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Meridian Bioscience Inc (VIVO.OQ)

VIVO.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

FDA Continues To Recommend Magellan Lead Tests Not Be Used With Samples Taken From Vein
Thursday, 22 Mar 2018 03:26pm EDT 

March 22 (Reuters) - U.S. FDA ::U.S FDA PROVIDES STATEMENT ON FINDINGS FROM ONGOING INVESTIGATION INTO LEAD TESTING ISSUES.U.S. FDA-CONCLUDED THAT STUDIES PERFORMED BY BD WERE ROBUST & SHOWED THERE WAS SIGNIFICANT CHANCE OF FALSE RESULTS WITH MAGELLAN’S LEADCARE TESTS ‍​.U.S FDA SAYS CONTINUES TO RECOMMEND THAT MAGELLAN LEAD TESTS NOT BE USED WITH BLOOD SAMPLES TAKEN FROM THE VEIN.U.S FDA SAYS MAGELLAN’S LEAD TEST SYSTEMS CAN CONTINUE TO BE USED WITH BLOOD SAMPLES FROM A FINGER OR HEEL STICK.AT FDA'S REQUEST, BD IS CONDUCTING TESTING TO DETERMINE IF LAB TESTS OTHER THAN MAGELLAN LEAD TESTS ARE AFFECTED BY THIURAM INTERFERENCE​‍​.  Full Article

Meridian Bioscience Reports Q1 GAAP EPS Of $0.15
Thursday, 25 Jan 2018 07:15am EST 

Jan 25 (Reuters) - Meridian Bioscience Inc ::MERIDIAN BIOSCIENCE REPORTS FIRST QUARTER 2018 OPERATING RESULTS, DECLARES REGULAR FIRST QUARTER CASH DIVIDEND, AND REAFFIRMS FISCAL 2018 GUIDANCE.Q1 NON-GAAP EARNINGS PER SHARE $0.15.Q1 GAAP EARNINGS PER SHARE $0.15.Q1 REVENUE $52.3 MILLION VERSUS I/B/E/S VIEW $49 MILLION.Q1 EARNINGS PER SHARE VIEW $0.15 -- THOMSON REUTERS I/B/E/S.REAFFIRMS FY 2018 NON-GAAP EARNINGS PER SHARE VIEW $0.65 TO $0.68.REAFFIRMS FY 2018 GAAP EARNINGS PER SHARE VIEW $0.59 TO $0.62.SEES FY 2018 REVENUE $207 MILLION TO $212 MILLION.‍CONTINUING TO WORK WITH FDA REGARDING USE OF VENOUS BLOOD WITH MAGELLAN'S LEADCARE TESTING SYSTEMS​.‍MAGELLAN LEAD TESTING BUSINESS UNIT REVENUES DECLINED BY 20% IN QUARTER YEAR-OVER-YEAR​.‍ANTICIPATE A REBOUND IN MAGELLAN BUSINESS IN Q2 AND A RETURN TO GROWTH FOR QUARTER​.‍ILLUMIGENE CMV, FIRST MOLECULAR TEST FOR CYTOMEGALOVIRUS, IS TARGETED TO LAUNCH LATE IN CALENDAR YEAR 2018​.‍BUSINESS OUTLOOK FOR FISCAL 2018 REMAINS UNCHANGED​.FY2018 EARNINGS PER SHARE VIEW $0.66, REVENUE VIEW $207.1 MILLION -- THOMSON REUTERS I/B/E/S.  Full Article

FDA Issues Warning Letter To Becton Dickinson & Co
Thursday, 11 Jan 2018 01:25pm EST 

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 09:39am EST 

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 05:30pm EDT 

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 01:43pm EDT 

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 07:30am EDT 

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 11:50am EDT 

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

FDA provides update on its investigation into inaccurate results from certain lead tests‍​
Thursday, 17 Aug 2017 06:03pm EDT 

Aug 17 (Reuters) - U.S. Food and Drug Administration-:U.S. FDA provides update on its investigation into inaccurate results from certain lead tests‍​.U.S. FDA - conducted an inspection of Becton Dickinson & Company, the manufacturer of certain blood collection tubes used alongside these tests‍​.‍U.S. FDA-Report issued at conclusion of inspection of BD’s Franklin Lakes, New Jersey facility includes observations that may be violations of federal law​.u.s. fda - at this time, not determined that Becton Dickinson tubes,any other brand of tube linked to cause of the inaccurate lead test results‍​.U.S. FDA-Reviewing evidence collected from inspection of BD’s facility to decide if there were violations of federal law & if further action is warranted.FDA-Conducted inspection of becton dickinson‍​ facility to understand what caused inaccurate results associated with magellan diagnostics’ leadcare tests.  Full Article

Meridian Bioscience Q3 gaap earnings per share $0.01
Thursday, 27 Jul 2017 07:45am EDT 

July 27 (Reuters) - Meridian Bioscience Inc ::Meridian Bioscience reports third fiscal quarter 2017 operating results, including non-cash goodwill impairment charge, declares regular cash dividend, and reaffirms fiscal 2017 guidance excluding the effect of goodwill impairment charge.Sees FY 2017 earnings per share $0.64 to $0.69 excluding items.Q3 gaap earnings per share $0.01.Sees FY 2017 revenue $193 million to $199 million.Q3 earnings per share view $0.17 -- Thomson Reuters I/B/E/S.FY 2017 earnings per share view $0.68, revenue view $197.5 million -- Thomson Reuters I/B/E/S.Meridian Bioscience Inc - recording of a non-cash goodwill impairment charge of $6.6 million, on both a pre-tax and after-tax basis, in Q3 of fiscal 2017.Qtrly net revenues $50.1 million versus $50.7 million.Q3 revenue view $49.1 million -- Thomson Reuters I/B/E/S.Meridian Bioscience Inc - "we do not anticipate, at this time, any further goodwill impairment charge from Magellan acquisition".  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