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Bayer AG (BAYGn.DE)

BAYGn.DE on Xetra

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Latest Key Developments (Source: Significant Developments)

Orion's And Bayer's Darolutamide Shows Substantial Efficacy And Favourable Safety Profile In Treatment Of Prostate Cancer In Aramis Trial
Thursday, 14 Feb 2019 

Feb 14 (Reuters) - Orion Oyj ::ORION'S AND BAYER'S DAROLUTAMIDE SHOWS SUBSTANTIAL EFFICACY AND A FAVOURABLE SAFETY PROFILE IN THE TREATMENT OF PROSTATE CANCER IN THE ARAMIS TRIAL.POSITIVE TREND IN OVERALL SURVIVAL WITH A 29% REDUCTION IN RISK OF DEATH AT INTERIM ANALYSIS OF DAROLUTAMIDE IN ARAMIS TRIAL.POSITIVE TREND IN OVERALL SURVIVAL WAS AOBSERVED, ALL OTHER SECONDARY ENDPOINTS DEMONSTRATED BENEFIT IN FAVOR OF DAROLUTAMIDE.  Full Article

Bayer Forms Research Alliance With Kyoto University
Thursday, 31 Jan 2019 

Jan 31 (Reuters) - Bayer AG ::BAYER AND KYOTO UNIVERSITY FORM RESEARCH ALLIANCE TO DISCOVER NEW TREATMENT APPROACHES AGAINST LUNG DISEASES (REMOVES REDUNDANT WORDS).GOAL OF RESEARCH ALLIANCE IS TO IDENTIFY SPECIFIC TARGETS AND PATHWAYS THAT ARE CAUSING DISEASE AND TO DISCOVER NEW TREATMENTS TO MODULATE THESE PATHWAYS AND PREVENT FURTHER LUNG FUNCTION DECLINE.  Full Article

Petiq Inc Announces Amicable Legal Resolution
Tuesday, 22 Jan 2019 

Jan 22 (Reuters) - PetIQ Inc ::PETIQ, INC. ANNOUNCES AMICABLE LEGAL RESOLUTION.PETIQ INC - BAYER HEALTHCARE & CO'S SUPPLIER OF ADVECTA3 AND PETLOCK MAX HAVE RESOLVED BAYER'S PATENT INFRINGEMENT COMPLAINT REGARDING PRODUCTS.PETIQ INC - PETIQ TO CONTINUE OFFERING CUSTOMERS ITS ADVECTA3 AND PETLOCK MAX FORMULATIONS.  Full Article

Bayer Sees No Impact Of Lilly Deal On Own Partnership With Loxo
Monday, 7 Jan 2019 

Jan 7 (Reuters) - Bayer says on Loxo, Lilly deal::We can't comment on M&A activities of other companies.We don't see an impact to our contract with Loxo Oncology for the time being.  Full Article

FDA Provides New Steps To Revise Bayer's Postmarket Surveillance Study On Essure Device
Thursday, 20 Dec 2018 

