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March 10, 2014
04:55 EDTPFE, PFE, PFE, DNA, DNA, DNA, DRTX, DRTX, DRTX, ACRX, ACRX, ACRX, CEMP, CEMP, CEMP, CUR, CUR, CUR, MRNA, MRNA, MRNA, NVO, NVO, NVO, MRK, MRK, MRK, ABBV, ABBV, ABBV, AZN, AZN, AZN, AMGN, AMGN, AMGN, RHHBY, RHHBY, RHHBYEBD Group to hold a conference
BIO-Europe Spring 2014 is being held in Turin, Italy on March 10-12.
News For PFE;AMGN;AZN;ABBV;MRK;NVO;MRNA;CUR;CEMP;ACRX;DRTX;DNA;RHHBY From The Last 14 Days
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December 8, 2014
17:30 EDTMRKMerck shares lower after reports of judge decision in Cubist/Hospira case
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16:24 EDTMRK, CEMPOn 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 dayís 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, Sanquinís Cofact and CSL Behringís 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 EDTMRK, CEMPAntibiotic makers rise after Merck agrees to buy Cubist
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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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08:30 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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07:13 EDTMRKMerck to host conference call
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07:05 EDTAZNInnocoll appoints Tony Zook as CEO
Innocoll AG (INNL) announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca (AZN), has been appointed CEO effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations.
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.
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