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Stock Market & Financial Investment News

News For PFE;ACT;JNJ;NVS;TEVA;MYL;GNK;BMY;GSK From The Last 14 Days
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December 18, 2014
07:28 EDTPFEPfizer shares poised to perform well in 2015, says Deutsche Bank
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07:15 EDTGSKAgenus reports GSK ZOE-50 Phase 3 study met primary endpoint
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December 17, 2014
15:09 EDTNVSNovartis unit gets FDA approval for swimmer’s ear treatment
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13:32 EDTTEVAPerrigo jumps after analyst discusses potential takeover by Teva
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10:53 EDTACTAckman says 'will take hard look' at Valeant shares after restrictions end
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09:26 EDTTEVAPerrigo would be good acquisition for Teva, says RBC Capital
RBC Capital views Perrigo (PRGO) as an attractive acquisition target and says in a note to investors that it thinks a takeover could be a good strategic fit with solid accretion for Teva (TEVA). Teva has interest in over-the-counter products and its growth rate would be boosted by the merger, RBC believes. The firm assumes a $200 per share value for Perrigo in its acquisition assumptions. Shares of the over-the-counter and generic pharmaceuticals company closed yesterday at $153.77.
09:04 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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09:02 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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08:06 EDTJNJInovio appoints Zane Yang as VP, Clinical Development, Oncology
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08:01 EDTPFEPfizer initiates Phase 2 PF-06252616 study
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07:29 EDTNVSFDA PDUFA Date for Novartis Bexsero is December 17, 2014
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December 16, 2014
16:53 EDTACTAuxilium updates court findings in Actavis testosterone gel patent suit
Auxilium (AUXL) disclosed in a filing that as previously disclosed, on May 23 , Auxilium Pharmaceuticals, and FCB I LLC, as licensor of Testim, filed a lawsuit in the U.S. District Court for the District of New Jersey against Actavis (ACT) for infringement of FCB’s 10 patents listed in the Orange Book as covering Testim testosterone gel. The lawsuit was filed in response to a notice letter, dated April 12, 2012, sent by Actavis Laboratories, regarding its filing with the U.S. Food and Drug Administration of an Abbreviated New Drug Application for a generic 1% testosterone gel product. This letter also stated that the ANDA contained Paragraph IV certifications with respect to the nine patents listed in the Orange Book on that date as covering Testim. The company’s lawsuit filed against Actavis initially involved those nine patents, as well as a 10th patent covering Testim that was issued on May 15, 2012 and is listed in the Orange Book. By the time that the trial commenced in September 2014, the parties had agreed to remove all but one of those patents from the litigation, with the trial focused solely on claim 3 of U.S. Patent # 7,608,607 . The trial commenced in September 2014 and closing arguments occurred in November 2014. On December 16 , the company learned that Judge Linares held that claim 3 of the ‘607 patent is invalid for obviousness. The Judge also found claim 3 invalid for derivation and improper inventorship, but he declined to rule on whether correction of inventorship would be appropriate because it would be futile in light of his ruling on obviousness. Auxilium believes that Actavis is now free to enter the market with its testosterone gel product once it obtains approval from the FDA. At this time, Auxilium is not aware of Actavis having received tentative approval or final approval from the FDA for its testosterone gel product. Auxilium is analyzing the District Court’s opinion and will explore its available options with regard to this matter.
09:52 EDTACT, MYL, TEVAFDA ruling on generic Celebrex reversed by appeals court
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08:53 EDTACTActavis accretion targets look more achievable, says Sterne Agee
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08:47 EDTBMY, NVSHemispherx Ampligen provides anti-tumor activity
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07:40 EDTACTActavis reports Saunders to lead combined company as CEO
Actavis (ACT) announced the planned senior management team that will lead the global pharmaceutical company following the successful close of the acquisition of Allergan (AGN), anticipated in the second quarter of 2015. Brent Saunders will continue to lead Actavis as CEO and President and a member of the Board of Directors. Paul Bisaro will remain Executive Chairman of the board of directors. The company noted that it anticipates continuing to define the subsequent management levels within the global organization as rapidly as possible between now and the close of the acquisition. Actavis announced that, following the close of the acquisition, its global brand sales and marketing will be structured into three organizations: International Brands, Branded Pharma and Allergan Medical. "Although we are acting rapidly in announcing these appointments, we are making them following extensive discussions with David Pyott, Chairman and CEO of Allergan, and his executive leadership team. We believe that by announcing the proposed structure of the combined organization our shareholders, customers and employee teams will better appreciate our commitment to create the most dynamic company in Growth Pharma and will share our confidence in seamless execution of this combination beginning on Day 1," Saunders said.
