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March 7, 2014
14:18 EDTPFE, REGN, RHHBY, AMGN, NVS, SNYConcerns with PCSK9 class not seen with Regeneron drug, says Citigroup
Citigroup said its talks with Regeneron (REGN) indicate that the issues the FDA has noted with PCSK9 drugs have not arisen in the ongoing Phase 3 studies of Regeneron and Sanofi's (SNY) Alirocumab. Citi suspects the events described in filings by Regeneron and Sanofi might have been seen with PCSK9 inhibitors being developed by Amgen (AMGN), Pfizer (PFE), Novartis (NVS) or Roche (RHHBY). Citi also notes that neurocognitive side effects are known to be caused by statins and it is unclear whether the effects were seen with PCSK9 inhibitors when used alone or when combined with statins.
News For REGN;SNY;AMGN;PFE;NVS;RHHBY From The Last 14 Days
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April 15, 2015
07:41 EDTSNYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 14, 2015
06:30 EDTRHHBYRoche to seek to have cancer drug tested in 11 trials in 2015, Reuters says
Roche said it would seek to have its immunotherapy cancer drug, MPDL3280A, in 11 late stage trials by the end of 2015, aaccording to Reuters. The drug is being tested in melanoma, as well as lung, bladder, kidney, bowel and blood cancers, the news service noted. Reference Link
April 13, 2015
16:51 EDTNVSDiplomat Pharmacy to dispense Novartis' JADENU
Diplomat Pharmacy is set to distribute JADENU, a drug recently approved by the U.S. FDA to treat patients with chronic iron overload. JADENU is a new oral formulation of EXJADE for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older, and chronic iron due to NTDT in patients age 10 and older.
15:12 EDTPFEMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.
10:01 EDTRHHBYRoche acquires CAPP Medical
Roche announced it has acquired CAPP Medical, a genomics research company founded by Stanford University oncologists and industry veterans, to advance the development of technology for cancer screening and monitoring through the detection of circulating tumor DNA in blood.
05:21 EDTNVSNovartis to present new data that confirms high efficacy of Gilenya
Novartis announced new Gilenya analyses to be presented at the 67th American Academy of Neurology, or AAN, Annual Meeting in Washington, DC, from April 18-25, showing how Novartis is advancing methods assessing the impact of relapsing multiple sclerosis, or RMS, for patients and physicians. Data will show how adding brain shrinkage to an existing tool to assess MS disease activity will give a more precise prediction of the likelihood of future disability progression. Accurate assessment of disease activity is key to guide treatment decisions in RMS. A pooled analysis from the two-year phase III FREEDOMS and FREEDOMS II trials will further confirm Gilenya's high efficacy in previously-treated patients with highly-active RMS in achieving 'no evidence of disease activity' across four key measures: relapses, MRI lesions, brain shrinkage and disability progression. Achieving NEDA4 is especially critical for highly-active RMS patients, who are likely to lose more physical and cognitive functions over time despite being treated.
April 10, 2015
07:17 EDTREGNExpert very bullish on outlook for Regeneron Eylea, says RBC Capital
RBC Capital reports that a retina expert with whom it spoke was "very bullish" on the outlook for Regeneron's Eylea, not just in DME but also in wet AMD. The firm says the expert's positive outlook was sparked by recently presented Protocol T data. RBC continues to believe that Eylea could beat guidance this year, while Phase III programs could boost the stock. RBC keeps a $490 price target and Outperform rating on the shares.
April 9, 2015
09:51 EDTPFEPerrigo did not expect Mylan takeover letter, CNBC's Faber reports
Perrigo (PRGO) did not expect the takeover letter it received from Mylan (MYL), CNBC's David Faber reports, citing sources. Perrigo will take its time in deciding what its next steps are, Faber added. Shares of Mylan are up 3% in early trading, which is being attributed, at least in part, to speculation the company could be a takeover target itself. Analysts this morning mentioned Teva (TEVA) as a potential acquirer of Mylan. Chatter this morning has Pfizer (PFE) also potentially interested in the EpiPen maker
09:25 EDTNVS, PFEPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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09:17 EDTNVSCourt lifts injunction on sales of generic copy of Spectrum's Fusilev
The U.S. Court of Appeals for the Federal Circuit yesterday issued an order that lifted a temporary injunction put in place March 6 that had blocked Novartis' (NVS) Sandoz unit from selling a generic version of Spectrum Pharmaceuticals' (SPPI) colorectal cancer treatment Fusilev. The appeals court ruled that Spectrum failed to meet the requirements for an injunction pending appeal.
