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Johnson & Johnson (JNJ.N)

JNJ.N on New York Stock Exchange

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19 Sep 2017
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Latest Key Developments (Source: Significant Developments)

EU Medicines Agency publishes recommendations for Sept 2017
Friday, 15 Sep 2017 07:55am EDT 

Sept 15 (Reuters) - EU MEDICINES AGENCY::EU MEDICINES AGENCY RECOMMENDS APPROVAL OF TESARO INC'S <<>> NIRAPARIB DRUG FOR TREATMENT OF RECURRENT OVARIAN CANCER.EU MEDICINES AGENCY RECOMMENDS APPROVAL OF JANSSEN-CILAG INTERNATIONAL N.V.'S GUSELKUMAB DRUG FOR TREATMENT OF PLAQUE PSORIASIS.  Full Article

Janssen submits supplemental New Drug Application to U.S. FDA for Zytiga
Thursday, 14 Sep 2017 04:05pm EDT 

Sept 15 (Reuters) - Johnson & Johnson :Janssen submits supplemental New Drug Application to U.S. FDA for Zytiga® (abiraterone acetate) to treat men with earlier stages of metastatic prostate cancer.Janssen - announced submission of supplemental New Drug Application to U.S. FDA seeking to expand indication of Zytiga.  Full Article

Macrogenics announces termination of duvortuxizumab collaboration
Thursday, 31 Aug 2017 04:30pm EDT 

Aug 31 (Reuters) - Macrogenics Inc ::Macrogenics announces termination of duvortuxizumab collaboration and license agreement with Janssen.Macrogenics Inc - ‍enrollment of phase 1 dose-escalation study of this molecule is being discontinued​.Macrogenics Inc - ‍Janssen has indicated that it anticipates initiating a first-in-human study with molecule in 2018​.Macrogenics Inc - ‍Janssen reaffirmed its commitment to MGD015, also known as JNJ-9383, a second dart molecule licensed from Macrogenics​.Macrogenics Inc - ‍Janssen is terminating collaboration and license agreement with Macrogenics relating to duvortuxizumab, a CD19 X CD3 dart molecule​.Macrogenics Inc - ‍unlikely that co will continue development of duvortuxizumab, a CD19 X CD3 dart molecule "at this time​".  Full Article

Minerva Neurosciences announces European Commission approval of amendment of MIN-202 agreement with Janssen
Friday, 25 Aug 2017 08:30am EDT 

Aug 25 (Reuters) - Minerva Neurosciences Inc :Minerva Neurosciences announces European Commission approval of amendment of MIN-202 agreement with Janssen.Minerva Neurosciences Inc - ‍combined proceeds are expected to support anticipated data readouts from five planned clinical trials with three product candidates​.Minerva Neurosciences Inc - ‍payments to Minerva by Janssen under new agreement include an upfront payment of $30 million​.Minerva Neurosciences Inc - ‍Minerva has assumed all financial responsibility for phase 3 development costs for MIN-202 in insomnia​.Minerva Neurosciences Inc - ‍Janssen waived remaining payments due from Minerva for phase 2 development of MIN-202, which total approximately $13 million​.Minerva Neurosciences - ‍all Minerva stock previously owned by JJDC will be repurchased by Minerva at par value of $.0001/ share or about $389 in total​.Minerva Neurosciences Inc - ‍under amended agreement, Minerva gains control of development of MIN-202 to treat insomnia​.Minerva Neurosciences Inc - ‍under amended agreement Janssen foregoes its right to royalties on MIN-202 insomnia sales in Minerva territories​.Minerva Neurosciences Inc - ‍ Minerva retains its rights to MIN-202 as adjunctive therapy for major depressive disorder​.  Full Article

Protagonist Therapeutics announces closing of Janssen license
Thursday, 24 Aug 2017 04:01pm EDT 

Aug 24 (Reuters) - Protagonist Therapeutics Inc ::Protagonist Therapeutics announces closing of Janssen license and collaboration agreement for PTG-200 and receipt of $50 million payment.Protagonist Therapeutics - ‍following closure of transaction, co received upfront payment of $50 million originally announced by two cos as part of agreement.Protagonist Therapeutics Inc - ‍PTG-200 is expected to enter phase 1 clinical testing before end of 2017​.  Full Article

Cerecor Inc Q2 loss per share $0.14
Monday, 14 Aug 2017 08:02am EDT 

Aug 14 (Reuters) - Cerecor Inc :Cerecor Inc reports second quarter 2017 financial results.Q2 loss per share $0.14.Q2 revenue $200,000.In August 2017, co sold its world-wide rights of CERC-501 to Janssen in exchange for an initial payment of $25 million​.Under agreement, Janssen will assume ongoing clinical trials and be responsible for any new development or commercialization of CERC-501..Expect existing cash & cash equivalents & proceeds from Janssen sale, to fund operating expenditure requirements through at least 2018.  Full Article

BRIEF-Genmab CEO confident to close some tech deals this year
Thursday, 10 Aug 2017 01:03am EDT 

