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AbbVie Inc (ABBV.N)

ABBV.N on New York Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Abbvie Receives Positive CHMP Opinion Fo Chemotherapy-Free Combination Of Venclyxto With Rituximab
Friday, 21 Sep 2018 07:28am EDT 

Sept 21 (Reuters) - AbbVie Inc ::ABBVIE RECEIVES POSITIVE CHMP OPINION FOR A NOVEL, CHEMOTHERAPY-FREE COMBINATION OF VENCLYXTO® (VENETOCLAX TABLETS) WITH RITUXIMAB AS A TREATMENT WITH A FIXED DURATION FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY.ABBVIE - SAFETY PROFILE OF COMBINATION OF VENCLYXTO PLUS RITUXIMAB IS CONSISTENT WITH KNOWN SAFETY PROFILE OF EACH MEDICINE ALONE.  Full Article

Mylan, Fujifilm Kyowa Receive European Marketing Authorization For Hulio, Biosimilar Adalimumab
Thursday, 20 Sep 2018 07:00am EDT 

Sept 20 (Reuters) - Mylan NV ::MYLAN AND FUJIFILM KYOWA KIRIN BIOLOGICS RECEIVE EUROPEAN MARKETING AUTHORIZATION FOR HULIO®, BIOSIMILAR ADALIMUMAB.MYLAN NV - FUJIFILM KYOWA KIRIN BIOLOGICS HAS A NONEXCLUSIVE ROYALTY BEARING LICENSE WITH ABBVIE FOR USE AND SALE OF HULIO IN EUROPEAN COUNTRIES.MYLAN NV - MYLAN PLANS TO LAUNCH HULIO ACROSS VARIOUS MARKETS IN EUROPE ON OR AFTER OCT. 16..MYLAN NV - EC APPROVAL OF HULIO APPLIES TO ALL 28 EUROPEAN UNION (EU) MEMBER COUNTRIES AND EUROPEAN ECONOMIC AREA (EEA) MEMBER STATES.  Full Article

Insurance Commissioner Dave Jones Sues Abbvie
Tuesday, 18 Sep 2018 02:33pm EDT 

Sept 18 (Reuters) - The California Department Of Insurance::INSURANCE COMMISSIONER DAVE JONES SUES BIOPHARMA ABBVIE ALLEGING ILLEGAL KICKBACKS IN PROMOTING HUMIRA.THE CALIFORNIA DEPARTMENT OF INSURANCE - CASE ALLEGES THAT PRIVATE INSURERS HAVE PAID OUT $1.2 BILLION IN HUMIRA-RELATED PHARMACY CLAIMS.THE CALIFORNIA DEPARTMENT OF INSURANCE - "ALLEGATIONS OF ABBVIE'S MISCONDUCT WERE BROUGHT TO THE ATTENTION OF THE DEPARTMENT BY A WHISTLEBLOWER".THE CALIFORNIA DEPARTMENT OF INSURANCE - "WHISTLEBLOWER" IS A REGISTERED NURSE AND WAS EMPLOYED AS AN ABBVIE NURSE AMBASSADOR IN FLORIDA.CALIFORNIA DEPARTMENT OF INSURANCE - ABBVIE'S REGISTERED NURSES, THAT CO SENDS DIRECTLY TO HOME, GET "PATIENTS TO TAKE HUMIRA BY DOWNPLAYING ITS RISK".  Full Article

Abbvie Inc - Files For Potential Debt Shelf, Size Not Disclosed - SEC Filing
Thursday, 13 Sep 2018 08:31am EDT 

Sept 13 (Reuters) - AbbVie Inc ::ABBVIE INC - FILES FOR POTENTIAL DEBT SHELF, SIZE NOT DISCLOSED - SEC FILING.  Full Article

Argenx Says Abbvie Exercises Exclusive Option To License Argx-115
Wednesday, 22 Aug 2018 02:00am EDT 

