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Stock Market & Financial Investment News

News For NVO;VPHM;INFI;MRK;AGN;SHPG;SGEN;OREX;AMGN;SNY;JNJ;PFE From The Last 14 Days
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December 19, 2014
11:32 EDTPFELigand reports Pfizer receives EU marketing authorization for Duavive
Ligand Pharmaceuticals (LGND) announced that its partner Pfizer (PFE) has received EU marketing authorization for DUAVIVE from the European Commission. In the EU, DUAVIVE is indicated for the treatment of estrogen deficiency symptoms in postmenopausal women with a uterus for whom treatment with progestin-containing therapy is not appropriate. Ligand will be entitled to a milestone payment following Pfizer obtaining pricing of DUAVIVE in a major European market, the company stated.
11:08 EDTJNJJohnson & Johnson receives positive CHMP opinion to extend Velcade indication
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10:59 EDTAGNActavis considering bid for Spain based Almirall, Bloomberg reports
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09:28 EDTOREXOn The Fly: Pre-market Movers
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08:07 EDTMRKMerck begins tender offer to acquire Cubist
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07:21 EDTOREXOrexigen Mysimba receives positive CHMP opinion
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07:20 EDTOREXOrexigen weight loss drug recommended in Europe
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended granting a marketing authorization for Mysimba for weight management of overweight or obese adults. The medicine is recommended for use in addition to a reduced-calorie diet and physical activity. Mysimba is made by Orexigen.
December 18, 2014
12:55 EDTPFECourt delays Teva's launch of generic Celebrex, Globes reports
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10:58 EDTMRKTetraphase seen as takeover target after antibiotic trial success
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09:03 EDTSGENSeattle Genetics initiates Phase 1b trial of SGN-CD33A
Seattle Genetics announced initiation of a phase 1b clinical trial of SGN-CD33A in combination with standard of care chemotherapy, including cytarabine and daunorubicin, for patients with newly diagnosed acute myeloid leukemia. The trial will also evaluate SGN-CD33A in the consolidation setting for AML, both in combination with cytarabine and as a single-agent maintenance regimen. SGN-CD33A is a novel antibody-drug conjugate targeted to CD33 utilizing Seattle Genetics’ newest technology. CD33 is expressed on most AML cells regardless of subtype, cytogenetic abnormality or underlying mutational heterogeneity. SGN-CD33A is also under evaluation in an ongoing phase 1 dose escalation trial as a single-agent or in combination with hypomethylating agents for the treatment of patients who have relapsed AML or have declined intensive frontline therapy. The study is a phase 1b, open-label, multi-center, dose-escalation clinical trial designed to evaluate SGN-CD33A administered in combination with frontline standard of care regimens for induction (cytarabine and daunorubicin) and/or consolidation. In addition, the study will evaluate single-agent SGN-CD33A as a maintenance regimen. The primary endpoints are determination of the maximum tolerated dose and safety profile of SGN-CD33A in these settings. In addition, the trial will evaluate anti-leukemic activity, pharmacokinetics, progression-free survival and overall survival. The phase 1b trial will enroll approximately 90 patients at multiple centers in the United States.
08:03 EDTNVOXencor and Novo Nordisk partner for novel drug development
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08:03 EDTPFEPfizer reports statistically significant results in Phase 3 pregabalin study
Pfizer announced top-line results from a double-blind Phase 3 study evaluating pregabalin controlled-release formulation in adult patients with postherpetic neuralgia. The results show that pregabalin CR resulted in a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response in pain reduction. PHN is a type of peripheral neuropathic pain caused by nerve damage. Symptoms include continued burning or electric shock-like pain.1 This study is the final of three Phase 3 studies of the pregabalin CR formulation conducted to ascertain the potential use of pregabalin as a once-a-day therapy. The first study in adults with partial onset seizures with epilepsy did not meet its primary endpoint. In the second study in patients with fibromyalgia, pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to LTR in pain reduction. The objective of the Phase 3 double-blind, randomized, placebo-controlled study was to evaluate the safety and efficacy of pregabalin CR compared with placebo in the durability of effect for the treatment of pain associated with PHN among patients who initially respond to single-blind pregabalin.
