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News Breaks
February 10, 2014
07:55 EDTPFE, PFE, NVS, NVS, BAYRY, BAYRYFDA to hold a joint committee meeting
The Arthritis Advisory and Drug Safety & Risk Management Advisory Committees, along with Pfizer, Novartis and Bayer, discuss data and analyses published in 2006 or later that are relevant to further understanding the relationship between nonsteroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk that is currently described in NSAID class labeling in a meeting being held at FDA Silver Spring, Maryland offices on February 10 at 8 am. Webcast Link
News For PFE;NVS;BAYRY From The Last 14 Days
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March 23, 2015
11:01 EDTPFEPfizer rallies to fresh 52-week high, levels to watch
Shares are up over 2.8% at time of writing to $35.14, just below the new 52-week high at $35.26 which is now initial resistance. Next resistance above is at $35.89 and then at $36.63. Support is at $34.89.
09:45 EDTNVSUBS to hold a field trip
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09:37 EDTPFEActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AUY SLB PFE MCP CELG VRTX SHPG GILD LOGI TSLA TASR NFLX SCTY WFM
09:03 EDTNVSLeerink analysts hold a meeting with a conference call hookup
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08:06 EDTPFEPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
Pfizer (PFE) and Eli Lilly and Company (LLY) announced that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200M upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. FDA to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February. In the prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed.
08:05 EDTPFEPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
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07:36 EDTPFEPfizer should rise 'significantly' over next two years, says Jefferies
Jefferies analyst Jeffrey Holford told investors this morning that he expects shares of Pfizer (PFE) to appreciate "significantly" over the next two years. A survey of U.S. oncologists indicated the company's Ibrance drug will be used in 50% of first line hormonal therapy within one year, with off-label use in all lines of therapy including adjuvant, Holford noted. He thinks peak sales of the drug could top $13B, which is well above consensus. In addition, the analyst views Pfizer's Global Established Pharmaceutical business as being underappreciated by the market. Potential value creating options for the pharmaceutical giant include spinning off its GEP unit by 2017 and accretive acquisitions, with possible takeover targets being Shire (SHPG), Actavis (ACT), AstraZeneca (AZN) and GlaxoSmithKline (GSK), in the eyes of Holford. He added the stock to the firm's Franchise Picks list, which encompasses its best ideas. He also raised his price target for Pfizer to $45 from $42. The stock closed Friday up 10c to $34.25.
March 20, 2015
13:03 EDTPFEPfizer says oral tofacitinib meets primary endpoint in Phase 3 trials
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12:33 EDTNVSNovartis says CLEAR Phase IIb study met primary endpoint
Novartis announced results from the CLEAR study demonstrating that Cosentyx is significantly superior to Stelara, a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, USA. Cosentyx -- at a dose of 300 mg -- is the first and only interleukin-17A inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index 90 response, known as clear to almost clear skin at Week 16. PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara. In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara. The CLEAR study follows the pivotal Phase III FIXTURE study, which showed Cosentyx was superior to Enbrel.
07:55 EDTPFEAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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07:41 EDTNVS, PFE, BAYRYAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
15:55 EDTNVSAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTNVSAmgen denied preliminary injunction for biologics against Novartis, Reuters says
11:00 EDTPFEPfizer participates in a conference call with Bernstein
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March 18, 2015
17:09 EDTPFEPfizer CAPiTA published in New England Journal of Medicine
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March 17, 2015
12:51 EDTNVSNovartis hit with $100M gender discrimination lawsuit, Reuters reports
A proposed class action lawsuit against Novartis claims the drug maker routinely denied female employees equal pay and promotional opportunities, reports Reuters. The $110M lawsuit filed on Tuesday says Novartis' Alcon Laboratories maintains a "boy's club atmosphere" that is hostile to women and bars them from leadership positions. Reference Link
05:32 EDTNVSIncyte announces Novartis receives EC approval for Jakavi
Incyte (INCY) announced that Novartis (NVS) received approval from the European Commission for Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Under the Incyte-Novartis Collaboration and License Agreement signed in 2009, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications, and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi. Jakafi is approved by the FDA for treatment of people with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
05:30 EDTNVSNovartis receives EU approval for Jakavi in polycythemia vera
Novartis announced that the European Commission has approved Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Jakavi is the only JAK 1/2 inhibitor available to treat PV and is also currently approved in more than 80 countries to treat myelofibrosis.
March 16, 2015
06:40 EDTPFEPCSK9 studies show potential improvement in heart health, WSJ says
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March 13, 2015
05:40 EDTNVSNovartis to present Cosentyx data at AAD 2015
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