Aug 22 (Reuters) - ARGENX SE ::REG-ARGENX ANNOUNCES THAT ABBVIE HAS EXERCISED ITS EXCLUSIVE OPTION TO LICENSE ARGX-115, A NOVEL IMMUNO-ONCOLOGY ANTIBODY.EXERCISE BY ABBVIE OF ITS EXCLUSIVE LICENSE OPTION TO DEVELOP AND COMMERCIALIZE ARGX-115.ARGENX AND ABBVIE ENTERED INTO AN OPTION AND LICENSE AGREEMENT FOR ARGX-115 IN APRIL 2016.  Full Article

Abbvie And Calico Announce Extension Of Groundbreaking Collaboration
Tuesday, 26 Jun 2018 08:00am EDT 

June 26 (Reuters) - AbbVie Inc ::ABBVIE AND CALICO ANNOUNCE EXTENSION OF GROUNDBREAKING COLLABORATION.ABBVIE INC - EXTENSION BUILDS ON COLLABORATION ESTABLISHED IN 2014.ABBVIE INC - UNDER TERMS OF AGREEMENT, COLLABORATION BETWEEN TWO COS EXTENDED FOR AN ADDITIONAL THREE YEARS.ABBVIE - CALICO WILL BE RESPONSIBLE FOR RESEARCH & EARLY DEVELOPMENT UNTIL 2022 & WILL ADVANCE COLLABORATION PROJECTS THROUGH PHASE 2A THROUGH 2027.ABBVIE INC - ABBVIE & CALICO WILL EACH COMMIT TO CONTRIBUTE AN ADDITIONAL $500 MILLION TO COLLABORATION.ABBVIE INC - COLLABORATION FOCUSES ON AGING AND AGE-RELATED DISEASES, INCLUDING NEURODEGENERATION AND CANCER.  Full Article

AbbVie Says Upadacitinib Monotherapy Meets All Primary, Ranked Secondary Endpoints Vs. Methotrexate In Phase 3 Study In Rheumatoid Arthritis
Tuesday, 5 Jun 2018 08:30am EDT 

June 5 (Reuters) - AbbVie Inc ::UPADACITINIB MONOTHERAPY MEETS ALL PRIMARY AND RANKED SECONDARY ENDPOINTS VERSUS METHOTREXATE IN A PHASE 3 STUDY IN RHEUMATOID ARTHRITIS.ABBVIE - SAFETY PROFILE OF UPADACITINIB IN PHASE 3 STUDY WAS CONSISTENT WITH PREVIOUSLY REPORTED PHASE 3 STUDIES, WITH NO NEW SAFETY SIGNALS DETECTED.ABBVIE - BOTH DOSES OF UPADACITINIB MONOTHERAPY ALSO SIGNIFICANTLY INHIBITED RADIOGRAPHIC PROGRESSION AT WEEK 24 COMPARED TO METHOTREXATE.ABBVIE - THERE WAS 1 DEATH IN 15 MG UPADACITINIB GROUP DUE TO METASTATIC MALIGNANT MELANOMA IN A PATIENT WITH A HISTORY OF MELANOMA PRIOR TO STUDY ENTRY.ABBVIE INC - PLANS GLOBAL REGULATORY SUBMISSIONS FOR UPADACITINIB IN RHEUMATOID ARTHRITIS IN SECOND HALF OF 2018.ABBVIE - IN STUDY THERE WERE 2 DEATHS IN 30 MG UPADACITINIB GROUP, ONE DUE TO PNEUMONIA AND SEPSIS AND ANOTHER DUE TO PERITONITIS.ABBVIE - THERE WERE 6 DEATHS THROUGH WEEK 24, 3 OF WHICH WERE MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) WITH ONE IN EACH TREATMENT GROUP.  Full Article

Abbvie And Neurocrine Biosciences Announce PDUFA Target Date Of Q3 2018 For Elagolix In Endometriosis Associated Pain
Tuesday, 10 Apr 2018 08:15am EDT 