07:36 EDTMRKMerck acquires OncoEthix, terms include upfront payment of up to $110M
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07:28 EDTPFEPfizer shares poised to perform well in 2015, says Deutsche Bank
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06:27 EDTAMGNAmgen's new leukemia drug to cost $178,000, Reuters reports
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December 17, 2014
17:47 EDTAMGNAmgen raises Q1 dividend 30% to 79c per share
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11:28 EDTSHPGNPS Pharmaceuticals calls active on Shire considering bid report
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11:13 EDTSHPGShire considering bid for NPS Pharmaceuticals, Bloomberg reports
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10:53 EDTAGNAckman says 'will take hard look' at Valeant shares after restrictions end
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10:49 EDTSHPGNPS Pharmaceuticals jumps 12%, halted after report of potential Shire bid
Shire (SHPG) has NPS Pharmaceuticals (NPSP) on the top of its list of potential takeover targets, but is also said to be considering other targets, according to Bloomberg.
10:47 EDTSHPGNPS Pharmaceuticals said to be on top of Shire takeover list, Bloommberg says
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10:47 EDTSHPGNPS halted for volatility after Bloomberg says Shire considers bid
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10:36 EDTMRKCowen pharmaceuticals analysts hold an analyst/industry conference call
Analyst Research Team discusses the imminent Merck/Cubist Zerbaxa opportunity and the Cempra SOLITAIRE-ORAL Trial readout on an Analyst/Industry conference call to be held on December 17 at 2 pm.
10:02 EDTAGNOn The Fly: Analyst Downgrade Summary
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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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06:28 EDTAGNAllergan downgraded to Neutral from Buy at UBS
UBS downgraded Allergan (AGN) to reflect acquisition by Actavis (ACT).
December 16, 2014
09:28 EDTAGNAllergan to host special shareholder meeting
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08:53 EDTAGNActavis accretion targets look more achievable, says Sterne Agee
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08:47 EDTMRKHemispherx Ampligen provides anti-tumor activity
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07:40 EDTAGNActavis 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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December 15, 2014
18:32 EDTPFEPfizer announces Palbociclib PALOMA-1 data published in The Lancet Oncology
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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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10:10 EDTOREXHigh option volume stocks:
High option volume stocks: RVBD AGCO FRO CRUS UBNT LH PAY PETM OREX KOS
10:00 EDTAGNOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: UPS (UPS) downgraded to Hold from Buy at Deutsche Bank... CGG SA (CGG) downgraded to Underperform from Market Perform at Raymond James... Ford (F) downgraded to Hold from Buy at Deutsche Bank... Cenovus Energy (CVE) downgraded to Market Perform from Outperform at BMO Capital... Cobalt (CIE) downgraded to Neutral from Buy at Goldman... Gastar Exploration (GST) downgraded to Neutral from Buy at SunTrust... Itau Unitbanco (ITUB) downgraded to Neutral from Buy at Goldman... Methanex (MEOH) downgraded to Outperform from Strong Buy at Raymond James... OGE Energy (OGE) downgraded to Hold from Buy at Jefferies... SandRidge Energy (SD) downgraded to Neutral from Buy at SunTrust... Sempra Energy (SRE) downgraded to Neutral from Overweight at JPMorgan... HollyFrontier (HFC) downgraded to Neutral from Buy at BofA/Merrill... CNA Financial (CNA) downgraded to Market Perform from Outperform at William Blair... Allergan (AGN) downgraded to Hold from Buy at Stifel... RF Micro Devices (RFMD) downgraded to Neutral from Buy at DA Davidson.