07:20 EDTJNJGeron announces early HSR clearance for collaboration with Janssen
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07:06 EDTNVSBioLineRx and Novartis enter into strategic collaboration agreement
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05:48 EDTNVSNovartis gains FDA approval for Signifor LAR
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December 15, 2014
18:32 EDTPFEPfizer announces Palbociclib PALOMA-1 data published in The Lancet Oncology
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15:14 EDTACTActavis to appeal injunction requiring Namenda IR distribution
Actavis confirmed that it is filing an emergency appeal to the U.S. Court of Appeals for the Second Circuit seeking to immediately overturn a lower court ruling requiring the company to continue distribution of NAMENDA immediate-release tablets after Judge Robert Sweet of the U.S. District Court for the Southern District of New York issued a preliminary injunction requiring Actavis to continue distribution of NAMENDA immediate-release tablets on Monday, December 15. Actavis reiterated that the ruling will have no impact on its ability to continue focusing its resources on transitioning patients to the convenient and innovative once-daily NAMENDA XR, and that the company is prepared to manage its business in a way that provides the least disruption in its ability to support the marketplace and minimize any financial impact. Further, the company noted that it will work to manage sales and R&D expenses to ensure that, if the District Court decision stands, it will have minimal to no impact on Actavis' 2015 NAMENDA franchise contribution to earnings and longer term company earnings aspirations.
12:09 EDTPFEPfizer increases dividend 8% to 28c per share
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10:40 EDTPFEOPKO Health deal with Pfizer removes financing overhang, says Ladenburg
Ladenburg views the agreement OPKO Health (OPK) signed with Pfizer (PFE) as a significant positive catalyst since the company is partnering with an established leader in short-acting hGH and because the large upfront payment removes near-term financing needs as an overhang on the stock. The firm reiterates its Buy rating and $14.50 price target on OPKO, but said it will re-examine its projections after the deal closes.
10:19 EDTPFEOPKO Health soars after entering hGP-CTP agreement with Pfizer
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09:03 EDTPFEBaxter to divest Vero cell vaccines platform to Nanotherapeutics
Baxter International (BAX) announced that it has entered into a definitive agreement to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics, Inc. Financial details were not disclosed. The agreement with Nanotherapeutics includes all assets related to the platform, including vaccines for H5N1, H1N1 and seasonal influenza. The agreement also includes investigational vaccine programs for Ross River virus, Chikungunya disease and West Nile virus. In recent weeks, the company has also completed the sale of its commercial vaccines business and related manufacturing facilities to Pfizer (PFE).
08:02 EDTPFEPfizer, OPKO Health enter into global agreement for hGH-CTP
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07:58 EDTACTAllergan downgraded to Hold from Buy at Stifel
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December 12, 2014
14:01 EDTJNJGenOn Energy to receive $3M milestone payment in Janssen collaboration
Genmab announced it has reached a milestone in its DuoBody technology platform collaboration with Janssen Biotech (JNJ), triggering a $3M payment. The milestone payment is for pre-clinical progress with a DuoBody product candidate targeting cancer. Today's news will not impact Genmab's 2014 financial guidance.
10:01 EDTTEVAOn The Fly: Analyst Upgrade Summary
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08:49 EDTTEVATeva upgraded at Sterne Agee
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08:36 EDTNVSNovartis reports BOLERO-1 trial did not meet primary objective
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07:06 EDTTEVATeva upgraded to Buy from Neutral at Sterne Agee
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05:31 EDTNVSNovartis reports Cosentyx 'superior' in head-to-head psoriasis study
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December 11, 2014
19:06 EDTACTActavis confirms court ruling to require continued distribution of Namenda IR
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09:39 EDTTEVATeva FY15 outlook appears strong, reasonable, says BMO Capital
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07:32 EDTMYLMylan launches generic version of Hikma Maple's Robaxin injection
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07:24 EDTTEVATeva to host conference call
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07:12 EDTTEVATeva sees FY15 Copaxone sales $3.5B-$3.7B
Sees FY15 Treanda sales $670M-$750M. Sees FY15 ProAir family sales $470M-$580M, Azilect sales $350M-$400M and Nuvigil sales $300M-$330M. Erez Vigodman, President & CEO of Teva, said, "Generics remain at the heart of our business, both as the cornerstone of the Company, but also as an area that has great impact on society. At the same time, we anticipate four specialty product approvals and five submissions in 2015 – which we believe will improve treatment options for patients, and add value for all of our stakeholders." The company expects 2015 generic revenues in the United States to be $4.2B-$4.6B, $2.6B-$3.0B in Europe and $2.0B-$2.3B in its ROW markets. Results of its specialty segment are expected to be impacted by the introduction of two AB-rated generic competitors to Copaxone in the U.S. beginning in September 2015, which is a modeling assumption only, as well as by increased competition from oral products for the treatment of multiple sclerosis. In addition, the company is expecting to invest in a significant number of product launches and in its specialty pipeline. "All of these will result in lower profit and profitability, as we focus on generating growth over the next few years," Teva said.
