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Stock Market & Financial Investment News

News Breaks
March 4, 2014
07:55 EDTAEGR, AEGR, TEVA, TEVA, DNDN, DNDN, CELG, CELG, BMRN, BMRN, ALXN, ALXN, BMY, BMY, MYL, MYL, MEIP, MEIP, ISIS, ISIS, GSK, GSK, FMI, FMI, CNAT, CNAT, BLUE, BLUE, XOMA, XOMACowen to host a conference
34th Annual Global Healthcare Conference is being held in Boston on March 3-5 with webcasted company presentations to begin on March 4 at 8:00 am; not all company presentations may be webcasted. Webcast Link
News For AEGR;BLUE;CNAT;FMI;GSK;ISIS;MEIP;MYL;BMY;ALXN;BMRN;CELG;DNDN;TEVA;XOMA From The Last 14 Days
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October 8, 2014
06:47 EDTTEVA, MYLLawmakers may push for new regulations on generic drug makers, NY Times says
After the prices of some generic drugs soared more than 1,000% over the last year, two influential members of Congress are probing the sector and threatening to look to impose new regulations on it, according to The New York Times. Generic drug makers include Teva (TEVA), Mylan (MYL), Actavis (ACT), and Lannett (LCI).Reference Link
06:11 EDTGSKNovartis 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
10:56 EDTMYL, ISISOptions with increasing implied volatility
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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 EDTCELG, BLUEAlliance for Regenerative Medicine
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07:16 EDTBLUEBiotech Industry Organization to hold a forum
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October 6, 2014
14:24 EDTISISIsis Pharmaceuticals volatility elevated into update on Phase 2 clinical studies
Isis Pharmaceuticals October weekly call option implied volatility is at 120, October is at 94, November is at 73, January is at 64; compared to its 26-week average of 65 according to Track Data, suggesting large price movement into management providing an update on the Phase 2 clinical studies of ISIS-SMN Rx results presented at the 19th International World Muscle Society Congress on October 10.
13:01 EDTXOMAXOMA, Texas A&M University System agree to non-exclusive license
The Texas A&M University System and XOMA announced that the Texas A&M University System agreed to a non-exclusive license for XOMA's innovative design of a manufacturing facility. The patented technology relates to an arrangement of mobile clean rooms within the manufacturing facility with each MCR providing a portable, self-contained environment that allows for drug development. The A&M System will use MCRs for certain government programs at The National Center for Therapeutics Manufacturing facility. Details of the license were not disclosed.
11:58 EDTTEVATeva simplifaction plans expected but positive, says BMO Capital
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11:09 EDTMYLOptions with increasing implied volatility
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08:32 EDTTEVATeva identifies 14 pipeline projects for discontinuation or divestment
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08:32 EDTTEVATeva announces results of strategic review of core specialty therapeutic areas
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08:04 EDTBMYBristol-Myers announces Opdivo clinical trial with Novartis therapies
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08:02 EDTBMYBristol-Myers announces research collaboration to evaluate Opdivo
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07:34 EDTCELGAlliqua expands exclusive licensing agreement with Celgene
Alliqua Biomedical (ALQA) announced that the company has amended its exclusive licensing agreement with Celgene Cellular Therapeutics, or CCT, a subsidiary of Celgene (CELG). Under the terms of the amended agreement, Alliqua has received the right to market the advanced wound care product, Biovance, for podiatric and orthopedic applications. Biovance is a, decellularized, and dehydrated, human amniotic membrane allograft, which was commercially launched by Alliqua on April 23. The product is currently indicated for the management of non-infected partial- and full-thickness wounds, including chronic and acute wounds such as diabetic ulcers, pressure ulcers, venous ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds, trauma wounds, and draining wounds, The field of use for Biovance has been expanded to include podiatric and orthopedic applications including sports medicine-related conditions pertaining to use during the repair of tendon, nerve and bone in the foot and ankle, as well as other surgical procedures in these specialty areas.
07:30 EDTMYLMylan launches generic Combivir
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07:13 EDTISISMobile Marketing & Technology Magazine to hold a conference
Mobile Payments Conference is being held in Chicago on October 6-8.
05:14 EDTBMYNovartis announce clinical collaboration with Bristol-Myers
Novartis (NVS) announced that it has entered into a clinical collaboration with Bristol-Myers Squibb (BMY) to evaluate the safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, Opdivo, in Phase I/II trials of patients with non-small cell lung cancer, or NSCLC. Both studies will be conducted by Novartis. One trial will evaluate the combination of Opdivo with Zykadia, an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. A second study will investigate Opdivo with INC280, a potent and highly selective inhibitor of c-MET receptor tyrosine kinase, and separately with EGF816, a potent, third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations. INC280 and EGF816 are currently being investigated in various Phase I/II NSCLC trials. Additional details of the collaboration were not disclosed.
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