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Stock Market & Financial Investment News

News Breaks
February 27, 2013
05:55 EDTRHHBY, RHHBY, JNJ, JNJ, AMGN, AMGN, CELG, CELG, BIIB, BIIB, RGLS, RGLS, MRK, MRK, NVS, NVS, GSK, GSK, BMY, BMYBiocom to host a conference
3rd Annual Global Life Science Partnering Conference is being held in San Diego, California on February 27-28.
News For BMY;GSK;NVS;MRK;RGLS;BIIB;CELG;AMGN;JNJ;RHHBY From The Last 14 Days
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October 9, 2014
07:02 EDTGSKIsis Pharmaceuticals receives $18M milestone payment from GlaxoSmithKline
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October 8, 2014
11:31 EDTRHHBYFDA grants priority review for Genentech's Lucentis
Genentech, a member of the Roche Group (RHHBY), announced that the U.S. FDA has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7M Americans. The FDA confirmed action date is February 6, 2015. The sBLA was submitted August 7 to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy. If approved by the FDA, Lucentis could be the first eye medicine available for diabetic retinopathy patients. The submission is based on results of the RISE and RIDE Phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with Lucentis at two years compared to patients treated with sham injections. Benefits of Lucentis treatment were maintained during year three of treatment. The safety in the RISE and RIDE Phase III trials was consistent with previous studies.
11:14 EDTMRKMerck presents new MK-5172/MK-8742 clinical study data
Merck announced that new data from clinical studies of the company’s investigational, oral, once-daily, fixed-dose combination chronic hepatitis C treatment grazoprevir/elbasvir, or MK-5172/MK-8742, are scheduled to be presented at the 65th American Association for the Study of Liver Diseases Annual Meeting, also known as The Liver Meeting. The meeting is scheduled to take place from November 7-11. New data will also be presented for MK-3682, formerly IDX21437, as part of its purchase of Idenix Pharmaceuticals.
11:08 EDTMRKLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses IMPROVE-IT's regulatory and commercial implications for novel LDL-lowering therapies on an Analyst/Industry conference call to be held on October 9 at 2 pm.
11:05 EDTNVSLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses congestive heart failure and the prospects for LCZ696 in HF-PEF on an Analyst/Industry conference call to be held on October 9 at 3 pm.
10:55 EDTRHHBY, MRKLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
10:20 EDTAMGNAmgen biosimilar franchise underappreciated, says Piper Jaffray
After Amgen announced positive Phase 3 results for its biosimilar Humira in psoriasis, Piper Jaffray said it believes that Amgen's overall pipeline is underappreciated since the company's biosimilar franchise is generally not included in consensus estimates. The firm views Amgen as a top large cap picks and reiterate its Overweight rating on the stock.
09:16 EDTAMGNAmgen's ABP 501 for psoriasis shows positive Phase 3 results
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08:03 EDTBMYBristol-Myers resolves outstanding U.S. litigation on efavirenz
Bristol-Myers Squibb Company says it has "successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva -- efavirenz -- and Atripla products. Accordingly, we believe that loss of exclusivity in the U.S. for efavirenz should not occur until December 2017. Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative treatments to help patients prevail over serious disease. Atripla is currently the #1 prescribed U.S. regimen in its category, with over 8 million prescriptions written since its launch in 2006. Earlier this year the company submitted a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments including an HIV-1 attachment inhibitor, an HIV-1 maturation inhibitor and an anti-PD-L1. The establishment of intellectual property rights allows Bristol-Myers Squibb to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We will continue to defend our intellectual property rights against infringement as we remain focused on providing a deep and broad portfolio of innovative medicines to patients around the world."
07:19 EDTAMGN, NVS, RHHBYCBI to hold a conference
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07:18 EDTMRK, BMYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
07:11 EDTCELG, AMGNEuropean Academy of Dermatology and Venereology to hold a conference
23rd EADV Congress is being held in Amsterdam, The Netherlands on October 8-12.
06:11 EDTNVS, GSKNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.
October 7, 2014
12:57 EDTJNJJohnson & Johnson October volatility increases into Q3 and outlook
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08:39 EDTNVSImmunoGen says Novartis exercises rights to take licenses under agreement
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08:34 EDTBMYBristol-Myers withdrawing NDA for asunaprevir
Given the rapidly evolving hepatitis C treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue U.S. Food and Drug Administration approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor, which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need. Bristol-Myers says "The dual regimen was developed to meet the distinct need of the Japanese patient population, and we believe this treatment has the potential to play a major role in curing HCV patients in Japan, as well as in other markets where the HCV patient population is similar to Japan. In the EU, daclatasvir was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults. Similarly, we believe that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world. We plan to submit additional data for daclatasvir to the FDA from our ongoing clinical trial program focused on difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant, and patients co-infected with HIV. Next month at the annual meeting of The American Association for the Study of Liver Diseases, we will present new data from several daclatasvir-based regimens. We look forward to bringing daclatasvir to patients in the U.S. and will continue to work closely with the FDA to advance our regulatory application, with the aim of bringing the investigational product to market as quickly as possible."
08:33 EDTBMYBristol-Myers withdrawing NDA for asunaprevir
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07:31 EDTCELGCelgene to present long-term efficacy and safety data on oral Otezla
Celgene International Sŕrl, a wholly-owned subsidiary of Celgene Corporation, announced that the latest research findings on OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4, in plaque psoriasis and psoriatic arthritis will be presented at the 23rd European Academy of Dermatology and Venereology Congress in Amsterdam, October 8 – 12. In total, 11 abstracts will be presented at the meeting. OTEZLA data to be presented include long-term results from Celgene’s pivotal trial, ESTEEM 2 and pooled analyses of safety and tolerability results from the ESTEEM 1 and 2 studies in patients with moderate to severe plaque psoriasis. Additional analyses will evaluate the effect of OTEZLA on pruritus, difficult-to-treat areas such as nail and scalp, and palmoplantar psoriasis, work productivity and improvements in health-related quality of life. An analysis of long-term results from the PALACE clinical trial program evaluating OTEZLA in patients with active psoriatic arthritis will also be presented at the meeting. The analysis assesses the effect of OTEZLA treatment through 52 weeks on the signs and symptoms of psoriatic arthritis, including enthesitis and dactylitis in patients with pre-existing enthesitis or dactylitis.
07:24 EDTBIIB, CELG, JNJAlliance for Regenerative Medicine
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06:08 EDTJNJJohnson & Johnson Remicade competition could come in 2016, says Wells Fargo
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