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October 11, 2012
05:55 EDTVRTX, VRTX, VRTX, ABT, ABT, ABT, ELMD, ELMD, ELMD, DNA, DNA, DNA, GILD, GILD, GILD, HRC, HRC, HRC, HOLX, HOLX, HOLX, NVS, NVS, NVSCystic Fibrosis Foundation to host a conference
26th Annual North American Cystic Fibrosis Conference (NACFC) is being held in Orlando, Florida on October 11-13.
News For VRTX;ABT;ELMD;DNA;GILD;HRC;HOLX;NVS From The Last 14 Days
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March 23, 2015
09:03 EDTVRTX, NVSLeerink analysts hold a meeting with a conference call hookup
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09:03 EDTABTFiserv says Abbott employee credit union expands partnership
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08:44 EDTGILDGilead volatility low into FDA hepatitis C drug warning
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08:23 EDTGILDGilead weakness a buying opportunity, says RW Baird
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07:47 EDTVRTXVertex says VX-661, ivacaftor generally well tolerated in 12-week Phase 2 study
Vertex Pharmaceuticals announced data from a 12-week Phase 2 study evaluating VX-661 in combination with ivacaftor in 39 people with CF ages 18 and older who have two copies of the F508del mutation. The study evaluated two doses of VX-661 in combination with ivacaftor. The primary endpoint of the study was safety. The study showed that the combination regimen was generally well tolerated, and all patients completed 12 weeks of treatment. The most common adverse events were pulmonary exacerbation, which occurred in 38% of all patients who received VX-661 and 44% of those who received placebo, and cough, which occurred in 33% of all patients who received VX-661 and 39% of those who received placebo. Secondary endpoints evaluated the effect of the combination on lung function, and the mean within-group absolute improvement from baseline in ppFEV1 for those who received 100 mg of VX-661 in combination with ivacafto was 4.4 and 3.0 percentage points at week 4 and through 12 weeks of treatment, respectively. Consistent with prior Phase 2 studies that evaluated 4 weeks of treatment with VX-661 in combination with ivacaftor, this study showed a rapid improvement in lung function within four weeks of treatment, and after patients completed treatment, lung function returned to baseline. These safety and efficacy data, together with other data from multiple previously completed Phase 2 studies of VX-661, support Vertex’s ongoing Phase 3 program of VX-661 in combination with ivacaftor. The Phase 3 program is evaluating VX-661 in combination with ivacaftor and consists of four Phase 3 studies, including a study in people with two copies of the F508del mutation that began enrollment in February. The other three studies will enroll people with CF who have one copy of the F508del mutation and a second mutation that is either a gating mutation, residual function mutation or a mutation that results in minimal CFTR function.
07:40 EDTGILDGilead weakness on FDA warning would be buying opportunity, says Wells Fargo
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06:08 EDTGILDGilead implied volatility of 23 at lower end of index mean range
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March 22, 2015
15:05 EDTGILDGilead warns after hepatitis C patient taking heart drug dies, Bloomberg says
Gilead said in an e-mailed drug warning to health-care providers on Friday that nine patients taking its hepatitis C drugs Harvoni or Sovaldi along with the heart treatment amiodarone developed abnormally slow heartbeats and one died of cardiac arrest, says Bloomberg. Reference Link
March 20, 2015
16:00 EDTGILDOptions Update; March 20, 2015
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15:02 EDTGILDAcelRx names Howard Rosen as interim CEO
AcelRx Pharmaceuticals (ACRX) announced the appointment of Howard Rosen as interim CEO of AcelRx, effective April 1. Rosen is a technically trained executive with over 25 years of success growing start-up and mid-size biopharmaceutical companies. Rosen previously held senior-level general management positions and functional roles in strategy, marketing, finance, business development, and research and development at Gilead Sciences (GILD) and ALZA Corporation. Rosen has served on the Board of Directors of AcelRx since 2008 and currently serves on the Board of Directors of Alcobra and several private biopharmaceutical companies.
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.
07:41 EDTNVSAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
16:01 EDTGILDOptions Update; March 19, 2015
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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
09:08 EDTGILDNew Gilead HIV drug likely to be approved in mid-2015, says Argus
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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
06:31 EDTGILDStudies find Gilead's hepatitis C drugs cost effective, Reuters says
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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.
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