Content about Heather Bresch

March 25, 2014

Mylan on Monday announced the U.S. District Court for the Northern District of West Virginia ruled in favor of upholding the validity of patents protecting Perforomist (formoterol fumarate) Inhalation Solution.

PITTSBURGH — Mylan on Monday announced the U.S. District Court for the Northern District of West Virginia ruled in favor of upholding the validity of patents protecting Perforomist (formoterol fumarate) Inhalation Solution. Mylan previously sued Teva alleging that Teva's abbreviated new drug application for this product infringed four Mylan patents covering Perforomist.  

The court's decision prevents Teva's ANDA, which has yet to receive a tentative approval from the Food and Drug Administration. 

January 8, 2014

Generic drug maker Mylan has hired a former Pfizer executive to its executive leadership team.

PITTSBURGH — Generic drug maker Mylan has hired a former Pfizer executive to its executive leadership team.

The company announced Wednesday the appointment of Adele Gulf as EVP global collaboration and strategic operations. Before working for Mylan, Gulfo served as regional president of Latin America for Pfizer's Emerging Markets Business Unit, overseeing more than 4,000 employees in 23 countries and achieving more than $3 billion in sales in Latin America in 2012.

December 18, 2013

Mylan has acquired rights to an experimental respiratory drug made by Pfizer, Mylan said.

PITTSBURGH — Mylan has acquired rights to an experimental respiratory drug made by Pfizer, Mylan said Wednesday.

The drug maker said it had bought exclusive worldwide development, manufacturing and commercialization rights to the drug, which was not named, but was described as a long-acting muscarinic antagonist about to enter phase-2b, or mid-stage, clinical trials. Mylan said it would develop the drug into combination therapies and that they would use a multidose dry powder inhaler technology, also licensed from Pfizer.

December 5, 2013

Mylan has completed its acquisition of the injectables business of Strides Arcolab, a deal worth nearly $2 billion, the drug maker said.

PITTSBURGH — Mylan has completed its acquisition of the injectables business of Strides Arcolab, a deal worth nearly $2 billion, the drug maker said.

Mylan said the acquisition of Agila could cost up to $1.75 billion, including a $250 million contingent consideration. As part of the acquisition, Mylan will gain full commercialization rights for most of Agila's U.S. portfolio of experimental and marketed products, including cancer drugs, as well as significant product rights in Canada, Australia, Brazil, Japan and South Korea.

November 14, 2013

New legislation signed into law Wednesday encourages states to adopt laws allowing schools to maintain a supply of emergency treatments for life-threatening allergy attacks.

NEW YORK — New legislation signed into law Wednesday encourages states to adopt laws allowing schools to maintain a supply of emergency treatments for life-threatening allergy attacks.

Barack Obama signed the School Access to Emergency Epinephrine Act, under which schools could maintain a supply of epinephrine, which is the only first-line treatment for life-threatening allergic reactions, also known as anaphylaxis.

The legislation received praise from Mylan, a drug maker that produces EpiPen, a popular epinephrine injector pen.

October 31, 2013

Mylan experienced a slight dip in sales in its third quarter, due primarily to fluctuating currency values, the generic drug maker said Thursday.

PITTSBURGH — Mylan experienced a slight dip in sales in its third quarter, due primarily to fluctuating currency values, the generic drug maker said Thursday.

October 17, 2013

Generic drug maker Mylan has appointed Jacek Glinka as president of its European division, the company said Thursday.

PITTSBURGH — Generic drug maker Mylan has appointed Jacek Glinka as president of its European division, the company said Thursday.

Glinka's appointment becomes effective Dec. 2. Before joining Mylan, he was CEO of Polpharma Group from 2003 to 2006 and again from 2009 until this year, helping the company expand from a small, local company to a leading drug company in central and eastern Europe, the Caucasus and Central Asia. The company became a leader in the Polish market and doubled its sales to more than $1 billion between 2011 and 2013.

September 3, 2013

Indian regulators have approved a deal from Mylan to buy the injectables business of Strides Arcolab, Mylan said Tuesday.

PITTSBURGH — Indian regulators have approved a deal from Mylan to buy the injectables business of Strides Arcolab, Mylan said Tuesday.

Following the approval of Agila by India's Foreign Investment Promotion Board, Mylan also received approval from the Cabinet Committee on Economic Affairs. The deal is expected to close in fourth quarter 2013. Mylan announced its plan to buy Agila for $1.6 billion in February 2013.

August 14, 2013

In its first year, more than 20,000 schools across all 50 states participated in the program that offers four free EpiPen or EpiPen Jr (epinephrine) Auto-Injectors to qualifying schools in the United States.

BASKING RIDGE, N.J. — Mylan Specialty, the fully integrated specialty pharmaceutical business of Mylan, today announced a second year of its EpiPen4Schools program. In its first year, more than 20,000 schools across all 50 states participated in the program that offers four free EpiPen or EpiPen Jr (epinephrine) Auto-Injectors to qualifying schools in the United States. Qualifications include having a valid prescription.

August 6, 2013

Mylan's sales ticked up slightly in second quarter 2013, compared with the same period last year, the company said.

PITTSBURGH — Mylan's sales ticked up slightly in second quarter 2013, compared with the same period last year, the company said.

The Pittsburgh-based generic drug maker reported sales of $1.7 billion, a 1% increase over second quarter 2012's $1.69 billion. For the six-month period that ended June 30, sales were $3.33 billion, a 2% increase over $3.27 billion during the same period last year.

June 24, 2013

Mylan Specialty has appointed Roger Graham as president, the Mylan subsidiary said Monday.

PITTSBURGH — Mylan Specialty has appointed Roger Graham as president, the Mylan subsidiary said Monday.

Graham previously worked for Advandx, a privately owned company that develops in-vitro diagnostic tests for infectious diseases and will report to Mylan North America president Tony Mauro. Mylan Specialty markets the EpiPen auto-injector for emergency treatment of severe allergic reactions, among other products.

May 29, 2013

Mylan Specialty is extending a marketing campaign around its line of emergency treatments for severe allergic reactions.

BASKING RIDGE, N.J. — Mylan Specialty is extending a marketing campaign around its line of emergency treatments for severe allergic reactions.

April 25, 2013

Mylan Specialty announced Thursday the introduction of a "$0 Co-Pay Offer" on a product used to treat severe allergic reactions.

BASKING RIDGE, N.J. — Mylan Specialty announced Thursday the introduction of a "$0 Co-Pay Offer" on a product used to treat severe allergic reactions.

The drug maker is offering a co-pay card to patients with or without insurance for the EpiPen in recognition of the 25th anniversary of its approval by the Food and Drug Administration. The co-pay card is available online at EpiPen.com, and the offer will expire on Dec. 31.

February 28, 2013

Mylan has bought a manufacturer of generic injectables for $1.6 billion, the company said.

PITTSBURGH — Mylan has bought a manufacturer of generic injectables for $1.6 billion, the company said.

Mylan announced the acquisition of Bangalore, India-based Agila from Strides Arcolab, which Mylan said would allow it to strengthen its injectables business and enter new markets around the world.

February 28, 2013

Mylan had sales of $1.72 billion in fourth-quarter 2012 and $6.8 billion for fiscal year 2012, the generic drug maker said.

PITTSBURGH — Mylan had sales of $1.72 billion in fourth-quarter 2012 and $6.8 billion for fiscal year 2012, the generic drug maker said.

Those figures compared with $1.53 billion in fourth-quarter 2011 and $6.13 billion for fiscal year 2011.

The latest sales figures include $1.58 billion in generics sales and $155.1 million in branded drug sales.

"2012 was an outstanding year for Mylan, with top-line growth of 11% and bottom-line growth of 27% versus last year," Mylan CEO Heather Bresch said.

January 2, 2013

Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets and rizatriptan benzoate tablets, generic versions of Merck's Maxalt MLT Tablets and Maxalt Tablets.

PITTSBURGH — Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and rizatriptan benzoate tablets, 5 mg and 10 mg. These products are the generic versions of Merck's Maxalt MLT® Tablets and Maxalt® Tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults.

December 28, 2012

Mylan on Friday announced that its partner Famy Care has received final approval from the Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol Tablets USP in the 0.15mg/0.03mg strength.

PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.

The product is a generic version of Teva Branded Pharmaceutical Products' Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.

October 24, 2012

Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

PITTSBURGH — Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

The generic drug maker said it filed a motion in the U.S. District Court for the District of Columbia Tuesday to stay the court's order, which called on the FDA to let Watson launch a generic version of Takeda's Type 2 diabetes drug Actos (pioglitazone).

October 17, 2012

Generic drug maker Mylan and World TeamTennis announced a three-year agreement under which WTT will be renamed Mylan World TeamTennis.

PITTSBURGH — Generic drug maker Mylan and World TeamTennis announced a three-year agreement under which WTT will be renamed Mylan World TeamTennis.

August 14, 2012

Drug maker Mylan will pass out free EpiPen injectors to children in schools, the company said Tuesday.

BASKING RIDGE, N.J. — Drug maker Mylan will pass out free EpiPen injectors to children in schools, the company said Tuesday.

Mylan Specialty, the Mylan unit that makes the EpiPen (epinephrine), announced the launch of the EpiPen4Schools program. The program offers four free EpiPen or EpiPen Jr. injectors to public and private school students in kindergarten, elementary, middle and high school, who have valid prescriptions.

August 10, 2012

Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

PITTSBURGH — Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

The generic drug maker announced the launch of modafinil tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Provigil, made by Cephalon — a company that Teva Pharmaceutical Industries acquired last year — and used to treat narcolepsy, obstructive sleep apnea and shift work disorder.

August 6, 2012

Generic drug maker Mylan has begun commercial operations in India, focusing on drugs to treat HIV and AIDS, the company said Monday.

PITTSBURGH — Generic drug maker Mylan has begun commercial operations in India, focusing on drugs to treat HIV and AIDS, the company said Monday.

The company is launching 18 antiretroviral drugs for HIV/AIDS in India, which has the world's third-largest population of people with the disease, according to the National AIDS Control Organization.

August 3, 2012

Mylan and Gilead Sciences have made an agreement under which Mylan will have rights to produce and market generic versions of Gilead drugs for HIV and AIDS in developing countries.

PITTSBURGH — Mylan and Gilead Sciences have made an agreement under which Mylan will have rights to produce and market generic versions of Gilead drugs for HIV and AIDS in developing countries.

The agreement, involving Gilead and Mylan subsidiary Mylan Labs Ltd., centers around drugs containing emtricitabine, the active ingredient in such drugs as Emtriva, and such fixed-dose combinations as Truvada (emtricitabine and tenofovir disoproxil fumarate) and the experimental Quad.

August 1, 2012

"Buy me some peanuts and Cracker Jacks," goes the line from the famous baseball anthem. For some people, however, that innocuous lyric is a ticket to the hospital, or worse.

PITTSBURGH — "Buy me some peanuts and Cracker Jacks," goes the line from the famous baseball anthem. For some people, however, that innocuous lyric is a ticket to the hospital, or worse.

February 14, 2012

Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

PITTSBURGH — Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

Sunovion Pharmaceuticals sued Mylan and several subsidiaries in the U.S. District Court for the District of Delaware when the latter sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution, a drug for asthma and chronic obstructive pulmonary disease. The jury's verdict includes an $18 million award.