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 EDTAGNAllergan downgraded to Hold from Buy at Stifel
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December 12, 2014
16:33 EDTMRKStocks finish week lower amid steep decline in oil prices
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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.
December 11, 2014
16:03 EDTAMGNAmgen, AstraZeneca to present results from Phase 3 plaque psoriasis study
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08:57 EDTSHPGLeerink major pharma & biotech analysts hold analyst/industry conference call
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08:27 EDTMRKNewLink Genetics falls after Ebola vaccine trial suspended
Shares of NewLink Genetics (NLNK) are falling in pre-market trading after a clinical trial of the Ebola vaccine being developed by the company and partner Merck (MRK) was temporarily suspended as a precautionary measure after four patients complained of joint pains in their hands and feet, the University of Geneva Hospital said. The trials are scheduled to resume next month in up to 15 volunteers after checks to make sure that the joint pain symptoms were benign and temporary, the hospital added. Shares of NewLink are down 6.5% to $34.50 in early morning trading following the news, while Merck shares are indicated to open fractionally higher.
06:29 EDTSHPGShire CEO sees no immediate need to spend break-up fee, Reuters reports
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December 10, 2014
16:00 EDTMRKOptions Update; December 10, 2014
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13:45 EDTMRKMerck's Gardasil 9 approved by FDA
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08:47 EDTMRKMerck, IBCSG, BIG announce opening of PANACEA study
The International Breast Cancer Study Group, Breast International Group, and Merck announced the opening of the PANACEA study, a global collaborative study exploring a new way to treat HER2+ breast cancer that has become resistant to the current standard of care. The PANACEA study will investigate the use of pembrolizumab in combination with trastuzumab to evaluate whether the addition of an anti-PD-1 therapy can reverse trastuzumab resistance in patients with HER2+ breast cancer whose cancer has spread while on trastuzumab therapy. The trial, “Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2+ Breast Cancer,” is a Phase 1b/2 study in patients with HER2+ breast cancer whose cancer has spread while on treatment with trastuzumab. Primary outcome measures of the study are recommended dose and efficacy and safety profile of pembrolizumab in combination with trastuzumab. Response will be assessed by RECIST 1.1 criteria. Secondary outcome measures include safety and tolerability, disease control, duration of response, time to progression, progression-free survival and overall survival. The study is enrolling adult females with unresectable or metastatic breast adenocarcinoma with confirmed HER2-positivity. There are 10 sites participating in the study across Europe and Australia: Peter MacCallum Cancer Centre and Westmead Hospital in Australia; Medical University of Vienna in Austria; Jules Bordet Institute and CHU Sart Tilman in Belgium; Institut de Cancérologie de l’OUEST, Centre Léon Bérard and Institut Gustave Roussy in France; and Istituto Europeo di Oncologia Milano and Azienda USL4 Prato in Italy.
08:32 EDTMRKMerck announces early findings showing 18.5% overall response rate with Keytruda
Merck announced early study findings demonstrating an overall response rate of 18.5% with KEYTRUDA, the company’s anti-PD-1 therapy, as assessed by RECIST v1.1, central review in PD-L1 positive, advanced triple-negative breast cancer – one of the most aggressive forms of breast cancer. At the time of analysis, the median duration of response had not been reached with three of five responders on therapy for 11 months or more. These early findings, from the ongoing Phase 1b KEYNOTE-012 study, were shared today for the first time as part of the official press program at the 2014 San Antonio Breast Cancer Symposium and will be presented in an oral session at 10:45 a.m. CST by Dr. Rita Nanda, the University of Chicago. Data presented were from a cohort of the ongoing Phase 1b KEYNOTE-012 study which evaluated KEYTRUDA monotherapy at 10 mg/kg every two weeks in patients with advanced TNBC whose tumors were determined to be positive for PD-L1 expression. As measured by Merck’s proprietary PD-L1 immunohistochemistry clinical trial assay, tumors were considered to be PD-L1 positive if staining was present in the stroma or in greater than or equal to one percent of tumor cells. In the study, 58 percent of patients screened had tumors determined to be positive for PD-L1 expression. Most patients enrolled in this study had received two or more prior chemotherapies for metastatic disease and 87.5 percent had received prior neo-adjuvant or adjuvant therapy.
