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News For GSK;NVS;CBST;TEVA;JAZZ;BP;CHK From The Last 14 Days
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September 28, 2015
16:40 EDTTEVAAllergan to begin reporting Global Generics business as discontinued ops in Q3
Allergan (AGN) intends to begin reporting its Global Generics business as discontinued operations with its third quarter 2015 results. The transaction with Teva (TEVA) is expected to close in the first quarter of 2016.
16:23 EDTTEVAAllergan sees 10% branded revenue growth after divestiture of generics unit
Following the close of the divestiture of the Generics business to Teva (TEVA), New Allergan (AGN) expects to have a powerful financial profile to drive continued long-term growth: 10% branded revenue growth; Non-GAAP gross margins of 77% to 79% with additional long-term expansion anticipated; Non-GAAP SG&A as a percentage of revenue between 21-24%, declining within that range over time; Non-GAAP tax rate of ~15%; Interest expense for New Allergan will be largely dependent on capital deployment decisions following the close of the transaction; Commitment to investment grade ratings. "New Allergan will have strong double-digit revenue growth and will be a development powerhouse stacked with 70 mid-to-late stage R&D projects to address customer and patient needs," said Brent Saunders, CEO and President. "The New Allergan will be lean and nimble with an expanded margin profile driven by leading brands in seven therapeutic categories, a streamlined operating model with one of the most efficient SG&A as a percentage of sales in the industry, a non-GAAP tax rate of approximately 15 percent, and a simplified manufacturing network globally. The continued robust performance of our overall business and strong mid-to-late stage pipeline puts Allergan in a strong position to meet our growth targets for the remainder of the year and over the long-term."
12:22 EDTNVSArray says binimetinib-encorafenib combo shows differentiated tolerability
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11:40 EDTCHKStocks with call strike movement; SUNE CHK
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10:00 EDTBPOn The Fly: Analyst Initiation Summary
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08:03 EDTBPBP initiated with an Outperform at BMO Capital
07:58 EDTNVSNovartis to hold a conference call
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07:52 EDTTEVA, GSKIIR Holdings to hold a conference
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07:46 EDTTEVAUBS to hold a field trip
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06:20 EDTBPBP not concerned over hostile takeover due to Macondo disclaimer, Bloomberg says
BP, which is allegedly readying defenses for potential acquisition offers, isn't concerned about a hostile takeover because of a disclaimer in its Macondo spill settlement that could put $12.6B onto the price tag, Bloomberg reports. A potential buyer may have to accelerate the payment of as much as two-thirds of the $18.7B in penalties BP agreed to pay the U.S. and several states, the report says, citing company filings. An option that provides the government and certain states the power to demand faster payment in a takeover basically hands them a veto over any deal, the report says. Reference Link
05:26 EDTTEVATeva announces approval of Copaxone in Japan
Teva announced the approval by the Japanese Ministry of Health, Labour and Welfare of once-daily COPAXONE 20mg injection for the prevention of relapse of multiple sclerosis . The product will be commercialized in Japan by Takeda Pharmaceutical Company Limited. In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., a wholly owned subsidiary of Teva, at the request of the MHLW. In March, 2013, Takeda and Teva signed an agreement in which Teva granted Takeda the right to commercialize COPAXONE in Japan. The Japanese approval for COPAXONE is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis in Japan as well as the pivotal trial data sets used for approvals in other countries.
September 27, 2015
18:48 EDTNVSNovartis reports updated Phase 3 data on Tafinlar-Mekinist for melanoma
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16:58 EDTGSKGlaxoSmithKline, Theravance report Phase 3 data on Anoro Ellipta for COPD
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16:53 EDTTEVATeva reports Phase 3 data on reslizumab for asthma exacerbations
Teva Pharmaceutical presented results from a post hoc analysis of two pivotal Phase 3 clinical trials showing that treatment with reslizumab reduced clinical asthma exacerbations by 75% versus placebo in a subgroup of patients with late onset asthma with elevated blood eosinophils, who were inadequately controlled on inhaled corticosteroids. Reslizumab is a humanized anti-interleukin-5 monoclonal antibody. Results were pooled from two Phase 3 clinical trials that investigated reslizumab IV 3mg/kg in patients who had at least one asthma exacerbation within the previous year. In the subgroup with late onset asthma, reslizumab showed a 75% reduction in asthma exacerbations and improvement in lung function as measured by forced expiratory volume in one second. In the overall pooled patient population, asthma exacerbations were reduced by 54%, and in the subgroup of subjects diagnosed with asthma at less than 40 years of age, exacerbations were reduced by 42%. Common adverse events in the reslizumab treatment group were comparable to placebo.
16:16 EDTNVSNovartis reports Phase 3 reults on Afinitor for neuroendocrine tumors
Novartis announced results of a Phase 3 pivotal study showing Afinitor, or everolimus, tablets reduced the risk of progression by 52% versus placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin. Additionally, the data show everolimus, a mammalian target of rapamycin inhibitor, extended median progression free survival by 7.1 months. Median PFS by central review was 11 months in the everolimus arm and 3.9 months in the placebo arm. Overall survival was a key secondary endpoint of the trial. While the OS data are not mature, the first interim analysis showed a trend favoring the everolimus arm, according to Novartis. Additional analyses are planned. Another secondary endpoint was best overall response rate. The study found that 64% of patients receiving everolimus experienced at least some degree of tumor shrinkage compared to 26% of those on placebo. Adverse events were consistent with the known safety profile of everolimus. The results of the RADIANT-4 study will serve as the basis of worldwide regulatory submissions for Afinitor for the treatment of advanced, progressive, nonfunctional GI and lung NET, Novartis said.
September 25, 2015
13:51 EDTJAZZBMO's pharma predictions for rest of year include take on Mylan, Perrigo
BMO Capital analyst David Maris rolled out his rest of year predictions for the Specialty Pharmaceuticals space. Among them is his belief that Mylan (MYL) will be unsuccessful in acquiring Perrigo (PRGO). Perrigo will either be acquired by another company or make an acquisition itself, Maris tells investors in a research note. His other predictions include Jazz Pharmaceuticals (JAZZ) proving to be a good buying opportunity amidst the current negative sentiment and ZS Pharma (ZSPH) offering upside following the recent pullback given the potential for a near-term buyout and prospects for its "best in class drug for hyperkalemia" winning approval in 2016.
09:02 EDTTEVATeva acquires Gecko Health Innovations, terms not disclosed
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08:37 EDTTEVAAntares Pharma could benefit from drug pricing controversy, says Oppenheimer
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07:22 EDTTEVA, NVSEuropean Society for Medical Oncology to hold a conference
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05:15 EDTNVSNovartis announces CHMP adopted positive opinion for Entresto
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