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News For ACT;TEVA;ENDP;COV;ABT From The Last 14 Days
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December 22, 2014
18:00 EDTABTUS files civil suit against Omnicare for alleged Abbott kickbacks
The United States has filed a civil False Claims Act complaint against Omnicare (OCR) alleging that it solicited and received millions of dollars in kickbacks from pharmaceutical manufacturer Abbott Laboratories (ABT), the Justice Department announced. Omnicare is the nation’s largest provider of pharmaceuticals and pharmacy consulting services to nursing homes. Federal regulations designed to protect nursing home residents from unnecessary drugs require nursing homes to retain consulting pharmacists such as those provided by Omnicare to ensure that residents’ drug prescriptions are appropriate. Reference Link
09:26 EDTACTActavis names Jonathan Kellerman Global Chief Compliance Officer
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December 19, 2014
16:20 EDTACTActavis confirms receipt of positive CHMP opinion for XYDALBA
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11:26 EDTACTAlmirall says unaware of Actavis approach, hasn't received bid, Reuters reports
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11:23 EDTACTActavis considering bid for Spain based Almirall, Bloomberg reports
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11:02 EDTACTActavis receives positive CHMP recommendation for dalbavancin
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10:59 EDTACTActavis considering bid for Spain based Almirall, Bloomberg reports
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09:11 EDTENDPEndo price target raised to $90 from $77 at Sterne Agee
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08:08 EDTTEVATeva Announces FDA Approval of QNASL for young children
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December 18, 2014
12:55 EDTTEVACourt delays Teva's launch of generic Celebrex, Globes reports
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12:46 EDTTEVATeva in legal dispute with former Russian partner, Globes reports
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December 17, 2014
13:32 EDTTEVAPerrigo jumps after analyst discusses potential takeover by Teva
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10:53 EDTACTAckman says 'will take hard look' at Valeant shares after restrictions end
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09:26 EDTTEVAPerrigo would be good acquisition for Teva, says RBC Capital
RBC Capital views Perrigo (PRGO) as an attractive acquisition target and says in a note to investors that it thinks a takeover could be a good strategic fit with solid accretion for Teva (TEVA). Teva has interest in over-the-counter products and its growth rate would be boosted by the merger, RBC believes. The firm assumes a $200 per share value for Perrigo in its acquisition assumptions. Shares of the over-the-counter and generic pharmaceuticals company closed yesterday at $153.77.
December 16, 2014
16:53 EDTACTAuxilium updates court findings in Actavis testosterone gel patent suit
Auxilium (AUXL) disclosed in a filing that as previously disclosed, on May 23 , Auxilium Pharmaceuticals, and FCB I LLC, as licensor of Testim, filed a lawsuit in the U.S. District Court for the District of New Jersey against Actavis (ACT) for infringement of FCB’s 10 patents listed in the Orange Book as covering Testim testosterone gel. The lawsuit was filed in response to a notice letter, dated April 12, 2012, sent by Actavis Laboratories, regarding its filing with the U.S. Food and Drug Administration of an Abbreviated New Drug Application for a generic 1% testosterone gel product. This letter also stated that the ANDA contained Paragraph IV certifications with respect to the nine patents listed in the Orange Book on that date as covering Testim. The company’s lawsuit filed against Actavis initially involved those nine patents, as well as a 10th patent covering Testim that was issued on May 15, 2012 and is listed in the Orange Book. By the time that the trial commenced in September 2014, the parties had agreed to remove all but one of those patents from the litigation, with the trial focused solely on claim 3 of U.S. Patent # 7,608,607 . The trial commenced in September 2014 and closing arguments occurred in November 2014. On December 16 , the company learned that Judge Linares held that claim 3 of the ‘607 patent is invalid for obviousness. The Judge also found claim 3 invalid for derivation and improper inventorship, but he declined to rule on whether correction of inventorship would be appropriate because it would be futile in light of his ruling on obviousness. Auxilium believes that Actavis is now free to enter the market with its testosterone gel product once it obtains approval from the FDA. At this time, Auxilium is not aware of Actavis having received tentative approval or final approval from the FDA for its testosterone gel product. Auxilium is analyzing the District Court’s opinion and will explore its available options with regard to this matter.
09:52 EDTTEVA, ACTFDA ruling on generic Celebrex reversed by appeals court
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08:58 EDTENDPEndo a top pick for 2015, says Sterne Agee
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08:53 EDTACTActavis accretion targets look more achievable, says Sterne Agee
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07:40 EDTACTActavis reports Saunders to lead combined company as CEO
Actavis (ACT) announced the planned senior management team that will lead the global pharmaceutical company following the successful close of the acquisition of Allergan (AGN), anticipated in the second quarter of 2015. Brent Saunders will continue to lead Actavis as CEO and President and a member of the Board of Directors. Paul Bisaro will remain Executive Chairman of the board of directors. The company noted that it anticipates continuing to define the subsequent management levels within the global organization as rapidly as possible between now and the close of the acquisition. Actavis announced that, following the close of the acquisition, its global brand sales and marketing will be structured into three organizations: International Brands, Branded Pharma and Allergan Medical. "Although we are acting rapidly in announcing these appointments, we are making them following extensive discussions with David Pyott, Chairman and CEO of Allergan, and his executive leadership team. We believe that by announcing the proposed structure of the combined organization our shareholders, customers and employee teams will better appreciate our commitment to create the most dynamic company in Growth Pharma and will share our confidence in seamless execution of this combination beginning on Day 1," Saunders said.
