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Bayer AG (BAYGn.DE)

BAYGn.DE on Xetra

98.51EUR
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€100.08
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Latest Key Developments (Source: Significant Developments)

Bayer Says U.S. FDA Accepts Larotrectinib New Drug Application
Tuesday, 29 May 2018 06:49am EDT 

May 29 (Reuters) - Bayer ::SAYS U.S. FDA ACCEPTS LAROTRECTINIB NEW DRUG APPLICATION AND GRANTS PRIORITY REVIEW.SAYS U.S. FDA GRANTED PRIORITY REVIEW FOR LAROTRECTINIB FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS.  Full Article

FDA Accepts Larotrectinib New Drug Application And Grants Priority Review
Tuesday, 29 May 2018 06:45am EDT 

May 29 (Reuters) - Loxo Oncology Inc ::FDA ACCEPTS LAROTRECTINIB NEW DRUG APPLICATION AND GRANTS PRIORITY REVIEW.LOXO ONCOLOGY INC - PDUFA DATE SET FOR NOVEMBER 26, 2018 FOR LAROTRECTINIB.LOXO ONCOLOGY INC - LAROTRECTINIB HAS ALSO BEEN GRANTED BREAKTHROUGH THERAPY DESIGNATION.LOXO ONCOLOGY INC - BAYER PLANS TO SUBMIT A MARKETING AUTHORIZATION APPLICATION (MAA) IN EUROPEAN UNION IN 2018.  Full Article

FDA Says Making List Of Cos Blocking Access To Samples Of Branded Products
Thursday, 17 May 2018 10:30am EDT 

May 17 (Reuters) - FDA::FDA COMMISSIONER SCOTT GOTTLIEB SAYS MAKING PUBLIC LIST OF COS THAT HAVE POTENTIALLY BEEN BLOCKING ACCESS TO THE SAMPLES OF THEIR BRANDED PRODUCTS.FDA'S GOTTLIEB - ALSO NOTIFYING FEDERAL TRADE COMMISSION ABOUT INQUIRIES RECEIVED FROM GENERIC DRUG DEVELOPERS.FDA'S GOTTLIEB - FDA WILL DETERMINE WHETHER THE PRODUCTS HAVE IN PLACE RISK EVALUATION & MITIGATION STRATEGY PROGRAM WITH ETASU THAT MAY IMPACT DISTRIBUTION.FDA'S GOTTLIEB SAYS IN MANY CASES, WE FIND THAT THERE’S NO SUCH REMS PROGRAM IN PLACE.FDA'S GOTTLIEB - COS FOR WHICH INQUIRIES HAVE BEEN RECEIVED INCLUDE NOVARTIS PHARMA, ACTELION PHARMA, VALEANT, SMITHKLINE BEECHAM, GILEAD, CELGENE.FDA'S GOTTLIEB - COS FOR WHICH INQUIRIES HAVE BEEN RECEIVED INCLUDE BIOGEN IDEC, INSYS THERAPEUTICS, LUNDBECK LLC, HYPERION THERAPEUTICS, VIVUS INC.FDA'S GOTTLIEB - COS FOR WHICH INQUIRIES HAVE BEEN RECEIVED INCLUDE PFIZER PHARMACEUTICALS PRODUCTION, SWEDISH ORPHAN BIOVITRUM, MEDA PHARMA.FDA'S GOTTLIEB - COS FOR WHICH INQUIRIES HAVE BEEN RECEIVED INCLUDE DANCO LABORATORIES, ROXANE LABORATORIES, CORCEPT THERAPEUTICS, AEGERION PHARMA.FDA'S GOTTLIEB - COS FOR WHICH INQUIRIES HAVE BEEN RECEIVED INCLUDE PHARMACIA AND UPJOHN CO, QUESTCOR PHARMACEUTICALS, BOEHRINGER INGELHEIM, NPS PHARMA.FDA'S GOTTLIEB - COS FOR WHICH INQUIRIES HAVE BEEN RECEIVED INCLUDE SHIRE ORPHAN THERAPIES, APOPHARMA, CEPHALON INC, JAZZ PHARMA, CUBIST PHARMA.  Full Article

Bayer Receives Approval For Eylea In China
Friday, 11 May 2018 02:02am EDT 

May 11 (Reuters) - Bayer AG ::SAYS RECEIVES APPROVAL FOR EYLEA IN CHINA.EYLEA GAINS APPROVAL IN CHINA FOR TREATMENT OF VISUAL IMPAIRMENT DUE TO NEOVASCULAR (WET) AGE-RELATED MACULAR DEGENERATION.  Full Article

