Aug 20 (Reuters) - Bayer Ag ::BAYER TO SELL ITS ANIMAL HEALTH BUSINESS UNIT TO ELANCO FOR 7.6 BILLION U.S. DOLLARS.DIVESTMENT IS EXPECTED TO BE CONCLUDED IN MID-2020.BAYER INTENDS TO EXIT ITS STAKE IN ELANCO OVER TIME.
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July 26 (Reuters) - EMA'S HUMAN MEDICINES COMMITTEE (CHMP): :RECOMMENDED GRANTING A CONDITIONAL MARKETING AUTHORISATION FOR BAYER'S VITRAKVI FOR CERTAIN SOLID TUMOURS.ADOPTED A POSITIVE OPINION FOR TROGARZO (IBALIZUMAB), FOR THE TREATMENT OF HIV INFECTION.
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July 26 (Reuters) - Bayer AG ::BAYER RECEIVES POSITIVE CHMP OPINION FOR PRECISION ONCOLOGY TREATMENT LAROTRECTINIB WITH FIRST EVER TUMOR-AGNOSTIC INDICATION IN IN EUROPE.UPON APPROVAL, LAROTRECTINIB WOULD BE THE FIRST THERAPY IN EUROPE WITH A TUMOR-AGNOSTIC INDICATION.FINAL DECISION FROM THE EUROPEAN COMMISSION IS ANTICIPATED WITHIN THE NEXT MONTHS.
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June 21 (Reuters) - BAYER AG ::HAS INITIATED A PHASE III TRIAL OF ITS ANTI-VEGF TREATMENT AFLIBERCEPT FOR INTRAVITREAL INJECTION IN RETINOPATHY OF PREMATURITY (ROP).APPROXIMATELY 100 INFANTS WILL BE ENROLLED IN 34 COUNTRIES.RETINOPATHY OF PREMATURITY IS EYE CONDITION IN PREMATURE INFANTS WHICH CAN LEAD TO IRREVERSIBLE BLINDNESS.
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June 4 (Reuters) - Arvinas Inc ::ARVINAS INC - UNDER TERMS OF BAYER COLLABORATION AGREEMENT, CO WILL RECEIVE UPFRONT PAYMENT OF $17.5 MILLION WITHIN 30 DAYS OF THE EFFECTIVE DATE..ARVINAS INC - ALSO ENTITLED TO RECEIVE UP TO AN ADDITIONAL $12.0 MILLION IN RESEARCH FUNDING PAYMENTS.ARVINAS-ELIGIBLE TO RECEIVE, ON NET SALES OF PROTAC TARGETED PROTEIN DEGRADER-RELATED PRODUCTS, MID-SINGLE DIGIT TO LOW-DOUBLE DIGIT TIERED ROYALTIES.ARVINAS-ALSO ELIGIBLE TO RECEIVE UP TO $197.5 MILLION IN DEVELOPMENT MILESTONES AND UP TO $490.0 MILLION IN SALES-BASED MILESTONES FOR ALL DESIGNATED TARGETS..
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June 4 (Reuters) - BAYER AG ::BAYER AND ARVINAS, INC. TO DEVELOP NOVEL PROTEOLYSIS-TARGETING CHIMERA CANDIDATES FOR HUMANS AND PLANTS.AGREEMENT WORTH MORE THAN USD 110 MILLION.BAYER AND ARVINAS TO LAUNCH JOINT VENTURE TO DEVELOP TARGETED PROTEIN DEGRADERS FOR AGRICULTURE APPLICATIONS.COLLABORATION AGREEMENT AND EQUITY INVESTMENT BY BAYER TO DEVELOP NEXT-GENERATION MEDICINES FOR PATIENTS WITH CARDIOVASCULAR, ONCOLOGICAL AND GYNECOLOGICAL DISEASES.UNDER TERMS OF AGREEMENT, ARVINAS WILL RECEIVE AN UPFRONT PAYMENT AND PHARMACEUTICAL R&D SUPPORT OVER NEXT FOUR YEARS, AS WELL AS A DIRECT EQUITY INVESTMENT.THESE INVESTMENTS COMBINED WILL EXCEED USD 60 MLN.ARVINAS MIGHT ALSO BE ELIGIBLE TO RECEIVE PRE-DEFINED DEVELOPMENT MILESTONES OF OVER USD 685 MLN AND COMMERCIAL ROYALTIES.