April 10 (Reuters) - Abbvie And Neurocrine Biosciences Announce Pdufa Target Date Of Q3 2018 For Elagolix In Endometriosis ::ASSOCIATED PAIN.FDA REQUIRES EXTENDED TIME FOR REVIEW OF ADDITIONAL INFORMATION IN NEW DRUG APPLICATION.BASED ON ABBVIE'S REVIEW OF DATA, COMPANY REMAINS CONFIDENT IN NDA AND CONTINUES TO WORK WITH FDA TO BRING ELAGOLIX TO PATIENTS.REGULATORY SUBMISSIONS FOR ELAGOLIX IN UTERINE FIBROIDS REMAIN ON TRACK.PRESCRIPTION DRUG USER FEE ACT DATE HAS BEEN EXTENDED THREE MONTHS TO Q3 2018 FOR ELAGOLIX.  Full Article

Biogen, Samsung Bioepis To Settle With AbbVie Over Humira Biosimilar
Thursday, 5 Apr 2018 08:05am EDT 

April 5 (Reuters) - Biogen Inc ::BIOGEN AND SAMSUNG BIOEPIS AGREE TO SETTLEMENT WITH ABBVIE ALLOWING COMMERCIALIZATION OF IMRALDI™ (ADALIMUMAB BIOSIMILAR) IN EUROPE.BIOGEN EXPECTS TO LAUNCH IMRALDI IN EUROPE ON OCTOBER 16, 2018.PRECISE TERMS OF AGREEMENT WITH ABBVIE ARE CONFIDENTIAL.UNDER TERMS OF AGREEMENT, ABBVIE WILL GRANT PATENT LICENSES FOR USE AND SALE OF IMRALDI IN EUROPE.COUNTRY BASIS.UNDER TERMS OF AGREEMENT, BIOGEN AND SAMSUNG BIOEPIS WILL MAKE ROYALTY PAYMENTS TO ABBVIE.COMPANIES HAVE AGREED TO DISMISS ALL PENDING PATENT LITIGATION.  Full Article

Abbvie Announces Results From Phase 2 Study Evaluating Rovalpituzumab Tesirine For Third-Line Treatment Of Patients With DLL3-Expressing Relapsed/Refractory Small Cell Lung Cancer
Thursday, 22 Mar 2018 08:45am EDT 

March 22 (Reuters) - Abbvie Inc ::ABBVIE ANNOUNCES RESULTS FROM PHASE 2 STUDY EVALUATING ROVALPITUZUMAB TESIRINE (ROVA-T) FOR THIRD-LINE TREATMENT OF PATIENTS WITH DLL3-EXPRESSING RELAPSED/REFRACTORY SMALL CELL LUNG CANCER.ABBVIE INC - ‍WILL NOT SEEK ACCELERATED APPROVAL FOR ROVA-T IN THIRD-LINE RELAPSED/REFRACTORY SMALL CELL LUNG CANCER​.ABBVIE INC - ‍SAFETY DATA IN TRINITY STUDY WERE CONSISTENT WITH PREVIOUSLY REPORTED STUDIES OF ROVA-T​.ABBVIE INC - ‍ROVA-T DEMONSTRATED SINGLE AGENT RESPONSES IN ADVANCED SCLC PATIENTS​.ABBVIE INC - ONGOING PHASE 3 STUDIES, MERU AND TAHOE, WILL CONTINUE TO INVESTIGATE ROVA-T IN FIRST- AND SECOND-LINE SCLC.  Full Article

BRIEF-Abbvie Receives Positive CHMP Opinion Fo Chemotherapy-Free Combination Of Venclyxto With Rituximab

* ABBVIE RECEIVES POSITIVE CHMP OPINION FOR A NOVEL, CHEMOTHERAPY-FREE COMBINATION OF VENCLYXTO® (VENETOCLAX TABLETS) WITH RITUXIMAB AS A TREATMENT WITH A FIXED DURATION FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY