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Johnson & Johnson (JNJ.N)

JNJ.N on New York Stock Exchange

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14 Dec 2017
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Latest Key Developments (Source: Significant Developments)

Janssen Submits Supplemental NDA To FDA Seeking New Indications For Xarelto
Monday, 11 Dec 2017 

Dec 11 (Reuters) - Johnson & Johnson ::JANSSEN SUBMITS SUPPLEMENTAL NEW DRUG APPLICATION TO FDA SEEKING NEW INDICATIONS FOR XARELTO® (RIVAROXABAN) FOR PATIENTS WITH CHRONIC CORONARY AND/OR PERIPHERAL ARTERY DISEASE (CAD/PAD).JANSSEN SUBMITS SUPPLEMENTAL NDA TO FDA SEEKING NEW INDICATIONS FOR XARELTO FOR PATIENTS WITH CHRONIC CORONARY AND/OR PERIPHERAL ARTERY DISEASE.  Full Article

J&J considers sale of anti-dandruff shampoo Nizoral - Bloomberg
Thursday, 7 Dec 2017 

Dec 7 (Reuters) - :J&J CONSIDERS SALE OF ANTI-DANDRUFF SHAMPOO NIZORAL- BLOOMBERG,CITING SOURCES‍​.SALE OF J&J'S NIZORAL COULD BE VALUED AT A FEW HUNDRED MILLION DOLLARS- BLOOMBERG,CITING SOURCES‍​.  Full Article

Genomic Health Announces Research Collaboration with Janssen Pharma
Wednesday, 6 Dec 2017 

Dec 6 (Reuters) - Genomic Health Inc ::GENOMIC HEALTH ANNOUNCES RESEARCH COLLABORATION WITH JANSSEN PHARMACEUTICALS TO EVALUATE THE ONCOTYPE DX® GENOMIC PROSTATE SCORE™ TEST FOR POTENTIAL DRUG DEVELOPMENT.GENOMIC HEALTH - AS PER AGREEMENT, CO WILL TEST SAMPLES FROM JANSSEN STUDIES TO EXAMINE ASSOCIATION OF GENOMIC PROSTATE SCORE RESULTS WITH CLINICAL OUTCOMES.  Full Article

Imbruvica Plus Rituximab Phase 3 Innovate Trial In Rare Waldenström's Macroglobulinemia Met Primary Endpoint
Tuesday, 5 Dec 2017 

Dec 5 (Reuters) - Abbvie Inc ::IMBRUVICA® (IBRUTINIB) PLUS RITUXIMAB PHASE 3 INNOVATE TRIAL IN RARE WALDENSTRÖM'S MACROGLOBULINEMIA MET PRIMARY ENDPOINT.ABBVIE - PHARMACYCLICS, JANSSEN PLAN TO SHARE INTERIM ANALYSIS DATA FROM PHASE 3 INNOVATE STUDY WITH REGULATORY AUTHORITIES.  Full Article

Morphosys Says Licensee Janssen Receives Approval For Tremfya In Canada
Tuesday, 5 Dec 2017 

Dec 5 (Reuters) - MORPHOSYS AG ::DGAP-NEWS: MORPHOSYS ANNOUNCES THAT ITS LICENSEE JANSSEN HAS RECEIVED APPROVAL FOR TREMFYA(R) (GUSELKUMAB) FOR THE TREATMENT OF MODERATE-TO-SEVERE PLAQUE PSORIASIS IN CANADA.MORPHOSYS IS ELIGIBLE TO RECEIVE ROYALTIES ON NET SALES OF TREMFYA.  Full Article

Moody's Says Pharma Manufacturers, Distributors Face Rising Risks Related To U.S. Opioid Crisis
Thursday, 30 Nov 2017 

Nov 30 (Reuters) - Moody's::MOODY'S SAYS PHARMA MANUFACTURERS AND DISTRIBUTORS FACE RISING RISKS RELATED TO U.S. OPIOID CRISIS.MOODY'S ON U.S. OPIOID CRISIS - BRANDED,GENERIC DRUG COS,DRUG DISTRIBUTORS WILL BE INCREASINGLY EXPOSED TO DECLINING PRODUCT SALES, RISING LEGAL RISKS.MOODY'S SAYS ABILITY OF PHARMA MANUFACTURERS,DISTRIBUTORS TO FACE RISKS RELATED TO U.S. OPIOID CRISIS WILL DEPEND ON SCALE,DIVERSITY,LIQUIDITY, OTHERS.MOODY'S SAYS AMONG COS,J&J IS SUFFICIENTLY STRONG TO ABSORB U.S. OPIOID-RELATED RISKS, WHILE ENDO PHARMACEUTICALS & TEVA HAVE MORE LIMITED FLEXIBILITY.  Full Article

Genmab Achieves $20 Million Milestone In Daratumumab Collaboration With Janssen
Wednesday, 29 Nov 2017 

Nov 29 (Reuters) - Genmab A/S ::GENMAB ACHIEVES USD 20 MILLION MILESTONE IN DARATUMUMAB COLLABORATION WITH JANSSEN AND UPDATES FINANCIAL GUIDANCE.GENMAB - EXPECT 2017 REVENUE TO BE IN RANGE OF DKK 2,240 - 2,440 MILLION.GENMAB - PAYMENT RELATES TO PHASE III ANDROMEDA STUDY OF DARATUMUMAB IN COMBINATION WITH CYCLOPHOSPHAMIDE, BORTEZOMIB & DEXAMETHASONE IN AMYLOIDOSIS.  Full Article

Janssen announces FDA approval of Juluca for the treatment of HIV-1 infection
Tuesday, 21 Nov 2017 

Nov 21 (Reuters) - ‍Janssen Therapeutics :Janssen announces U.S. FDA approval of first and only complete, single-pill, two-drug regimen, Juluca (dolutegravir and rilpivirine), for the treatment of HIV-1 infection.says U.S. FDA approval for single-pill, two-drug regimen, juluca for treatment of HIV-1 infection​.  Full Article

Janssen seeks expanded use of Darzalex from EMA
Tuesday, 21 Nov 2017 

Nov 21 (Reuters) - Janssen-Cilag International NV::Says submission of type II variation application to European Medicines Agency, for immunotherapy Darzalex​​.  Full Article

Ionis eligible to get nearly $800 mln in milestones from deal with Janssen
Thursday, 16 Nov 2017 

Nov 16 (Reuters) - Ionis Pharmaceuticals Inc -:Ionis Pharmaceuticals licenses second orally delivered antisense drug to Janssen.Ionis Pharmaceuticals - licensed second orally delivered generation 2.5 antisense drug to Janssen Biotech, Inc. for which Ionis earned $5 million​.Ionis Pharmaceuticals -Janssen to now assume all global development, regulatory, commercialization responsibilities for IONIS-JBI2-2.5(RX )for GI diseases​.Ionis Pharma- ‍under global collaboration deal with Janssen, co eligible to receive nearly $800 million in regulatory, sales milestone payments, others.Ionis Pharma- ‍in addition, will receive tiered royalties that on average are double-digits on sales from any product that is successfully commercialized​.Ionis Pharmaceuticals Inc - ‍IONIS-JBI1-2.5(RX), first collaboration target, was licensed to Janssen last year.  Full Article