07:08 EDTTEVATeva sees FY15 gross profit 59.5%-61.5%
Teva sees FY15 cash flow from operations $4.3B-$4.7B and free cash flow $3.5B-$3.7B.
07:07 EDTTEVATeva sees spending $1B-$1.2B on share buybacks in 2015
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07:06 EDTMYLMylan launches generic version of Orapred ODT
Mylan announced the U.S. launch of its Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg. This product is the first generic version of Shionogi's Orapred ODT. Mylan received final approval from the FDA for its Abbreviated New Drug Application for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg, and was awarded 180 days of generic drug marketing exclusivity. This product is indicated as an anti-inflammatory or immunosuppressive agent for certain conditions; and also for the treatment of certain endocrine conditions, and for palliation of certain neoplastic conditions. Prednisolone Sodium Phosphate Orally Disintegrating Tablets had U.S. sales of approximately $19.9M for the 12 months ending September 30.
07:02 EDTTEVATeva sees FY15 EPS $5.00-$5.30, consensus $5.06
Sees FY15 revenue $19B-$19.4B, consensus $20.07B.
December 10, 2014
11:40 EDTACTActavis management to meet with Sterne Agee
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09:33 EDTACTActavis launches generic version of Celebrex
Actavis (ACT) announced that it has launched a generic version of Celebrex 50 mg, 100 mg, 200 mg and 400 mg capsules, as part of a settlement agreement with Pfizer (PFE). Celebrex is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. For the 12-month period ending June 30, 2014, Celebrex had U.S. sales of approximately $2.4 billion, according to IMS Health data.
08:31 EDTPFE, TEVATeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 2014.
07:38 EDTPFE, MYLMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
06:08 EDTBMYBristol-Myers partners with Ono Pharma and Kyowa Hakko Kirin for oncology trial
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December 9, 2014
16:35 EDTBMYBristol-Myers raises dividend to 37c per share from 36c per share
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12:22 EDTPFEPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
10:32 EDTPFEPfizer says in talks with FDA on path forward for Mylotarg
Pfizer announced the presentation of encouraging early- and late-stage data from clinical studies across several hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and chronic myeloid leukemia. Among the highlights are results from several investigator-led, large, randomized studies evaluating the antibody-drug conjugate MYLOTARG in select adult AML populations. Research was presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, December 6-9. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology, said “In particular, we are encouraged by the significant clinical evidence emerging from large randomized trials, such as AML-19 and ALFA-0701, demonstrating a positive impact of MYLOTARG when added to standard first-line treatment for patients with acute myeloid leukemia. We are engaging in discussions with the U.S. FDA and other health authorities to determine the best path forward for MYLOTARG. In addition, we plan to initiate an expanded access protocol for the therapy by the end of 2014 in the United States in patients with relapsed or refractory acute myeloid leukemia for whom there are no other treatment options.”
10:23 EDTGSKOn The Fly: Analyst Downgrade Summary
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09:31 EDTACTZoetis drops after report of Valeant abandoning growth by acquisitions strategy
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09:10 EDTGSKARIAD takeover rumors rekindled, Independent says
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08:25 EDTBMYBristol-Myers data positive, says BMO Capital
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07:44 EDTPFE, TEVA, GSKAmerican Association for Cancer Research to hold a symposium
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06:14 EDTACTAllergan price target raised to $245 from $210 at Citigroup
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05:50 EDTJNJPharmacyclics data demonstrates safety, durability response
New, 27-month IMBRUVICA median follow-up data announced by Pharmacyclics (PCYC) support the use of IMBRUVICA over longer periods of time in patients with relapsed/refractory mantle cell lymphoma, or MCL, an aggressive type of lymphoma. More than 30% of IMBRUVICA patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Nearly half of the 111 patients treated were still living at the time of the data analysis. A second Phase II trial looked at IMBRUVICA's efficacy and safety as a single-agent treatment for MCL patients who previously had received rituximab combination therapy and at least two cycles of bortezomib. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:43 EDTJNJPharmacyclics reports IMBRUVICA data shows 84% PFS rate at one year
Pharmacyclics (PCYC) announced new, longer term data in IMBRUVICA patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, including high-risk CLL patients with deletion 17p. Results from the Phase III RESONATE trial demonstrated an 84% progression-free survival, or PFS, rate in all patients with previously treated CLL or small lymphocytic lymphoma, or SLL, who received IMBRUVICA and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATE-17, or PCYC-1117, the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICA was associated with an 83% overall response rate, or ORR, at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%. These results and additional data were presented here at the 56th American Society of Hematology, or ASH, Annual Meeting, highlighting IMBRUVICA's sustained efficacy in relapsed/refractory patients who have received at least one prior therapy. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:37 EDTGSKGlaxoSmithKline downgraded to Underperform from Neutral at BofA/Merrill
BofA/Merrill downgraded GlaxoSmithKline to Underperform citing a lack of pipeline catalysts and its belief the European pharma sector is close to fair value.
05:27 EDTJNJPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 8, 2014
13:32 EDTPFE, BMYPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
13:32 EDTGSKEpizyme announces results for PRMT5 inhibitor
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13:07 EDTNVSNovartis announces data from Jakavi trial
Novartis (NVS) announced data from the largest clinical trial of myelofibrosis patients treated with Jakavi, supporting the safety profile and efficacy benefit as measured in primary and secondary endpoints respectively. In an analysis of 1,144 patients treated with Jakavi to date in this ongoing expanded access study, 69% of patients achieved >50% reduction in spleen size from baseline and patients also experienced a clinically meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis. Findings from the study were presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, California. Novartis research and development efforts, in collaboration with Incyte Corporation (INCY), include early-phase and post-marketing studies in myelofibrosis and other myeloproliferative neoplasms. More than 50 abstracts on ruxolitinib are being presented at ASH, including three oral presentations exploring combinations of ruxolitinib with various investigational compounds, evaluating the possibility of simultaneously targeting multiple cancer pathways that may be involved in the pathogenesis of myelofibrosis. The JUMP study is a Phase IIIb, expanded-access trial for countries with no access to Jakavi outside of a clinical trial. The open-label, multicenter study analyzed 1,144 enrolled myelofibrosis patients who received daily starting doses of either 5 mg, 15 mg or 20 mg of Jakavi twice daily based on platelet counts at baseline. The primary endpoint is assessment of safety and tolerability of Jakavi. Overall, the safety and efficacy profile of Jakavi was consistent with previous studies.
13:05 EDTNVSNovartis reports six-year results from Phase III ENESTnd study
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12:25 EDTACTAntibiotic makers rise after Merck agrees to buy Cubist
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11:30 EDTTEVA, ACT, MYL, NVSLeerink generics pharmaceutical analyst holds analyst/industry conference call
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08:21 EDTTEVAMerck says looked at all risks, including patent litgation, before Cubist deal
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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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06:47 EDTTEVAArena says Teva files marketing authorization of Belviq in Israel
Arena Pharmaceuticals (ARNA) disclosed late Friday that Teva Pharmaceutical's (TEVA) local Israeli subsidiary, Abic Marketing Limited, has filed for marketing authorization of Belviq in Israel. In connection with the filing, Arena will receive a milestone payment of $250K.
05:53 EDTBMYStocks with implied volatility movement; BSX BMY
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05:42 EDTNVSSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
December 7, 2014
14:54 EDTJNJIMBRUVICA data suggests promise in multiple myeloma
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14:10 EDTBMYAmerican Society of Hematology to hold a meeting
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13:06 EDTBMYBMY announces positive results in Phase 1b trial evaluating Opdivo
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December 5, 2014
16:49 EDTACTAdvisory Committee recommends approval Of Actavis' ceftazidime-avibactam
Actavis announced that the Anti-Infective Drugs Advisory Committee convened by the U.S. Food and Drug Administration has voted to recommend approval of Actavis' New Drug Application for ceftazidime-avibactam, an investigational antibiotic being developed to treat hospitalized patients when limited or no treatment options are available for complicated intra-abdominal infections and complicated urinary tract infections caused by Gram-negative pathogens. The committee found the scientific and clinical evidence submitted by Cerexa, a wholly owned subsidiary of Actavis, adequately demonstrated the safety and efficacy of ceftazidime-avibactam in the treatment of the proposed cIAI and cUTI indications. The committee voted not to recommend approval of the combination for hospital-acquired bacterial pneumonia /ventilator-associated bacterial pneumonia and bacteremia.The Advisory Committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for ceftazidime-avibactam during the first quarter of 2015.
