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AbbVie Inc (ABBV.N)

ABBV.N on New York Stock Exchange

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20 Apr 2018
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Latest Key Developments (Source: Significant Developments)

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

AbbVie and International Myeloma Foundation Partner To Study Role Of Genetic Mutation
Wednesday, 21 Mar 2018 09:00am EDT 

March 21 (Reuters) - AbbVie Inc ::ABBVIE AND THE INTERNATIONAL MYELOMA FOUNDATION ANNOUNCE PARTNERSHIP TO STUDY THE ROLE OF A GENETIC MUTATION IN OUTCOMES OF PATIENTS WITH MULTIPLE MYELOMA.ABBVIE INC - ‍STUDY WILL ASSESS OUTCOMES FROM 1,500 PATIENTS WITH MM AND T(11;14) TRANSLOCATION​.  Full Article

EMA Recommends Immediate Suspension, Recall Of Multiple Sclerosis Medicine Zinbryta
Wednesday, 7 Mar 2018 05:09am EST 

March 7 (Reuters) - EU Medicines Agency::EMA RECOMMENDS IMMEDIATE SUSPENSION AND RECALL OF MULTIPLE SCLEROSIS MEDICINE ZINBRYTA.EMA RECOMMENDATION FOLLOWING 12 REPORTS OF SERIOUS INFLAMMATORY BRAIN DISORDERS WORLDWIDE, INCLUDING ENCEPHALITIS AND MENINGOENCEPHALITIS.EMA’S RECOMMENDATION TO SUSPEND ZINBRYTA AND RECALL THE PRODUCT IS BEING SENT TO THE EUROPEAN COMMISSION FOR A LEGALLY BINDING DECISION.PRELIMINARY REVIEW OF EVIDENCE INDICATES IMMUNE REACTIONS OBSERVED IN REPORTED CASES MAY BE LINKED TO USE OF ZINBRYTA‍​.  Full Article

AbbVie Gets Positive Recommendation From Pan-Canadian Oncology Drug Review For Venclexta
Tuesday, 6 Mar 2018 08:00am EST 

March 6 (Reuters) - AbbVie Inc ::ABBVIE RECEIVES POSITIVE RECOMMENDATION FROM THE PAN-CANADIAN ONCOLOGY DRUG REVIEW FOR VENCLEXTA™ - AN ORAL THERAPY FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL).ABBVIE CANADA - PCODR CONDITIONALLY RECOMMENDS REIMBURSEMENT OF VENCLEXTA FOR CLL PATIENTS WHO HAVE RECEIVED AT LEAST 1 PRIOR THERAPY & FAILED A BCRI​.  Full Article

Biogen And Abbvie Announce The Voluntary Worldwide Withdrawal Of Marketing Authorizations For Zinbryta
Friday, 2 Mar 2018 05:07am EST 

March 2 (Reuters) - Abbvie Inc ::BIOGEN AND ABBVIE ANNOUNCE THE VOLUNTARY WORLDWIDE WITHDRAWAL OF MARKETING AUTHORIZATIONS FOR ZINBRYTA® (DACLIZUMAB) FOR RELAPSING MULTIPLE SCLEROSIS.ABBVIE INC - EMA HAS INITIATED AN ARTICLE 20 REFERRAL PROCEDURE FOLLOWING REPORTS OF INFLAMMATORY ENCEPHALITIS AND MENINGOENCEPHALITIS.ABBVIE - ‍BIOGEN WILL CONTINUE TO WORK WITH REGULATORY AUTHORITIES & WITH HEALTHCARE PROVIDERS IN THEIR MANAGEMENT OF ZINBRYTA PATIENTS​.ABBVIE - GIVEN NATURE OF ADVERSE EVENTS REPORTED, CHARACTERIZING PROFILE OF ZINBRYTA TO NOT BE POSSIBLE GOING AHEAD WITH LIMITED PATIENTS BEING TREATED.ABBVIE INC - BIOGEN BELIEVES VOLUNTARY WORLDWIDE WITHDRAWAL OF ZINBRYTA "IS IN BEST INTEREST OF PATIENTS".  Full Article

Abbvie Canada Says ‍Canadians Diagnosed With Advanced Parkinson's Disease Living In Nova Scotia Now Have Public Access To Duodopa​
Thursday, 22 Feb 2018 07:00am EST 

Feb 22 (Reuters) - Abbvie Inc ::ABBVIE CANADA - ‍CANADIANS DIAGNOSED WITH ADVANCED PARKINSON'S DISEASE LIVING IN NOVA SCOTIA NOW HAVE PUBLIC ACCESS TO DUODOPA​.  Full Article

Abbvie Announces Positive Topline Results From Phase 3 Study Evaluating Investigational Elagolix In Women With Uterine Fibroids
Wednesday, 21 Feb 2018 08:00am EST 

Feb 21 (Reuters) - Abbvie Inc ::ABBVIE ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE 3 STUDY EVALUATING INVESTIGATIONAL ELAGOLIX IN WOMEN WITH UTERINE FIBROIDS.PHASE 3 ELARIS UF-I STUDY (M12-815) OF ELAGOLIX MET ITS PRIMARY ENDPOINT.RESULTS DEMONSTRATED ELAGOLIX, IN COMBINATION WITH LOW-DOSE ADD-BACK THERAPY, REDUCED HEAVY MENSTRUAL BLEEDING COMPARED TO PLACEBO.PHASE 3 ELARIS UF-I STUDY ALSO MET ALL RANKED SECONDARY ENDPOINTS (P<0.001) AT MONTH SIX.  Full Article

Voyager Therapeutics And Abbvie Announce Global Strategic Collaboration
Tuesday, 20 Feb 2018 07:00am EST 

Feb 20 (Reuters) - Abbvie Inc ::VOYAGER THERAPEUTICS AND ABBVIE ANNOUNCE GLOBAL STRATEGIC COLLABORATION TO DEVELOP POTENTIAL NEW TREATMENTS FOR ALZHEIMER’S DISEASE AND OTHER TAU-RELATED NEURODEGENERATIVE DISEASES.VOYAGER THERAPEUTICS INC - VOYAGER TO RECEIVE $69 MILLION UPFRONT PAYMENT AND POTENTIALLY UP TO $155 MILLION IN PRECLINICAL AND PHASE 1 OPTION PAYMENTS.VOYAGER THERAPEUTICS - IS ALSO ELIGIBLE TO GET UP TO $895 MILLION IN DEVELOPMENT AND REGULATORY MILESTONES FOR EACH VECTORIZED TAU ANTIBODY COMPOUND.  Full Article

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Germany's Merck seeks partners for cancer and immune system drugs

FRANKFURT Merck KGaA will seek development partners for experimental treatments including tepotinib as the German company looks to licensing deals to help fund clinical trials, according to its head of drug R&D.