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Stock Market & Financial Investment News

News Breaks
April 17, 2014
08:38 EDTTEVA, PFETeva settles patent ligitigation with Pfizer on Celebrex
Teva (TEVA) announced that its subsidiary Teva Pharmaceuticals USA, Inc. has entered into a settlement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December 2014 or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
News For TEVA;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
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 EDTTEVALannett 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
17:08 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.”
12:58 EDTTEVAJANA 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).
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.
August 8, 2014
06:39 EDTPFEPfizer faces torrent of Lipitor suits, Reuters says
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August 7, 2014
13:55 EDTTEVATeva won't be meaningfully hurt soon by new Copaxone filing, says BMO Capital
After Teva (TEVA) confirmed that it received the first paragraph IV notice for the 3x per week version of its Copaxone drug from Dr. Reddy's (RDY), BMO Capital said it had expected companies to seek to market a generic version of the latest Copaxone formulation, but was surprised that Dr. Reddy's took this action. The firm notes that Teva's decision to file a lawsuit against Dr. Reddy over the application will trigger a 30 month stay of approval of the generic version,. BMIO Capital says that investors should keep this issue on their radar, but the firm does not expect Teva to be meaningfully hurt in the near-term by this development. It keeps an Outperform rating on Teva.
12:06 EDTTEVATeva will continue to defend COPAXONE intellectual property rights
Teva (TEVA) confirmed that it has received the first paragraph IV notice for its three-times-a-week COPAXONE 40 mg/mL product from Dr. Reddy’s Laboratories (RDY). Teva will continue to vigorously defend its COPAXONE intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Dr. Reddy’s within the 45 day period provided under the Hatch-Waxman Act. The filing of the lawsuit will trigger a 30 month stay of FDA approval of Dr. Reddy’s ANDA. COPAXONE 40 mg/mL is protected by two Orange Book patents that expire in 2030.
10:20 EDTTEVAMylan says litigation ins ongoing in India regarding Teva
Mylan (MYL) said that it expects Teva's (TEVA) efforts to seek an injunction will "as ineffective as it was in U.S. courts." The company said it will not provide further comment on the matter. Mylan said it will also postpone its 2014 Investor Day due to the ongoing nature of the Abbott (ABT) transaction. It expects its fully realized savings and profit from new products will not be realized till 2015. Comments taken from Q2 earnings conference call.
08:12 EDTPFEPfizer says EMA accpets application seeking new indication for Prevenar 13
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August 6, 2014
12:10 EDTPFEPfizer settles multi-state complaint on improper promotion of Rapamune
Attorney General Eric T. Schneiderman announced that he, along with 40 other state Attorneys General and the District of Columbia, reached a $35M settlement with Pfizer arising from alleged improper marketing and promotion of the immunosuppressive drug Rapamune. New York’s share of the settlement is over $1.7M. Pfizer, as parent of Wyeth Pharmaceuticals, agrees to be bound by the judgment and to resolve allegations that Wyeth unlawfully promoted Rapamune. Attorney General Schneiderman’s office served on the Executive Committee of this multi-state investigation. Reference Link
06:23 EDTPFEMitsubishi UFJ to hold a conference
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06:21 EDTPFEPiper Jaffray to hold a summit
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