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December 11, 2012
07:54 EDTACOR, PFE, ALKS, PRXL, MEDI, TEVA, NPSP, CELG, AZNElsevier Business Intelligence to host a summit
The FDA/CMS Summit for Biopharma Executives: Life After 2012 is being held in Washington, D.C. on December 10-11.
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September 28, 2015
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."
15:01 EDTPFEPfizer volatility at high end of one-year range
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07:52 EDTPFE, AZN, TEVAIIR Holdings to hold a conference
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07:46 EDTTEVAUBS to hold a field trip
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07:27 EDTPFEFDA and the Parental Drug Association to co-host a conference
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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
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.
September 25, 2015
16:17 EDTCELGOn The Fly: Top stock stories for Friday
Stocks opened with sharp gains the day after Fed Chair Janet Yellen gave some clarity to the market by suggesting the Fed will most likely raise interest rates by the end of the year. During afternoon trading, the news flow slowed and the volume lightened on the buy side, leaving the sellers with the upper hand. The Nasdaq was the first index to move into negative territory, led by broad weakness in biotech stocks, while the Dow was helped to stay in the green by a big post-earnings move higher in Nike (NKE). The averages limped into the close, leaving the market with an interesting set-up to begin next week. Outside of stock news, it was certainly a headline packed day, as Speaker of the House John Boehner announced that he will resign at the end of October, Chinese President Xi Jinping continued his U.S. visit and Pope Francis addressed the United Nations while spending a second day in New York City. ECONOMIC EVENTS: In the U.S., the third estimate of second quarter GDP showed the economy grew 3.9% quarter-over-quarter, versus expectations for the GDP growth estimate to stay at 3.7%. Personal consumption in Q2 is now believed to have grown 3.6%, up from the prior estimate of 3.1%. The final University of Michigan consumer sentiment reading for September came in at 87.2, which was down from August's 91.9 but above the expected 86.2 reading... Federal Reserve Chair Janet Yellen said during a speech at UMass Amherst last night that the central bank remains inclined to hike rates this year. Yellen's remarks were incrementally hawkish, but welcomed by the market, since they helped clarify the message the Fed delivered a week ago. Of note, the Fed chair paused multiple times toward the end of her speech and received medical attention afterward, but returned to her regular schedule later in the evening, with the bank explaining that Yellen was dehydrated after a long day but was otherwise fine. COMPANY NEWS: Nike jumped $10.23, or 8.9%, to $125.02 after Thursday night's report of better than expected earnings and futures orders prompted numerous price target hikes at Street research firms. Additionally, Sterne Agee upgraded Nike to Buy from Neutral, saying it thinks the company is benefiting from its "global grass roots engagement with its customers," which enables it to meet its customers' needs and determine to what extent it can raise prices. The firm, which thinks that the company is continuing to gain share, has a $150 price target on the athletic gear giant... Biotech stocks, which were already having a bad week, ended the week on a down note, as the iShares NASDAQ Biotechnology Index (IBB) fell 4.9%, giving it a weekly decline of about 13%. Among the biggest large-cap losers in the space were Vertex (VRTX), which fell 7%, Regeneron (REGN), which dropped 6% and Celgene (CELG), which slid 4.8%. MAJOR MOVERS: Among the notable gainers was Jabil Circuit (JBL), which advanced $2.38, or 12.2%, to $21.88 after it reported higher than expected earnings and gave guidance for its November quarter that was significantly above expectations. Also higher was Cirrus Logic (CRUS), which gained $3.90, or 14.4%, to $31.03 after tear downs of Apple's (AAPL) iPhone 6S and 6S Plus led analysts to conclude that the chipmaker appears poised to obtain more revenue from the new devices than from the previous generation of the market-leading smartphone. Among the noteworthy losers was Finish Line (FINL), which fell $4.86, or 19.6%, to $19.91 after reporting second quarter revenue that missed expectations and saying it expects adjusted earnings this fiscal year to increase in a low single to mid single digits percentage from last year. Also lower following its earnings report was smartphone and software maker BlackBerry (BBRY), which slid 7.68% to $6.49 after the company posted a second quarter loss that was steeper than analysts expected. BlackBerry also confirmed press reports that it plans to launch a new phone that uses Google's (GOOG) Android operating system instead of its own proprietary BB10 OS. Shares of Aratana Therapeutics (PETX), which dropped $6.81, or 38.97%, to $10.68 after the company said that, based on "mixed clinical and scientific results," it does not believe that canine lymphoma products AT-004 and AT-005 in their current, first-generation forms will capture the desired lymphoma market opportunity. INDEXES: The Dow rose 113.35, or 0.7%, to 16,314.67, the Nasdaq fell 47.98, or 1.01%, to 4,686.50, and the S&P 500 added/slipped 0.90, or 0.05%, to 1,931.34.
16:00 EDTPFEOptions Update; September 25, 2015
iPath S&P 500 VIX Short-Term Futures up 66c to 25.09. Option volume leaders: AAPL NFLX BAC FB AU NKE PFE INTC AMZN TSLA
09:34 EDTPFEActive equity options trading on open
Active equity options trading on open: AAPL BAC FB NKE NFLX PFE AU TSLA
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 EDTAZN, CELG, TEVA, PFEEuropean Society for Medical Oncology to hold a conference
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07:03 EDTPFEMerck KGaA, Pfizer announce FDA orphan drug designation for avelumab
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05:21 EDTCELGCelgene's VIDAZA receives positive CHMP opinion
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05:08 EDTPFEStocks with implied volatility movement; PFE HLF
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September 24, 2015
17:04 EDTPFEMerck, Pfizer to collaborate with Agilent's Dako on Avelumab diagnostic
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07:33 EDTPFEBIND says Pfizer exercises option to obtain license for Accurin drug candidate
BIND Therapeutics (BIND) announced that Pfizer (PFE) exercised its option to obtain an exclusive license to develop and commercialize an Accurin drug candidate for the treatment of solid tumors under the companies' global collaboration agreement. The actively targeted Accurin is designed to impart cellular targeting capability and was engineered by BIND using one of Pfizer's proprietary kinase inhibitors and one of BIND's proprietary ligands. As a result of the option exercise, BIND will receive a $2.5 million option exercise fee from Pfizer. In parallel with exercising its first option, Pfizer informed BIND that it will not exercise its option for the second compound in the collaboration. Under terms of the original collaboration agreement, which was established in April 2013, Pfizer was granted options to obtain exclusive licenses to pursue development and commercialization of two Accurins that incorporate specified Pfizer small molecular targeted therapies. For the Accurin that has been selected, both companies will work together on preclinical research; Pfizer will have responsibility for development and commercialization, and BIND will conduct chemistry, manufacturing and control activities. In addition to the $2.5 million option exercise fee, BIND received an upfront payment of $4.0 million in 2013 and achieved a $1.0 million preclinical development milestone for the selected Accurin in December 2014. BIND has the potential to receive additional milestone payments for the selected Accurin of up to $86.0 million in aggregate upon the achievement of additional specified development and regulatory events under the Pfizer collaboration agreement. BIND may also receive additional milestone payments for the selected Accurin of up to $110 million in aggregate for specified commercial events as well as royalties in the low single to high single digit percentages on potential future sales of the selected Accurin, if any.
07:26 EDTTEVATeva stock performance can improve into year-end, says Deutsche Bank
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07:12 EDTTEVATeva added to short-term buy list at Deutsche Bank
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