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News Breaks
May 13, 2013
07:49 EDTACT, TEVA, IPXL, ENDPFDA decision on Opana a modest positive for Impax, says Leerink
Leerink views the FDA's denial of Endo's (ENDP) Citizen Petition as a modest positive for Impax (IPXL), which it notes is the sole holder of 180 day exclusivity on generic Opana. However, Leerink says upside for Impax will be limited as Actavis (ACT), Sandoz, and Teva (TEVA) have settlements to enter the market starting in June 2013 when Impax's 180-day generic exclusivity expires.
News For IPXL;ACT;ENDP;TEVA From The Last 14 Days
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December 11, 2014
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.
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 EDTIPXL, TEVA, 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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07:29 EDTIPXLUBS to hold investor trip
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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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