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News Breaks
February 14, 2013
12:15 EDTAZN, MYLAstraZeneca wins appeal to block generic Seroquel XR from Mylan, others
After a New Jersey district court ruled last March that AstraZeneca's (AZN) formulation patent protecting Seroquel XR extended release tablets was valid, the U.S. Court of Appeals for the Federal Circuit affirmed the lower court's ruling today. The lower court had also ruled that Anchen Pharmaceuticals, Osmotica Pharmaceutical, Torrent Pharmaceuticals and Mylan Pharmaceuticals (MYL) have infringed the Seroquel XR formulation patent, which expires in 2017. Reference Link
News For AZN;MYL From The Last 14 Days
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September 2, 2014
06:45 EDTAZNAstraZeneca volatility elevated
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September 1, 2014
11:34 EDTAZNBrookings Institution to hold a workshop
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August 31, 2014
12:50 EDTAZNEuropean Society of Cardiology to hold a conference
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August 29, 2014
15:29 EDTMYLMylan receives FDA approval for generic lamivudine, aidovudine
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August 28, 2014
11:22 EDTMYLMylan ANDA for three times per week generic Copaxone accepted by FDA for filing
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
06:27 EDTAZNAstraZeneca volatility increases on price movement
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August 27, 2014
09:05 EDTAZNAstraZeneca gefitinib granted orphan designation by FDA
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August 25, 2014
06:29 EDTAZNPfizer mulls possible AstraZeneca offer options, FT says
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August 22, 2014
10:07 EDTAZNOptions with increasing implied volatility: ORPH EXAS AZN
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08:02 EDTMYLMylan launches first generic Klor-Con Extended-release tablets
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05:19 EDTAZNStocks with implied volatility movement; JRJC AZN
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August 21, 2014
09:54 EDTAZNPotential Pfizer, AstraZeneca deal seen around year-end, Reuters says
Investors and analysts see Pfizer (PFE) making another attempt to acquire AstraZeneca (AZN) around year-end, even though talks between the two can resume on August 26 per British takeover rules, Reuters reports. Reference Link
07:47 EDTAZNPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
05:42 EDTAZNIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
August 20, 2014
11:44 EDTMYLMylan completes second bidding round for GSK prescription portfolio, WSJ says
Mylan (MYL), TPG Capital, Advent International, KKR (KKR), Warburg Pincus and a few Indian prescription manufacturers have completed the second round of bidding for GlaxoSmith Kline's (GSK) portfolio of mature medications, according to The Wall Street Journal, citing people familiar with the sales process. GSK noted that it aims to sell a portfolio of drug brands in the U.S. and EU with yearly sales of approximately $1.66B. Reference Link
11:33 EDTMYLMylan into second round of bidding for GSK drug portfolio, WSJ reports
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