08:31 EDTPFETeva 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 EDTPFEMylan 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.
December 9, 2014
16:28 EDTMRKOn The Fly: Closing Wrap
Stocks on Wall Street opened in the red on the heels of a sharp sell-off in China and amid continued concern over tumbling oil prices. The domestic economic calendar offered little in the way of a catalyst and the market moved in a narrow range throughout the morning. However, the averages began to pare their losses once the European markets closed. By mid-afternoon the averages had turned mixed with the Nasdaq higher, the S&P flat, and the Dow the laggard, which is the way the trading day closed. ECONOMIC EVENTS: In the U.S., the National Federation of Independent Business' optimism index rose to 98.1 from a prior reading of 96.1. The JOLTS report showed job openings increased 149K to 4.83M in October, which was above the expectation for 4.795M openings. Wholesale sales increased 0.2% in October and inventories grew 0.4%, both of which were better than expected. In Asia, China's Shanghai composite index plunged 5.4%, making for the stock market's sharpest selloff in years, after the country’s securities clearing house raised the threshold for the type of collateral used for short-term loans and policymakers warned about potentially slower economic growth. In Europe, Greek stocks and bonds also tumbled after a move to bring forward presidential elections, which could potentially derail Greece’s bailout and austerity efforts. COMPANY NEWS: Verizon (VZ) was among the Dow's worst performers, sinking $1.98, or 4.05%, to $46.92 after the company warned that Q4 impacts of its promotional offers, together with the strong customer volumes this quarter, will put short-term pressure on its earnings per share. After last night's commentary from the company, Robert W. Baird downgraded Verizon shares to Neutral from Outperform and lowered its price target on the stock to $50 from $54... Merck (MRK) also weighed on the Dow, as the drugmaker fell $1.87, or 3.02%, to $60.01 after a Delaware court denied Cubist's (CBST) bid to stop Hospira (HSP) from selling a generic version of Cubicin in 2016. Merck announced just yesterday morning that it had agreed to buy Cubist in a transaction with a total value of approximately $9.5B. The news is a "tough start" to Merck's takeover and makes the $9.5B buyout price look $2B to $3B too high, according to analysts at Leerink. Shares of Cubist also fell $xxx, or xxx%, to $xxx following the court ruling. MAJOR MOVERS: Among the notable gainers was bluebird bio (BLUE), which surged $35.39, or 72.39%, to $84.28 after the company announced data from eight subjects treated with its LentiGlobin drug product and Piper Jaffray more than doubled its price target for the shares to $112 from $52. Among the noteworthy losers was Conn's (CONN), which plunged $14.26, or 40.64%, to $20.83 after unexpectedly reporting losses for its third fiscal quarter, withdrawing its FY15 guidance and announcing the departure of its CFO. Also lower was Spirit Airlines (SAVE), which slid $10.70, or 12.67%, to $73.77 after the company said last night that since late October there has been compression in the fare structure for close-in bookings, believed to be driven by the industry’s willingness to trade lower fuel prices for lower fares. Also, this morning, Raymond James downgraded Spirit Airlines to Market Perform from Outperform, citing valuation, European deflation headwinds, and earnings that are still being revised down. INDEXES: The Dow fell 51.28, or 0.29%, to 17,801.20, the Nasdaq rose 25.77, or 0.54%, to 4,766.46, and the S&P 500 slipped 0.49, or 0.02%, to 2,059.82.
13:08 EDTMRKMerck may have paid $2B-$3B too much for Cubist, analyst says
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12:25 EDTMRKOn The Fly: Midday Wrap
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12:22 EDTNVO, PFE, SHPGPiper 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.
