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January 22, 2014
06:25 EDTBMY, AZNAstraZeneca, Bristol-Myers say Xigduo approved in the EU for type 2 diabetes
AstraZeneca (AZN) and Bristol-Myers Squibb (BMY) announced that Xigduo has been granted Marketing Authorization by the European Commission for the treatment of type 2 diabetes in the European Union. Xigduo combines dapagliflozin, a selective and reversible inhibitor of SGLT2 with metformin hydrochloride, two anti-hyperglycaemic products with complementary mechanisms of action to improve glycaemic control, in a twice daily tablet. This is the first regulatory approval for a fixed dose combination of an SGLT2 inhibitor and metformin. Xigduo is indicated for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control.
News For AZN;BMY From The Last 14 Days
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November 19, 2014
07:11 EDTAZNSanofi drawing up list of CEO candidates to repalce Viehbacher, Reuters reports
Sanofi's (SNY) board is in the process of drawing up a short list of CEO candidates to replace Chris Viehbacher, sources tell Reuters. Jean-Rene Fourtou, a Sanofi director and the honorary chairman of media group Vivendi (VIVHY), has been selected to lead the appointments and governance committee that will select the next CEO. Smith & Nephew (SNN) CEO Olivier Bohuon, AstraZeneca (AZN) CEO Pascal Soriot and former Wyeth CEO Bernard Poussot have been rumored to be potential contenders for the CEO position. Reference Link
06:36 EDTAZNClovis rociletinib data 'good news/bad news,' says Mizuho
Mizuho analyst Peter Lawson says his initial read of the new rociletinib data is "good news/bad news," which leaves his price target for Clovis unchanged. Lawson pegs the bad news as the drug losing its progression-free survival lead since the estimated PFS dropped from 12 months to 10.4 months, essentially in-line with AstraZeneca's (AZN) competing drug AZD9291. Lawson sees the good news as the "encouraging" PFS of 7.5 months in T790M-negative patients. He keeps a Buy rating on Clovis with a $100 price target.
06:07 EDTBMYBristol-Myers' Opdivo for melanoma shows positive Phase 3 results
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November 18, 2014
14:59 EDTAZNRanbaxy sues FDA for rescinding approval of Nexium, Valcyte copies, Reuters says
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07:29 EDTAZNPfizer less likely to pursue AstraZeneca after PD-L1 deal, says JPMorgan
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07:18 EDTAZNWoodford confident in Astra, sees 50% chance of new Pfizer bid, Reuters reports
Investment manager Neil Woodford of Woodford Investment Management said he now has an even stronger belief in AstraZeneca (AZN), citing the company's strong product pipeline, and put the chances of a new takeover bid from Pfizer (PFE) at 50/50, reported Reuters, citing a statement from Woodford. Reference Link
06:39 EDTAZNAstraZeneca: 'Hard to comment' on whether Pfizer will come back, Reuters reports
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November 17, 2014
11:06 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
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09:37 EDTAZNAstraZeneca to host investor day
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08:13 EDTBMYPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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08:10 EDTBMYBristol-Myers presents results from Phase IIIb AVERT trial at ACR
Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase IIIb AVERT trial that investigated the use of Orencia plus methotrexate in biologic and MTX-na´ve citrullinated protein-positive early moderate to severe rheumatoid arthritis patients. These data were presented this week at the American College of Rheumatology 2014 annual meeting. Orencia is currently indicated in adults for moderate to severe RA. Orencia should not be administered with tumor necrosis factor antagonists and should not be used with other biologic RA drugs. One of the analyses looked at anti-CCP antibodies, which are a marker of RA and may contribute to disease progression. The analysis assessed the development of anti-CCP antibodies in patients with early rapidly progressing RA by measuring isotypes and the number of epitopes recognized after treatment with Orencia plus MTX, Orencia alone, or MTX alone. Results demonstrated Orencia plus MTX numerically reduced the concentrations of all CCP isotypes and the average number of epitopes recognized over one year of treatment more than Orencia alone or MTX alone. Over 12 months of treatment, 6.7 percent, 12.1 percent, and 7.8 percent of patients on Orencia plus MTX, Orencia alone, and MTX alone, respectively, experienced a serious adverse event and 1.7 percent, 4.3 percent and 2.6 percent led to discontinuation. Serious infections were observed in 0.8 percent of patients in the combination arm and 3.4 percent in the Orencia monotherapy arm. None of the patients in the MTX alone arm experienced a serious infection. Malignancies were reported in 0.8 percent, 1.7 percent, and 0 percent of patients in the Orencia + MTX, Orencia, and MTX arms, respectively. Additionally at ACR, investigators presented 12-month efficacy data from AVERT, including new results assessing the effect of Orencia on more clinically stringent remission criteria than DAS-defined remission, as well as new MRI data. Significantly more patients on Orencia plus MTX achieved the stringent clinical endpoint of Boolean-defined remission at 12 months.
07:16 EDTAZNMilken Institute--Faster Cures to hold a conference
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07:08 EDTAZNMedImmune presents positive Phase IIb data for mavrilimumab in RA
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07:07 EDTAZNMedImmune presents new data in systemic lupus
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06:43 EDTAZNAstraZeneca, Pfizer deal seen less likely after Merck transaction, Reuters says
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November 16, 2014
13:36 EDTAZNAstraZeneca presents data from studies of lesinurad combined with allopurinol
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13:07 EDTBMYBristol-Myers announces results from CheckMate -066 study
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November 14, 2014
14:53 EDTBMY, AZNCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
07:14 EDTBMY, AZNAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
06:05 EDTBMYBristol-Myers to construct biologics manufacturing facility in Ireland
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