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Mylan N.V. stock price
Mylan N.V. latest news:
BRIEF-Mylan announces voluntary delisting from the Tel Aviv Stock Exchange (TASE)
* Mylan announces voluntary delisting from the Tel Aviv
BRIEF-Theravance Biopharma and Mylan reports positive Phase 3 data for Revefenacin
Mylan Nv(MYL). * Theravance Biopharma(TBPH) and mylan report additional positive phase 3 data for Revefenacin in multiple presentations at 2017 Chest Annual Meeting.
U.S. stocks open slightly lower; Dow on track to end 5-day win streak
U.S. stocks opened with modest losses on Wednesday, with major indexes set to take a pause after a series of record finishes. The Dow Jones Industrial Average slipped 5 points to 22,637. The S&P 500 was down 2 points to 2,533, a drop of 0.1%. The Nasdaq Composite Index was off 9 points, or 0.1%, to 6,523. All three indexes closed at records for a second straight day on Tuesday. In the latest economic data, private-sector employers added 135,000 jobs in September, fewer than had been expected, and down sharply from the 237,000 that had been added in August. Among the day's most actively traded names, Mylan NV jumped 18% after the Food and Drug Administration approved its generic versions for Teva Pharmaceutical Industries Ltd.'s Copaxone, a drug for people with relapsing forms of multiple sclerosis. Shares of Teva dropped 14%.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-Mylan announces FDA approval of first generic for Copaxone 40 mg/ml
* Mylan announces U.S. FDA approval of first generic for
Copaxone® 40 mg/ml 3-times-a-week and may be eligible for
BRIEF-Mylan launches generic Cancidas for injection
Mylan Nv(MYL): * Mylan launches generic Cancidasfor injection. * Mylan received final approval from U.S. FDA for its Abbreviated New Drug Application for this antifungal which has multiple indications Source text for Eikon: Further company coverage:
UPDATE 1-U.S. FDA moves to smooth path for complex generic drugs
WASHINGTON, Oct 2 (Reuters) - The U.S. Food and Drug
Administration on Monday announced a series of measures designed
to speed to market generic versions of complex drugs such as
Mylan NV's emergency EpiPen in an effort to address the
rising cost of pharmaceuticals.
BRIEF-Mylan launches generic Gleevec tablets
Mylan Nv(MYL). * Mylan launches generic Gleevec® tablets. * Mylan - Annouces U.S. launch of imatinib mesylate tablets, 100 mg, 400 mg ; co received final approval from U.S. FDA for ANDA on the product Source text for Eikon: Further company coverage:
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.
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