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Stock Market & Financial Investment News

News For PFE;BMY;NVS;LLY From The Last 14 Days
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November 28, 2014
08:10 EDTNVSNovartis consensus estimates 'significantly' too low, says JPMorgan
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06:26 EDTNVSNovartis says LCZ696 granted accelerated assessment in Europe
Novartis announced that the Committee for Medicinal Products for Human Use has granted accelerated assessment to LCZ696, an investigational medicine for patients with heart failure with reduced ejection fraction. The company said, "The expedited review procedure is granted infrequently by the EMA and has never been awarded in the cardiovascular area until now." The designation allows the CHMP to grant an opinion at day 150 versus a normal 210 day procedure, meaning a decision on EU approval is expected within 2015. Novartis expects to submit the file for marketing authorization in the European Union in early 2015. In the U.S., LCZ696 has been granted Fast Track designation by the FDA and a rolling submission is expected to be complete by the end of 2014.
November 26, 2014
14:38 EDTNVSNovartis to divest Habitrol nicotine patch to settle FTC charges over Glaxo jv
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13:25 EDTBMYAchillion to benefit from Bristol-Myers CRL, says FBR Capital
FBR Capital expects Achillion (ACHN) to benefit from the complete response letter that the FDA sent to Bristol-Myers (BMY) on its daclatasvir HCV drug. The firm thunks the letter increases the value of GT-3 HCV patients for Achillion. FBR says that GT-3 patients constitute 5% of HCV patients in the U.S. and significantly higher in Europe. It keeps an Outperform rating on Achillion.
11:38 EDTBMYBristol-Myers receives CRL from FDA for daclatasvir
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11:36 EDTBMYBristol-Myers receives CRL from FDA for daclatasvir
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10:43 EDTPFEMylan calls active after called 'most likely' Pfizer takeover target
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10:34 EDTPFEMylan advances after called 'most likely' Pfizer takeover target
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07:48 EDTPFEMylan now most likely takeover target for Pfizer, says Jefferies
Jefferies believes Mylan (MYL), following its combination with Abbott's (ABT) Developed Markets Established Products business, is now the most likely takeover target of Pfizer (PFE). The firm thinks Pfizer management is highly motivated to either merge with, invert into or acquire a foreign company. It believes Actavis (ACT) and AstraZeneca (AZN) are off the table as potential Pfizer targets given the former's takeover of Allergan (AGN) and latter's oncology deal with Merck KGaA (MKGAY). Jefferies calls GlaxoSmithKline (GSK) the "wild card" potential takeover target for Pfizer. The firm estimates Pfizer could pay a 25% premium for Mylan and have the deal be highly accretive.
November 25, 2014
10:00 EDTNVSOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: 3M Company (MMM) initiated with an Underperform at RBC Capital... Ametek (AME) initiated with an Outperform at RBC Capital... AstraZeneca (AZN) initiated with an Outperform at Exane BNP Paribas... Bayer (BAYRY) initiated with a Neutral at Exane BNP Paribas... Carlisle (CSL) initiated with a Sector Perform at RBC Capital... Colfax (CFX) initiated with a Sector Perform at RBC Capital... Dover (DOV) initiated with a Sector Perform at RBC Capital... Eaton (ETN) initiated with a Sector Perform at RBC Capital... Emerson (EMR) initiated with a Sector Perform at RBC Capital... Evercore Partners (EVR) initiated with an Outperform at Macquarie... Fifth Street Asset (FSAM) initiated with a Buy at MLV & Co.... Flowserve (FLS) initiated with an Underperform at RBC Capital... General Electric (GE) initiated with an Outperform at RBC Capital... GlaxoSmithKline (GSK) initiated with an Underperform at Exane BNP Paribas... Grainger (GWW) initiated with a Sector Perform at RBC Capital... Hanesbrands (HBI) initiated with a Buy at UBS... Hercules Technology (HTGC) initiated with a Neutral at Macquarie... HomeStreet (HMST) initiated with a Neutral at Macquarie... Honeywell (HON) initiated with an Outperform at RBC Capital... IDEX Corp. (IEX) initiated with an Outperform at RBC Capital... Illinois Tool Works (ITW) initiated with a Sector Perform at RBC Capital... Ingersoll-Rand (IR) initiated with a Sector Perform at RBC Capital... ManTech (MANT) initiated with a Buy at Maxim... Novartis (NVS) initiated with an Outperform at Exane BNP Paribas... Nu Skin (NUS) initiated with a Neutral at Citigroup... Oppenheimer Holdings (OPY) initiated with a Neutral at Macquarie... Pentair (PNR) initiated with an Outperform at RBC Capital... Raymond James (RJF) initiated with a Neutral at Macquarie... Roche (RHHBY) initiated with an Outperform at Exane BNP Paribas... Roper Industries (ROP) initiated with an Outperform at RBC Capital... SPX Corp. (SPW) initiated with a Sector Perform at RBC Capital... Sanofi (SNY) initiated with an Outperform at Exane BNP Paribas... Tyco (TYC) initiated with an Outperform at RBC Capital... United Technologies (UTX) initiated with an Outperform at RBC Capital... WESCO (WCC) initiated with an Outperform at RBC Capital... Xylem (XYL) initiated with a Sector Perform at RBC Capital.
