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News Breaks
April 10, 2014
11:42 EDTGILD, GSK, RHHBYReport claims Tamiflu, Relenza do little to prevent the spread of flu
The Cochrane Collaboration, an independent nonprofit organization that aims to help health professionals, patients, and policy makers access evidence-based medicine to guide their decisions, concluded in a newly published report that neuraminidase inhibitors Tamiflu and Relenza are stockpiled and recommended by public health agencies but have not been proven to prevent the spread of flu or reduce dangerous complications. Tamiflu was co-developed by and is marketed by Gilead Sciences (GILD) and Roche (RHHBY), while Relenza is marketed by GlaxoSmithKline (GSK). Roche said "we disagree with the overall conclusions" and warned they could "potentially have serious public health implications," according to a company statement quoted by BBC News. Reference Link
News For GILD;RHHBY;GSK From The Last 14 Days
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July 27, 2015
08:03 EDTGSKNephroGenex names Jaikrishna Patel as Chief Medical Officer
NephroGenex (NRX) announced the appointment of Dr. Jaikrishna Patel to the position of Chief Medical Officer. Dr. Patel will help guide the company’s Phase 3 PIONEER program with oral Pyridorin for the treatment of diabetic nephropathy, and the development of an intravenous formulation of Pyridorin for acute kidney injury. Patel has held numerous positions of increasing responsibility at GlaxoSmithKline (GSK) and its predecessor companies, most recently serving as Vice President of Cardiovascular and Cardiovascular Metabolism, Global Regulatory Affairs.
05:56 EDTGILDStocks with implied volatility movement; CRM GILD
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July 24, 2015
06:27 EDTGILDGilead price target raised to $131 from $120 at Piper Jaffray
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05:04 EDTGSKAgenus reports GSK Malaria vaccine receives positive opinion from CHMP of EMA
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July 23, 2015
12:45 EDTGILDGilead July weekly volatility elevated into Q2 and outlook
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06:27 EDTRHHBYRoche CEO expects biosimilars in Europe by late 2017, Reuters reports
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05:46 EDTRHHBYRoche expects FY15 sales to grow low- mid-single digits
Expects FY15 core EPS to grow ahead of sales at constant exchange rates. Roche expects to further increase dividend in Swiss francs.
05:45 EDTRHHBYRoche reports 1H15 core EPS CHF 7.22 vs. 7.57 last year
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July 21, 2015
14:12 EDTGILDGilead reports study of E/C/F/TAF met primary endpoint
Gilead Sciences announced detailed 48-week data from an open-label Phase 3 study evaluating its investigational once-daily single tablet regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg, or E/C/F/TAF, among 1,436 virologically suppressed adult patients switching from tenofovir disoproxil fumarate-containing regimens. The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. The study also demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL at Week 48 and statistically significant improvements in bone and renal laboratory parameters. These data were presented in an oral session at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada. Among the 1,436 patients who were randomized in the study, virologic success rates at Week 48 were higher in patients taking E/C/F/TAF, 97% versus 93% for all TDF-based regimens; difference in percentages: 4.1%, 95% CI: 1.6% to 6.7%. The rates of virologic failure were similar between the two arms, with E/C/F/TAF, 1.0% and TDF-based regimen, 1.3%. General safety was similar between the two arms through 48 weeks of treatment, with similar percentages of patients in each group having any adverse events. Adverse events leading to treatment discontinuation were more common among patients treated with a TDF-based regimen.
07:05 EDTRHHBYOphthotech names Shima as Chief Scientific Officer, Bjarke as CCO
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July 20, 2015
07:33 EDTGILD, RHHBYInternational AIDS Society to hold a conference
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05:13 EDTRHHBYRoche expands HIV Global Access Program
Roche announced an expansion to the HIV Global Access Program to include early infant HIV diagnostic testing for low and middle income countries. Roche, in partnership with the Joint United Nations Programme on HIV/AIDS, or UNAIDS, the Clinton Health Access Initiative, or CHAI, UNITAID, the U.S. President's Emergency Plan For AIDS Relief, or PEPFAR, and the Global Fund to fight AIDS, TB and Malaria, is committed to working with the Diagnostics Access Initiative by providing state-of-the-art solutions to achieve the 90-90-90 goal set forth by UNAIDS. Announced in 2014, the HIV Global Access Program is Roche's most recent addition to the AmpliCare Initiative, which launched in 2002 in South Africa.
July 17, 2015
10:21 EDTGILDCigna says 98.4% of customers treated with hep C drug Harvoni are cured
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09:03 EDTGILDGilead granted orphan status for gastric cancer treatment
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July 16, 2015
09:22 EDTGILDBristol-Myers says EU approves Evotaz for treatment of HIV-1 infection in adults
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08:03 EDTGSKGlaxoSmithKline expects to ship 32M-38M flu vaccines over 2015-16 season
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July 15, 2015
07:58 EDTGILDAnalysts break down impact of $7.2B Receptos buyout
After Celgene (CELG) announced last night that the company has agreed to acquire Receptos (RCPT) for $232 per share in cash, or a total of about $7.2B net of cash acquired, research firms have chimed in with their opinions on how the proposed deal may impact others in the biotech space. Receptos key asset is Ozanimod, which is being studied in Phase III trials for relapsing multiple sclerosis and ulcerative colitis. DERIVATIVE CALLS: Piper Jaffray analyst Edward Tenthoff told investors that he views Celgene's deal for Receptos as good for Arena Pharmaceuticals (ARNA). The analyst notes that Arena's APD334 is already showing dose-dependent decreases in circulating lymphocyte counts and that the company will initiate Phase II studies in ulcerative colitis and Crohn's disease this year. Tenthoff reiterates an Overweight rating and $7.50 price target on Arena, which has a market capitalization around $1B and closed yesterday up 8c to $4.47. In its own note to investors this morning, Nomura said Celgene's deal could put downward pressure on Biogen's (BIIB) long-term multiple sclerosis estimates. Nomura's M. Ian Somaiya contended that one-year Phase II efficacy data for Ozanimod looked as good as Novartis’s (NVS) Gilenya and Biogen's Tecfidera’s Phase III at year 2. Somaiya also wondered if rival Gilead (GILD) could be "looking for something bigger" than Receptos for its own deal, telling investors that the firm views Incyte (INCY) as Gilead's most likely takeout target. Incyte's shares closed up $4.46 at $117.46 yesterday, giving the company a market cap of about $20B. RIVAL BID?: Wedbush analyst Liana Moussatos believes another bidder may seek to acquire Receptos, noting that she previously estimated Receptos could be valued at $348 per share, or about $10.9B, in a buyout. Moussatos noted that Celgene said it expects annual peak sales for Ozanimod to reach about $4B-$6B for RMS and UC, making its acquisition price of $7.2BN only a bit more than about 1X peak sales without accounting for other possible indications or the rest of its pipeline. Moussatos told investors she sees "plenty" of potential upside to justify a rival bidder stepping in and reiterated the firm's Outperform rating on Receptos shares. PRICE ACTION: In pre-market trading, Receptos rose 10% to $228.61 while Gilead gained 1.4% to about $119 per share.
05:57 EDTGSKGlaxoSmithKline, Francis Crick Institute to collaborate on range of new drugs
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July 14, 2015
06:04 EDTRHHBYRoche says atezolizumab met primary endpoint in IMvigor 210 trial
Roche announced that in the IMvigor 210 study, the investigational cancer immunotherapy atezolizumab shrank tumors -- objective response rate, ORR, the primary end point of this Phase II study -- in people with locally advanced or metastatic urothelial bladder cancer who had progressed on initial treatment. High amounts of PD-L1 expression by a person’s cancer correlated with increased response to the medicine. Adverse events were consistent with what has been previously observed for atezolizumab. Sandra Horning, M.D., chief medical officer and head of Global Product Development, said, “We plan to present results at an upcoming medical meeting and will discuss next steps with health authorities to bring a new treatment option to patients as soon as possible.” Last year, the U.S. FDA granted Breakthrough Therapy Designation for atezolizumab in people whose metastatic bladder cancer expressed PD-L1. This designation is designed to expedite the development and review of medicines intended to treat serious diseases. In addition to the IMvigor 210 study, Roche has an ongoing randomised Phase III study, IMvigor 211, comparing atezolizumab with standard-of-care chemotherapy in people who have relapsed UBC, and a planned Phase III study, IMvigor 010, that will evaluate atezolizumab compared with observation in people with early-stage muscle-invasive bladder cancer who are selected for PD-L1 expression and are at risk for recurrence.
July 13, 2015
07:44 EDTRHHBYEli Lilly price target raised to $105 from $100 at Jefferies
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