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Meridian Bioscience Inc (VIVO.OQ)

VIVO.OQ on NASDAQ Stock Exchange Global Select Market

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15 Dec 2017
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Latest Key Developments (Source: Significant Developments)

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

Meridian Bioscience comments on FDA statement concerning inspection of Magellan diagnostics
Thursday, 13 Jul 2017 01:38pm EDT 

July 13 (Reuters) - Meridian Bioscience Inc ::Meridian Bioscience comments on recent FDA press statement.Meridian Bioscience Inc- ‍Consistent with FDA policy, Magellan will promptly submit responses to form FDA-483 for agency's consideration​.Meridian Bioscience - Providing comments regarding FDA statement concerning posting of form FDA-483 issued following inspection of Magellan diagnostics.  Full Article

U.S. FDA releases statement from Alberto Gutierrez on status of FDA’s investigation into inaccurate results from certain lead tests‍​
Thursday, 13 Jul 2017 11:22am EDT 

July 13 (Reuters) - U.S. FDA::Statement from Alberto Gutierrez on status of FDA’s investigation into inaccurate results from certain lead tests‍​.Says as part of investigation, we inspected Magellan Diagnostics’ facility in North Billerica, Massachusetts.Says design validation for Magellan Diagnostics’ leadcare test systems did not ensure device conforms to defined user needs and intended uses‍​.Report regarding leadcare test systems device correction, removal actions was not sent to FDA within 10 days of initiating correction or removal.Says the design change implemented by Magellan Diagnostics to increase incubation time is inadequate.MDR report was not submitted within 30 days of receiving information that suggests that marketed device has malfunctioned.Reviewing evidence from Magellan Diagnostics’ facility inspection to determine if there have been violations of federal law.  Full Article

Meridian Bioscience comments on FDA matters related to Magellan Diagnostics
Friday, 30 Jun 2017 12:02pm EDT 

June 30 (Reuters) - Meridian Bioscience Inc ::Meridian Bioscience comments on recent FDA matters related to Magellan Diagnostics.Meridian Bioscience Inc says FDA concluded an inspection of Magellan's quality system on June 29, 2017.Meridian Bioscience Inc - Magellan is committed to addressing FDA investigators' observations..  Full Article

BRIEF-Co-Diagnostics Announces Sale Of Molecular Diagnostic Tests

* CO-DIAGNOSTICS, INC. ANNOUNCES SALE OF MOLECULAR DIAGNOSTIC TESTS, INCLUDING ZIKA VIRUS, TO MAJOR CARIBBEAN LABORATORY Source text for Eikon: Further company coverage: