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News Breaks
June 18, 2014
04:55 EDTJNJ, JNJ, JNJ, MDT, MDT, MDTElsevier Business Intelligence to hold a conference
IN3 Medial Device 360 to be held in Boston on June 18-20.
News For JNJ;MDT From The Last 14 Days
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July 1, 2015
16:33 EDTJNJGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gileadís emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naÔve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDAís acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gileadís Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.
June 29, 2015
18:13 EDTMDTMedtronic says AHA/ASA recommends stent retriever technology
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June 25, 2015
11:03 EDTMDTMedtronic announces U.S. launch of Advisa SR MRI SureScan pacing system
Medtronic announced the U.S. FDA approval and commercial launch of the Advisa SR MRI SureScan single-chamber pacemaker with the 5076 MRI lead, which allows for magnetic resonance imaging scans positioned on any region of the body without restrictions. The new system includes the Advisa SR MRI pacemaker and a SureScan lead, which must be used together to be considered MR- conditional.
09:23 EDTMDTMedtronic announces resignation of Christopher O'Connell
Medtronic (MDT) announced in a regulatory filing that Christopher J. OíConnell is resigning as the companyís EVP and President, Restorative Therapies Group. The company also announced the appointment of Geoff Martha as the companyís EVP and President, Restorative Therapies Group, effective immediately. The Fly notes that Waters (WAT) this morning named O'Connell as its new president, CEO and member of its Board of Directors, effective in September.
09:15 EDTMDTWaters names Christopher O'Connell as CEO, effective in September
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June 23, 2015
17:03 EDTMDTMedtronic implements voluntary recall for certain lots of Covidien Shiley tubes
Medtronic announced that on May 8, it began notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012. The company initiated the field action following a small number of customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels immediately upon tube placement or discomfort. Replacement of the tracheostomy tube with product manufactured prior to November 29, 2012 addressed the patient breathing difficulty or discomfort. The notification requested all customers and distributors to quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit. Medtronic also took the necessary steps to prevent future shipments of the recalled products. The company also notified regulatory agencies around the world, as appropriate. Since November 29, 2012, Shiley tracheostomy tubes were shipped into Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the United States of America.
11:20 EDTMDTMedtronic competitive with Edwards after approval, says Wells Fargo
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09:22 EDTMDTMedtronic announces FDA approval for new TAVR system
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07:25 EDTMDTPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
June 21, 2015
12:42 EDTMDTMedtronic reports five-year follow-up results for Endurant AAA stent graft
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June 19, 2015
17:02 EDTMDTMedtronic acquires Aptus Endosystems for $110M
Medtronic announced it has acquired the assets of Aptus Endosystems, a Sunnyvale, Calif. based, privately held medical device company focused on developing advanced technology for endovascular aneurysm repair and thoracic endovascular aneurysm repair. Medtronic completed its acquisition of the assets of Aptus Endosystems in a transaction valued at approximately $110M. Additional terms of the acquisition were not disclosed.
09:23 EDTMDTMedtronic acquires CardioInsight Technologies
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09:21 EDTMDTMedtronic approves repurchase of addition 80M shares
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09:20 EDTMDTMedtronic raises quarterly dividend by 25% to 38c per share
The board of Medtronic approved a 25% increase in its cash dividend for FY16, raising the quarterly amount to 38c per ordinary share for an annual amount of $1.52 per ordinary share. The dividend is payable on July 17, to shareholders of record at the close of business on June 29.
June 17, 2015
07:21 EDTJNJGeneric ADHD drugs still sold despite FDA non-equivalance finding, NYT reports
The FDA announced last November that two generic versions of Johnson & Johnson's (JNJ) Concerta ADHD drug, one made by Mallinckrodt (MNK) and the other by UCB, could no longer be considered the equivalent of the branded drug after tests and analyses suggested that their effectiveness began to wear off much more quickly, but the drugs are still being sold despite an FDA mandated deadline having passed for the companies to either prove the drugs were equivalent or remove them from the market, said The New York Times. The report noted a third generic product, sold by Actavis (AGN), was found to be equivalent to the branded Concerta. Reference Link

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