December 15, 2014
15:14 EDTACTActavis to appeal injunction requiring Namenda IR distribution
Actavis confirmed that it is filing an emergency appeal to the U.S. Court of Appeals for the Second Circuit seeking to immediately overturn a lower court ruling requiring the company to continue distribution of NAMENDA immediate-release tablets after Judge Robert Sweet of the U.S. District Court for the Southern District of New York issued a preliminary injunction requiring Actavis to continue distribution of NAMENDA immediate-release tablets on Monday, December 15. Actavis reiterated that the ruling will have no impact on its ability to continue focusing its resources on transitioning patients to the convenient and innovative once-daily NAMENDA XR, and that the company is prepared to manage its business in a way that provides the least disruption in its ability to support the marketplace and minimize any financial impact. Further, the company noted that it will work to manage sales and R&D expenses to ensure that, if the District Court decision stands, it will have minimal to no impact on Actavis' 2015 NAMENDA franchise contribution to earnings and longer term company earnings aspirations.
07:58 EDTACTAllergan downgraded to Hold from Buy at Stifel
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December 12, 2014
11:19 EDTABTAbbott board increases quarterly dividend to 24c from 22c
The board of Abbott increased the company's quarterly common dividend to 24c per share from 22c per share. The cash dividend is payable Feb. 13, 2015, to shareholders of record at the close of business on Jan. 15, 2015.
10:01 EDTTEVAOn The Fly: Analyst Upgrade Summary
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08:49 EDTTEVATeva upgraded at Sterne Agee
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07:06 EDTTEVATeva upgraded to Buy from Neutral at Sterne Agee
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December 11, 2014
19:06 EDTACTActavis confirms court ruling to require continued distribution of Namenda IR
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17:04 EDTENDPEndo registration statement relating to Auxilium declared effective by SEC
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09:39 EDTTEVATeva FY15 outlook appears strong, reasonable, says BMO Capital
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07:24 EDTTEVATeva to host conference call
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07:12 EDTTEVATeva sees FY15 Copaxone sales $3.5B-$3.7B
Sees FY15 Treanda sales $670M-$750M. Sees FY15 ProAir family sales $470M-$580M, Azilect sales $350M-$400M and Nuvigil sales $300M-$330M. Erez Vigodman, President & CEO of Teva, said, "Generics remain at the heart of our business, both as the cornerstone of the Company, but also as an area that has great impact on society. At the same time, we anticipate four specialty product approvals and five submissions in 2015 – which we believe will improve treatment options for patients, and add value for all of our stakeholders." The company expects 2015 generic revenues in the United States to be $4.2B-$4.6B, $2.6B-$3.0B in Europe and $2.0B-$2.3B in its ROW markets. Results of its specialty segment are expected to be impacted by the introduction of two AB-rated generic competitors to Copaxone in the U.S. beginning in September 2015, which is a modeling assumption only, as well as by increased competition from oral products for the treatment of multiple sclerosis. In addition, the company is expecting to invest in a significant number of product launches and in its specialty pipeline. "All of these will result in lower profit and profitability, as we focus on generating growth over the next few years," Teva said.
07:08 EDTTEVATeva sees FY15 gross profit 59.5%-61.5%
Teva sees FY15 cash flow from operations $4.3B-$4.7B and free cash flow $3.5B-$3.7B.
07:07 EDTTEVATeva sees spending $1B-$1.2B on share buybacks in 2015
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07:02 EDTTEVATeva sees FY15 EPS $5.00-$5.30, consensus $5.06
Sees FY15 revenue $19B-$19.4B, consensus $20.07B.
05:24 EDTABTAbbott IRIDICA now available in Europe
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December 10, 2014
11:40 EDTACTActavis management to meet with Sterne Agee
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09:33 EDTACTActavis launches generic version of Celebrex
Actavis (ACT) announced that it has launched a generic version of Celebrex 50 mg, 100 mg, 200 mg and 400 mg capsules, as part of a settlement agreement with Pfizer (PFE). Celebrex is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. For the 12-month period ending June 30, 2014, Celebrex had U.S. sales of approximately $2.4 billion, according to IMS Health data.
08:31 EDTTEVATeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 2014.
December 9, 2014
09:31 EDTACTZoetis drops after report of Valeant abandoning growth by acquisitions strategy
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07:44 EDTTEVAAmerican Association for Cancer Research to hold a symposium
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07:08 EDTENDPEndo completes acquisition of rights to Natesto from Trimel BioPharma
Endo International announced the completion of the acquisition of rights to Natesto, a testosterone nasal gel, the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism, from Trimel BioPharma, a wholly-owned subsidiary of Trimel Pharmaceuticals for $25M including additional payments upon the achievement of certain regulatory and sales milestones. Endo will collaborate with Trimel on all regulatory and clinical development activities regarding Natesto. Endo intends to launch the product, through its Endo Pharmaceuticals subsidiary, in the Q1 of 2015.
06:14 EDTACTAllergan price target raised to $245 from $210 at Citigroup
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December 8, 2014
12:25 EDTACTAntibiotic makers rise after Merck agrees to buy Cubist
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11:30 EDTTEVA, ACTLeerink generics pharmaceutical analyst holds analyst/industry conference call
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09:32 EDTENDPSyneron Medical signs agreement with AMS to supply holmium laser for urology
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08:21 EDTTEVAMerck says looked at all risks, including patent litgation, before Cubist deal
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06:47 EDTTEVAArena says Teva files marketing authorization of Belviq in Israel
Arena Pharmaceuticals (ARNA) disclosed late Friday that Teva Pharmaceutical's (TEVA) local Israeli subsidiary, Abic Marketing Limited, has filed for marketing authorization of Belviq in Israel. In connection with the filing, Arena will receive a milestone payment of $250K.
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