11:31 EDTINFIInfinity Pharmaceuticals reports results from Phase 1 study of duvelisib
Infinity Pharmaceuticals reported updated data from a Phase 1 monotherapy study of duvelisib, an inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma, which showed activity among patients with relapsed/refractory indolent non-Hodgkin lymphoma, a fatal type of blood cancer. In the study, duvelisib demonstrated an overall response rate of 72%, including a 33% complete response rate, among 18 patients with iNHL who received the dose administered in ongoing registration-focused studies. In a separate presentation, updated Phase 1 data were also reported showing the activity of duvelisib in patients with relapsed/refractory T-cell lymphoma.
11:19 EDTSNYSanofi reportedly ready to make acquisitions in animal medicine, Bloomberg says
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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 EDTSHPGOn The Fly: Analyst Downgrade Summary
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10:10 EDTMRKMerck trades sharply lower, levels to watch
The stock is down over 4.3% to $59.23 at time of writing. At that price next support is at $57.95. Resistance is at $60.25.
09:31 EDTAGNZoetis drops after report of Valeant abandoning growth by acquisitions strategy
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08:25 EDTMRKBristol-Myers data positive, says BMO Capital
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08:23 EDTMRKMerck has 'no way out' of Cubist deal after court decision, says Leerink
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08:12 EDTMRKMerck still sees Cubist acquisition neutral to modestly accretive to 2015 EPS
Merck (MRK) issued the following statement regarding the decision of the U.S. District Court for the District of Delaware. The decision, which upheld the patent for CUBICIN that expires on June 15, 2016 and invalidated four others, is subject to appeal. The company continues to believe the acquisition of Cubist (CBST) will create strong fundamental value for Merck’s shareholders. The combined strength of both companies will provide both incremental and long-term value, and Merck expects the transaction to add more than $1B of revenue to its 2015 base, with strong growth potential thereafter. The court’s decision does not change Merck’s expectation that the transaction will be neutral to modestly accretive to 2015 non-GAAP EPS. The company also continues to expect that the transaction will contribute mid-single digit accretion on a percentage basis to non-GAAP EPS in 2016, and will continue to be accretive thereafter.
08:11 EDTMRKCubist downgraded to Sector Perform from Outperform at RBC Capital
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07:44 EDTPFE, AMGNAmerican Association for Cancer Research to hold a symposium
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06:14 EDTAGNAllergan 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).
05:40 EDTAMGNAmgen presents new BLINCYTO Phase 2 study data at ASH meeting
Amgen announced that new data from a pivotal Phase 2 study evaluating BLINCYTO for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia, or ALL was presented at the 56th American Society of Hematology, or ASH, Annual Meeting and Exposition. In one analysis from the '211 study, 40% of patients treated with BLINCYTO who achieved a complete remission, or CR, or complete remission with partial hematologic recovery, or CRh, were enabled to proceed to allogeneic hematopoietic stem cell transplant, or HSCT. Additionally, a secondary analysis from the study found that 82% of patients who had a CR or CRh also had a minimal residual disease, or MRD, response, a measure used to predict disease recurrence in patients with ALL. In one analysis of the '211 study, 40% of patients treated with BLINCYTO who achieved a CR or CRh were enabled to proceed to HSCT, including both patients who had received prior HSCT and patients who had not received prior HSCT. A secondary analysis of the study demonstrated that, among patients receiving BLINCYTO who had a CR or CRh and had evaluable MRD data, 82% had an MRD response, with 70% of those patients achieving a complete MRD response. Median overall survival was longer among patients who had a CR or CRh and an MRD response compared to patients who didn't have an MRD response.
05:38 EDTSHPGShire downgraded to Neutral from Buy at BofA/Merrill
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05:27 EDTJNJPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 8, 2014
19:42 EDTSGENSeattle Genetics says Adcetris 'demonstrates antitumor activity'
Seattle Genetics highlighted two separate Adcetris data presentations in relapsed/refractory and frontline diffuse large B-cell lymphoma, or DLBCL, at the 56th American Society of Hematology, or ASH, Annual Meeting and Exposition. Adcetris is an antibody-drug conjugate directed to CD30, which is expressed in classical Hodgkin lymphoma, anaplastic large cell lymphoma and several other types of non-Hodgkin lymphoma. Seattle Genetics CEO Clay Siegall said, “The updated phase 2 data at ASH demonstrate encouraging activity of Adcetris in relapsed/refractory DLBCL, even when CD30 is undetectable by standard immunohistochemistry methods. In addition, our data show that Adcetris can be safely combined with RCHOP in the frontline setting with a strong complete remission rate in high-intermediate and high-risk patients. The activity observed supports our plans to initiate a randomized phase 2 clinical trial of Adcetris for relapsed CD30-positive DLBCL patients during 2015 and to pursue possible frontline DLBCL combination trials."
19:41 EDTSGENSeattle Genetics says planning phase 1b combination trial for SGN-CD33A
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19:00 EDTMRKCubist CEO says Cubicin patent ruling will not affect Merck transaction
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18:00 EDTMRKCubist loses bid to stop Hospira's generic Cubicin after 2016, Bloomberg says
Cubist's (CBST) patent for Cubicin that expires in June 2016 upheld by judge, Bloomberg added. Note that this morning Merck (MRK) and Cubist Pharmaceuticals announced that the companies have entered into a definitive agreement under which Merck will acquire Cubist for $102 per share in cash.
17:54 EDTMRKFour Cubist Cubicin patents invalidated as Hospira wins ruling, Bloomberg says
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17:30 EDTMRKMerck acquisition of Cubist could be a 'winner', Barron's says
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17:30 EDTMRKMerck shares lower after reports of judge decision in Cubist/Hospira case
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16:24 EDTMRKOn The Fly: Closing Wrap
Stocks on Wall Street were lower amid another drop in crude oil prices, which tumbled to five-year lows. The market opened slightly lower following weaker than expected data from China and Japan, with nothing of note on the domestic calendar to get buyers involved in the day’s activity. Near noon, the averages gained downside momentum and though the market pared its losses several times, it was never able to gain any steam to pull the indexes back into the green. ECONOMIC EVENTS: In the U.S., no major economic data was released. In Asia, Chinese exports rose 4.7% from a year earlier in November, which missed the consensus estimate for an 8% increase. Chinese imports fell 6.7% from the prior year last month, compared with projections for a 3.8% increase. Additionally, Japan's revised third quarter gross domestic product estimate showed the economy shrank more than initially thought, with growth contracting an annualized 1.9%. COMPANY NEWS: Shares of Cubist Pharmaceuticals (CBST) surged $26.24, or 35.29%, to $100.60 after Merck (MRK) agreed to acquire the maker of next-generation antibiotics for $102 per share in cash, or $8.4B and the assumption of $1.1B in debt. A number of other antibiotic makers also climbed, including Tetraphase (TTPH), which rose $2.45, or 8.82%, to $30.24, and Cempra (CEMP), which advanced $1.64, or 11.37%, to $16.06, while shares of Merck finished fractionally higher, adding 39c, or 0.63%, to $61.88 following the deal announcement. MAJOR MOVERS: Among the notable gainers following their presentations at the American Society of Hematology, or ASH, annual meeting were Calithera Biosciences (CALA), which gained $2.38, or 22.52%, to $12.95, and Acceleron Pharma (XLRN), which jumped $5.11, or 13.6%, to $42.67. Among the noteworthy losers was McDonald's (MCD), which fell $3.70, or 3.84%, to $92.61 after the Dow member reported a 2.2% decline in global same-restaurant sales in November. Additionally, the fast-food giant warned that its fourth quarter results would be hurt by its sales pressures, supplier issues in China and a stronger U.S. dollar. Also lower were shares of Liquidity Services (LQDT), which plunged $2.77, or 27.0%, to $7.49 after the company disclosed that Wal-Mart (WMT) had terminated a deal to provide it with surplus merchandise. INDEXES: The Dow fell 106.31, or 0.59%, to 17,852.48, the Nasdaq dropped 40.06, or 0.84%, to 4,740.69, and the S&P 500 slipped 15.06, or 0.73%, to 2,060.31.
16:24 EDTMRK, AMGNAmgen initiates new combination trial for talimogene laherparepvec with KEYTRUDA
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13:32 EDTPFEPfizer, 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.
13:12 EDTMRKMerck paid full price but made good deal for Cubist, says UBS
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12:40 EDTMRKOn The Fly: Midday Wrap
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12:25 EDTMRKAntibiotic makers rise after Merck agrees to buy Cubist
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10:47 EDTINFIInfinity reports updated Phase 1 data from duvelisib study, says well tolerated
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10:04 EDTSGENSeattle Genetics highlights 'encouraging' long-term outcomes in Phase 1 trial
Seattle Genetics highlighted multiple ADCETRIS data presentations in frontline and salvage Hodgkin lymphoma at the 56th American Society of Hematology Annual Meeting and Exposition taking place in San Francisco, CA, December 6-9. ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma, a type of T-cell lymphoma. Data highlighted in oral sessions include encouraging long-term outcomes from a phase 1 trial evaluating ADCETRIS in combination with AVD chemotherapy in frontline HL, as well as strong activity evaluating ADCETRIS combination therapy in second-line HL and ADCETRIS monotherapy or combination therapy in frontline HL patients age 60 and older. In addition, encouraging data from multiple investigator-sponsored trials were featured in oral and poster sessions evaluating ADCETRIS in frontline and salvage HL and in non-Hodgkin lymphoma settings.
09:09 EDTAMGNAmgen announces FDA approval for XGEVA
Amgen announced that the FDA has approved a new indication for XGEVA for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA, which is reserved for drugs that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S. HCM is a serious complication in patients with advanced cancer, including those with hematologic malignancies, and indicates poor prognosis.1,2 The condition results from cancer-driven increases in bone resorption, and if untreated, can lead to renal failure, progressive mental impairment, coma and death. The approval of XGEVA is based on positive results from an open-label, single-arm study, which enrolled patients with advanced cancer and persistent hypercalcemia after recent bisphosphonate treatment. The primary endpoint was the proportion of patients with a response, defined as albumin-corrected serum calcium <11.5 mg/dLwithin 10 days after the first dose of XGEVA. Secondary endpoints included the proportion of patients who experienced a complete response (defined as CSC <10.8 mg/dL by day 10, time to response and response duration. The study achieved its primary endpoint with a response rate at day 10 of 63.6 percent in the 33 patients evaluated. The overall complete response rate was 63.6 percent. The estimated median time to response was nine days, and the median duration of response was 104 days.4,5
09:09 EDTAMGNAmgen announces FDA approval for XGEVA
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08:33 EDTSGENSeattle Genetics should be bought on weakness, says RBC Capital
RBC Capital believes that Seattle Genetics' shares could be under pressure today due to questions around its AETHERA data and the checkpoint inhibitor efficacy of its ADCETRIS drug. However, the firm says that other issues are more important over the longer term, including the efficacy of ADCs as a cancer treatment, the emergence of other pipeline products and therapeutic approaches, and efficient development pathways to the market. The firm keeps a $48 price target and Outperform rating on Seattle Genetics.