10:22 EDTBMY, PFEBristol-Myers call activity attributed to takeover speculation
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10:05 EDTMYL, BMY, PFEBristol-Myers jumps 2% amid talk of potential Pfizer bid
Shares of Bristol-Myers (BMY) are up in early trading amid chatter of a potential takeover bid from Pfizer (PFE). The stock is up $1.26 to $60.15. Bristol's market capitalization stands around $99B, less than twice that of Pfizer's $200B. A Jefferies analyst last week called Mylan (MYL) the most likely takeover target for Pfizer. Pfizer is "highly motivated" to buy a foreign company using its overseas cash and Mylan looks like the most likely target, Jefferies analyst Jeffrey Holford wrote.
09:56 EDTPFE, BMYRumor: Bristol-Myers strength attributed to takeover speculation
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07:54 EDTTEVALannett names Michael Bogda as president, effective December 1
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06:04 EDTGSKGSK won't pursue divestment of certain brands in established products portfolio
As announced at the company’s Q2 results in July, GSK started a process to consider the divestment of certain North American and European brands in its Established Products Portfolio.The company has evaluated all bids received and has concluded, consistent with its key criteria of maximizing shareholder value, not to pursue divestment of these products.
December 4, 2014
12:22 EDTNVSOn The Fly: Midday Wrap
Stocks on Wall Street began the session slightly lower despite relatively in-line jobless claims data, as European markets moved down following a rate decision and accompanying commentary from ECB President Mario Draghi. Adding to the modest pressure seen in morning trading may be the fact that oil prices continue to move lower. ECONOMIC EVENTS: In the U.S., initial jobless claims fell 17K to 297K in the week ended November 29, which was nearly in-line with the expectation for 295K first-time claims. Challenger reported announced layoffs fell 15.2K in November to 35.9K. In Europe, the European Central Bank kept its key rates unchanged, as expected. ECB President Mario Draghi said in his accompanying press conference that the latest euro area macroeconomic projections indicate lower inflation, accompanied by weaker real GDP growth and subdued monetary dynamics. Additionally, he stated that early next year the Governing Council will reassess the monetary stimulus achieved, the expansion of the balance sheet and the outlook for price developments. "Should it become necessary to further address risks of too prolonged a period of low inflation, the Governing Council remains unanimous in its commitment to using additional unconventional instruments within its mandate. This would imply altering early next year the size, pace and composition of our measures," Draghi said. COMPANY NEWS: Shares of Barnes and Noble (BKS) slid about 10% after the company reported lower than expected second quarter earnings and said it continues to expect both Retail comparable bookstore sales and Retail Core comparable bookstore sales to decline in the low-single digits this fiscal year. Additionally, Barnes & Noble and Microsoft (MSFT) agreed to terminate their commercial agreement and B&N agreed to acquire Microsoft's entire preferred interest in NOOK Media in exchange for $62.4M cash and 2.74M shares of its stock. MAJOR MOVERS: Among the notable gainers was Hawaiian Electric (HE), which jumped 16% after its board approved a plan to spin off ASB Hawaii, the parent company for American Savings Bank, and establish it as an independent publicly traded company and NextEra Energy (NEE) agreed to acquire the company, excluding the banking subsidiary. Array BioPharma (ARRY) rose 15% after announcing it has reached a definitive agreement with Novartis (NVS) to regain full worldwide rights to binimetinib, a MEK inhibitor in three Phase 3 trials, which Piper Jaffray called a "big win" for the company. Among the noteworthy losers was UTi Worldwide (UTIW), which fell 11.5% after confirming that exploratory conversations have taken place with DSV, but adding those discussions never progressed beyond a preliminary stage and that no talks are currently taking place. Also lower were shares of Express (EXPR), which declined over 9% after the apparel retailer reported lower than expected Q3 revenue and gave EPS guidance that fell short of estimates. INDEXES: Near midday, the Dow was down 53.56, or 0.3%, to 17,859.06, the Nasdaq was down 2.80, or 0.06%, to 4,771.67, and the S&P 500 was down 5.49, or 0.26%, to 2,068.84.
