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Becton Dickinson

FDA panel wants more, better data on paclitaxel-eluting devices

June 21, 2019 By Brad Perriello

FDA

An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Stents, Vascular Tagged With: Becton Dickinson, Boston Scientific, cook medical, Medtronic, Peripheral Artery Disease, Royal Philips

FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices

June 20, 2019 By Brad Perriello

FDA

Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Becton Dickinson, Boston Scientific, Medtronic, Peripheral Artery Disease

FDA: More data needed on paclitaxel devices

June 19, 2019 By Brad Perriello

FDA

More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today. A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular, Wall Street Beat Tagged With: Becton Dickinson, Boston Scientific, cook medical, Medtronic, Peripheral Artery Disease, Philips

DHS warns again on cybersecurity flaw in BD’s Alaris infusion pump

June 14, 2019 By Danielle Kirsh

BD

The U.S. Homeland Security Dept. yesterday warned of two more cybersecurity vulnerabilities with the Alaris infusion pump made by Becton, Dickinson (NYSE:BDX). The DHS Industrial Control Systems Cyber Emergency Response Team, acting on weaknesses unearthed by researchers at CyberMDX, said the vulnerabilities could allow a malicious attacker to completely disable BD’s Alaris Gateway Workstation and install malware […]

Filed Under: Hospital Care, Regulatory/Compliance Tagged With: BD, Becton Dickinson

Becton Dickinson cuts earnings outlook on paclitaxel warning

May 9, 2019 By Brad Perriello

Becton Dickinson

Becton Dickinson & Co. (NYSE:BDX) missed the consensus sales forecast for its fiscal second quarter and cut its outlook for the rest of the year, sending its share price down today on Wall Street. The cut to its earnings guidance is due to “recent regulatory and market pressures related to paclitaxel-coated devices,” Franklin Lakes, N.J.-based BD […]

Filed Under: MassDevice Earnings Roundup, Wall Street Beat Tagged With: Becton Dickinson

BD launches second-gen ergonomic injection pen

January 25, 2019 By Sarah Faulkner

BD logo

Becton Dickinson & Co. (NYSE:BDX) said this week that its second-generation BD Nano pen needle won 510(k) clearance from the FDA. The company’s needles are designed to provide a more reliable subcutaneous injection depth, according to BD. Using a contoured needle base and distributed pressure, the pen needle lessens the risk resulting from user injection force […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance Tagged With: Becton Dickinson

FDA releases BD lock flush syringe facility warning letter

October 10, 2018 By Fink Densford

Becton Dickinson

The FDA this week released a warning letter it sent to Becton Dickinson (NYSE: BDX) last month over issues it found at the company’s Franklin, Wisc.-based facilities, which produces pre-filled Heparin and 0.9% sodium chloride lock flush syringes. The warning letter came from an inspection of the facilities which took place between May 16, 2018 and August […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Becton Dickinson

BD inks UAE insulin pen distro deal with Julphar

August 28, 2018 By Fink Densford

Becton Dickinson, Julphar

Pharmaceutical manufacturer Julphar said yesterday it inked a deal with BD (NYSE: BDX) to supply disposable insulin pens to the United Arab Emirates. Through the deal, individuals will be able to purchase BD’s Vystra disposable pens featuring Julphar’s human insulin formulations, including its Jusline R, Jusline N and Jusline 30/70. The same system is slated to be […]

Filed Under: Business/Financial News, Diabetes, Distribution, Drug-Device Combinations, Featured Tagged With: Becton Dickinson, julphar

DHS warns on BD’s Alaris pump

August 24, 2018 By Sarah Faulkner

Becton Dickinson

The U.S. Dept. of Homeland Security issued an advisory this week, warning consumers that BD’s (NYSE: BDX) Alaris syringe pumps can be hacked via a vulnerability that gives a remote attacker unauthorized access to the device when it is connected to a terminal server. BD determined that the affected products are not sold within the U.S., a […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Becton Dickinson

BD partners with Helmer Scientific to launch drug-dispensing system for refrigerated meds

June 4, 2018 By Sarah Faulkner

Becton Dickinson

Becton Dickinson (NYSE: BDX) said today that it’s teaming up with Helmer Scientific to launch a medical-grade refrigerated solution that automatically dispenses medications. Automated medication dispensing has been a norm in the industry for decades, BD noted, but there hasn’t been a solution that securely dispenses refrigerated drugs. The two companies have co-developed a temperature monitoring system […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Becton Dickinson

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