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Stock Market & Financial Investment News

News Breaks
May 23, 2014
17:14 EDTQGEN, AMGNAmgen announces FDA approval of Vectibix in combination with FOLFOX
Amgen (AMGN) announced that the FDA has approved Vectibix for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-type KRAS metastatic colorectal cancer. With this approval, Vectibix becomes the first and only biologic to offer a significant survival benefit as a first-line treatment with FOLFOX, one of the most commonly used chemotherapy regimens in the first-line setting for patients with wild-type KRAS mCRC. In addition, this approval converts the accelerated monotherapy approval to a full approval for Vectibix. FDA also approved the therascreen KRAS RGQ PCR Kit developed by QIAGEN (QGEN) as a companion diagnostic for Vectibix.
News For AMGN;QGEN From The Last 14 Days
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May 22, 2015
16:24 EDTAMGNAmgen to end participation in co-development and commercialization of brodalumab
Amgen (AMGN) announced the company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca (AZN). Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. The decision was based on events of suicidal ideation and behavior in the brodalumab program, which Amgen believes likely would necessitate restrictive labeling. After Amgen transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab. Amgen has decided to focus its efforts and resources on other key molecules that address unmet medical needs and deliver value to patients and shareholders. The Company continues to make progress against its strategic and financial commitments and does not expect any meaningful impact from this decision on its ability to meet them.
07:32 EDTAMGNAmgen receives positive CHMP opinion for use of Repatha
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the marketing authorization of Repatha recommending approval for use in certain patients with high cholesterol. Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood. The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
May 21, 2015
14:48 EDTAMGNRegeneron primary driver remains Praluent, says Piper Jaffray
Piper Jaffray noted that Regeneron (REGN) shares are at all-time highs after the company and partner Sanofi reported Phase IIb data on Dupilumab and Phase III data on Sarilumab. However, the firm believes the primary driver for Regeneron remains Praluent and firm expects launch costs to outstrip sales growth. Piper acknowledges Regeneron has "one of the richest pipelines in all of biotech," but it sees risk around Amgen's (AMGN) patent suit and keeps its Neutral rating and $484 price target on the stock.
May 20, 2015
09:52 EDTAMGNAlliance for Health Reform holds a webcast on biosimilars
"Biosimilars in the U.S.: Current & Emerging Issues" provides essential background on the U.S. and international markets for reference biologics and biosimilars, outline current policy and regulatory issues, and describe implications for the future. Speakers include Chief Scientific Officer Ramachandra from Hospira, Executive Director Eich from Amgen on the briefing being held on May 20 at 12 pm. Webcast Link
May 19, 2015
09:18 EDTQGENBofA/Merrill life sciences analysts hold an analyst/industry conference call
Analysts, along with Nancy J. Kelley, a nationally recognized executive and lawyer who has championed the field of Synthetic/Engineering Biology in the U.S., discuss what Synthetic Biology is and whether it will disrupt the Healthcare landscape and how Synthetic Biologic-based products would be regulated on an Analyst/Industry conference call to be held on May 19 at 2 pm.
08:57 EDTAMGNLeerink biotech analyst holds an analyst/industry conference call
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07:51 EDTAMGNFDA PDUFA Date for Amgen's Blinatumomab is May 19, 2015
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May 15, 2015
12:13 EDTAMGNThird Point gives quarterly update on stakes
NEW STAKES: Yum! Brands (YUM), NXP Semiconductors (NXPI), FedEx (FDX), McKesson (MCK), and J M Smucker (SJM). INCREASED STAKES: Actavis (ACT), Roper Technologies (ROP), Delta Air Lines (DAL), and FleetCor Technologies (FLT). DECREASED STAKES: Ally Financial (ALLY), Amgen (AMGN), Phillips 66 (PSX), eBay (EBAY), and Anheuser Busch Inbev SA (BUD). LIQUIDATED STAKES: Alibaba Group (BABA), Citigroup (C), EMC Corporation (EMC), Anglo American (AAL), and Williams Companies (WMB).
10:28 EDTQGENMAC updates positive for NanoString, Myriad, Invitae, QIAGEN, says Leerink
Leerink said that coverage updates posted yesterday by Medicare Administrative Contractors were favorable for NanoString (NSTG), Myriad Genetics (MYGN), Invitae (NVTA) and QIAGEN (QGEN). The firm has Outperform ratings on NanoString and Invitae and Market Perform rating on the other two stocks listed.
08:05 EDTQGENQIAGEN has a conference call hosted by JPMorgan
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05:32 EDTAMGNAmgen presents first Phase 2 data for AMG 334
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May 14, 2015
10:41 EDTAMGNAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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07:44 EDTAMGNInternational Headache Society to hold a conference
17th Congress of the International Headache Society is being held in Valencia, Spain on May 14-17.
May 13, 2015
17:17 EDTAMGNAmgen to present key results in solid tumor, hematologic malignancy treatments
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