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Stock Market & Financial Investment News

News Breaks
March 13, 2014
03:18 EDTRHHBYFDA advisory committee unanimously recommends Roche's cobas HPV test
Roche announced that the U.S. FDA Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas HPV Test as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks. The panel also voted unanimously that the cobas HPV Test is safe and effective for the proposed indication for use. If approved, the cobas HPV Test would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the United States. The Committee's recommendation will be considered by the FDA in its review of the primary screening indication for the cobas HPV Test. The FDA is not bound by the Committee's guidance, but takes its advice into consideration when reviewing medical devices.
News For RHHBY From The Last 14 Days
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August 17, 2014
13:40 EDTRHHBYChugai makes statement denying media reports on Roche deal
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August 15, 2014
11:28 EDTRHHBYRoche in talks on $10B deal to buy remainder of Chugai, Bloomberg reports
Roche is in talks to purchase the 38% stake of Chugai Pharmaceutical that it doesn't already own, according to Bloomberg, citing people familiar with the matter. The potential deal is valued at approximately $10B. Though no financial decision has been made, the deal may be announced as early as next week, the sources added. Reference Link
11:02 EDTRHHBYRoche in talk on $10B deal to buy remainder of Chugai, Bloomberg says
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06:12 EDTRHHBYGilead announced favorable ruling in arbitration against Roche
Gilead (GILD) announced that an arbitration panel determined that Roche (RHHBY) failed to establish any of their claims and ruled in favor of Gilead. As a result, Roche is not entitled to any damages or other relief. In March 2013, Roche initiated an arbitration against Gilead and Pharmasset, predecessor to Gilead Pharmasset, regarding a 2004 collaboration agreement between Roche and Pharmasset. In the arbitration demand, Roche asserted that it had an exclusive license to sofosbuvir pursuant to the collaboration agreement because sofosbuvir, a prodrug of a uridine monophosphate analog, is allegedly a prodrug of PSI-6130, a cytidine analog. Roche further claimed that, because it had exclusive rights to sofosbuvir, it also had an exclusive license to a patent covering sofosbuvir, and that we infringed that patent by selling and offering for sale products containing sofosbuvir.
August 14, 2014
16:02 EDTRHHBYFDA approves Genentech’s Avastin plus chemotherapy for cervical cancer treatment
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09:11 EDTRHHBYOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Kohl's (KSS), up 2.5%... Plug Power (PLUG), up 10%... Perrigo (PRGO), up 4.5%. HIGHER: Aruba Networks (ARUN), up 3% after shares upgraded at Stifel... KaloBios (KBIO), up 7.9% after publication shows EphA3 as target for anticancer therapy... Supernus (SUPN), up 4.4% after receiving FDA fast track designation for SPN-810. DOWN AFTER EARNINGS: Noodles & Company (NDLS), down 22%... Vipshop (VIPS), down 5.8%. LOWER: ExOne (XONE), down 10.7%, Voxeljet (VJET), down 6.6%, after earnings reports. Peers in the 3D space are lower as well, with Stratasys (SSYS) down 1% and 3D Systems (DDD) down 0.2%... Enphase Energy (ENPH), down 2.6% after filing to sell common stock for holders... InterMune (ITMN), down 3% after downgraded at Goldman following yesterday's advance on Bloomberg report that the company received takeover bids from Sanofi (SNY), Roche (RHHBY).
August 13, 2014
16:19 EDTRHHBYOn The Fly: Closing Wrap
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13:13 EDTRHHBYInterMune exploring sale after bids from Sanofi, Roche, Glaxo, Bloomberg says
InterMune (ITMN) is working with its financial advisers Goldman Sachs (GS) and Centerview Partners to evaluate takeover bids it has received from Sanofi (SNY), Roche (RHHBY), GlaxoSmithKline (GSK) and Actelion (ALIOF), said Bloomberg, citing people with knowledge of the matter. The report noted that one of the sources said Sanofi has so far shown the most interest in a deal for InterMune, whose shares are up more than 13% to $51.56 following the first headlines from the report. Reference Link
13:00 EDTRHHBYInterMune received takeover bids from Sanofi, Roche, Bloomberg says
August 11, 2014
05:53 EDTRHHBYCuris shares look attractive, says Piper Jaffray
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August 8, 2014
11:33 EDTRHHBYRoche submits supplemental Biologics License application to FDA for Lucentis
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August 7, 2014
14:05 EDTRHHBYPTC Therapeutics reports publication of preclinical study results in SMA models
PTC Therapeutics (PTCT) announced that he journal Science published results of a preclinical study demonstrating that treatment with orally available RNA splicing modifiers of the SMN2 gene starting early after birth is preventing deficits in mouse models of Spinal Muscular Atrophy or SMA. Stuart Peltz, CEO of PTC Therapeutics, said, "Using the experience and expertise in RNA biology we have gained at PTC over the last 16 years, we used our alternative splicing technology to identify and subsequently optimize investigational compounds that target the SMN2 splicing to produce the SMN protein. Our unique partnership with Roche and the SMA Foundation has allowed this project to rapidly move into clinical development." Luca Santarelli, Head of Neuroscience, Ophthalmology and Rare Diseases at Roche (RHHBY), said, "Although still preclinical, these results demonstrate how SMN2 splicing modifiers could correct the molecular deficit that causes SMA. This study represents an important step towards developing a potential therapeutic option for this devastating and currently untreatable condition. Early clinical trials are currently underway to determine the safety and tolerability of this approach."
August 6, 2014
10:43 EDTRHHBYRoche says Avastin gets EU approval for Ovarian cancer
Roche announced that the European Commission, EU, approved the use of Avastin in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy as a treatment for women with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy.
06:19 EDTRHHBYCFA Society of Minnesota to hold a conference
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