Fresenius SE & Co KGaA (FREG.DE)

Latest Key Developments (Source: Significant Developments)

Fresenius says rules out meaningful restructuring charges in 2019
Friday, 7 Dec 2018

Dec 7 (Reuters) - Fresenius SE & Co KGaA ::CEO SAYS RULES OUT MEANINGFUL RESTRUCTURING CHARGES IN 2019. Full Article

Fresenius SE & Co Expects Mid-Single Digit Organic Growth In The Medium-Term, After Strong Investment Year 2019
Thursday, 6 Dec 2018

Dec 6 (Reuters) - :DGAP-ADHOC: FRESENIUS SE & CO. KGAA: FRESENIUS EXPECTS MID-SINGLE DIGIT ORGANIC GROWTH IN THE MEDIUM-TERM, AFTER STRONG INVESTMENT YEAR 2019.GIVEN ITS CURRENT EXPECTATIONS FOR FY 2018 AND FY 2019, FRESENIUS NOW BELIEVES ITS AMBITIOUS GROUP TARGETS FOR 2020 WILL NOT BE MET.FROM 2020 ONWARDS, FRESENIUS NOW EXPECTS SUSTAINABLE ORGANIC GROUP SALES GROWTH IN MID-SINGLE DIGITS.FRESENIUS EXPECTS MID-SINGLE DIGIT ORGANIC SALES GROWTH FOR FY 2019.FY 2019 GROUP NET INCOME IS EXPECTED TO BE BROADLY STABLE OVER FY 2018.FROM 2020 ONWARDS GROUP NET INCOME IS EXPECTED TO GROW ORGANICALLY SLIGHTLY FASTER THAN SALES.UPON FRESENIUS KABI'S BIOSIMILARS BUSINESS BREAKING EVEN, FRESENIUS EXPECTS AN ACCELERATION OF GROUP EARNINGS GROWTH. Full Article

Fresenius Kabi USA Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9%
Tuesday, 20 Nov 2018

Nov 20 (Reuters) - Fresenius Kabi USA::FRESENIUS KABI ISSUES VOLUNTARY NATIONWIDE RECALL OF SODIUM CHLORIDE INJECTION, USP, 0.9% DUE TO PRODUCT LABELING INCORRECTLY STATING STOPPERS DO NOT CONTAIN LATEX.FRESENIUS KABI USA SAYS VOLUNTARILY RECALLING 163 LOTS OF SODIUM CHLORIDE INJECTION, USP, 0.9% 10 ML FILL IN A 10 ML VIAL & 20 ML FILL IN A 20 ML VIAL.FRESENIUS KABI USA SAYS TO DATE, CO HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO RECALL OF SODIUM CHLORIDE INJECTION, USP, 0.9%. Full Article

Fresenius Kabi Introduces Leukemia Drug Arsenic Trioxide Injection In 10 mg per 10 mL Vial
Friday, 26 Oct 2018

Oct 26 (Reuters) - Fresenius Kabi::FRESENIUS KABI SAYS ANNOUNCES IMMEDIATE AVAILABILITY IN U.S. OF ARSENIC TRIOXIDE INJECTION IN A 10 MG PER 10 ML VIAL PRESENTATION.FRESENIUS KABI SAYS ARSENIC TRIOXIDE INJECTION IS FIRST-TO-MARKET GENERIC OF TRISENOX INDICATED FOR RELAPSED/REFRACTORY ACUTE PROMYELOCYTIC LEUKEMIA. Full Article

Fresenius Says Simplist Palonosetron Hydrochloride Injection Available In The U.S
Monday, 22 Oct 2018

Oct 22 (Reuters) - Fresenius SE & Co KGaA ::FRESENIUS KABI SAYS ANNOUNCED IMMEDIATE AVAILABILITY IN UNITED STATES OF SIMPLIST PALONOSETRON HYDROCHLORIDE INJECTION. Full Article

