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Mylan N.V. stock price
Mylan N.V. latest news:
BRIEF-Mylan expands women's healthcare portfolio with launch of generic Minastrin 24 FE tablets
Mylan NV(MYL): * Mylan expands women's healthcare portfolio with launch of generic Minastrin 24 FE tablets. * Announced U.S. launch of Norethindrone Acetate and Ethinyl Estradiol tablets USP, and Ferrous Fumarate Tablets, 1 mg/20 mcg Source text for Eikon: Further company coverage:
Allergan $13.75 mln agreement with Saint Regis Mohawk Tribe a play to protect key dry eye product
Allergan PLC shares rose 1.8% in heavy Friday afternoon trade on news of an unorthodox agreement the company has made with the Saint Regis Mohawk Tribe that could protect patents on a key Allergan dry eye product, Restasis. Under the agreement, the Saint Regis Mohawk Tribe now owns patents on Restasis -- which are expected to expire at the end of August 2024 -- and has granted Allergan exclusive licenses on the product. The Saint Regis Mohawk Tribe is filing to dismiss patent challenges under the U.S. Patent and Trade Office's inter partes review process "based on their sovereign immunity from IPR challenges," Allergan said, although the agreement does not affect recent patent litigation in a Texas federal court. Teva Pharmaceutical Industries Ltd. , Mylan NV and Akorn Inc. have all filed IPR challenges related to Restasis. Allergan will pay the Saint Regis Mohawk Tribe $13.75 million upfront and $15 million in annual royalties; an Allergan spokesperson said the latter is for commercial rights to Restasis. The Saint Regis Mohawk Tribe and its lawyer approached Allergan about the agreement, according to a Friday Allergan statement, and there is case law precedent of universities using this approach. The Allergan agreement is "part of our overall economic diversification strategy," the Saint Regis Mohawk Tribal Council said in a statement. "We realize that we cannot depend solely on casino revenues and, in order for us to be self-reliant, we must enter into diverse business sectors to address the chronically unmet needs of the Akwesasne community; such as housing, employment, education, healthcare, cultural and language preservation." Allergan shares have lifted 1.2% over the last three months, compared to a 1.2% rise in the S&P 500 .Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
FDA warns of serious manufacturing violations in letter to EpiPen manufacturing facility
The Food and Drug Administration described "significant violations of current good manufacturing practice" in a warning letter to a Pfizer unit that manufactures Mylan's EpiPen allergic reaction treatment. The unit, Meridian Medical Technologies Inc., "failed to thoroughly investigate multiple serious component and product failures... including failures associated with patient deaths and severe illness," the warning letter said, referring to an FDA inspection of a Missouri manufacturing facility between February and March of this year. "You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA's inspection." The regulator asked the company to review its manufacturing investigations and provide its plan for addressing safety risks, all within 15 days. If the company doesn't promptly fix the violations, there may be legal action, and the FDA may not approve applications listing the manufacturing facility, the FDA said. Mylan shares declined nearly 1% in moderate Thursday afternoon trade, while Pfizer shares rose a scant 0.3% in heavy trade, compared with a 0.1% decline in the S&P 500 Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
BRIEF-Otsuka and Mylan announce license agreement to commercialize Delamanid
* Mylan NV- Otsuka Pharmaceutical Co Ltd, co entered into
license agreement between their respective subsidiaries ONPG and
Mylan Pharmaceuticals Private Limited
Feds finalize $465M Mylan settlement for EpiPen overcharges
Agreement means drugmaker will pay higher rebates to the Medicaid program on
Mylan, U.S. finalize $465 million EpiPen settlement
BOSTON (Reuters) - Mylan NV has finalized a $465 million settlement with the U.S. Justice Department, resolving claims it overcharged the government for its EpiPen emergency allergy treatment, which became the center of a firestorm over price increases.
BRIEF-Mylan gives details on genric approval processes
* Says disappointed with the execution by FDA on approval
process of generic Copaxone
Express Scripts to cover Mylan's EpiPen, exclude rivals
Pharmacy benefit manager Express Scripts Holding Co (ESRX) said on Monday it would favor drugmaker Mylan Inc's versions of the EpiPen lifesaving allergy treatment over the allergy auto-injectors of other companies.
BRIEF-Mylan receives who prequalification for Generic Sovaldi
* Approval from World Health Organization prequalification
of medicines program of its application for Sofosbuvir tablets,
Mylan's Biosimilar Herceptin Gets FDA Advisory Committee Nod
Mylan N V MYL and partner Biocon Ltd announced that the FDA Oncologic Drugs Advisory Committee ODAC unanimously recommended approval of its biosimilarversion of Roche s RHHBY breast cancer drug Herceptin trastuzumab In fact the FDA s ODAC voted 16 to 0 in favor of biosimilar
Mylan shares rise as FDA advisors recommend breast-cancer drug approval
Mylan NV shares rose in the extended session Thursday after the drug maker said a Food and Drug Administration advisory committee recommended approval of its generic version of Roche's breast-cancer drug Herceptin. Mylan shares rose 1.3% to $39.55 after hours. The FDA's Oncologic Drugs Advisory Committee voted 16 to 0 recommending that the agency approve trastuzumab, a biologically similar version of Roche's breast-cancer drug Herceptin, Mylan said. Mylan and partner Biocon Ltd., based in Bengaluru, India, developed the drug. The FDA is not obligated to follow the recommendations of its advisory committees but generally does.Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
Investors call on Mylan chairman, director to step down
NEW YORK (Reuters) - An investor group led by New York City's comptroller called for Mylan NV's Chairman Robert Coury and Director Wendy Cameron to step down, as part of a campaign against the firm's executive pay packages and high prices for an allergy treatment.
More than a third of Mylan investors voted against chairman
NEW YORK (Reuters) - More than a third of investors voting at Mylan NV annual meeting last week cast votes against Chairman Robert Coury's re-election as the generic drugmaker faced a shareholder campaign against its directors and executive pay packages.
BRIEF-Mylan shareholders approve appointment of 11 director nominees
* Says shareholders approved appointment of all 11 director
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