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Johnson & Johnson (JNJ.N)

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9 Dec 2016
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Latest Key Developments (Source: Significant Developments)

Genmab says U.S. FDA grants priority review for daratumumab in relapsed multiple myeloma
Friday, 7 Oct 2016 06:07pm EDT 

Genmab : u.s. Fda grants priority review for daratumumab in relapsed multiple myeloma . Sbla was submitted by genmab's licensing partner, janssen biotech, inc. In august 2016 . Pdufa date set at june 17, 2017 . Fda has assigned pdufa target date of february 17, 2017 to take a decision on daratumumab . Fda has assigned a prescription drug user fee act (pdufa) target date of february 17, 2017 . Sbla submission also included data from phase i study of daratumumab in combination with pomalidomide and dexamethasone .Pdufa date for combination of daratumumab with pomalidomide/dexamethasone is june 17, 2017.  Full Article

U.S. FDA warns about the risk of Hepatitis B
Tuesday, 4 Oct 2016 05:31pm EDT 

: U.S. FDA warns about the risk of Hepatitis B reactivating in some patients treated with direct-acting antivirals for Hepatitis C .Requiring a boxed warning about risk of HBV reactivation to be added to drug labels of direct-acting antiviral medicines for Hepatitis C virus.  Full Article

Tracon Pharmaceuticals announces a strategic licensing collaboration for two Janssen Oncology assets and a $5 mln equity investment from Johnson & Johnson Innovation – JJDC Inc
Wednesday, 28 Sep 2016 08:00am EDT 

Tracon Pharmaceuticals Inc : Tracon Pharmaceuticals announces a strategic licensing collaboration for two Janssen Oncology assets and a $5 million equity investment from Johnson & Johnson Innovation – JJDC, Inc. . TRC253 has completed ind-enabling studies and tracon expects to initiate a phase 1/2 proof of concept clinical study in first half of 2017 . Says transaction grants tracon rights to develop two Janssen Oncology programs . Johnson & Johnson Innovation - JJDC also made $5 million equity investment in Tracon through purchase of common stock .TRC694 is currently in preclinical development and Tracon expects to file an investigational new drug application in 2018.  Full Article

Janssen Biotech submits application for approval of sirukumab in U.S. for rheumatoid arthritis
Friday, 23 Sep 2016 08:00am EDT 

Janssen Biotech Inc:Janssen submits application seeking approval of sirukumab in United States for rheumatoid arthritis.  Full Article

J&J wins dismissal of New Jersey lawsuits over talc claims - Bloomberg
Friday, 2 Sep 2016 04:04pm EDT 

:J&J wins dismissal of New Jersey lawsuits over talc claims - Bloomberg.  Full Article

Johnson & Johnson reports 15 pct passive stake in Protagonist Therapeutics - SEC filing
Friday, 19 Aug 2016 10:31am EDT 

Johnson & Johnson:Johnson & Johnson reports 15.0 pct passive stake in Protagonist Therapeutics Inc as of Aug. 16.  Full Article

Genmab to receive $15 mln in milestone payments from Janssen
Wednesday, 17 Aug 2016 03:40pm EDT 

Genmab A/S : Genmab announces submission of Supplemental Biologics License Application to FDA for daratumumab in relapsed multiple myeloma .Genmab to receive USD 15 million in milestone payments from Janssen.  Full Article

Janssen submits application to U.S. FDA to expand indication for daratumumab
Wednesday, 17 Aug 2016 03:25pm EDT 

Janssen Biotech Inc : Janssen submits application to u.s. Fda to expand indication for daratumumab (darzalex®) . Application seeks second indication for daratumumab in combination with standard of care regimens for patients with multiple myeloma .Has also submitted a request for priority review of sbla for daratumumab.  Full Article

Johnson & Johnson announces ruling related to Remicade
Wednesday, 17 Aug 2016 01:54pm EDT 

Johnson & Johnson : Johnson & Johnson announces ruling related to Remicade in the District of Massachusetts Federal Court hearing . Janssen is also continuing appeal process in proceedings related to 471 patent before U.S. Patent & Trademark office . Commercial launch of an infliximab biosimilar prior to outcome of appeals would be considered an at-risk launch .Reaffirms its sales guidance for operational sales growth for FY 2016 of 3 pct to 4 pct, notwithstanding possibility of a biosimilar launch on or after Oct. 3, 2016.  Full Article

Bristol-Myers Squibb collaborates with Johnson and Johnson for lung cancer research
Tuesday, 26 Jul 2016 06:59am EDT 

Bristol-myers Squibb Co : Bristol-Myers squibb announces new research collaboration with janssen in immuno-oncology focused on lung cancer .Myers squibb co - phase 2 clinical trial will evaluate tolerability and clinical activity of combination of these agents in nsclc patients.  Full Article

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J&J questions fairness of hip implant trial, $1 billion verdict

Johnson & Johnson will challenge the fairness of a trial that produced a verdict of $1 billion in damages against the company last week over allegations of design flaws in its Pinnacle hip implant.