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Stock Market & Financial Investment News

News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
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November 26, 2014
17:16 EDTGSKGSK says Ebola candidate vaccine well-tolerated, gets immunological response
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14:38 EDTGSK, NVSNovartis 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 EDTPFE, GSKMylan advances after called 'most likely' Pfizer takeover target
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10:21 EDTJNJJohnson & Johnson Zytiga lost share for second month, says Wells Fargo
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07:48 EDTGSK, PFEMylan 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
13:00 EDTMRKMerck raises quarterly dividend to 45c from 44c per share
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10:00 EDTSNY, NVS, GSKOn 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 EDTGSKGlaxoSmithKline initiated with an Underperform at Exane BNP Paribas
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05:26 EDTNVSNovartis initiated with an Outperform at Exane BNP Paribas
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05:25 EDTSNYSanofi initiated with an Outperform at Exane BNP Paribas
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
11:25 EDTJNJStryker, Smith & Nephew rise after reports of renewed bid
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09:26 EDTJNJFDA updates warning on laparoscopic power morcellators to treat uterine fibroids
The FDA announced it is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April, the FDA warns against using laparoscopic power morcellators in the removal of the uterus or fibroids in the vast majority of women. In an Immediately in Effect guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications. Johnson & Johnson (JNJ), the largest manufacturer of morcellators, stopped selling the gynecological surgical tool in April and in August told customers to return any devices in their inventory. Intuitive Surgical's (ISRG) da Vinci surgical system can be used with tissue morcellators in such surgical procedures.
09:00 EDTBMYBristol-Myers, Five Prime announce clinical collaboration for Opdivo, FPA008
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08:02 EDTMRKMerck submits NDA to Japanese PMDA for Omarigliptin
Merck announced that the company has submitted a new drug application for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency. The new drug application for omarigliptin is based on a comprehensive clinical development program in Japan. The results from the first Phase 3 study of omarigliptin, conducted in Japan, were presented recently at the 50th European Association for the Study of Diabetes Annual Meeting. Japan is the first country with a regulatory filing for omarigliptin. Worldwide, Merck is supporting omarigliptin with a clinical development program that includes nine Phase 3 clinical trials involving approximately 7,500 patients with type 2 diabetes in support of planned regulatory filings.
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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07:33 EDTMRKMerck, NewLink enter licensing, collaboration agreement for Ebola vaccine
Merck (MRK) and NewLink Genetics (NLNK) announced that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink's investigational rVSV-EBOV vaccine candidate. Under the terms of the agreement, Merck will be granted the exclusive rights to the rVSV-EBOV vaccine candidate as well as any follow-on products. The vaccine candidate is under an exclusive licensing arrangement with a wholly-owned subsidiary of NewLink Genetics. Under these license arrangements, the PHAC retains non-commercial rights pertaining to the vaccine candidate. Phase I clinical trials of the rVSV-EBOV vaccine are now underway at the Walter Reed Army Institute of Research and the NIAID at the NIH. Additional Phase I studies are underway or planned to begin in the near future at clinical research centers in Switzerland, Germany, Kenya, and Gabon in a World Health Organization-coordinated effort, and in Canada by the Canadian Immunization Research Network.
07:31 EDTMRK, GSKMerck, NewLink Genetics enter into agreement for investigational Ebola vaccine
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06:32 EDTNVS, GSKGSK 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
07:51 EDTMRKBofA/Merrill biotech analysts hold analyst/industry conference call
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07:16 EDTSNYGenzyme says EU's CHMP adopts positive opinion for Cerdelga capsules
Genzyme, a Sanofi company, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Cerdelga capsules, an oral treatment for certain adults living with Gaucher disease type 1. The European Commission is expected to make a final decision on granting marketing authorization for Cerdelga in the EU in the coming months. Cerdelga was approved by the U.S. Food and Drug Administration in August, and is under review by other regulatory authorities around the world. The CHMP opinion was based on data from the Cerdelga clinical development program, which is the largest ever conducted in Gaucher disease, with approximately 400 patients treated in 29 countries. Genzyme has been researching an oral therapy for Gaucher disease for fifteen years.
