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April 19, 2012
05:55 EDTACTC, ACTC, SNY, SNY, ATHX, ATHX, BAX, BAX, GENZ, GENZ, PFE, PFE, NVS, NVS, PSTI, PSTI, LIFE, LIFE, CYTX, CYTX, SGMO, SGMOGlobal Technology to host a summit
8th GTC Stem Cell Summit is being held in Boston on April 19-20.
News For ACTC;CYTX;LIFE;PSTI;NVS;PFE;GENZ;BAX;ATHX;SNY;SGMO From The Last 14 Days
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January 23, 2015
08:10 EDTNVSArray agrees to acquire rights to encorafenib
Array BioPharma (ARRY) announced that it has reached a definitive agreement with Novartis (NVS) to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in Phase 3 development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline (GSK) on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals. Array previously announced a definitive agreement with Novartis to regain global rights to the Phase 3 MEK inhibitor binimetinib, the material terms of which remain in place following this agreement. In order to address competition concerns raised by the European Commission, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. The European Commission is expected to issue a decision regarding the Novartis-GSK transaction on January 28, 2015. Upon satisfaction of all conditions and closing of the deal, Array will acquire global rights to encorafenib. Other than a de minimis payment due to Novartis from Array, there are no milestone payments or royalties payable under this agreement by either party. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array all patent and other intellectual property rights Novartis owns to the extent relating to encorafenib. As part of the transaction, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Novartis will conduct and fund the COLUMBUS trial through the earlier of June 30, 2016 or completion of last patient first visit. At that time, Array will assume responsibility for the trial, while Novartis will reimburse Array for out-of-pocket costs along with 50% of Array's full time equivalent costs in connection with completing the COLUMBUS trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50% of Array's FTE costs in connection with completing the trials. Novartis will supply encorafenib for clinical and commercial use for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib. The effectiveness of the agreement is subject to the receipt of regulatory approvals and to the consummation of the Novartis-GSK transaction. In addition, Array agreed to undertake to obtain certain third party consents or waivers necessary for Array to consummate the transactions under the Novartis Agreement.
07:36 EDTNVSIncyte earns $25M milestone payment from Novartis for Jakavi
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07:25 EDTNVSNovartis drug Jakavi recommended by CHMP for EU approval
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January 22, 2015
11:27 EDTCYTXCytori Therapeutics management to meet with Roth Capital
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11:23 EDTPFEPfizer says CHMP adopted positive opinion on Prevenar 13 expansion
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07:15 EDTATHXAthersys announces GBP 2M grant to support Phase 2a clinical study of MultiStem
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05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
12:35 EDTNVSNovartis confirms FDA approval for Cosentyx
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12:33 EDTNVSFDA approves Novartis psoriasis drug Cosentyx
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12:30 EDTPFEGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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10:26 EDTNVSHigh option volume stocks
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10:16 EDTSNYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 20, 2015
16:25 EDTCYTXCytori says STAR trial will begin enrolling in 2015
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09:02 EDTBAXBaxter receives FDA approval for PHOXILLUM solution
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08:40 EDTCYTXCytori Therapeutics price target raised to $6 from $3.50 at Roth Capital
Roth Capital increased its price target on Cytori after the company received final FDA approval for a clinical trial of its treatment for scleroderma., and the firm attended an event hosted by the company with a scleroderma expert. Roth says that the expert highlighted the unmet medical need in scleroderma as well its significant morbidity and mortality. The firm expects the company's visibility to improve this year, and it keeps a Buy rating on the stock.
08:16 EDTBAXMerrimack data of Phase 3 MM-398 NAPOLI-1 study supports development programs
Merrimack Pharmaceuticals (MACK) announced that additional analyses were presented on January 16, 2015 from the Phase 3 NAPOLI-1 study of MM-398, also known as nal-IRI, in patients with metastatic pancreatic cancer previously treated with gemcitabine-based therapy. Merrimack and Baxter International's (BAX) biopharmaceutical business are collaborating on the development and commercialization of MM-398 outside of the United States and Taiwan. PharmaEngine holds the rights to commercialize MM-398 in Taiwan. Additionally, Merrimack presented preclinical and clinical data from studies of its investigational agents MM-141 and MM-151 in pancreatic and colorectal cancer, respectively. An investigator-sponsored study of MM-398 in colorectal cancer was also presented. The extended analyses for the global NAPOLI-1 Phase 3 trial presented at ASCO GI support the robustness of the overall survival benefit of MM-398 in combination with 5-fluorouracil, or 5-FU, and leucovorin presented in June 2014, at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer, or ESMO GI. The primary analysis, presented at ESMO GI, demonstrated a statistically significant advantage in overall survival with an unstratified hazard ratio of 0.67, and a median of 6.1 months for the combination of MM-398 plus 5-FU and leucovorin compared to 4.2 months in the control arm.
January 16, 2015
12:20 EDTCYTXCytori Therapeutics price target raised to $6 from $3.50 at Roth Capital
Roth Capital raised its price target for Cytori Therapeutics to $6 and keeps a Buy rating on the name. The stock is rating up 3% to 46c.
08:31 EDTNVSGlaxoSmithKline CEO says more IPOs like ViiV could happen, Retuers says
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January 15, 2015
11:20 EDTPFEGoldman cuts J&J to sell citing competitive pressures
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07:59 EDTPFEAmerican Society of Clinical Oncology to hold a symposium
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