Akorn Appeals Fresenius Kabi Ruling
Thursday, 18 Oct 2018

Oct 18 (Reuters) - Akorn Inc ::AKORN APPEALS FRESENIUS KABI RULING.HAS ALSO FILED A MOTION SEEKING EXPEDITED PROCEEDINGS IN ITS APPEAL."DISAGREES WITH OPINION ISSUED OCTOBER 1 BY COURT OF CHANCERY". Full Article

Abbvie Announces Resolution Of Humira Patent Disputes With Fresenius Kabi
Thursday, 18 Oct 2018

Oct 18 (Reuters) - AbbVie Inc ::ABBVIE ANNOUNCES GLOBAL RESOLUTION OF HUMIRA (ADALIMUMAB) PATENT DISPUTES WITH FRESENIUS KABI.ABBVIE INC - AGREEMENTS PROVIDE NON-EXCLUSIVE LICENSE TO FRESENIUS KABI FOR HUMIRA-RELATED INTELLECTUAL PROPERTY IN U.S. EFFECTIVE SEPTEMBER 30, 2023.ABBVIE INC - FRESENIUS KABI ACKNOWLEDGES VALIDITY OF ABBVIE'S INTELLECTUAL PROPERTY FOR HUMIRA.ABBVIE INC - PRECISE TERMS ARE CONFIDENTIAL BETWEEN PARTIES.ABBVIE INC - ALL LITIGATION PENDING BETWEEN PARTIES WILL BE DISMISSED. Full Article

Fresenius Kabi Biosimilar Candidate Meets Primary Endpoints In Two Studies
Tuesday, 9 Oct 2018

Oct 9 (Reuters) - Fresenius SE & Co KGaA ::FRESENIUS KABI BIOSIMILAR CANDIDATE MEETS PRIMARY ENDPOINTS IN THE TWO PIVOTAL CLINICAL STUDIES.FRESENIUS KABI HAS REACHED A MILESTONE ON THE ROAD TO APPROVAL FOR ANOTHER BIOSIMILAR.MSB11455, A BIOSIMILAR CANDIDATE FOR NEULASTA® (PEGFILGRASTIM), HAS MET ITS PRIMARY ENDPOINTS IN THE TWO PIVOTAL CLINICAL STUDIES. Full Article

Akorn Comments On Delaware Chancery Court Ruling
Monday, 1 Oct 2018

Oct 1 (Reuters) - Akorn Inc ::AKORN COMMENTS ON DELAWARE CHANCERY COURT RULING.AKORN INC - "CONTINUE TO BELIEVE FRESENIUS' ATTEMPT TO TERMINATE TRANSACTION IS IN BREACH OF OUR BINDING MERGER AGREEMENT".AKORN INC - "INTEND TO APPEAL, IN AN EFFORT TO VIGOROUSLY ENFORCE OUR RIGHTS". Full Article

Fresenius CEO Expects Akorn Matter To Be Resolved By Early 2019
Tuesday, 31 Jul 2018

July 31 (Reuters) - Fresenius Se ::CEO SAYS ARE CONVINCED OF MERITS OF CASE TO TERMINATE AKORN DEAL.CEO SAYS EVEN IF COURT DOES NOT AGREE IT WAS THE RIGHT DECISION TO TERMINATE DEAL.CEO SAYS EXPECTS AKORN MATTER TO BE FINALLY RESOLVED BY EARLY NEXT YEAR.CFO SAYS LESS LIKELY TO REACH UPPER END OF 2018 SALES GUIDANCE OF 5-8 PERCENT.CEO SAYS IF WE ARE FORCED TO CLOSE AKORN DEAL, WILL NEED TO DO SOME PRETTY SUBSTANTIAL REMEDIATION REGARDLESS OF HOW FDA RESPONDS. Full Article

Fresenius SE & Co KGaA News

Will Europe's clampdown on faulty medical devices hurt patients?

BERLIN When a Californian company founded by a U.S. veteran wounded in Afghanistan sought to register a new medical device this year, it turned to Europe before the United States. The European approvals system had long been quicker, the company said, but the introduction of new rules is changing all that.

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