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December 19, 2012
17:54 EDTJNJ, PFE, BMYFDA says Pradaxa not safe for use on patients with mechanical heart valves
The U.S. Food and Drug Administration ,FDA, is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users. Boehringer Ingelheim's is the manufacturerof Pradaxa. Note that Pradaxa competitors include: Eliquis, from Bristol-Myers Squibb (BMY) and Pfizer (PFE), Xarelto from Johnson & Johnson (JNJ) and Coumadin, an older drug from from Bristol-Myers Squibb.
News For BMY;PFE;JNJ From The Last 14 Days
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November 19, 2015
06:06 EDTPFEAllergan weekly volatility elevated into reports of near deal with Pfizer
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05:29 EDTPFEServier exercises licensing option with Cellectis for UCART19
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November 18, 2015
20:00 EDTPFEPfizer nears deal for Allergan at $370-$380 per share, Bloomberg says
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19:00 EDTPFEPfizer nearing acquisition of Allergan at $370-$380 per share, Bloomberg says
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17:00 EDTPFETreasury Department to release new 'guidance' deterring tax inversions, WSJ says
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12:01 EDTBMYBristol-Myers Squibb says Opdivo data shows 'superior' overall survival
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08:11 EDTBMY, JNJ, PFEIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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08:11 EDTJNJAduro Biotech receives milestone payment from Janssen
Aduro Biotech (ADRO) announced that it has received a milestone payment from Janssen Biotech (JNJ) for Aduro's submission of an Investigational New Drug, or IND, Application to the FDA for ADU-741, a LADD immunotherapy product candidate for the treatment of prostate cancer. The IND will enable Janssen, Aduro's license partner for ADU-741, to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-741 in patients with metastatic castration-resistant prostate cancer.
08:06 EDTPFEPfizer says Phase 3 XALKORI trial shows 'positive' results
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07:02 EDTPFEMerck KGaA, Pfizer win FDA breakthrough therapy designation for Avelumab
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06:09 EDTPFEValeant's Addyi sees hardly any sales, Bloomberg says
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November 17, 2015
10:47 EDTBMYBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
05:22 EDTPFEStocks with implied volatility movement; P PFE
Stocks with implied volatility movement; Pandora (P) 104, Pfizer (PFE) 29 according to iVolatility.
November 16, 2015
17:05 EDTBMYBristol-Myers announces FDA accepts for priority review sBLA for Opdivo
Bristol-Myers Squibb Company announced that the U.S. FDA has accepted for filing and priority review a supplemental Biologics License Application for Opdivo for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior therapy. The projected FDA action date is March 16, 2016.
14:38 EDTJNJGenmab confirms FDA approval of Darzalex
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13:32 EDTPFECantor helps Moelis clinches advisory role for Pfizer, Reuters reports
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13:09 EDTJNJFDA approves Darzalex to treat multiple myeloma
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09:59 EDTPFEOmega bought Valeant in Q3, sold some SuneEdison
Leon Cooperman's Omega Advisors gave a quarterly update on its stakes in a filing this morning, disclosing its positions as of September 30. NEW STAKES: Pfizer (PFE), Valeant (VRX) Walgreens Boots Alliance (WBA), TerraForm Global (GLBL), Cigna (CI). INCREASED STAKES: Google Class A (GOOGL), Facebook (FB), Delta Air Lines (DAL). DECREASED STAKES: SunEdison (SUNE), Shire (SHPG), Citi (C), KAR Auction (KAR), LyondellBasell (LYB). LIQUIDATED STAKES: McKesson (MCK), 21st Century Fox (FOXA), General Motors (GM), QEP Resources (QEP), eBay (EBAY).
07:00 EDTBMYBristol-Myers announces data from Phase 3 ALLY-3+ trial for Daklinza
Bristol-Myers announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response rates, or cure, have proved harder to achieve. The results show that 100% of patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively.
06:33 EDTPFEPfizer, Allergan deal brings focus on U.S. tax-inversion deals, Reuters says
Pfizer's (PFE) takeover bid for Allergan (AGN) has refocused financial markets over a potential move by the U.S. Treasury Department against tax-inversion deals, Reuters reported Friday. The outlook for such a move remained unclear on Friday, the report says. Reference Link
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