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Stock Market & Financial Investment News

News Breaks
August 19, 2014
05:11 EDTNVS, EMITF, TEVA, AMGNGamida Cell announces investment, option agreement with Novartis
Gamida Cell announced that it has signed an investment and option agreement with Novartis (NVS). According to the agreement, Novartis will invest $35M in Gamida Cell and in return will receive 15% equity and an option to fully acquire Gamida Cell. The option is exercisable for a limited period of time following achievement of certain milestones connected to the development of NiCord, anticipated to be met during 2015. Upon exercising the Option, Novartis would pay the other shareholders in Gamida Cell cash payments of approximately $165M, in accordance with the terms of the agreement. In addition, the Sellers will be entitled to potential future payments which can reach a total of $435M, depending on certain development and regulatory milestones and on sales of Gamida Cell's products. Gamida Cell's current shareholders include Elbit Imaging (EMITF), Teva Pharmaceutical (TEVA), and Amgen (AMGN).
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October 14, 2014
11:19 EDTTEVATeva upgraded to Buy from Hold at Standpoint Research
October 12, 2014
12:19 EDTEMITFElbit Imaging begins negotiations for sale of operation of Mango retail stores
Elbit Imaging announced that following its previous announcement dated September 29, that its subsidiary Elbit Fashion received from PUNTO FA, S.L written notice of its intention not to extend the term of the franchise rights of Elbit Fashion for operation of the "Mango" retail stores in Israel, that Elbit Fashion and the company are negotiating with Fox-Wisel and Punto the purchase of the operation of the Mango retail stores by Fox-Wisel. The consideration expected under the Transaction is estimated at approximately NIS 28M in addition to the price of Elbit Fashion's inventory that will be transferred to Fox-Wisel. The negotiations are expected to be consummated at the end of November.The closing of the transaction will be conditioned upon the approval of the Israeli Antitrust Authority as well as the satisfaction of certain conditions precedent as shall be set forth in the definitive agreements.
October 10, 2014
05:13 EDTNVSNovartis reports new analyses of AIN457 Phase III data show consistent efficacy
Novartis announced that new analyses of AIN457 Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity. Secukinumab's new mode of action stops interleukin-17A, which plays a central role in the development of psoriasis. In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI, or Psoriasis Area and Severity Index. Skin clearance was sustained through one year of treatment. This is important as historically, psoriasis patients' disease severity at the start of treatment has been shown to negatively impact their response to other therapies. Disease severity subgroups were PASI less than or equal to 20 and PASI greater than 20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel, a standard of care anti-TNF medication.
October 9, 2014
16:11 EDTTEVAAlexza reports 32,278 Adasuve units shipped to Teva in Q3
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16:11 EDTAMGNAmgen blinatumomab granted priority review by FDA
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October 8, 2014
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.
10:20 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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08:05 EDTTEVATeva initiates NDA submission to FDA for CEP-33237
Teva Pharmaceutical announced the initiation of a rolling New Drug Application submission to the U.S. Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties CEP-33237 as allowed for fast track designated products. Teva expects to complete the NDA submission by the end of 2014. Teva also announced positive results from a nasal Human Abuse Liability study which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone. Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal. CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included nausea, constipation, vomiting, headache, somnolence and dizziness.
07:19 EDTNVS, AMGNCBI to hold a conference
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07:11 EDTAMGNEuropean Academy of Dermatology and Venereology to hold a conference
23rd EADV Congress is being held in Amsterdam, The Netherlands on October 8-12.
06:47 EDTTEVALawmakers 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 EDTNVSNovartis 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
08:39 EDTNVSImmunoGen says Novartis exercises rights to take licenses under agreement
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October 6, 2014
11:58 EDTTEVATeva simplifaction plans expected but positive, says BMO Capital
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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 EDTNVSBristol-Myers announces Opdivo clinical trial with Novartis therapies
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07:19 EDTAMGNLeerink healthcare analysts hold an analyst/industry conference call
Healthcare Analysts discuss PCSK9 antibodies and evaluate the commercial potential and unmet need on an Analyst/Industry conference call. Relevant companies Amgen, Sanofi and Regeneron may be discussed on the Analyst/Industry conference call being held on October 6 at 11 am.
05:14 EDTNVSNovartis 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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