Repeats Wednesday's story without changes to text:IS IN PROGRESSING TALKS WITH SEVERAL COMPANIES ON NEW TECHNOLOGY COLLABORATIONS, CONFIDENT TO CLOSE SOME DEALS IN 2017, AND SOME IN 2018.DEALS ARE MORE COMPLICATED TO MAKE NOW THAN EARLIER AS GENMAB WANTS CO-OWNERSHIP OR THE OPTION OF CO-OWNERSHIP AND THAT IS NOT WHAT THE LARGE BIOTECH AND PHARMA COMPANIES LIKE TO HEAR.NEW DEALS ARE GOING TO BE MORE FAVOURABLE TOWARDS GENMAB IN THE FUTURE AS ITS DRUGS ARE WORKING WELL AND POTENTIAL PARTNERS ARE VERY EAGER TO GET ACCESS TO ITS TECHNOLOGIES.IS MOVING AGGRESSIVELY FORWARD TOGETHER WITH JANSSEN ON SUBCUTANEOUS FORMULATION OF DARATUMUMAB.IT IS INCREDIBLY IMPORTANT THAT GENMAB HAS REACHED AGREEMENT WITH REGULATORS ON HOW TO GET SUBCUTANEOUS FORMULATION OF DARATUMUMAB TO MARKET.STILL SEE LOT OF UNCERTAINTIES IN 2017, STILL NEED TO SEE PICK-UP IN DARZALEX SALES IN H2.  Full Article

Genmab CEO confident to close some tech deals this year
Wednesday, 9 Aug 2017 10:15am EDT 

Aug 9 (Reuters) - GENMAB'S CEO JAN VAN DE WINKEL SAYS IN TELEPHONE INTERVIEW WITH REUTERS::IS IN PROGRESSING TALKS WITH SEVERAL COMPANIES ON NEW TECHNOLOGY COLLABORATIONS, CONFIDENT TO CLOSE SOME DEALS IN 2017, AND SOME IN 2018.DEALS ARE MORE COMPLICATED TO MAKE NOW THAN EARLIER AS GENMAB WANTS CO-OWNERSHIP OR THE OPTION OF CO-OWNERSHIP AND THAT IS NOT WHAT THE LARGE BIOTECH AND PHARMA COMPANIES LIKE TO HEAR.NEW DEALS ARE GOING TO BE MORE FAVOURABLE TOWARDS GENMAB IN THE FUTURE AS ITS DRUGS ARE WORKING WELL AND POTENTIAL PARTNERS ARE VERY EAGER TO GET ACCESS TO ITS TECHNOLOGIES.IS MOVING AGGRESSIVELY FORWARD TOGETHER WITH JANSSEN ON SUBCUTANEOUS FORMULATION OF DARATUMUMAB.IT IS INCREDIBLY IMPORTANT THAT GENMAB HAS REACHED AGREEMENT WITH REGULATORS ON HOW TO GET SUBCUTANEOUS FORMULATION OF DARATUMUMAB TO MARKET.STILL SEE LOT OF UNCERTAINTIES IN 2017, STILL NEED TO SEE PICK-UP IN DARZALEX SALES IN H2.  Full Article

DePuy Synthes collaborates with Medical Enterprises Distribution to co-market ME1000
Monday, 7 Aug 2017 08:38am EDT 

Aug 7 (Reuters) - Johnson & Johnson :DePuy Synthes says exclusive agreement with Medical Enterprises Distribution to co-market ME1000 surgical impactor for use in Total Hip Arthroplasty.DePuy Synthes - is expected to begin co-marketing ME1000 with Medical Enterprises Distribution LLC within current quarter​.DePuy Synthes says is expected to begin co-marketing ME1000 with Medical Enterprises Distribution LLC within current quarter.DePuy Synthes - ME1000 is designed to replace handheld mallet used in Total Hip Arthroplasty.  Full Article

J&J says received subpoena in June from U.S. attorney's office
Thursday, 3 Aug 2017 05:32pm EDT 

Aug 3 (Reuters) - Johnson & Johnson -:J&J - in June 2017, co received a subpoena from the united states attorney's office for the district of Massachusetts‍​ - sec filing.J&J - June subpoena seeks information regarding practices related to sterilization of depuy synthes spinal implants at three hospitals in boston.J&J - June subpoena also seeks information regarding interactions of company employees with physicians at 3 boston hospitals.J&J - expects restructuring actions in medical devices segment will result eliminations of about 4 to 6 percent of segment’s global workforce over next 18 months‍​.J&J says about 2,100 positions have been eliminated of which 1,650 received separation payments since the restructuring announcement.  Full Article

PhRMA urges 1st Circuit to reconsider J&J whistleblower ruling

The drug industry's largest trade group is urging a federal appeals court to reconsider a decision reviving a whistleblower lawsuit against Johnson & Johnson, saying it incorrectly relaxed standards that can protect companies from "parasitic" lawsuits.