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February 3, 2013
14:25 EDTRHHBY, BSX, MDT, MRK, LLY, BMY, PFE, SNY, AZN, GSK, JNJ, STJDrug, medical device makers must disclose doctor payments, Bloomberg says
Payments from drugmakers and medical device companies to doctors must be disclosed to the U.S. government beginning next March, says Bloomberg. Reference Link
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August 13, 2014
13:00 EDTSNY, RHHBYInterMune received takeover bids from Sanofi, Roche, Bloomberg says
08:31 EDTAZNAstraZeneca says Phase 3 trials of lesinurad for gout met primary endpoints
AstraZeneca announced top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor, as a combination therapy for the treatment of patients with symptomatic gout. Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby lowering serum uric acid. In the CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination with allopurinol met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0mg/dL at month 6 compared to allopurinol alone. In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone. Although lesinurad 200mg did not achieve statistical significance at month 6, this dose in combination with febuxostat, was superior to placebo plus febuxostat at all other time points. Results from these Phase III clinical trials will be submitted to a scientific meeting later in 2014. The company is proceeding with preparation of regulatory submissions for lesinurad 200mg combination therapy.
08:25 EDTMDTMedtronic August weekly volatility elevated into Q1 and outlook
Medtronic August weekly call option implied volatility is at 24, September is at 19, November is at 18; compared to its 26-week average of 19 according to Track Data, suggesting large near term price movement into the expected release of Q1 results on August 19.
August 12, 2014
17:07 EDTPFEPfizer announces results from Lyrica studies conducted in China
Pfizer announced top-line results from two placebo-controlled studies conducted in China with Lyrica in patients with postherpetic neuralgia, pain after shingles or PHN, and painful diabetic peripheral neuropathy, pDPN, respectively.The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo. The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed. The safety profile in this study was consistent with the known profile for Lyrica.
09:35 EDTJNJActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GOOG C TSL EXAS BAC DNDN JNJ TSLA
08:52 EDTSNYSanofi launches authorized generic version of Eloxatin through Winthrop US
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07:15 EDTGSKWHO says ethical to offer unproven interventions in light of Ebola outbreak
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06:18 EDTGSKGSK CEO faces pressure as company deals with weak sales, allegations, WSJ says
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05:58 EDTAZNStocks with implied volatility movement; P AZN
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August 11, 2014
15:51 EDTSNYMannKind price target raised to $10 from $6.50 at Piper Jaffray
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12:57 EDTGSKGlaxoSmithKline facing new bribery allegations in Syria, Reuters reports
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11:58 EDTLLY, SNYMannKind rallies after inking licensing agreement with Sanofi
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11:04 EDTBSXActive equity options trading on open
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09:06 EDTSNYOn The Fly: Pre-market Movers
HIGHER: PharmAthene (PIP), up 55% after announcing that a Delaware court awarded the company lump sum expectation damages for the value of its lost profits for SIGA Technologies' (SIGA) smallpox antiviral, Tecovirimat... MannKind (MNKD), up 19% after entering exclusive licensing agreement for development and commercialization of Afrezza inhaled insulin with Sanofi (SNY)... Kinder Morgan (KMI), up 19% after announcing it will acquire all of the outstanding equity securities of Kinder Morgan Energy Partners (KMP), Kinder Morgan Management (KMR) and El Paso Pipeline Partners (EPB)... Tesla (TSLA), up 2.7% following upgrade at Deutsche Bank... Achillion (ACHN), up 6% following upgrades at Wells Fargo and at Piper Jaffray... PepsiCo (PEP), up 0.9% following upgrade at UBS. LOWER: Dean Foods (DF), down 8.6% after reporting Q2 losses that were steeper than expected, saying balance of year "appears rocky," which makes it difficult to provide guidance beyond the immediate quarter... Priceline (PCLN), down 0.7% after reporting Q2 revenue that missed expectations, guiding Q3 EPS below consensus... SIGA Technologies, down 31% after ruling in suit with PharmAthene... 2U (TWOU), down 4.3% after downgraded at Goldman.
08:47 EDTGSKGlaxo to conduct Ebola vaccine trials later this year, Guardian says
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07:45 EDTSNYMannKind partnership likely to be viewed favorably, says Piper Jaffray
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07:07 EDTSNYIgnyta names Adrian Senderowicz as Chief Medical Officer
Ignyta (RXDX) announced that Adrian Senderowicz, M.D., has been appointed as Chief Medical Officer and SVP, Clinical Development and Regulatory Affairs. Senderowicz was most recently Vice President, Global Regulatory Oncology at Sanofi (SNY).
06:31 EDTSNYMannKind to host conference call
Conference call to discuss the collaboration with Sanofi about global licensing agreement for development and commercialization of Afrezza will be held on August 11 at 8:30 am. Webcast Link
05:53 EDTRHHBYCuris shares look attractive, says Piper Jaffray
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05:13 EDTSNYSanofi, MannKind announce global licensing agreement for Afrezza
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