11:23 EDTJNJAppeals court reverses patent ruling in favor of J&J unit over Covidien
Ethicon Endo-Surgery, a Johnson & Johnson (JNJ) company, appealed a district court judgment regarding certain asserted patent claims of Tyco Healthcare. The appeals court affirmed-in-part, reversed-in-part, and vacated-in-part the prior judgment, because the lower court’s 102(g) findings were correct, but its 103 determination was improper, "including its decision to exclude the 102(g) prior art from the obviousness analysis," the court stated. In 2007, Tyco Healthcare changed its name to Covidien (COV). Reference Link
10:32 EDTTEVATeva receives positive outcomes in Europe for three-times-a-week COPAXONE
Teva Pharmaceutical Industries announced that it has received a positive outcome in the decentralized procedure for its new, three-times-a-week COPAXONE 40 mg/ml formulation for the treatment of adults with relapsing forms of multiple sclerosis RMS. The outcome follows a Positive Assessment Report from the United Kingdom, the Reference Member State’s Medicines and Healthcare Products Regulatory Agency, and all Concerned Member States in Europe who were involved in the procedure. Granting of national authorizations will happen in the near future. The three-times-a-week COPAXONE 40 mg/ml formulation will allow for an improved, less-frequent, subcutaneous dosing regimen for adults with RMS. The new formulation reduces the total number of injections by almost 60%, while maintaining the known benefits of once daily COPAXONE 20 mg/ml. “We welcome the opportunity to make COPAXONE 40 mg/ml available to patients with RMS in Europe,” said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. “Three-times-a-week COPAXONE 40 mg/ml will be available in Europe as early as the first quarter of 2015 with expected launches in Germany, Netherlands and Denmark. Launches in other EU countries are expected throughout 2015.”
10:03 EDTMYLMylan receives tentative FDA approval for abacavir/lamivudine NDAs
Mylan announced that its subsidiary Mylan Laboratories has received tentative approval from the FDA for its New Drug Applications for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients. This is the first version of abacavir/lamivudine with scoring to allow for dose adjustment and is also flavored, Mylan said. The FDA's tentative approval through the President's Emergency Plan for AIDS Relief program means the formulations meet all of the agency's quality, safety and efficacy standards, it stated. The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation to a total of 115 resource limited countries including all low-middle income, least developed countries and sub-Saharan Africa. Mylan's products are expected to be eligible for purchase in early 2015.
09:15 EDTNVSArray BioPharma to host conference call
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09:01 EDTJNJVA negotiated $594 per dose price for Gilead HCV treatment
A Veterans Health Administration official told a Senate committee yesterday that Veterans' Affairs has "moved rapidly to deploy new, more effective, less toxic HCV treatments and has been able to negotiate significant discounts for these newer therapies." The agency negotiated a price of $594 per dose for Gilead's (GILD) Hepatitis C virus drug Sofosbuvir, below the commercial price of $1,000 per dose, VHA Chief Consultant for Pharmacy Benefits Management Michael Valentino told the Senate's Committee on Veterans' Affairs. The agency also received a $413 per dose price for Johnson & Johnson's (JNJ) Simeprevir, below the commerical price of $790. The VA has approximately 174,000 veterans in care with HCV, making it the largest single HCV provider in the U.S., Valentino pointed out. He added, "Like the rest of the country, VA has treated only a portion of Veterans for HCV because treatment and cures have been difficult to achieve due to low efficacy and high toxicity of standard drug therapies." Reference Link
08:45 EDTPFE, NVSAbbVie price target raised to $80 from $72 at Jefferies
Jefferies raised its price target for AbbVie shares to $80 while calling the company one of its top five global pharma picks for 2015. The firm's top U.S. pick is Pfizer (PFE) and its top Europe pick is Novartis (NVS). Bayer (BAYRY) and AstraZeneca (AZN) round out the top five. Jefferies thinks AbbVie's "strong momentum" will continue into the first half of 2015 and keeps a Buy rating on the name.
07:56 EDTACTActavis price target raised to $315 from $266 at Morgan Stanley
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05:54 EDTNVSArray BioPharma regaining binimetinib a 'big win,' says Piper Jaffray
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05:30 EDTTEVACTI BioPharma receives $15M payment from Teva for TRISENOX
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