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News Breaks
February 17, 2013
15:32 EDTABBV, RHHBYAbbVie suspends Leukemia therapy trials. Bloomberg reports
AbbVie (ABBV) and its partner in the trials, Roche (RHHBY), have cancelled five studies on an experimental leukemia and lymphoma medicine after two patient deaths said an AbbVie spokesperson, adding that AbbVie and its partner, Roche Holding, suspended the dose-escalation portion of the studies to determine the amount of drug that is safest and most effective, reported Bloomberg Friday afternoon. Reference Link
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April 23, 2014
11:34 EDTABBVGilead climbs after hep C drug sales top $2B in Q1
Shares of drug maker Gilead (GILD) are surging after the company reported better than expected first quarter results and noted that its Hepatitis C drug had generated sales of $2.27B during the quarter. WHAT'S NEW: Gilead reported Q1 earnings per share of $1.48, versus analysts' consensus estimate of 89c. The company's revenue came in at $5B, versus the consensus forecast of $3.9B. Gilead obtained $2.27B of revenue from its Hepatitis C treatment, Solvaldi, which was launched in December. There was strong demand for Sovaldi from U.S. hepatitis C patients, Gilead Executive VP, Commercial Operations Paul Carter said on the company's results conference call. ANALYST REACTION: A number of analysts reacted positively to Gilead results. In a note to investors earlier today, Robert W. Baird analyst Brian Skorney wrote that last quarter, Sovaldi tied Lipitor for the highest U.S. quarterly sales of any drug in history. In light of Sovaldi's performance, analysts' 2014 and 2015 estimates for the company clearly must increase, the analyst contended. Even if Sovaldi's sales are cut in half from their peak levels in 2015-2017, the stock should still rise, Skorney wrote. He kept a $103 price target and Outperform rating on the stock. Also upbeat on Gilead was Wells Fargo. The launch of Sovaldi was "as good as it gets," and Gilead's results were "outstanding," the firm contended. It kept an $87-$91 price target and Outperform rating on the stock. OTHERS TO WATCH: AbbVie (ABBV) is also developing a treatment for hepatitis C. PRICE ACTION: In morning trading, Gilead gained $2.11, or 2.9%, to $74.97, while AbbVie shares were down 0.6% to $49.71.
06:16 EDTRHHBYPharmaceutical companies narrowing focus, WSJ reports
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April 22, 2014
08:56 EDTABBVEnanta announces ABT-450 NDA submission
Enanta (ENTA) announced that AbbVie (ABBV), Enanta’s collaboration partner for ABT-450, has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for an investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection. The three direct-acting antiviral regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. ABT-450 is the lead protease inhibitor developed through Enanta’s collaboration with AbbVie. The U.S. NDA filing triggers a $20M milestone payment to Enanta from AbbVie. AbbVie also plans to submit applications for regulatory approval of its regimen in the European Union in early May. Enanta is entitled to receive an additional $20M upon the first regulatory filing in the European Union for a regimen containing a collaboration compound.
08:49 EDTABBVAbbVie submits NDA to FDA for GT1 hepatitis C virus infection
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April 21, 2014
12:44 EDTRHHBYRoche management to meet with Jefferies
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April 19, 2014
11:12 EDTRHHBYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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April 17, 2014
06:18 EDTRHHBYEMA warns that stolen Roche drug found on market
The European Medicines Agency has been informed that vials of the cancer medicine Herceptin, thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries. This is currently being investigated by Member State authorities and updates will be provided as more information becomes available. Italian law enforcement authorities are currently investigating the theft and are looking at whether other medicines may also be affected. No affected product has so far been identified at hospital level and there are no reports that any harm has come to patients in relation to the falsified medicine and authorities are working to avoid this. The marketing authorisation holder for Herceptin is Roche.
April 16, 2014
07:32 EDTRHHBYRegeneron may be taking market share from Roche, says Brean Capital
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April 15, 2014
09:22 EDTABBVAbbVie initiates Phase III clinical trial of veliparib in lung cancer
AbbVie announced the initiation of a global Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib or ABT-888, in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer. The trial will compare patients randomized to receive either the standard chemotherapies of carboplatin and paclitaxel with the addition of veliparib, versus patients receiving carboplatin and paclitaxel with the addition of placebo. The trial will recruit approximately 900 patients.
09:02 EDTRHHBYRoche confirms FY outlook for low-to mid-single digit growth in sales
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09:01 EDTRHHBYRoche reports Q1 sales CHF11.496B vs. CHF11.589B a year ago
Roche reported Q1 group sales rose 5% at constant exchange rates and fell 1% in Swiss francs compared to the prior year. Pharma sales were up 4%, with continued growth of Avastin, MabThera/Rituxan, Actemra/RoActemra and Herceptin compensating for expected decline in Xeloda sales, while Diagnostics division sales were up 7%. Roche CEO Severin Schwan said: “Both the Pharma and Diagnostics Divisions posted solid growth in the first quarter. I am particularly pleased with the strong uptake of our recently launched medicines Perjeta and Kadcyla for HER2-positive breast cancer."
08:23 EDTRHHBYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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08:19 EDTRHHBYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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06:32 EDTRHHBYPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers 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). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
17:31 EDTABBVAbbVie stock could reach $55, Barron's says
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07:45 EDTABBVAbbVie defended at BMO Capital
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April 12, 2014
19:23 EDTABBVEnanta reports detailed results from Turquoise ll study
Enanta Pharmaceuticals (ENTA) announced that detailed results from AbbVie’s (ABBV) pivotal phase 3 TURQUOISE-II study, will be presented as a late-breaking oral presentation at the International Liver Congress, ILC, which is the 49th Annual Meeting of the European Association for the Study of the Liver, EASL. Results from the TURQUOISE-II study were featured in the ILC press conference and were published on-line in the New England Journal of Medicine. The TURQUOISE-II study reports results from AbbVie’s investigational three direct-acting antiviral regimen containing ABT-450, Enanta’s lead protease inhibitor discovered through Enanta’s collaboration with AbbVie. The regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. TURQUOISE-II is a global, multi-center, randomized, open-label study evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie's three direct-acting antiviral regimen with ribavirin, RBV, in adult patients with genotype 1, GT1, chronic hepatitis C virus, HCV, infection with compensated liver cirrhosis. Patients achieved sustained virologic response rates 12 weeks post-treatment, SVR12, of 91.8% and 95.9% in the 12-week and 24-week treatment arms, respectively. Patients in the study were either new to therapy or treatment-experienced, failed previous treatment with pegylated interferon and RBV.
April 11, 2014
05:27 EDTABBVEnanta announces results for partner AbbVie's HCV studies
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05:24 EDTABBVAbbVie announces 96% sustained virologic response rates in HCV study
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April 10, 2014
11:42 EDTRHHBYReport claims Tamiflu, Relenza do little to prevent the spread of flu
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