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Meridian Bioscience Inc (VIVO.OQ)

VIVO.OQ on NASDAQ Stock Exchange Global Select Market

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21 Jun 2018
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Latest Key Developments (Source: Significant Developments)

FDA Issues Warning Letter To Becton Dickinson & Co
Thursday, 11 Jan 2018 

Jan 11 (Reuters) - U.S. Food and Drug Administration::FDA WARNS BECTON DICKINSON & COMPANY OF SIGNIFICANT VIOLATIONS OF THE LAW AS PART OF ONGOING INVESTIGATION INTO LEAD TESTING ISSUES‍​.U.S. FDA SAYS BECTON DICKINSON'S VIOLATIONS INCLUDE MARKETING MODIFIED VERSIONS OF CERTAIN BD VACUTAINER BLOOD COLLECTION TUBES WITHOUT REQUIRED APPROVAL.FDA SAYS INSPECTION SHOWED BD VIOLATED LAW BY MAKING SIGNIFICANT CHANGE TO SOME OF ITS DEVICES WITHOUT NOTIFYING FDA.‍FDA​ SAYS VIOLATIONS WERE DISCOVERED THROUGH AN INSPECTION OF BECTON DICKINSON ’S NEW JERSEY FACILITY.FDA SAYS BECTON DICKINSON HAS UNTIL FEB 1, 2018 TO NOTIFY FDA ABOUT SPECIFIC STEPS CO HAS TAKEN TO ADDRESS FDA IDENTIFIED VIOLATIONS.FDA - BD DID NOT ADDRESS COMPLAINT OF VARIABILITY IN RESULTS WHEN SOME BD VACUTAINER BLOOD COLLECTION TUBES WERE USED WITH MAGELLAN DIAGNOSTICS’ LEADCARE TEST SYSTEMS.  Full Article

Meridian Bioscience Files For Mixed Shelf Of Up To $100 Million
Wednesday, 29 Nov 2017 

Nov 29 (Reuters) - Meridian Bioscience Inc ::MERIDIAN BIOSCIENCE INC <<>> FILES FOR MIXED SHELF OF UP TO $100 MILLION - SEC FILING.  Full Article

Meridian Bioscience says FDA issued warning letter related to matters at Magellan Diagnostics subsidiary​
Monday, 23 Oct 2017 

Oct 23 (Reuters) - Meridian Bioscience Inc : :Meridian Bioscience Inc - ‍announced that FDA has issued a warning letter related to matters at its Magellan Diagnostics subsidiary​.Meridian Bioscience - ‍since issuance of FDA warning letter, ‍Magellan​ initiated comprehensive quality system remediation activities​.  Full Article

U.S. FDA issues warning letter to Magellan Diagnostics
Monday, 23 Oct 2017 

Oct 23 (Reuters) - ‍U.S. Food and Drug Administration : :‍U.S. Food and Drug Administration says issued a warning letter to Magellan Diagnostics Inc​.‍U.S. FDA - Magellan diagnostics has until Nov. 10, to notify FDA about specific steps co has taken to address violations, to prevent them from recurring​.U.S. FDA says in letter that Magellan marketed significantly modified versions of two of its blood lead testing systems without FDA's required approval​.‍U.S. FDA - Inspection showed Magellan altered two of its blood lead testing systems after they were already FDA cleared.‍U.S. FDA - During inspection investigators observed violations, including failing to submit medical device reports regarding discrepancies in test results​.  Full Article

Meridian bioscience comments on preliminary fiscal 2017 operating results
Thursday, 19 Oct 2017 

Oct 19 (Reuters) - Meridian Bioscience Inc :Meridian Bioscience Inc comments on preliminary fiscal 2017 operating results and provides fiscal 2018 revenue and earnings guidance.Sees FY 2018 GAAP earnings per share $0.59 to $0.62.Sees FY 2017 GAAP earnings per share $0.50 to $0.51.Sees FY 2018 revenue up 3 to 6 percent.Sees FY 2018 revenue $207 million to $212 million.Sees FY 2017 revenue about $200.5 million.Sees FY 2018 non-GAAP earnings per share $0.65 to $0.68.FY2018 earnings per share view $0.68, revenue view $202.4 million -- Thomson Reuters I/B/E/S.FY2017 earnings per share view $0.67, revenue view $198.4 million -- Thomson Reuters I/B/E/S.Meridian Bioscience Inc - expect ‍C.difficile Toxins A/B & GDH test to launch in late fiscal 2018​.Meridian - ‍expect to complete development on H.pylori/Clarithromycin resistance assay during fiscal 2018, enter clinical trials in early 2019​.Meridian Bioscience Inc - ‍expect to launch illumigene CMV late in fiscal 2018​.  Full Article

MERIDIAN BIOSCIENCE APPOINTS JACK KENNY AS CEO
Tuesday, 10 Oct 2017 

Oct 10 (Reuters) - Meridian Bioscience Inc ::MERIDIAN BIOSCIENCE, INC. APPOINTS JACK KENNY AS CHIEF EXECUTIVE OFFICER.SAYS JACK KENNY APPOINTED CEO.‍KENNY HAS ALSO BEEN APPOINTED TO MERIDIAN'S BOARD OF DIRECTORS EFFECTIVE OCTOBER 9, 2017​.A. KRAEUTLER STEPS DOWN AS CEO AND TAKES TITLE OF EXECUTIVE CHAIRMAN​.‍JOHN (JACK) A. KRAEUTLER STEPS DOWN AS CEO​.  Full Article

Meridian Bioscience introduces expansion of its ImmunoCard STAT! product line
Tuesday, 8 Aug 2017 

Aug 8 (Reuters) - Meridian Bioscience Inc : :Meridian Bioscience Inc- ‍Announced expansion of its ImmunoCard Stat! product line with addition of ImmunoCard Stat! FLU A&B​.  Full Article

Meridian Bioscience reports Q3 EPS of $0.21
Thursday, 28 Jul 2016 

Meridian Bioscience Inc : Meridian Bioscience reports third quarter 2016 operating results, declares regular cash dividend, and updates fiscal 2016 guidance . FY 2016 earnings per share view $0.88, revenue view $203.4 million -- Thomson Reuters I/B/E/S . Sees FY 2016 NON-GAAP earnings per share $0.86 to $0.90 . Q3 earnings per share $0.21 . Sees FY 2016 revenue $195 million to $200 million . Q3 earnings per share view $0.22 -- Thomson Reuters I/B/E/S .Q3 revenue $50.7 million versus I/B/E/S view $52.8 million.  Full Article

BRIEF-Meridian Bioscience Reports Q2 GAAP EPS Of $0.12

* MERIDIAN BIOSCIENCE REPORTS SECOND QUARTER 2018 OPERATING RESULTS, DECLARES REGULAR SECOND QUARTER CASH DIVIDEND, AND UPDATES FISCAL 2018 GUIDANCE