its fourth-quarter earnings, topping expectations despite a rise in expenses.         

Mylan Recalls 10 Lots of Etomidate Injection

February 14, 2014 1:26 pm | News | Comments

Mylan has announced that its subsidiary Agila Specialties Private Limited is conducting a voluntary nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL - 10 mL and 20 mL.        

Mylan Named as Gilead's Business Partner for India

January 31, 2014 8:30 am | News | Comments

Mylan Inc. has announced that its India-based subsidiary Mylan Pharmaceuticals Private Limited has been named Gilead Sciences, Inc.'s exclusive branded medicines business partner for India.          

Rakesh Bamzai Joins Mylan as President, India Commercial and Emerging Markets

January 3, 2014 8:32 am | News | Comments

Bamzai has more than 20 years of experience in the Indian and global biopharmaceutical industry. Prior to joining Mylan, he was president of Marketing at Biocon, where he played a key role in building the company's global biopharmaceutical business.

Mylan-Biocon Receive First Indian Biosimilar Regulatory Approval for Herceptin

November 25, 2013 2:25 pm | News | Comments

Mylan has announced that its partner Biocon has received approval for a Mylan-Biocon trastuzumab product from the Drug Controller General of India. This is the first regulatory approval for a Mylan-Biocon developed biosimilar product. The product is a biosimilar to Roche's Herceptin, indicated for the treatment of HER2 overexpressing breast cancer.

Teva Announces Favorable Court Ruling in AZILECT® Patent Infringement Litigation

September 23, 2013 9:16 am | News | Comments

Teva Pharmaceutical today announced the U.S. District Court for the District of New Jersey has issued a favorable ruling in the company’s patent infringement lawsuit against Mylan regarding an AZILECT ® (rasagiline tablets) patent which covers methods of treating Parkinson’s disease (PD).

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