Bayer Announces Executive Leadership Team For New Crop Science Division
Monday, 7 May 2018 08:35am EDT 

May 7 (Reuters) - BAYER AG ::ANNOUNCES EXECUTIVE LEADERSHIP TEAM FOR NEW CROP SCIENCE DIVISION.NEW EXECUTIVE LEADERSHIP TEAM WILL BE LED BY LIAM CONDON.  Full Article

U.S. DoJ To Allow Bayer's Acquisition Of Monsanto After Companies Make Concessions - WSJ
Monday, 9 Apr 2018 01:59pm EDT 

April 9 (Reuters) - :U.S. JUSTICE DEPARTMENT TO ALLOW BAYER'S ACQUISITION OF MONSANTO AFTER COMPANIES MAKE CONCESSIONS - WSJ, CITING SOURCES.  Full Article

U.S. FDA Continues To Monitor Adverse Events Connected With Essure
Wednesday, 7 Mar 2018 02:44pm EST 

March 7 (Reuters) - U.S. Food And Drug Administration::U.S. FDA SAYS AT CURRENT TIME, IS ACTIVELY EVALUATING A COLLECTION OF NEW MEDICAL DEVICE REPORTS SUBMITTED TO FDA ON ESSURE DEVICE.U.S FDA SAYS OF THE NEARLY 12,000 REPORTS RECEIVED IN 2017 FOR ESSURE, THE MAJORITY WERE SENT TO FDA IN LAST QUARTER OF THE YEAR.U.S. FDA SAYS CONTINUES TO BELIEVE THAT ESSURE MAY BE APPROPRIATE FOR SOME WOMEN BASED ON FDA'S CURRENT INFORMATION.U.S. FDA SAYS ALSO RECOGNIZES THAT "SERIOUS PROBLEMS" HAVE BEEN ASSOCIATED WITH USE OF ESSURE.U.S. FDA SAYS CONTINUING TO MONITOR ADVERSE EVENTS CONNECTED WITH ESSURE REPORTED TO FDA'S DATABASE, AS WELL AS OTHER DATA SOURCES.  Full Article

Bayer Says Antitrust Procedure More Advanced in EU Than in U.S.
Wednesday, 28 Feb 2018 06:29am EST 

Feb 28 (Reuters) - Bayer ::CFO SAYS MONSANTNO DEAL VALUE INCLUDING DEBT NOW $62.5 BILLION VERSUS $63.5 PREVIOUSLY.CFO SAYS CAPITAL INCREASE COULD BE CARRIED OUT BEFORE MONSANTO DEAL CLOSING BUT WILL NEED SUFFICIENT CERTAINTY THAT DEAL WILL CLOSE.CEO SAYS BIG INTEREST FROM POTENTIAL BUYERS IN VEGETABLE SEED BUSINESS, FROM SEED COMPANIES AND FROM FINANCIAL INVESTORS.EXEC CONDON SAYS OFFERING TO SELL MORE OR LESS BAYER'S ENTIRE SEED BUSINESS TO WIN ANTITRUST APPRPOVAL.EXEC WEINAND SAYS WILL CONTINUE TO AUGMENT DRUGS PIPELINE WITH EXTERNAL OPPORTUNITIES.CEO SAYS ANTITRUST PROCEDURE MORE ADVANCED IN EUROPE THAN IN THE U.S. BUT ARE CONFIDENT THAT WE WILL MAKE FURTHER PROGRESS THERE OVER THE NEXT FEW WEEKS.  Full Article

Bayer Proposes Increased Dividend For 2017 Of EUR 2.80/Shr
Tuesday, 27 Feb 2018 07:32am EST 

Feb 27 (Reuters) - Bayer AG ::PROPOSES INCREASED DIVIDEND FOR 2017 OF 2.80 EUROS PER SHARE.  Full Article

Monsanto Paid $2.5 Million In Cash For CEO
Friday, 16 Feb 2018 05:12pm EST 

Feb 16 (Reuters) - Bayer Ag ::MONSANTO - SPECIAL AWARDS WERE PAID IN CASH ON FEB 13, IN AMOUNT OF $2.5 MILLION FOR CHAIRMAN & CEO AND $250,000 FOR OTHER NAMED EXECUTIVE OFFICERS.  Full Article

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With deal to close this week, Bayer to retire Monsanto name

FRANKFURT Germany's Bayer will wrap up the $63 billion takeover of Monsanto on Thursday and also retire the U.S. seeds maker's 117 year-old name. | Video