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News Breaks
September 23, 2013
04:55 EDTGSK, GSK, GSK, IRWD, IRWD, IRWD, PFE, PFE, PFE, MRK, MRK, MRK, REGN, REGN, REGN, LLY, LLY, LLY, BMY, BMY, BMY, ALNY, ALNY, ALNY, LIFE, LIFE, LIFE, BIIB, BIIB, BIIB, AZN, AZN, AZN, SCLN, SCLN, SCLNElsevier Business Intelligence to hold a conference
Pharmaceutical Strategy Conference is being held in New York on September 23-25.
News For GSK;AZN;BIIB;LIFE;ALNY;BMY;LLY;REGN;MRK;PFE;IRWD;SCLN From The Last 14 Days
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August 13, 2014
18:02 EDTMRKMerck provides statement on role of PNEUMOVAX 23 in updated ACIP recommendations
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16:52 EDTMRKMerck confirms FDA approval of BELSOMRA
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16:19 EDTGSKOn The Fly: Closing Wrap
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15:30 EDTMRKFDA approves Belsomra sleep drug
The Food and Drug Administration approved Belsomra tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance because it can be abused or lead to dependence. Belsomra is made by Merck, Sharpe & Dohme.
13:13 EDTGSKInterMune exploring sale after bids from Sanofi, Roche, Glaxo, Bloomberg says
InterMune (ITMN) is working with its financial advisers Goldman Sachs (GS) and Centerview Partners to evaluate takeover bids it has received from Sanofi (SNY), Roche (RHHBY), GlaxoSmithKline (GSK) and Actelion (ALIOF), said Bloomberg, citing people with knowledge of the matter. The report noted that one of the sources said Sanofi has so far shown the most interest in a deal for InterMune, whose shares are up more than 13% to $51.56 following the first headlines from the report. Reference Link
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.
06:29 EDTALNYAlnylam called at top mid-cap pick for second half at Piper Jaffray
Piper Jaffray calls Alnylam a top mid-cap pick for the second half of 2014 and reiterates an Overweight rating on the name with a $101 price target. Piper thinks shares can rally into 2015 based on data read-outs and pipeline expansion.
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.
15:55 EDTALNYAlnylam to hold a roundtable webinar
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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
16:25 EDTSCLNSciClone raises FY14 EPS view to 51c-57c from 41c-47c, one estimate 40c
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16:22 EDTSCLNSciClone reports Q2 EPS 20c, one estimate 10c
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12:57 EDTGSKGlaxoSmithKline facing new bribery allegations in Syria, Reuters reports
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11:58 EDTLLYMannKind rallies after inking licensing agreement with Sanofi
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10:50 EDTBIIBBiogen weakness attributed to Forward Pharma IPO filing
Shares of Biogen Idec (BIIB) came off their earlier highs and moved into negative ground in early trading, with some attributing the move lower to another pharmaceutical company, Forward Pharma (FWP), filing its registration statement with the SEC relating to a proposed initial public offering and reporting that Joel Sendek has been appointed CFO. WHAT'S NOTABLE: Forward Pharma focuses on a proprietary formulation of dimethyl fumarate, or DMF, for the treatment of multiple sclerosis. DMF is the Active Pharmaceutical Ingredient, or API, found in Tecfidera, which Biogen Idec began selling for the treatment of RRMS following approval by the FDA in March 2013 and approval by the European Commission in February 2014, Forward Pharma indicated in its IPO filing. In addition to its filing, Forward Pharma announced this morning that it has hired Joel Sendek from Stifel Financial, where he served as Managing Director, Biotechnology and led the firm's healthcare equity research group. PRICE ACTION: Shares of Biogen are down fractionally in mid-morning trading after being up over 1% soon after today's opening bell.
08:47 EDTGSKGlaxo to conduct Ebola vaccine trials later this year, Guardian says
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07:07 EDTREGNRegeneron reports Q2 EPS 9c, consensus 6c
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05:32 EDTREGNRegeneron Eylea injection receives EU approval for DME treatment
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