Dec 20 (Reuters) - U.S. Food and Drug Administration::FDA SAYS ANNOUNCES NEW STEPS TO STRENGTHEN LONG-TERM SAFETY OVERSIGHT OF ESSURE DEVICE FOLLOWING DISCONTINUATION OF ITS U.S. SALES.FDA SAYS PROVIDING AN UPDATE ON NEW STEPS TO REVISE AND STRENGTHEN BAYER'S POSTMARKET STUDY ON ESSURE DEVICE .FDA SAYS REGULATORY ACTIONS INCLUDES ITS DECISION TO TAKE STEP OF MAKING ESSURE A RESTRICTED DEVICE.FDA SAYS AS PART OF REVISED PROTOCOL FOR BAYER'S POSTMARKET SURVEILLANCE STUDY ON ESSURE, WOMEN IN STUDY WILL NOW BE FOLLOWED FOR 5 YEARS.FDA - AS PART OF REVISED PROTOCOL IT HAS WORKED WITH BAYER TO SEE THAT MANUFACTURER IMPLEMENTS SEVERAL APPROVED MODIFICATIONS TO POSTMARKET STUDY.FDA SAYS REQUIRING ADDITIONAL BLOOD TESTING OF PATIENTS ENROLLED IN FOLLOW-UP VISITS DURING BAYER'S POSTMARKET SURVEILLANCE STUDY ON ESSURE.FDA - REQUIRING BAYER TO CONTINUE TO ENROLL PATIENTS WHO MIGHT STILL OPT TO RECEIVE ESSURE IN ADVANCE OF ITS FULL DISCONTINUATION FROM U.S. MARKET.FDA - ALSO REQUIRING BAYER TO CONTINUE TO SUBMIT MORE FREQUENT REPORTS TO FDA ON ESSURE POSTMARKET STUDY'S PROGRESS AND RESULTS.FDA SAYS RECOGNIZES THAT BAYER IS HAVING CHALLENGES REACHING ESSURE POSTMARKET SURVEILLANCE STUDY'S INITIAL SAMPLE SIZE.  Full Article

Bayer Statement On Updated Protocol For Postmarket Essure Study
Thursday, 20 Dec 2018 

Dec 20 (Reuters) - Bayer AG ::BAYER STATEMENT ON UPDATED PROTOCOL FOR POSTMARKET ESSURE STUDY.BAYER SAYS "WE ARE COMMITTED TO THE POSTMARKET STUDY FOR ESSURE".BAYER AG - "BENEFIT-RISK PROFILE OF ESSURE HAS NOT CHANGED".BAYER SAYS "CONTINUES TO STAND BEHIND" ESSURE PRODUCT'S SAFETY AND EFFICACY .  Full Article

Bayer Receives Approval In China For Endometriosis Treatment Visanne
Thursday, 20 Dec 2018 

Dec 20 (Reuters) - Bayer AG ::RECEIVES APPROVAL IN CHINA FOR ENDOMETRIOSIS TREATMENT VISANNE™.  Full Article

Bayer Updates Betaseron Prescribing Information
Monday, 17 Dec 2018 

Dec 17 (Reuters) - Bayer AG ::BAYER UPDATES BETASERON (INTERFERON BETA-1B) PRESCRIBING INFORMATION IN ACCORDANCE WITH THE U.S. FOOD AND DRUG ADMINISTRATION'S PREGNANCY AND LACTATION LABELING RULE.FDA HAS APPROVED INCLUSION OF NEW SAFETY DATA ON PREGNANCY IN PRESCRIBING INFORMATION FOR BETASERON.BETASERON IS INDICATED FOR TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS.  Full Article

German Chemicals Association Sees 2019 Sales Rising By 2.5 Pct
Tuesday, 4 Dec 2018 

Dec 4 (Reuters) - German chemicals association VCI::SEES 2019 SALES +2.5 PERCENT, PRICES +1.0 PERCENT, PRODUCTION +1.5 PERCENT.SEES 2018 PRODUCTION +2.5 PERCENT (VERSUS PREVIOUS F'CAST OF +3.5 PERCENT), PRICES +2.0 PERCENT (VERSUS PREVIOUS F'CAST +1.5 PERCENT), SALES STILL AT +4.5 PERCENT.  Full Article

Bayer: FDA Grants Breakthrough Device Designation To AI Software For CTEPH Pattern Recognition
Monday, 3 Dec 2018 

Dec 3 (Reuters) - Bayer AG ::FDA GRANTS BREAKTHROUGH DEVICE DESIGNATION TO ARTIFICIAL INTELLIGENCE SOFTWARE FOR CTEPH PATTERN RECOGNITION FROM BAYER AND MSD.  Full Article

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Bayer gains full Vitrakvi rights from Eli Lilly's Loxo

FRANKFURT German drugmaker Bayer took full control of Vitrakvi, a drug used against a variety of cancers driven by a rare genetic mutation, in a deal with from Eli Lilly's Loxo Oncology.