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News Breaks
May 30, 2014
12:47 EDTMYL, PFEMylan sees 'imminently' receiving final approval on 50 mg generic Celebrex
Mylan (MYL) commented on the decision by the U.S. District Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against the FDA, challenging the agency's decision regarding generic drug marketing exclusivity on Celecoxib Capsules, the generic version of Pfizer's (PFE) Celebrex. Mylan said it continues to believe that FDA "seriously erred" in its decision regarding eligibility for 180 days of exclusivity on Celecoxib. "Mylan will review all of its options, including filing an expedited appeal in the United States Court of Appeals for the Fourth Circuit," the company said. Mylan expects to receive final approval on the 50 mg strength of Celecoxib capsules "imminently" and has received tentative approval from FDA on all Celecoxib strengths, the company said.
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July 16, 2014
07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
July 15, 2014
14:40 EDTMYLEarnings Preview: Abbott targets continued gains in emerging markets
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11:17 EDTMYLStocks with call strike movement; KORS MYL
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06:15 EDTMYLAbbott unit sale to Mylan 'a wash,' says Citigroup
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July 14, 2014
16:30 EDTMYLOn The Fly: Closing Wrap
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12:21 EDTMYLOn The Fly: Midday Wrap
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09:45 EDTMYLMylan moves higher, levels to watch
Abbott (ABT) sold its developed markets generics pharmaceuticals business to Mylan (MYL), which is sending shares of the latter higher to $51.83. At that price next resistance is at $53, the session high. Support is at $50.88.
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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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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