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Stock Market & Financial Investment News

News Breaks
March 7, 2014
14:18 EDTREGN, SNY, AMGN, PFE, NVS, RHHBYConcerns 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.
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July 25, 2014
09:19 EDTAMGNAmgen weekly volatility elevated into Q2 and outlook
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07:36 EDTAMGNEMA adopts positive opinion on new indication for Xgeva
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07:35 EDTRHHBYEMA recommends new indication for RoActemra in severe arthritis
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07:29 EDTPFEEMA recommends indication for Ecalta to treat invasive candidiasis
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Ecalta, offered by Pfizer. The CHMP adopted a change to an indication as follows: "Treatment of invasive candidiasis in adult patients."
05:35 EDTAMGNBayer, Onyx reports NEXAVAR Phase 3 trial did not meet primary endpoint
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July 24, 2014
06:13 EDTRHHBYRoche reaffirms outlook for 2014
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06:12 EDTRHHBYRoche reports 1H core EPS CHF 7.57 vs. CHF 7.58 last year
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05:41 EDTNVSNovartis announces FDA acceptance of Sandoz application for filgrastim
Sandoz, a Novartis Group company, announced that the FDA has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009.
July 23, 2014
09:08 EDTRHHBYUltragenyx appoints Sunil Agarwal, M.D. as Chief Medical Officer
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06:41 EDTNVSArray BioPharma shares attractive at current levels, says Piper Jaffray
Piper Jaffray says shares of Array BioPharma are attractive at current levels ahead of Phase III data readouts for binimetinib in melanoma, selumetinib in Kras-mutant lung, thyroid and uveal melanoma, and filanesib in multiple myeloma. Piper sees the biggest overhang on Array shares as being the financing requirement and it notes that binimetinib could be returned to the company from current partner Novartis (NVS). Nonetheless, it feels investors should take a "serious look" at Array and keeps an Overweight rating on the stock with a $9 price target.
July 22, 2014
16:18 EDTPFEPuma Biotech now responsible for R&D expenses associated with legacy trials
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05:21 EDTRHHBYRoche announces Genentech Avastin granted priority review by FDA
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July 21, 2014
10:02 EDTREGNOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Adeptus Health (ADPT) initiated with a Buy at Dougherty... Amphastar (AMPH) initiated with a Buy at Jefferies... Eclipse Resources (ECR) initiated with a Neutral at SunTrust... Fidelity National (FNF) initiated with a Buy at SunTrust... First American (FAF) initiated with a Buy at SunTrust... GoPro (GPRO) initiated with a Hold at Stifel... Imprivata (IMPR) initiated with an Outperform at Wells Fargo... Lifetime Brands (LCUT) initiated with a Buy at Sidoti... Materialise (MTLS) initiated with a Buy at BB&T... Regeneron (REGN) initiated with a Buy at Argus... STAG Industrial (STAG) initiated with a Buy at Sandler O'Neill... Signature Group (SGGH) initiated with a Buy at B. Riley... TCP International (TCPI) initiated with a Buy at Canaccord... Tessera (TSRA) initiated with a Buy at Craig-Hallum... Xunlei (XNET) initiated with a Perform at Oppenheimer.
07:42 EDTREGNRegeneron initiated with a Buy at Argus
Target $375.
07:38 EDTNVSNovartis management to meet with JPMorgan
Meetings to be held in Los Angeles/Pasadena on July 24 and in San Francisco on July 25 hosted by JPMorgan.
07:11 EDTRHHBY, NVS, SNYInternational Society of DNA Vaccines to hold a conference
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07:03 EDTNVSAnacor, Sandoz enter into agreement for commercialization of Kerydin in the U.S.
Anacor Pharmaceuticals (ANAC) announced that it has entered into an exclusive agreement with Sandoz, a Novartis (NVS) company, pursuant to which Sandoz will distribute and commercialize Anacorís drug KERYDIN topical solution, 5% in the United States. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN. On July 8, Anacor announced that the U.S. FDA approved the New Drug Application for KERYDIN, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today. The agreement with Sandoz entitles Anacor to upfront payments totaling $40M and an additional milestone payment of $25M expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50M of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45M. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacorís contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.
06:43 EDTRHHBYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 20, 2014
15:42 EDTRHHBYRoche not looking for big acquisitions, Reuters says
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July 18, 2014
06:10 EDTREGNRegeneron announces results from Phase 3 VIVID-DME trial of EYLEA
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