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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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May 22, 2015
10:52 EDTJNJ, MRK, NVS, SNY, BMY, GSK, PFEJPMorgan says Actavis shares cheap compared to peers
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08:17 EDTJNJJohnson & Johnson reports STELARA receives CHMP positive opinion
Janssen-Cilag announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency adopted a positive opinion recommending approval for the use of STELARA for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
07:33 EDTBMYBristol-Myers receives positive CHMP opinion for Nivolumab
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07:22 EDTMRKMerck receives positive CHMP opinion for Pembrolizumab in advanced melanoma
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07:15 EDTMRKMerck receives positive CHMP opinion for KEYTRUDA in advanced melanoma
Merck announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma, as both first-line therapy and in previously treated patients. The CHMP positive opinion for KEYTRUDA, which is based on data in more than 1,500 adult patients with advanced melanoma, will now be reviewed by the European Commission for central marketing authorization in the European Union.
May 21, 2015
17:08 EDTJNJJohnson & Johnson Chief Accounting Officer Stephen Cosgrove to retire in October
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14:48 EDTSNYRegeneron primary driver remains Praluent, says Piper Jaffray
Piper Jaffray noted that Regeneron (REGN) shares are at all-time highs after the company and partner Sanofi reported Phase IIb data on Dupilumab and Phase III data on Sarilumab. However, the firm believes the primary driver for Regeneron remains Praluent and firm expects launch costs to outstrip sales growth. Piper acknowledges Regeneron has "one of the richest pipelines in all of biotech," but it sees risk around Amgen's (AMGN) patent suit and keeps its Neutral rating and $484 price target on the stock.
08:39 EDTNVSNovartis initiates Phase 1 PCA062, triggering milestone payment to ImmunoGen
In a regulatory filing, ImmunoGen disclosed Novartis (NVS) Institutes for BioMedical Research notified ImmunoGen (IMGN) that Novartis had initiated Phase I, first-in-human clinical testing of a product candidate, PCA062, utilizing antibody-drug conjugate technology. Pursuant to the license taken under our 2010 Multi-Target Agreement, this start of clinical testing triggers a $5M milestone payment to ImmunoGen.
08:08 EDTCELGAgios Pharmaceuticals to present data at 20th Congress of EHA
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07:37 EDTBMY, PFE, SHPG, GSK, ABTPfizer replaces AbbVie as top global pharma pick at Jefferies
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05:19 EDTNVSNovartis Afinitor extended PFS in Phase III trial in GI or lung origin NET
Novartis announced that the Phase III study of Afinitor tablets plus best supportive care in patients with advanced nonfunctional neuroendocrine tumors, or NET, of gastrointestinal, or GI, or lung origin met its primary endpoint: significant extension of progression-free survival, or PFS, compared to placebo plus best supportive care. The RADIANT-4 study is part of one of the largest clinical trial programs in NET.
05:15 EDTSNYRegeneron, Sanofi announce positive topline results from sarilumab Phase 3 study
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May 20, 2015
16:26 EDTJNJOn The Fly: Top stock stories for Wednesday
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11:36 EDTNVSNovartis says COPD programs met endpoints in Phase III study
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10:26 EDTJNJJanssen acquires licence from Novo Nordisk for autoimmune disease development
Novo Nordisk (NVO) announced it has signed an agreement with Janssen Biotech (JNJ) under which Janssen will acquire an exclusive global license to further develop and commercialize a clinical program focused on therapy within autoimmune diseases. The program targets modulation of certain immune cells via a cell surface receptor, specifically the NKG2D receptor. Terms of the agreement have not been disclosed.
09:07 EDTJNJJohnson & Johnson says exploring eight new indications for Imbruvica
Imbruvica is jointly developed and commercialized by Pharmacyclics (PCYC) and Johnson & Johnson (JNJ) subsidiary Janssen Biotech. AbbVie (ABBV) is in the process of acquiring Pharmacyclics.
