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Stock Market & Financial Investment News

News Breaks
May 30, 2014
09:17 EDTTEVA, MYL, PFETeva receives favorable court decision regarding generic Celebrex capsules
Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. District Court for the Northern District of West Virginia denied a motion filed by Mylan (MYL) and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex 100, 200 and 400 mg capsules. On April 17, Teva entered into a settlement agreement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December, 2014, or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
News For TEVA;MYL;PFE From The Last 14 Days
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July 14, 2014
09:16 EDTMYLOn The Fly: Pre-market Movers
HIGHER: Citigroup (C), up 3.6% after reporting better than expected Q2 results, announcing $7B settlement with DOJ and FDIC... Apple (AAPL), up 0.7% after Barclays upgrades stock to Overweight, Morgan Stanley raises Apple estimates above consensus... Shire (SHPG), up 1.6% after receiving revised proposal from AbbVie (ABBV) of GPB 53.20 per share, which it says it would be willing to recommend to Shire shareholders. AbbVie is down 2.8% after the news... Mylan (MYL), up 4% after acquiring Abbott's (ABT) non-U.S. developed markets specialty and branded generics business in all-stock transaction valued at about $5.3B. Abbott up 1.6% after the news... Progenics (PGNX), up 13% after FDA says RELISTOR can be approved on data submitted in sNDA... Exelixis (EXEL), up 13% after announcing coBRIM Phase 3 trial met primary endpoint... URS (URS) up 8% after acquired by AECOM Technology (ACM) for $56.31 per share. AECOM shares alos up 2% after deal announcement... Whiting Petroleum (WLL), up 4.5% after agreeing to acquire Kodiak Oil & Gas (KOG) in a $6B transaction. Kodiak Oil & Gas up 3%... Kandi Technologies (KNDI), up 11% after announcing JV's sale of 4,114 EVs in Q2. LOWER: Riverbed (RVBD), down 4.5% after saying it sees its Q2 adjusted EPS at low end of 26c-28c range... Harmonic (HLIT), down 13% after reporting preliminary Q2 earnings results.. EBay (EBAY), down 0.5% after downgraded at Pacific Crest, confirming partnership plans with Sotheby's (BID).
08:55 EDTMYLMylan says does not anticipate regulatory hurdles prohibiting close of deal
08:49 EDTMYLMylan says Abbott assets unlike other mature generic drug portfolios
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08:36 EDTMYLMylan accretive tax inversion deal makes sense, says UBS
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08:27 EDTMYLMylan sees Abbott transaction to be 'immediately and significantly accretive'
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08:26 EDTMYLMylan sees $10B in pro forma 2014 sales after closing Abbott deal
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08:12 EDTMYLMylan says Abbott deal 'first in series' of planned transactions
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08:04 EDTTEVATeva announces FDA acceptance of NDA filing for albuterol MDPI
Teva Pharmaceuticals Industries announced that the U.S. Food and Drug Administration has accepted for review the company’s new drug application for albuterol multi-dose dry-powder inhaler, an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents with asthma and exercise-induced bronchospasm. The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.
07:28 EDTMYLMylan to host conference call
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07:20 EDTMYLAbbott to host conference call
Conference call to discuss agreement to sell developed markets branded generics pharmaceuticals business to Mylan will be held on July 14 at 9:30 am. Webcast Link
06:54 EDTMYLWhiting Petroleum volatility expected to move on acquisition of Kodiak Oil & Gas
Whiting Petroleum (WLL) option implied volatility is expected to move on the acquisition of Kodiak Oil & Gas (KOG) in an all-stock transaction valued at $6B. Overall option implied volatility of 31 is at its 26-week average according to Track Data, suggesting non-directional price movement.
06:33 EDTMYLAbbott to sell developed markets generics pharmaceuticals business to Mylan
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06:33 EDTMYLMylan to acquire Abbott assets in all-stock transaction valued at about $5.3B
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06:31 EDTMYLAbbott to sell developed markets generics pharmaceuticals business to Mylan
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July 13, 2014
20:22 EDTMYLMylan near buying Europe-based drug portfolio from Abbott, Reuters says
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July 9, 2014
07:15 EDTMYL, TEVATeva, others fined $583.4M by EU regulators, Reuters says
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06:49 EDTTEVA, MYLGeneric drug prices have risen significantly, NY Times says
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06:49 EDTPFEPfizer given dismissal of U.S. investor class action before trial, Reuters says
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July 8, 2014
07:34 EDTMYLMylan launches Telmisartan Tablets
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07:03 EDTTEVAEagle Pharmaceuticals receives orphan drug designation for bendamustine HCl
Eagle Pharmaceuticals (EGRX) announced that the FDA has granted orphan drug designation to bendamustine hydrochloride, a ready-to-dilute concentrate solution for injection that will be administered by infusion over 10 minutes after dilution in 50mL of sodium chloride or a saline / dextrose mixture, for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin’s lymphoma. Pursuant to the orphan drug designation, Eagle is eligible to receive tax incentives and Prescription Drug User Fee Act fee savings, and believes it may receive seven years of marketing exclusivity. The currently marketed bendamustine HCI product, Treanda, which is manufactured by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries (TEVA), is a lyophilized powder requiring reconstitution and dilution in 500mL of saline or a sodium chloride / dextrose mixture before administration over 30 minutes for CLL and 60 minutes for NHL.
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