08:30 EDTMRKMerck says deals with Cubist includes $250M break-up fee clause
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08:21 EDTMRKMerck says looked at all risks, including patent litgation, before Cubist deal
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08:11 EDTMRKCubist volatility elevated into Merck acquiring for $8.4B in cash
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08:08 EDTMRKMerck says about $9.5B of debt to be issued related to Cubist deal
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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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07:35 EDTMRKAdvaxis reports FDA acceptance of IND application for ADXS-PSA combination trial
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07:29 EDTAGNUBS to hold investor trip
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07:18 EDTAGNUBS to hold investor trip
2014 Annual West Coast Investor Trip travels on the West Coast on December 8-10.
07:13 EDTMRKMerck to host conference call
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07:01 EDTMRKMerck to acquire Cubist for $102 per share in cash, or $9.5B
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07:00 EDTMRKMerck to acquire Cubist for $102 per share in cash
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05:42 EDTAMGNSandoz 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
16:29 EDTMRKMerck in discussions to buy Cubist for $7B, Bloomberg reports
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14:54 EDTJNJIMBRUVICA data suggests promise in multiple myeloma
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14:38 EDTAMGNAmgen announces new data from Phase 2 BLINCYTO immunotherapy study
Amgen announced new data from the Phase 2 BLAST study which evaluated the bispecific T cell engager, BiTE, immunotherapy BLINCYTO in patients with minimal residual disease, MRD, positive B-cell precursor acute lymphoblastic leukemia, ALL. In the study, 78% of patients who received BLINCYTO experienced a complete MRD response , a measure of eradication of residual disease at the molecular level, after one treatment cycle. Nearly all complete responses occurred within the first treatment cycle. The results from the BLAST study will be featured during the 56th American Society of Hematology Annual Meeting and Exposition press briefing on Saturday, December 6, at 10 a.m. PT and will be presented in an oral session at ASH on Monday, December 8, at 10:30 a.m. PT. "BLINCYTO is the most advanced of Amgen's BiTE immunotherapies, a new and innovative approach that helps the body's own immune system fight cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Achieving molecular complete remission is an important goal in the treatment of ALL, and the data presented at ASH demonstrates that BLINCYTO can produce deep responses in patients that have trace amounts of residual disease." MRD is a state of disease in which the microscopic analysis does not show malignant cells, but more sensitive techniques still detect disease at the molecular level. Patients who have persistent or recurrent MRD after their first therapy have a higher risk of relapse than those with no detectable MRD. In addition to the majority of patients achieving a compete MRD response within one cycle of treatment, 80% achieved a complete MRD response across all cycles. Responses occurred in all subgroups including older patients and patients with high MRD level; no predictive factor for MRD response was identified. In the study, adverse events of all grades occurring in 20% or more patients included pyrexia, tremor, chills, fatigue, nausea, vomiting and diarrhea. Grade =3 AEs occurring in five percent or more patients included neutropenia , pyrexia and tremor. Two fatal AEs occurred on treatment: subdural hemorrhage and pneumonitis in conjunction with influenza. Treatment interruptions due to AEs occurred in 31% of patients.
14:31 EDTINFIInfinity Pharmaceuticals to hold a luncheon and data presentation meeting
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14:18 EDTAMGNAmgen, Onyx announce detailed results from Phase 3 ASPIRE study of Kyprolis
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14:10 EDTAMGNAmerican Society of Hematology to hold a meeting
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13:23 EDTSGENSeattle Genetics, Takeda announce four-year data from ADCETRIS trial
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12:58 EDTMRKMerck presents KEYTRUDA data at ASH
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12:50 EDTSGENSeattle Genetics presents data from SGN-CD19A antibody-drug conjugate
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12:44 EDTSGENSeattle Genetics, Takeda report Phase 3 AETHERA trial data from Adcetris
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December 5, 2014
13:41 EDTSHPGShire to host research and development day with a conference call hookup
Research and Development meeting to be held in New York on December 10 at 8 am. Webcast Link
10:22 EDTPFEBristol-Myers call activity attributed to takeover speculation
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10:05 EDTPFEBristol-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 EDTPFERumor: Bristol-Myers strength attributed to takeover speculation
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