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June 4 (Reuters) - Arvinas Inc ::BAYER AND ARVINAS TO COLLABORATE ON HUMAN PROTAC® THERAPIES AND LAUNCH A SEPARATE JOINT VENTURE TO DEVELOP AGRICULTURAL PROTAC® APPLICATIONS.ARVINAS INC - BAYER AND ARVINAS TO LAUNCH A JOINT VENTURE TO DEVELOP TARGETED PROTEIN DEGRADERS FOR AGRICULTURAL APPLICATIONS.ARVINAS INC - $110M+ LIFE SCIENCES DEAL TO DEVELOP NOVEL PROTAC® CANDIDATES.ARVINAS INC - OVERALL SERIES OF ARRANGEMENTS INCLUDES OVER $110 MILLION IN UPFRONT CASH AND COMMITTED FUNDING FOR HUMAN DISEASE COLLABORATION.ARVINAS INC - CLOSING OF THE MULTI-FACETED DEAL WITH BAYER, OTHERS WILL LEAD TO UPDATED FINANCIAL GUIDANCE FOR ARVINAS.ARVINAS INC - BAYER WILL OWN RIGHTS TO NOVEL LEAD STRUCTURES GENERATED IN COLLABORATION.ARVINAS - ALSO ELIGIBLE TO GET DEVELOPMENT MILESTONES OF OVER $685 MILLION & COMMERCIAL ROYALTIES RANGING FROM MID-SINGLE DIGITS TO LOW DOUBLE-DIGITS.ARVINAS INC - ARVINAS WILL RECEIVE AN UPFRONT PAYMENT AND COMMITTED RESEARCH AND DEVELOPMENT FUNDING, AS WELL AS A DIRECT EQUITY INVESTMENT IN ARVINAS.ARVINAS INC - BAYER AND ARVINAS WILL EQUALLY SHARE GOVERNANCE AND EQUITY OWNERSHIP OF JV.ARVINAS - THE JV WILL BE SUPPORTED BY IP & OVER $55 MILLION IN COMMITTED FUNDING FROM BAYER, AND BY TECHNOLOGY AND INTELLECTUAL PROPERTY FROM ARVINAS.
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May 29 (Reuters) - Bayer AG ::BAYER & FOUNDATION MEDICINE ANNOUNCE GLOBAL COLLABORATION TO DEVELOP NEXT-GENERATION SEQUENCING (NGS)-BASED COMPANION DIAGNOSTICS IN ONCOLOGY.BAYER - COLLABORATION WILL START WITH DEVELOPMENT OF A COMPANION DIAGNOSTIC FOR VITRAKVI.BAYER - FINANCIAL TERMS OF AGREEMENT WERE NOT DISCLOSED.
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May 29 (Reuters) - Bayer AG ::BAYER RECEIVES U.S. FDA BREAKTHROUGH THERAPY DESIGNATION FOR ALIQOPA™ (COPANLISIB) FOR THE TREATMENT OF MARGINAL ZONE LYMPHOMA.BAYER-CONDUCTING 2 ADDITIONAL PHASE III STUDIES-CHRONOS-3, CHRONOS-4-TO CONFIRM EFFICACY AND SAFETY OF ALIQOPA IN COMBINATION WITH OTHER THERAPIES IN INHL.
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May 15 (Reuters) - U.S. Food and Drug Administration::U.S. FDA SAYS UPDATED ITS ESSURE WEBSITE TO INCLUDE AN ANALYSIS OF MEDICAL DEVICE REPORTS RECEIVED IN 2018.U.S. FDA - RECEIVED ABOUT 6,000 MEDICAL DEVICE REPORTS IN 2018 RELATED TO ESSURE, DOWN FROM THE NEARLY 12,000 MEDICAL DEVICE REPORTS RECEIVED IN 2017.U.S. FDA - MOST OF THE REPORTS RELATED TO ESSURE RECEIVED BY FDA IN 2018 WERE SUBMITTED BY BAYER AND ARE RELATED TO LITIGATION AGAINST THE COMPANY.U.S. FDA - MOST OF THE REPORTS RELATED TO ESSURE RECEIVED BY FDA IN 2018 MENTION POTENTIAL DEVICE REMOVAL.U.S. FDA - AS OF APRIL 1, 891 PATIENTS HAVE BEEN ENROLLED IN THE POSTMARKET SURVEILLANCE STUDY ON ESSURE THAT FDA ORDERED BAYER TO CONDUCT IN 2016.
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