09:01 EDTBMYBristol-Myers receives amended breakthrough therapy designation for daclatasvir
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08:49 EDTJNJJohnson & Johnson: Priorities for free cash flow include dividends, repurchases
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08:30 EDTJNJAchillion price target lowered to $16 from $25 at Leerink
Leerink says Achillion's deal with Johnson & Johnson (JNJ) increases the probability that it will be a competitive commercial-stage player in hepatitis C. The firm believes the collaboration limits share downside as well as upside by making the "home-run scenario of great combo data leading to an acquisition less likely." It lowered its price target for Achillion shares to $16 and keeps an Outperform rating on the name.
08:15 EDTJNJJohnson & Johnson CEO Alex Gorsky says won't pursue pure-play strategy
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08:02 EDTJNJJohnson & Johnson to hold a meeting
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07:51 EDTJNJAchillion shares remain undervalued after HCV pact with J&J, says Cowen
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07:46 EDTGSK, PFEDeutsche Bank positive on potential Pfizer, GSK merger
Deutsche Bank analyst Gregg Gilbert believes a large foreign deal for Pfizer (PFE) may make sense and says a buyout of GlaxoSmithKline (GSK) could be "materially" accretive to earnings while improving the company's tax situation over time. Gilbert assumes a $60 per share buyout price for GlaxoSmithKline in a research note this morning titled "Introducing 'PfizerKline'". The stock closed yesterday up 2c to $44.68. Gilbert reiterates a Buy rating on Pfizer with a $41 price target. Shares ended yesterday up 23c to $34.21.
07:33 EDTJNJJ&J to file more than 10 new '$1B potenital' products by 2019
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07:30 EDTJNJAchillion downgraded on valuation at JMP Securities
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07:21 EDTBMYUBS to hold a conference
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06:17 EDTJNJAchillion downgraded to Neutral from Buy at UBS
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May 19, 2015
16:10 EDTJNJAchillion enters into collaboration for HCV with Janssen
Achillion (ACHN) announced that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize one or more of Achillion's lead hepatitis C virus, or HCV, assets which include ACH-3102, ACH-3422, and sovaprevir. Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets. A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration. Additionally, in an equity transaction separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation – JJDC, Inc. will invest $225M in Achillion and, in return, receive approximately 18.4M newly issued, unregistered shares of Achillion at a price of $12.25 per share. The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. Transitional clinical development and technology transfer activities under the collaboration are expected to take place over the next several months.
09:25 EDTGSKGlaxoSmithKline asthma drug overused, risks underappreciated, ProPublica says
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08:57 EDTBMY, NVSLeerink biotech analyst holds an analyst/industry conference call
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08:17 EDTCELGCelgene says patients experienced clinical remission in Phase II GED-0301 trial
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08:02 EDTABTAbbott announces CE Mark for new advancement of Absorb stent system
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07:56 EDTBMYGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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07:45 EDTBMYJacobs Engineering receives contract from Bristol-Myers
Jacobs Engineering (JEC) received a contract from Bristol-Myers Squibb Company (BMY) to provide construction management services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. Jacobs is also providing architectural and engineering services for the facility, which is being built to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
07:28 EDTMRKUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 19 at 8 am; not all company presentations may be webcasted. Webcast Link
06:55 EDTGSK, NVS, SNY, MRK, PFEGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
May 18, 2015
12:34 EDTSNYRegeneron, Sanofi announce positive pivotal Phase 2b dupilumab data in asthma
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12:29 EDTNVSCorium announces publication of data for needle-free transdermal flu vaccine
Corium International announced the publication of "promising" data on the use of its needle-free transdermal system to deliver influenza vaccine in the June 9 issue of Vaccine. The manuscript, entitled "Fabrication of cell culture-derived influenza vaccine dissolvable microstructures and evaluation of immunogenicity in guinea pigs," details results of a preclinical study conducted by Novartis Vaccines (NVS) and Corium. The results demonstrate the compatibility of Corium's MicroCor needle-free transdermal system with cell culture-derived influenza vaccines, and establish its potential as a next-generation vaccine delivery system, the company said.
11:23 EDTABTFitch downgrades Abbott's L-T IDR to A; outlook revised to stable
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08:44 EDTCELGCelgene data positive, says SunTrust
SunTrust believes that data presented for Celgene's GED-0301 in Crohn's indicated that the drug is effective irrespective of baseline disease severity and CRP levels.Consequently, the firm thinks the data addressed questions raised in an NEJM editorial about the drug. It keeps a $141 price target and Buy rating on the shares.
07:38 EDTNVSNovartis outlook has improved, says Bernstein
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07:31 EDTCELGCelgene, Acceleron granted fast track designations for luspatercept
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06:58 EDTPFEActavis CEO says chances of Pfizer offer are 'unlikely', Financial Times says
Actavis (ACT) CEO Brent Saunders said the chances of Pfizer (PFE) making an offer are "incredibly unlikely," reports the Financial Times. Saunders said he has heard the gossip that Actavis could become a takeover target for a larger group, but he spends "zero time thinking about it." Reference Link
May 17, 2015
14:59 EDTSNYL'Oreal CEO 'ready' to sell Sanofi stake if needed, Barron's says
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May 15, 2015
15:11 EDTGSKGlaxoSmithKline reports 16.12% stake in HTG Molecular
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11:08 EDTSHPGOmega Advisors gives quarterly update on stakes
NEW STAKES: Targa Resources (TRGP), Targa Resources Partners (NGLS), Humana (HUM), Dow Chemical (DOW), and Twenty-First Century Fox (FOXA). INCREASED STAKES: Kinder Morgan (KMI), Chimera Investment Corporation (CIM), AerCap Holdings (AER), Shire (SHPG), and KKR & Co. (KKR). DECREASED STAKES: eBay (EBAY), Altisource Portfolio Solutions (ASPS), Caesars Entertainment (CZR), Navient (NAVI), and TerraForm Power (TERP). LIQUIDATED STAKES: HCA Holdings (HCA), Gilead (GILD), Cabot Oil & Gas (COG), and Apple (AAPL).
10:29 EDTSNYAmerican Urological Association to hold an annual meeting
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09:31 EDTPFE, NVS, GSKAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
07:35 EDTJNJMedivation price target raised to $148 from $128 at Leerink
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May 14, 2015
14:54 EDTJNJJohnson & Johnson unit reports results of VENTURE-AF trial
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12:29 EDTPFEPfizer receives 'second request' from FTC regarding potential Hospira merger
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11:11 EDTCELGAnalysts divided on significance of Celgene blood cancer drug data
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11:03 EDTBMYBristol-Myers treatment of progressive supranuclear palsy granted orphan status
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10:41 EDTBMYAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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09:41 EDTJNJ, ABTLeerink medical devices analyst holds a cardiology luncheon meeting
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09:22 EDTBMY, MRKLeerink pharma/biotech analysts hold an analyst/industry conference call
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09:09 EDTBMYBristol-Myers down 1.3% after release of ASCO abstracts
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08:39 EDTPFETargacept, Catalyst Biosciences amend definitive merger agreement
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08:08 EDTPFEPfizer director Marc Tessier-Lavigne to step down from board
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May 13, 2015
19:17 EDTPFEHospira and FDA detect security vulnerabilities in infusion pumps
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18:33 EDTMRKMerck to present new Keytruda data on 10 types of cancer at 2015 ASCO meeting
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17:50 EDTJNJPharmacyclics to showcase new 'promising' Imbruvica data at ASCO
Pharmacyclics announced that ibrutinib, also known as Imbruvica, single-agent and combination data will be featured in seven oral and poster sessions at the 51st American Society of Clinical Oncology, ASCO, Annual Meeting being held May 29-June 2 in Chicago, IL. According to a statement from ASCO, Imbruvica data will also be included in the official press program during the meeting for the second time in two years. Imbruvica is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a Johnson & Johnson (JNJ) subsidiary. Data being presented include, among others, an oral presentation from the Phase III HELIOS study of ibrutinib in combination with bendamustine and rituximab in relapsed or refractory chronic lymphocytic leukemia, a poster presentation of ibrutinib in steroid-dependent or refractory chronic graft-versus-host-disease as well as a dose adherence analysis of ibrutinib 420 mg administered to previously treated CLL patients. "We look forward to sharing promising data at this year's ASCO that examines the use of Imbruvica across a broad range of hematologic disease settings from our clinical studies," said Danelle James, M.D., M.S., Head of Oncology at Pharmacyclics.
17:42 EDTCELGCelgene announces over 55 blood, solid tumor cancer study presentations at ASCO
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17:19 EDTPFEPfizer, Merck KGaA to present data at ASCO for avelumab
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13:43 EDTPFEHospira shareholders approve merger with Pfizer
Hospira (HSP) announced that Hospira shareholders voted in favor of the proposal to adopt the merger agreement with Pfizer (PFE) at a special meeting of stockholders held May 13 in Denver, Colorado. On February 5, Hospira and Pfizer announced they had entered into a merger agreement under which Pfizer will acquire Hospira for $90 per share in cash for a total enterprise value of approximately $17B. The merger is subject to customary closing conditions, one of which was approval of the merger by Hospira's shareholders. Additional closing conditions to be met include obtaining regulatory approvals in several jurisdictions. Hospira and Pfizer continue to expect the merger to close in the second half of 2015.
13:12 EDTBMY, MRKSen. Sanders urges VA to break patents on Gilead hepatitis C drugs
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11:38 EDTGSKGlaxoSmithKline downgraded to Neutral from Buy at UBS
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07:31 EDTPFE, SNYHeart Rhythm Society to hold a conference
Heart Rhythm 2015 is being held in Boston on May 13-16.
07:07 EDTGSKGSK, Emergent BioSolutions, Oxford initiate Prime Boost study of Ebola vaccine
A new phase 1 study has begun at the University of Oxford that will investigate the use of a modified vaccinia Ankara, or MVA, Ebola Zaire vaccine candidate, or MVA EBOZ, as a prime-boost to GlaxoSmithKline's (GSK) Chimp Adenovirus type 3, or ChAd3, Ebola vaccine candidate. The study, being conducted by the clinical research group of Professor Adrian Hill of the Jenner Institute, has received regulatory approval to begin from the United Kingdom's Medicines and Healthcare Products Regulatory Agency, or MHRA. The phase 1 study has a planned enrollment of 38 volunteers of which 6 will receive MVA EBOZ only while the other 32 will receive ChAd3-EBO-Z prime followed by MVA EBOZ boost. Emergent BioSolutions (EBS) manufactured the supply of MVA EBOZ to be used in this phase 1 study, which is being conducted in the U.K. with support from the Wellcome Trust and the U.K. Department for International Development.
07:05 EDTSNYSanofi exercises option on therapeutic program with Selecta Biosciences
Selecta Biosciences., a clinical stage biotechnology company developing a novel class of targeted antigen-specific immune therapies, today announced that, under the terms of an existing strategic global collaboration, Sanofi has exercised its option to an exclusive license to develop an immunotherapy for the treatment of celiac disease. Under the terms of the collaboration, Selecta is eligible to receive research support and several pre-clinical, clinical, regulatory and sales milestones totaling up to $300 million for this new program in celiac disease. Additionally, Selecta is also entitled to up to double digit tiered royalties as percentage of product net sales for any commercialized immunotherapy resulting from these efforts with Sanofi. November 2012, Selecta announced that they had formed a strategic global collaboration to discover highly targeted, antigen-specific immunotherapies for life threatening allergies. Under the agreement, Sanofi obtained a first exclusive license to develop an immunotherapy designed to abate acute immune responses against a life threatening food allergen and an option to develop two additional candidate immunotherapies for allergies and celiac disease. With the exercise of this option by Sanofi, Selecta and Sanofi now have two initiatives actively advancing immune tolerance treatments under the terms of the 2012 agreement. In October 2014, Selecta and JDRF announced another collaboration with Sanofi to research novel antigen-specific immune therapies for Type 1 Diabetes.
May 12, 2015
13:13 EDTMRKExpert says Norway biosimilar case an 'outlier,' CT Financial News reports
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09:26 EDTNVSNovartis Animal Health issued FDA warning letter over marketing materials
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07:52 EDTSHPGLeerink to hold a tour
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07:33 EDTCELGAlliqua announces licensing agreement with Celgene
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06:09 EDTMRKThreshold announces Merck receives FDA Fast Track designation for evofosfamide
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06:02 EDTGSKGSK CEO cites 'poor choices' in rivals' M&A deals, Financial Times reports
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