Medtronic’s Pipeline Flex problems expand

The FDA today issued a notice confirming a Class I recall of the Pipeline Flex embolization device from Medtronic (NYSE:MDT).

Several models of the Pipeline Flex embolization device and Pipeline Flex embolization device with Shield Technology were affected, with 8,825 devices recalled in the U.S., having been distributed between April 18, 2019, and Aug. 13, 2020.

According to an FDA release, Medtronic initiated the recall on July 13, 2021. There have been 59 reported device malfunctions, 10 serious injuries and two deaths related to the recall.

The company recalled the devices due to a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is in use to place, retrieve or move the stent inside a patient. Fractured pieces could stay inside the patient’s brain bloodstream, while there is the possibility that attempts to retrieve the fractured pieces may worsen the patient’s condition. The fragments can als…

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FDA approves first Lucentis injection biosimilar for treating eye diseases

The FDA announced today that it approved Samsung Bioepis’ Byooviz injection, making it the first approved biosimilar to Lucentis for treating eye diseases.

Byooviz (ranibizumab-nuna), the first biosimilar to Lucentis (ranibizumab injection), treats several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD). The treatment is administered by intravitreal injection (delivered into the vitreous humor of the eye) once a month.

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Glaukos announces licensing deal with Attillaps for pharmaceutical compounds

Glaukos (NYSE:GKOS) announced today that it entered into a licensing agreement with Attillaps for its library of pharmaceutical compounds.

San Clemente, California-based Glaukos was granted a global exclusive license to research, develop, manufacture and commercialize Attillaps’ proprietary library of investigational pharmaceutical compounds that target the eradication of Demodex mites — the root cause of Demodex blepharitis often associated with meibomian gland dysfunction and related ophthalmic diseases.

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Abbott enters U.S. TAVR market with FDA approval of its Portico with FlexNav

Abbott (NYSE:ABT) today announced U.S. FDA approval of its Portico with FlexNav TAVR system.

The approval launches Abbott into a U.S. TAVR space that Edwards Lifesciences and Medtronic have dominated. (Check out our recent DeviceTalks Weekly podcast that recounted Edwards Lifesciences’ pioneering work in the space.) Boston Scientific is out of the TAVR market for now after the retirement of its Lotus program in late 2020.

Abbott officials think they’ll have an edge through the comprehensive nature of their structural heart portfolio.

“With the approval of our TAVR therapy in the U.S., physicians now have access to an even more robust set of solutions to treat structural heart disease,” said Michael Dale, SVP of Abbott’s structural heart business.

“This latest and important introduction of Portico with FlexNav represents another milestone in our work to advance our mission to restore health and improve quality of…

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Former Theranos scientist testifies to blood test inaccuracies prior to Walgreens deal in Elizabeth Holmes trial

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]A former Theranos scientist testified on Friday on the inaccuracies of the company’s device during Elizabeth Holmes’ federal fraud trial.

Surekha Gangakhedhar, who worked at Theranos from 2005 to 2013 and reported directly to Holmes at one point, testified that Holmes allegedly pressured her to validate blood test results to speed up a rollout of the Edison device to a number of Walgreens locations despite its inaccuracies, CNBC reports.

Gangakhedkar said that she returned from vacation in August 2013 to discover that the company was on track to launch the Edison 3.0 and 3.5 in Walgreens stores. She resigned from the company the following month because she was uncomfortable with the pending launch and plans to test patient blood samples. Gangakhedkar met with Holmes prior to her resignation to disc…

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Boston Scientific touts data from Phase 3 study of selective internal radiation therapy

Boston Scientific (NYSE:BSX) today touted data from a Phase 3 clinical trial of its TheraSphere Y-90 glass microspheres treatment.

In the trial, the TheraSphere treatment successfully met both primary endpoints, including progression-free survival (PFS) and hepatic progression-free survival (hPFS) in patients with metastatic colorectal cancer (mCRC) of the liver.

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PerkinElmer completes $5.25B acquisition of BioLegend

PerkinElmer (NYSE:PKI) announced that it completed its acquisition of BioLegend for approximately $5.25 billion.

Waltham, Mass.-based PerkinElmer looks to use the acquisition — the largest in the company’s history — to expand its life science franchise into high-growth areas including cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation and bioprocessing.

The company in July announced the acquisition of the antibody and reagent developer for approximately $5.25 billion in a combination of cash and stock.

“BioLegend’s stellar leaders, teams and technologies will play a critical role in our combined companies’ ability to provide new, innovative solutions to scientists — helping drive novel therapeutic discovery and development,” PerkinElmer president & CEO Prahlad Singh said in a news release. “We also look forward to BioLegend significantly enhancing our leading reagents portfolio as we pa…

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FDA advisory panel recommends boosters only for older and high-risk individuals

Doses of the COVID-19 vaccine are seen at Walter Reed National Military Medical Center, Bethesda, Md., Dec. 14, 2020. (DoD photo by Lisa Ferdinando)

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19.

The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals 16 years of age and older. A total of 16 panelists voted ‘no’ while two others voted ‘yes.’

“With regard to the extrapolation of data from much older populations to 16- and 17-year-olds, we have no data on the safety in these populations at all that have been presented so far. And that concerns me significantly,” said Dr. Archana Chatterjee, VRBPAC member and dean of the Chicago Medical School. While supporting boosters in older populations…

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Medtronic, Johnson & Johnson warn of hospital worker burnout headwind for medical devices

[Photo by Eugene Chystiakov]Medical device manufacturers are worried that the COVID-19 pandemic’s latest wave will make for a tougher recovery in elective procedures after Delta variant cases subside.

Top officials from Medtronic (NYSE:MDT), Johnson & Johnson (NYSE:JNJ), NuVasive (NASDAQ: NUVA) and Zimmer Biomet Holdings (NYSE:ZBH) warned investors that the highly contagious COVID-19 mutation filling U.S. hospitals with mostly unvaccinated patients is leaving a lasting mark on the healthcare workers who will be needed to catch up on routine procedures.

Johnson & Johnson’s hardest-hit business in the pandemic is its Medical Devices line, which faces another slowdown from elective procedures again delayed due to the Delta wave. But a looming shortage of hospital system workers is “a little bit of a new dynamic” facing the business, J&J CFO Joseph Wolk said Wednesday at the Morgan Stanley Global Healthcare Conference.

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Report: U.S. set to buy hundreds of millions of Pfizer’s COVID-19 vaccine to share

[Image courtesy of Wikipedia]The Biden administration reportedly plans to purchase and share with the world hundreds of millions of doses of Pfizer’s COVID-19 vaccine.

The Washington Post reported today that the U.S. has plans to make another large purchase of COVID-19 vaccines, although details of the deal have not been made clear. Neither the White House nor Pfizer have offered comment or confirmation regarding the deal, according to the report.

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Navidea Biopharmaceuticals makes board of directors changes

Navidea Biopharmaceuticals (NYSE:NAVB) announced today that it made a number of changes on its board of directors.

Dublin, Ohio-based Navidea ‘s chair of the board and director S. Kathryn Rouan, along with director Claudine Bruck, retired from those positions, effective immediately.

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European regulators offer positive opinion on Janssen’s schizophrenia treatment

Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion to recommend the use of long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia in adults who are clinically stable on 1-month paliperidone palmitate (PP1M) or 3-monthly paliperidone palmitate.

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