06:04 EDTCELGCelgene receives positive CHMP opinion for OTEZLA
Celgene announced that the European Medicines Agency’s, or EMA, Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for OTEZLA, the company’s oral selective inhibitor of phosphodiesterase 4, or PDE4, in two therapeutic indications, for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light, or PUVA; alone or in combination with Disease Modifying Antirheumatic Drugs, or DMARD, for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
05:39 EDTSNYMannKind, Sanofi on track to launch Afrezza in Q1, says Piper Jaffray
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05:22 EDTNVSNovartis Cosentyx receives positive CHMP opinion
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November 20, 2014
07:11 EDTMRKBofA/Merrill to hold a conference
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06:09 EDTSNYSanofi says has potential to launch up to six new drugs in 2015
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05:22 EDTSNYRegeneron, Sanofi receive FDA Breakthrough Therapy designation in AD
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November 19, 2014
09:39 EDTCELGCelgene management to meet with ISI Group
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09:28 EDTSHPGShire to establish Lexington, Massachusetts as U.S. operational headquarters
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09:26 EDTSHPGShire appoints Poulton as interim CFO
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09:04 EDTJNJJohnson & Johnson submits NDA for three-month paliperidone palmitate
Janssen Research & Development, a Johnson & Johnson company, announced the submission of a New Drug Application, or NDA, for three-month atypical antipsychotic paliperidone palmitate to the FDA. The NDA seeks approval for the medication as a treatment for schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic that has a four times a year dosing schedule.
08:17 EDTSNYRegeneron, Sanofi report new data from six alirocumab trials
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07:52 EDTMRK, SNY, PFE, BMY, GSKInforma Business Information to hold a conference
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07:11 EDTSNYSanofi drawing up list of CEO candidates to repalce Viehbacher, Reuters reports
Sanofi's (SNY) board is in the process of drawing up a short list of CEO candidates to replace Chris Viehbacher, sources tell Reuters. Jean-Rene Fourtou, a Sanofi director and the honorary chairman of media group Vivendi (VIVHY), has been selected to lead the appointments and governance committee that will select the next CEO. Smith & Nephew (SNN) CEO Olivier Bohuon, AstraZeneca (AZN) CEO Pascal Soriot and former Wyeth CEO Bernard Poussot have been rumored to be potential contenders for the CEO position. Reference Link
07:08 EDTSHPGSangamo says study demonstrates in vivo reversal of Huntington's disease signs
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06:30 EDTJNJJohnson & Johnson, Boston Scientific trial set to start tomorrow, Reuters says
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06:07 EDTBMYBristol-Myers' Opdivo for melanoma shows positive Phase 3 results
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November 18, 2014
15:48 EDTSNYGenzyme, Isis present KYNAMRO data at AHA meeting
Genzyme, a Sanofi (SNY) company, and Isis Pharmaceuticals (ISIS) announced that new two-year data from a phase 3 long-term extension study of KYNAMRO injection was presented at a scientific session at the annual American Heart Association meeting. In the study, a retrospective analysis showed that patients treated with KYNAMRO for a mean of two years had a significant reduction in Major Adverse Cardiovascular Events compared to two years prior to therapy. The rate of MACE in patients treated with KYNAMRO for two years were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with KYNAMRO. In this analysis, MACE were identified in 62% of patients during two years prior to KYNAMRO treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with KYNAMRO.
12:16 EDTSNYSanofi to host seminar on New Medicines
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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.
07:34 EDTCELGCelgene presents long-term OTEZLA data at ACR/ARHP meeting
Celgene announced that results from long-term efficacy and safety analyses of OTEZLA from the open-label phase of two PALACE phase III clinical trials were presented at the 2014 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting in Boston. OTEZLA is the Company’s oral, selective inhibitor of phosphodiesterase 4, approved by the U.S. FDA for the treatment of adult patients with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In PALACE 1, 84 percent of patients who completed one year of 30 mg twice daily therapy continued to receive OTEZLA at two years. Improvements in efficacy measures observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, among patients receiving OTEZLA 30 mg twice daily, the ACR20 response rate was 65.3 percent. ACR50 and 70 response rates were 34.0 percent and 19.6 percent, respectively, at week 104. Similar findings were observed in PALACE 4. In this trial, nearly 84 percent of DMARD-naïve patients who completed one year of OTEZLA 30 mg twice daily monotherapy continued to receive OTEZLA at two years. At week 104, among patients treated with OTEZLA 30 mg twice daily monotherapy, an ACR20, 50 and 70 response was reached by 61.4 percent, 40.7 percent and 19.2 percent of patients, respectively. In both PALACE 1 and PALACE 4, changes in other efficacy measures—including the HAQ-DI, which assesses improvements in physical function, and swollen and tender joint counts—were also generally sustained between weeks 52 and 104 with continued OTEZLA treatment. In PALACE 4, treatment with OTEZLA in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic arthritis, resulted in improvements in enthesitis and dactylitis that were sustained through 104 weeks of treatment.
07:29 EDTPFEPfizer less likely to pursue AstraZeneca after PD-L1 deal, says JPMorgan
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07:20 EDTGSKEuro Organization for Research & Treatment of Cancer co-hosts a symposium
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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 EDTMRK, PFE, SHPGAstraZeneca: 'Hard to comment' on whether Pfizer will come back, Reuters reports
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November 17, 2014
17:02 EDTGSKClovis in oncology clinical trial collaboration with GlaxoSmithKline
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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%.
14:27 EDTPFEPfizer volatility flat into investor meeting
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11:55 EDTMRKMerck says IMPROVE-IT study met all primary, secondary endpoints
Merck announced that the investigational IMPROVE-IT study met its primary and all secondary composite efficacy endpoints. In IMPROVE-IT, patients taking the LDL-cholesterol-lowering medicine VYTORIN – which combines simvastatin with the non-statin ZETIA -- experienced significantly fewer major cardiovascular events than patients treated with simvastatin alone. The results from this 18,144-patient study of high-risk patients presenting with acute coronary syndromes were presented today during the late-breaking clinical trials session at the American Heart Association 2014 Scientific Sessions. Merck plans to submit the data from IMPROVE-IT to the U.S. Food and Drug Administration in mid-2015 to support a new indication for reduction of major cardiovascular events for VYTORIN and ZETIA. VYTORIN and ZETIA are currently indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia. The current U.S. Prescribing Information for both products states that the effect of ezetimibe on cardiovascular morbidity and mortality, alone or incremental to statin therapy, has not been determined.
11:06 EDTBMY, NVSLeerink 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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08:34 EDTMRKMerck says IMPROVE-IT met primary endpoint
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08:16 EDTABTZoetis to purchase assets of Abbott Animal Health for about $255M
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08:15 EDTABTZoetis to purchase assets of Abbott Animal Health for about $255M
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 EDTJNJ, PFE, SNY, CELGMilken 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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05:32 EDTGSKMedidata announces collaboration with GlaxoSmithKline
Medidata (MDSO) announced the completion of a method development project conducted in partnership with GlaxoSmithKline (GSK) to evaluate the impact of unifying mobile health, or mHealth, devices with cloud-based technologies in a clinical trial setting. The joint initiative assessed the capabilities of mHealth tools and evaluated how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs. The collaborative project, which took place at GSK’s Human Performance Lab, demonstrated that mHealth technologies have the power to comprehensively collect large volumes of objective data that is reliable, secure and analysis-ready, and provides real-time, continuous insight into the well being of patients. All of the data collected was audited and is compliant with FDA regulations. Additionally, the effort indicated that mobile devices can support the long-term goal of lessening the burden on patients participating in studies by streamlining routine procedures, eliminating unnecessary ones and reducing visits to clinical trial sites.
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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14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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13:26 EDTMRKMerck: KEYTRUDA showed superiority to chemotherapy for primary endpoint of PFS
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13:07 EDTBMYBristol-Myers announces results from CheckMate -066 study
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12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
November 14, 2014
17:27 EDTSHPGPaulson & Co. gives quarterly update on stakes
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17:13 EDTSHPGAppaloosa gives quarterly update on stakes
NEW STAKES: NXP Semiconductors (NXPI), Lorillard (LO), Alibaba (BABA), and Shire (SHPG). INCREASED STAKES: Whirlpool (WHR), Priceline (PCLN), Delta (DAL), CBS (CBS), and General Motors (GM). DECREASED STAKES: American Airlines (AAL), Disney (DIS), Apple (AAPL), MGM Resorts (MGM), and Eastman Chemical (EMN). LIQUIDATED STAKES: Expedia (EXPE), AIG (AIG), Prudential (PRU), Celanese (CE), and ASML Holding (ASML).
17:07 EDTCELGSoros Fund Management gives quarterly update on stakes
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16:58 EDTSHPGThird Point gives quarterly update on stakes
NEW STAKES: Alibaba (BABA), eBay (EBAY), Bed Bath & Beyond (BBBY), Shire (SHPG), and Parker Hannifin (PH). INCREASED STAKES: Actavis (ACT), Amgen (AMGN), EQT (EQT), Sensata (ST), Coca-Cola Enterprises (CCE). DECREASED STAKES: Williams Cos (WMB), Ally Financial (ALLY), Cheniere Energy (LNG), YPF (YPF), and FedEx (FDX). LIQUIDATED STAKES: AIG (AIG), T-Mobile (TMUS), Rackspace (RAX), Hertz (HTZ), and Citrix Systems (CTXS).
16:21 EDTJNJOn The Fly: Closing Wrap
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14:53 EDTJNJ, NVS, PFE, BMY, MRK, SNY, GSKCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
11:46 EDTMRKMerck management to meet with SunTrust
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07:14 EDTBMY, NVS, CELG, GSK, PFEAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
06:05 EDTBMYBristol-Myers to construct biologics manufacturing facility in Ireland
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November 13, 2014
16:28 EDTJNJGeron announces global strategic collaboration with Janssen Biotech
Geron (GERN) announced that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses. Imetelstat is a modified oligonucleotide that is currently in early phase clinical development for myelofibrosis, or MF, and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome, or MDS, and acute myelogenous leukemia, or AML. Under the terms of the agreement, Geron will receive an initial payment of $35M due after the applicable waiting periods under the Hart-Scott Rodino Act and is eligible to receive additional payments up to a potential total of $900M for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. All sales will be booked by Janssen.
13:32 EDTNVS, BMYLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTBMY, NVSLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTNVS, BMYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.
12:59 EDTGSKApollo plans bid for GSK mature drugs business, Reuters reports
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11:54 EDTJNJJanssen announces FDA approved sNDA for INVEGA SUSTENNA
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10:44 EDTJNJMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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10:01 EDTBMYOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: ATK (ATK) downgraded to Hold from Buy at Argus... Adeptus Health (ADPT) downgraded to Hold from Buy at Deutsche Bank... American Woodmark (AMWD) downgraded to Neutral from Buy at Longbow... Avnet (AVT) downgraded to Sell from Neutral at Goldman... Baxano Surgical (BAXS) downgraded to Sell from Buy at Summer Street... Beazer Homes (BZH) downgraded to Neutral from Overweight at JPMorgan... Bristol-Myers (BMY) downgraded to Equal Weight from Overweight at Morgan Stanley... Centene (CNC) downgraded to Market Perform from Outperform at FBR Capital... Cherry Hill Mortgage (CHMI) downgraded to Equal Weight from Overweight at Barclays... Discover (DFS) downgraded to Hold from Buy at Deutsche Bank... Fleetmatics (FLTX) downgraded to Neutral from Buy at BofA/Merrill... Gazprom (OGZPY) downgraded to Neutral from Overweight at JPMorgan... Jabil Circuit (JBL) downgraded to Neutral from Buy at Goldman... LabCorp (LH) downgraded to Hold from Buy at Deutsche Bank... Laredo Petroleum (LPI) downgraded at BMO Capital... Macy's (M) downgraded to Market Perform from Outperform at Wells Fargo... Madison Square Garden (MSG) downgraded to Equal Weight from Overweight at Morgan Stanley... Marvell (MRVL) downgraded to Sell from Neutral at Goldman... Meritor (MTOR) downgraded to Neutral from Overweight at Piper Jaffray... Swedbank (SWDBY) downgraded to Underperform from Sector Perform at RBC Capital... TransGlobe (TGA) downgraded to Sector Perform from Outperform at Scotia Capital... UIL Holdings (UIL) downgraded to Hold from Buy at Argus... Verint Systems (VRNT) downgraded to Fair Value from Buy at CRT Capital... ZAIS Financial (ZFC) downgraded to Equal Weight from Overweight at Barclays.
07:40 EDTSNYSanofi investor meeting timing tough in light of CEO ouster, Reuters says
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07:38 EDTPFEBloomberg Link to hold a conference
The Year Ahead: 2015 is being held in Washington, D.C. with a pre-conference dinner on November 13 followed by company presentations on November 14,
06:09 EDTBMYBristol-Myers' oral daclatasvir regimen shows high cure rates for hepatitis C
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06:05 EDTBMYBristol-Myers' daclatasvir reports high cure rates for genotype 3 hepatitis C
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04:23 EDTBMYBristol-Myers downgraded to Equal Weight from Overweight at Morgan Stanley
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