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January 27, 2014
04:55 EDTFCSC, FCSC, FCSC, SNY, SNY, SNY, GSK, GSK, GSK, NVS, NVS, NVS, PFE, PFE, PFE, SAFC, SAFC, SAFC, CLDX, CLDX, CLDX, CELG, CELG, CELG, WX, WX, WX, XON, XON, XON, OPXA, OPXA, OPXA, BLUE, BLUE, BLUE, BIIB, BIIB, BIIBPhacilitate to hold a forum
Cell & Gene Therapy Forum 2014 is being held in Washington, D.C. on January 27-29.
News For FCSC;BLUE;OPXA;XON;WX;CELG;CLDX;SAFC;PFE;NVS;GSK;SNY;BIIB From The Last 14 Days
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July 17, 2014
05:32 EDTNVSNovartis reconfirms FY14 revenue guidance up at low to mid single digit rate
The company stated, "We are reconfirming our outlook for FY14. Group net sales in 2014 are expected to grow at a low to mid-single digit rate. Group core operating income is expected to grow ahead of sales in 2014, and now refined to mid to high-single digit. This outlook recognizes the entry of generic competition for Diovan monotherapy in the U.S. on July 7, including an authorized generic from Sandoz on the same date. If June average exchange rates prevail for the remainder of the year, the currency impact for the year would be -1% on sales and -3% to -4% on core operating income."
05:29 EDTNVSNovartis reports Q2 Core EPS $1.34, consensus $1.42
Reports Q2 revenue $14.6B, consensus $14.81B. Reports continued pipeline progress with positive regulatory decisions and significant clinical trial data released in Q2.
July 16, 2014
10:36 EDTPFETreasury calls on Congress to halt inversion deals
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10:24 EDTXONHigh option volume stocks:
High option volume stocks: AMSC FTNT LYG TSEM FOXA HCA BKE XON LCI ASML
09:27 EDTPFEPfizer to acquire InnoPharma for upfront cash payment of $225M
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09:03 EDTSNYSanofi held talks on mature drugs with Abbott, Mylan, PE firms, Reuters says
Sanofi (SNY) has shopped an $8.5B portfolio of mature drugs to Abbott (ABT), Mylan (MYL) and private equity firms, according to Reuters, citing an internal company document circulated by the CGT union. Sanofi is considering whether to sell, carve out or create a joint venture for the portfolio of about 200 drugs, but a Sanofi spokesman said no decision has yet been made, the report noted. Reference Link
07:59 EDTPFETreasury Secretary urges Congress to take action on tax inversions
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07:14 EDTGSKIsis Pharmaceuticals earns $1M milestone payment from GlaxoSmithKline
Isis Pharmaceuticals (ISIS) has earned a $1M milestone payment from GlaxoSmithKline (GSK) related to the advancement of the Phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy. ISIS-TTRRx is an antisense drug in development with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Including this milestone payment, Isis has generated $27M in upfront and milestone payments for advancing ISIS-TTRRx. If GSK elects to exercise its option to exclusively license the ISIS-TTRRx program, Isis is eligible to receive a license fee, regulatory and sales milestone payments and double-digit royalties on sales of ISIS-TTRRx.
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.
05:38 EDTGSKGSK, Theravance initiate Phase III IMPACT study
GlaxoSmithKline (GSK) and Theravance (THRX) announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease, or COPD. IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid, or ICS; a long-acting muscarinic antagonist, or LAMA; and a long-acting beta2-adrenergic agonist, or LABA, in patients with COPD. The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF, or fluticasone furoate, an ICS, UMEC, or umeclidinium, a LAMA, and VI, or vilanterol, a LABA, all delivered in GSK's Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta, FF/VI, which is an ICS/LABA combination, and Anoro Ellipta, UMEC/VI, which is a LAMA/LABA combination.