08:04 EDTPFEPfizer launches PCSK9 competitive grants program
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April 8, 2015
16:22 EDTNVSOn The Fly: Closing Wrap
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15:19 EDTRHHBYRoche says receives European approval for Avastin plus chemotherapy
Roche announced that the European Commission approved Avastin -- bevacizumab -- in combination with standard chemotherapy for the treatment of adult patients with persistent, recurrent or metastatic carcinoma of the cervix. The EU approval was based on the significant survival benefit in the pivotal GOG-0240 study, which showed that women who received Avastin plus chemotherapy had a statistically significant 26% reduction in the risk of death, representing a median improvement in survival of nearly four months, compared to women who received chemotherapy alone.
14:23 EDTNVSAdditional bidders for Perrigo could emerge after Mylan offer, says Stifel
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April 7, 2015
08:09 EDTPFEPfizer, Merck KGaA finalize agreement to co-promote XALKORI
Merck KGaA (MKGAY) and Pfizer (PFE) announced the finalization of the co-promotion agreement allowing the companies to co-promote Pfizerís anaplastic lymphoma kinase inhibitor XALKORI. Under the agreement, XALKORI will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 in the United States, Canada, Japan and five European Union countries: France, Germany, Italy, Spain and the United Kingdom. In the U.S. and Canada, XALKORI will be co-promoted by EMD Serono, the U.S. and Canadian biopharmaceutical businesses of Merck KGaA. The second wave will begin in 2016 and includes China and Turkey. n 2015, Merck KGaA will receive a reimbursement associated with its promotion of XALKORI, followed by an 80% for Pfizer, 20% for Merck KGaA profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the U.S., Canada, Japan, France, Germany, Italy, Spain and the U.K. and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of XALKORI in countries where it is co-promoted with Merck KGaA.
07:14 EDTNVS, RHHBY, SNY, PFEEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
07:02 EDTPFEGlycoMimetics updates on Pfizer's plans to initiate Phase 3 Rivipansel trial
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April 6, 2015
10:37 EDTPFETargacept says Pfizer terminates research & license agreement with Catalyst
In a regulatory filing from earlier, Targacept (TRGT) said: "As previously reported, on March 5, Targacept, Talos Merger Sub, a Delaware corporation and a wholly owned subsidiary of Targacept and Catalyst Biosciences, entered into an Agreement and Plan of Merger, pursuant to which, among other things, subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Catalyst, with Catalyst becoming a wholly owned subsidiary of Targacept and the surviving corporation of the merger. On April 1, Catalyst notified Targacept that Pfizer (PFE) would be exercising its right to terminate in its entirety the June 29, 2009, research and license agreement between Catalyst and Wyeth, which governs the development and commercialization of Catalystís leading human Factor VIIa product candidate for the treatment of hemophilia and surgical bleeding indications. On April 2, Pfizer provided Catalyst with its formal written notice of termination of the research and license agreement. Upon the June 1, effective date of the termination, the license and certain rights under the research and license agreement will terminate and revert to Catalyst. Catalyst has informed Targacept that Pfizer is committed to an orderly transfer of data, regulatory documentation and related technology under the agreement to Catalyst to enable Catalyst to continue the clinical development of this product candidate. Targacept is currently reviewing the implications of this event on the proposed Merger. In morning trading shares of Targacept are down almost 12% to $2.51.
08:13 EDTNVSJuno Therapeutics announces patent litigation settlement
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05:19 EDTAMGNAmgen announces EC approval of Vectibix in combination with Folfiri
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