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Novartis AG (NVS.N)

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Latest Key Developments (Source: Significant Developments)

Novartis updates analyses from Kisqali pivotal late-stage trial
Thursday, 18 May 2017 06:24am EDT 

May 18 (Reuters) - Novartis Ag -:Novartis -data at ASCO, ICML and EHA meetings demonstrate meaningful advancements in cancer care- updated analyses from Kisqali pivotal phase iii monaleesa-2 trial.  Full Article

Durect Corp, Sandoz AG sign U.S. development and commercialization agreement for posimir
Thursday, 11 May 2017 08:45am EDT 

May 11 (Reuters) - Durect Corp :Durect Corp - co and Sandoz AG, a division of Novartis, have signed a development and commercialization agreement for U.S. for posimir.Durect Corp - under terms of agreement, Sandoz will make an upfront payment to Durect of $20 million.Durect Corp - co remain's responsible for conducting persist Phase 3 trial, comparing posimir to bupivacaine HC1 after laparoscopic gall bladder removal.Durect Corp - company anticipates completing dosing patients in Q3/17 for persist Phase 3 trial and expects to have top-line data shortly thereafter.Durect - deal also includes potential for up to additional $43 million in development, regulatory milestones, up to additional $230 million in sales based milestones.  Full Article

Novartis receives FDA approval for first-of-its-kind kisqali femara co-pack for initial treatment of hr+/her2- advanced or metastatic breast cancer
Monday, 8 May 2017 04:15pm EDT 

May 8 (Reuters) - Novartis Ag :Novartis receives FDA approval for first-of-its-kind Kisqali® Femara® co-pack for initial treatment of hr+/her2- advanced or Metastatic breast cancer.  Full Article

Durect and Sandoz signs a $293 mln development and commercialization agreement for Posimir
Monday, 8 May 2017 07:00am EDT 

May 8 (Reuters) - Durect Corp : :Durect and Sandoz have signed a $293 million development and commercialization agreement for Posimir (saber-bupivacaine) covering the United States.Durect Corp - Durect will remain responsible for completion of ongoing persist phase 3 clinical trial for posimir as well as fda interactions through approval.  Full Article

Incyte Q1 loss per share $0.96
Thursday, 4 May 2017 07:00am EDT 

May 4 (Reuters) - Incyte Corp :Incyte reports 2017 first-quarter financial results and updates on key clinical programs.Q1 revenue $384 million versus i/b/e/s view $360.1 million.Q1 loss per share $0.96.Q1 earnings per share view $-1.00 -- Thomson Reuters I/B/E/S.Incyte corp - Olumiant(®) (baricitinib) approved by european commission for treatment of moderate to severe active rheumatoid arthritis.Incyte corp - incyte and lilly disagree with fda's complete response letter for baricitinib.Incyte corp - expects that lilly will now engage with fda to discuss agency's concerns and determine a potential path forward.Incyte corp - novartis anticipates submitting an nda for capmatinib, incyte's potent and selective c-met inhibitor, in 2018.  Full Article

Bluebird Bio entered into a worldwide license agreement around its proprietary lentiviral vector platform with Novartis Pharma
Tuesday, 2 May 2017 08:00am EDT 

May 2 (Reuters) - Bluebird Bio Inc :Bluebird bio inc- entered into a worldwide license agreement around its proprietary lentiviral vector platform with novartis pharma ag.Bluebird bio inc- financial terms of agreement with novartis include an upfront payment to bluebird as well as milestone and royalty payments.Bluebird bio-under terms novartis to non-exclusively license certain of co's patent rights to develop, commercialize chimeric antigen receptor t cell therapies for oncology.  Full Article

Celyad grants to Novartis a non-exclusive license for its allogeneic TCR-Deficient CAR-T Cells Patents
Tuesday, 2 May 2017 01:00am EDT 

May 2 (Reuters) - Celyad Sa : :Celyad grants to Novartis <<>> a non-exclusive license for its allogeneic TCR-Deficient CAR-T Cells Patents.This license agreement is related to two targets currently under development by Novartis.Under the terms of the agreement Celyad receives an upfront payment and is eligible to receive success based clinical, regulatory and commercial milestone payments.If all success based milestones are achieved, Celyad is eligible to receive payments, including the upfront payment, totalling $96 million.In addition, Celyad will receive single digit royalties based on net sales of the licensed target associated products.Novartis has the option to extend the agreement to additional targets and/or to convert its license into an exclusive license. Celyad retains all rights to grant further licenses to third parties for the use of allogeneic CAR-T cells.  Full Article

Novartis says U.S. wholesale acquisition cost of Rydapt for AML indication to be $7,495 for 14-day package
Friday, 28 Apr 2017 12:57pm EDT 

April 28 (Reuters) - Novartis AG ::Says U.S. wholesale acquisition cost of Rydapt for AML indication is $7,495 for 14-day package and $14,990 for 28-day package - spokeswoman.  Full Article

U.S. FDA approves new combination treatment for acute myeloid leukemia
Friday, 28 Apr 2017 10:07am EDT 

April 28 (Reuters) - U.S. Food and Drug Administration ::FDA approves new combination treatment for acute myeloid leukemia.Says granted approval of Rydapt to Novartis Pharmaceuticals Corporation.Approved Rydapt for treatment of adult patients with newly diagnosed acute myeloid leukemia with genetic mutation FLT3, in combination with chemotherapy.Rydapt was also approved for adults with certain types of rare blood disorders.Rydapt is approved for use with a companion diagnostic, LeukoStrat CDx FLT3 mutation assay.Granted approval of LeukoStrat CDx FLT3 mutation assay to Invivoscribe Technologies Inc.  Full Article

Novartis CEO says takeover prices have risen, focusing on early-stage targets
Tuesday, 25 Apr 2017 01:57am EDT 

April 25 (Reuters) - Novartis Ag :CEO Joe Jimenez says thinks with Cosentyx "we can hold our own" against lilly drug taltz.Says price of potential acquisitions has increased, prompting company to "go upstream" for early stage drug acquisitions.Jimenez says Entresto on track for the objectives for the year, expects growth quarter-by-quarter.Jimenez says timing of Novartis's involvement in Turkey campaign was unfortunate, but principle of supporting patients around the world remains, declined to comment on plans for campaign.  Full Article

More From Around the Web

CHMP backs Novartis's Zykadia for first-line use in lung cancer

ZURICH Novartis's push to win approval for Zykadia as an initial treatment for a type of lung cancer got a lift on Friday with a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).