06:29 EDTNVSMallinckrodt says Questcor received subpoena from FTC in June
Mallinckrodt (MNK) disclosed in its quarterly regulatory filing that on June 11, Questcor received a subpoena and Civil Investigative Demand from the Federal Trade Commission seeking documentary materials and information regarding the FTC’s investigation into whether Questcor’s acquisition of certain rights to develop, market, manufacture, distribute, sell and commercialize Synacthen Depot from Novartis (NVS) violates the antitrust laws.
05:26 EDTNVSNovartis initiated with an Outperform at Exane BNP Paribas
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05:16 EDTNVSNovartis announces extension to FDA review period for MML compound LBH589
Novartis announced that the FDA has extended their priority review period by up to three months for the new drug application, or NDA, of LBH589 in combination with bortezomib and dexamethasone for patients with previously treated multiple myeloma. The NDA for LBH589 was submitted to the FDA in March. In May, the FDA granted priority review status to LBH589, reducing the standard 12-month review period to eight months. The extension to the LBH589 NDA review period follows an FDA Oncologic Drugs Advisory Committee meeting earlier this month.
November 24, 2014
15:32 EDTLLYEli Lilly reports 9.1% passive stake in Coherus Biosciences
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09:00 EDTBMYBristol-Myers, Five Prime announce clinical collaboration for Opdivo, FPA008
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08:02 EDTNVSReceptos price target raised to $186 from $130 at Leerink
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07:46 EDTPFEPfizer seen set to move on from AstraZeneca as restrictions lift, Telegraph says
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06:32 EDTNVSGSK investors expected to vote on Novartis deal in December, Reuters reports
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05:13 EDTNVSNovartis drug Signifor approved in EU
Novartis announced that the European Commission has approved Signifor as a new long acting release formulation for once monthly intramuscular injection to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue, or SSA. Next-generation SSA Signifor offers the first alternative treatment option directly targeting the pituitary tumor for patients whose acromegaly remains inadequately controlled on currently available SSAs. Additional regulatory applications for the new long acting release formulation of Signifor have been filed worldwide for the treatment of acromegaly, including an application currently filed in the United States.
November 21, 2014
05:22 EDTNVSNovartis Cosentyx receives positive CHMP opinion
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November 19, 2014
07:52 EDTPFE, BMYInforma Business Information to hold a conference
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06:07 EDTBMYBristol-Myers' Opdivo for melanoma shows positive Phase 3 results
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November 18, 2014
08:33 EDTPFEPfizer announces availability of Trumenba vaccine
Pfizer announced hat TRUMENBA, the first and only FDA-approved vaccine for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age, is now available for order by healthcare providers in the United States.
07:29 EDTPFEPfizer less likely to pursue AstraZeneca after PD-L1 deal, says JPMorgan
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07:18 EDTPFEWoodford confident in Astra, sees 50% chance of new Pfizer bid, Reuters reports
Investment manager Neil Woodford of Woodford Investment Management said he now has an even stronger belief in AstraZeneca (AZN), citing the company's strong product pipeline, and put the chances of a new takeover bid from Pfizer (PFE) at 50/50, reported Reuters, citing a statement from Woodford. Reference Link
06:39 EDTPFEAstraZeneca: 'Hard to comment' on whether Pfizer will come back, Reuters reports
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November 17, 2014
16:52 EDTNVSNovartis' LCZ696 could change course of heart failure for patients, study shows
New data on Novartis' investigational medicine, LCZ696, for patients with heart failure with reduced ejection fraction shows it has the potential to change the course of the disease for patients. In August, Novartis presented topline results from the landmark PARADIGM-HF study showing LCZ696 was superior to ACE inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization. The new analyses being presented for the first time at the American Heart Association Scientific Sessions 2014, with a paper being simultaneously published in Circulation, show that versus enalapril, LCZ696 significantly: reduced the risk of dying suddenly by 20% in HFrEF patients 45% of CV deaths and 36% of all cause deaths are sudden; reduced first and subsequent HFrEF hospitalizations by 21% and 23% respectively; reduced hospitalizations for a cardiovascular reason or for any reason both by 16%; reduced the need for more intense treatment at home by 16%; reduced emergency room visits because of rapid symptom worsening by 30%.