July 15, 2014
12:21 EDTGSKOn The Fly: Midday Wrap
Stocks on Wall Street were lower at midday despite better than expected quarterly reports from two of the nation's largest financial institutions. Stock futures improved during the pre-market trading session, leading to a higher open for the broader market, following better than expected earnings reports from JP Morgan (JPM) and Goldman Sachs (GS). The earnings news also came alongside another huge M&A deal, as tobacco giants Reynolds American (RAI) and Lorillard (LO) confirmed plans to merge. However, the major averages weakened throughout the morning and fell into negative ground against the backdrop of Fed Chair Janet Yellen giving testimony on Capital Hill. In the Board of Governors' Monetary Policy Report, the central bank said valuation metrics in "some sectors" appear substantially stretched, "particularly those for smaller firms in the social media and biotechnology industries." ECONOMIC EVENTS: In the U.S., retail sales increased 0.2% in June compared to the month prior, making for the weakest reading since January and missing the consensus forecast for an increase of 0.6%. The Empire State manufacturing index climbed to a four-year high of 25.6 in July, beating expectations for a reading of 16.5. Import prices rose 0.1% in June, with export prices slipping 0.4%. Business inventories grew 0.5% in May, which was just below the 0.6% consensus growth expectation. In Europe, Germany's ZEW survey missed expectations, as both its Current Situation and Expectations reading were lower than forecast. COMPANY NEWS: Shares of JPMorgan advanced nearly 4% after the bank reported a profit of $1.46 a share, which included a legal expense of 13c a share, beating analysts' consensus forecast of $1.29. The earnings report comes after CEO Jamie Dimon recently disclosed that he has throat cancer. During the company's conference call, Dimon said he was "feeling great," that doctors had found no evidence of cancer anywhere except in the location where it had originally been detected, and that his prognosis for recovery is "excellent"... Also in the large-cap bank sector, Goldman Sachs' headline earnings and revenue similarly beat expectations. The firm, which said it ranks first in worldwide announced and completed mergers and acquisitions for the year-to-date, advanced about 1% following its report... Along with JPMorgan in the Dow Jones Industrial Average, Johnson & Johnson (JNJ) reported quarterly sales and profits that beat expectations and the healthcare conglomerate raised its fiscal year EPS view to $5.85-$5.92 from $5.75-$5.85. However, its increased outlook range still fell short of the $5.90 per share consensus forecast that analysts had prior to its report... Reynolds American confirmed news that has been speculated for many weeks, announcing that it will acquire peer Lorillard in a cash-and-stock transaction currently valued at $68.88 per Lorillard share, or a total of $27.4B, including the assumption of net debt. Shares of both fell afterward, with Lorillard down 8% to trade near $61.75 at midday and Reynolds slipping 5%. MAJOR MOVERS: Among the notable gainers was small-cap pharma biotechnology research company Codexis (CDXS), which surged nearly 50% after announcing a collaboration and license agreement with GlaxoSmithKline (GSK). Among the noteworthy losers was Aaron's (AAN), which is engaged in the lease ownership and retail sale of a variety of consumer products. Its stock fell over 6% after the company lowered its second quarter outlook, citing lower than expected performance of its core business as the reason for the revision. INDEXES: Near midday, the Dow was down 33.45, or 0.2%, to 17,021.97, the Nasdaq was down 40.48, or 0.91%, to 4,399.94, and the S&P 500 was down 9.24, or 0.47%, to 1,967.86.
10:56 EDTCELGFed calls small cap social media, biotech valuations 'stretched'
The Board of Governors of the Federal Reserve in its Monetary Policy Report dated today said valuation metrics in "some sectors" appear substantially stretched, "particularly those for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms early in the year." A later part in the document reads, "Equity valuations of smaller firms as well as social media and biotechnology firms appear to be stretched, with ratios of prices to forward earnings remaining high relative to historical norms." The specific targeting of sectors by the Fed seems to be having an impact on stocks in the social media and biotech spaces. Shares of Yelp (YELP) are down over 5% to $67.51, while Twitter (TWTR) and Facebook (FB) are each down 2%. Celgene (CELG) and Amgen (AMGN) are leading the biotech space lower with pullbacks of greater than 1%.
