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Stock Market & Financial Investment News

News Breaks
March 18, 2013
06:03 EDTACT, TEVA, IPXL, MYL, PFEGeneric Drug sector downgraded to Market Weight at Wells Fargo
Wells Fargo downgraded its rating on the Generic Drug sector to Market Weight from Overweight citing the outperformance of the group over the past four years and concerns about new growth drivers. Coinciding with the sector downgrade, Wells cut its ratings on Actavis (ACT) and Teva (TEVA) to Market Perform from Outperform. The firm keeps Market Perform ratings on Impax (IPXL) and Mylan (MYL) and recommends rotation into Large Cap Pharma. Wells calls Pfizer (PFE) its top large cap pick in Pharma.
News For ACT;TEVA;IPXL;MYL;PFE From The Last 14 Days
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August 20, 2014
08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
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August 19, 2014
11:44 EDTMYLMylan launches generic Precedex Injection
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11:18 EDTACTDepomed announces favorable ruling in Gralise case
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10:32 EDTACTDepomed higher after favorable ruling in Gralise case
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07:26 EDTACTActavis confirms positive results from RECLAIM pivotal Phase III studies
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05:11 EDTTEVAGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
11:41 EDTPFECubist rises after report sparks takeover interest speculation
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10:06 EDTMYL, ACT, TEVALannett surges after upbeat Q4, FY14 outlook
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08:50 EDTTEVATeva management to meet with JPMorgan
Meeting to be held in Boston on August 20 hosted by JPMorgan.
08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
07:57 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 14, 2014
17:31 EDTACTZogenix says Actavis files ANDA for generic version of Zohydro ER
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17:08 EDTTEVASoros Fund Management gives quarterly update on stakes
NEW STAKES: CONSOL Energy (CNX), Google (GOOG), Level 3 (LVLT), Time Warner (TWC), and New Oriental (EDU). INCREASED STAKES: YPF SA (YPF), Apple (AAPL), Facebook (FB), AIG (AIG), and American Airlines (AAL). DECREASED STAKES: Teva (TEVA), Liberty Global (LBTYK), Barrick Gold (ABX), EQT (EQT), and Comcast (CMCSA). LIQUIDATED STAKES: FedEx (FDX), Monster Beverage (MNST), Google (GOOGL), Devon Energy (DVN), Marathon Petroleum (MPC).
17:05 EDTPFEPfizer says FDA accepted for review BLA for bivalent recombinant LP2086
Pfizer announced that the FDA has accepted for review the Biologics License Application,BLA, for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act, PDUFA, action date of February 14, 2015. “Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “Both the acceptance of Pfizer’s Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents.”
14:13 EDTACTOmega Advisors gives quarterly update on stakes
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12:58 EDTTEVA, ACTJANA Partners gives quarterly update on stakes
NEW STAKES: Apache (APA), FMC Corp (FMC), Civeo (CVEO), PetSmart (PETM), and Charter Communications (CHTR). INCREASED STAKES: Actavis (ACT), AIG (AIG), Mallinckrodt (MNK), HD Supply (HDS), and American Capital (ACAS). DECREASED STAKES: Liberty (LVNTA), Oil States International (OIS), eBay (EBAY), Liberty Media (LMCA), and Liberty Interactive (LINTA). LIQUIDATED STAKES: Sirius XM (SIRI), Juniper (JNPR), Golar LNG (GLNG), Outerwall (OUTR), and Teva (TEVA).
12:46 EDTACTHayman Capital gives quarterly update on stakes
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August 12, 2014
17:07 EDTPFEPfizer announces results from Lyrica studies conducted in China
Pfizer announced top-line results from two placebo-controlled studies conducted in China with Lyrica in patients with postherpetic neuralgia, pain after shingles or PHN, and painful diabetic peripheral neuropathy, pDPN, respectively.The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo. The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed. The safety profile in this study was consistent with the known profile for Lyrica.
07:55 EDTACTActavis recent weakness a buying opportunity, says Argus
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August 11, 2014
07:36 EDTMYLMylan launches generic Xeloda tablets
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