16:04 EDTLLYEli Lilly says empagliflozin tablets reduced A1C, body weight and abdominal fat
Empagliflozin tablets reduced hemoglobin A1C (a measure of average blood sugar over the past two to three months), body weight and several markers of abdominal fat in adults with type 2 diabetes, according to a new retrospective analysis of clinical trial data presented on behalf of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company at the 2014 Scientific Sessions of the American Heart Association in Chicago. Abdominal fat, also known as visceral fat, sits on or near vital organs. The study presented at AHA included analyses of two sets of adults with T2D treated with either empagliflozin or placebo. The first group consisted of 823 adults with high blood pressure who were treated for 12 weeks, while the second examined a pool of 2,476 adults from four different trials who were treated for 24 weeks. These randomized studies compared empagliflozin with placebo as an add-on to existing therapy, including metformin, metformin plus sulfonylurea, or pioglitazone with or without metformin. In both groups, treatment with empagliflozin significantly reduced A1C, body weight and several markers of abdominal fat compared with placebo. Changes in estimated total body fat did not reach statistical significance.
14:27 EDTPFEPfizer volatility flat into investor meeting
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11:06 EDTNVS, BMY, LLYLeerink biotech analysts hold an analyst/industry conference call
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09:42 EDTPFEPfizer to host investor day
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09:22 EDTPFEOn The Fly: Pre-market Movers
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08:13 EDTBMY, PFEPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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08:10 EDTBMYBristol-Myers presents results from Phase IIIb AVERT trial at ACR
Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase IIIb AVERT trial that investigated the use of Orencia plus methotrexate in biologic and MTX-naïve citrullinated protein-positive early moderate to severe rheumatoid arthritis patients. These data were presented this week at the American College of Rheumatology 2014 annual meeting. Orencia is currently indicated in adults for moderate to severe RA. Orencia should not be administered with tumor necrosis factor antagonists and should not be used with other biologic RA drugs. One of the analyses looked at anti-CCP antibodies, which are a marker of RA and may contribute to disease progression. The analysis assessed the development of anti-CCP antibodies in patients with early rapidly progressing RA by measuring isotypes and the number of epitopes recognized after treatment with Orencia plus MTX, Orencia alone, or MTX alone. Results demonstrated Orencia plus MTX numerically reduced the concentrations of all CCP isotypes and the average number of epitopes recognized over one year of treatment more than Orencia alone or MTX alone. Over 12 months of treatment, 6.7 percent, 12.1 percent, and 7.8 percent of patients on Orencia plus MTX, Orencia alone, and MTX alone, respectively, experienced a serious adverse event and 1.7 percent, 4.3 percent and 2.6 percent led to discontinuation. Serious infections were observed in 0.8 percent of patients in the combination arm and 3.4 percent in the Orencia monotherapy arm. None of the patients in the MTX alone arm experienced a serious infection. Malignancies were reported in 0.8 percent, 1.7 percent, and 0 percent of patients in the Orencia + MTX, Orencia, and MTX arms, respectively. Additionally at ACR, investigators presented 12-month efficacy data from AVERT, including new results assessing the effect of Orencia on more clinically stringent remission criteria than DAS-defined remission, as well as new MRI data. Significantly more patients on Orencia plus MTX achieved the stringent clinical endpoint of Boolean-defined remission at 12 months.
07:16 EDTPFEMilken Institute--Faster Cures to hold a conference
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06:43 EDTPFEAstraZeneca, Pfizer deal seen less likely after Merck transaction, Reuters says
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05:27 EDTPFEPfizer lowers FY14 Reported EPS view to $1.40-$1.49 from $1.50-$1.59
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05:23 EDTPFEPfizer forms strategic alliance with Merck KGaA
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November 16, 2014
15:07 EDTNVSNovartis says arthritis drug secukinumab met primary endpoint
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13:07 EDTBMYBristol-Myers announces results from CheckMate -066 study
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