10:33 EDTCELGFacebook, Twitter slip following cautious valuation comments from Fed
Shares of a number of companies in the social media and biotech industries moved lower following the circulation of cautious comments about their stock valuations that were included in the Federal Reserve's latest Monetary Policy Report. WHAT'S NEW: In the report, presented by the Board of Governors of the Federal Reserve and signed on behalf of the governors by Chair Janet Yellen, the central bank wrote that some broad equity price indexes have increased to all-time highs in nominal terms since the end of 2013, but that valuation measures for the overall market in early July were "generally at levels not far above their historical averages." However, the Fed's report also cautioned that valuation metrics in some sectors do appear substantially "stretched," particularly those for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms early in the year. As support for its assessment, the Fed noted that ratios of prices to forward earnings for "smaller firms as well as social media and biotechnology firms" remain "high relative to historical norms." PRICE ACTION: Following the circulation of the comments in the Fed report, shares of Facebook (FB) are down 88c, or 1.3%, to $67.02, Twitter (TWTR) is down 24c, or 0.6%, to $38.07 and LinkedIn (LNKD), is down 21c, or 0.1%, to $159.57. Shares of some biotechnology companies including Celgene (CELG) and Amgen (AMGN) also ticked lower following the circulation of the comments from the Fed's report.
09:21 EDTGSKOn The Fly: Pre-market Movers
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05:44 EDTNVSNovartis to license Google 'smart lens' technology
Novartis (NVS) announced that its eye care division Alcon has entered into an agreement with a division of Google (GOOG) to in-license its "smart lens" technology for all ocular medical uses. The agreement with Google[x], a team within Google that is devoted to finding new solutions to big global problems, provides Alcon with the opportunity to develop and commercialize Google's "smart lens" technology with the potential to transform eye care and further enhance Alcon's pipeline and global leadership in contact lenses and intraocular lenses. The transaction remains subject to anti-trust approvals. The agreement between Google and Alcon represents an important step for Novartis, across all of its divisions, to leverage technology to manage human diseases and conditions. Google's key advances in the miniaturization of electronics complement Novartis's deep pharmaceuticals and medical device expertise. Novartis aims to enhance the ways in which diseases are mapped within the body and ultimately prevented.
05:35 EDTNVSNovartis collaborates with Banner Alzheimer's Institute on study
Novartis announced a collaboration with Banner Alzheimer's Institute, or BAI, on a pioneering clinical study in Alzheimer's disease, or AD, prevention. The study will determine whether two Novartis investigational anti-amyloid treatments can prevent or delay the emergence of symptoms of AD in people identified as being at genetic risk for developing the late-onset form of the disease. Using an innovative trial design, the two treatments will be given in cognitively healthy people at genetic risk of developing the build-up of amyloid protein in the brain that may eventually lead to AD. One treatment is an active immunotherapy, a treatment that stimulates an immune response, and triggers the production of natural antibodies against amyloid. This investigational treatment, given via an injection, is in phase II clinical development. The second treatment, a BACE inhibitor, is an oral medication about to enter phase I trials and is designed to prevent the production of different forms of amyloid.
July 14, 2014
21:08 EDTGSKCodexis to host conference call
Conference call to discuss the strategic collaboration and license agreement with GSK will be held on July 15 at 8:30 am. Webcast Link
16:06 EDTGSKCodexis announces $25M collaboration, license agreement with GlaxoSmithKline
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07:23 EDTNVSAlzheimer's Association to hold a conference
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06:17 EDTGSKXinhua: China indicts two GSK foreign investigators, The Guardian reports
Prosecutors in China have indicted two foreign investigators, British national Peter Humphrey and his wife, Yu Yingzeng, linked to GlaxoSmithKline, for illegally obtaining private information on Chinese citizens, reports The Guardian. Citing state media news agency Xinhua, the case is the first indictment by Chinese prosecutors against foreigners for illegal investigation. Reference Link
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