dilluns, 26 de febrer del 2018

Ex-Medtronic chief George: CEOs can do more on gun control

Former Medtronic CEO Bill GeorgeFormer Medtronic (NYSE:MDT) CEO William George said last week that the CEOs of corporate America can have a larger impact than the U.S. Congress when it comes to gun control.

“All of Congress is afraid of the NRA, so I’m worried about getting something done there,” George told CNBC last week. “CEOs can do a lot more locally, in organizing coalitions among mayors, governors, state legislators and coalitions of business people and educators – school boards – to make something happen locally.

“Frankly I’d like to get rid of the assault weapons myself,” he said, adding that the Trump administration’s proposal to arm teachers “is a crazy idea.”

“If a few shareholders object, so be it,” said George, who led the medical device-making giant from 1991 to 2001. “These are our employees’ children. These are part of our companies’ families. We want to make sure they’re safe, otherwise people are not going to come to work for our companies and live in our communities. They have to be in a safe environment. It’s inexcusable.”

And although such a morality-based stance could turn off some investors, he noted, “the companies that do that are going to perform. If your only purpose is making money, you’re going to run, ultimately, into difficulties.”

“This is what inspires your employees. This is what motivates them, that inspires your customers. You’re creating a larger family,” George said.

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Anthem exec chairman joins Proteus board | Personnel Moves – Feb. 26, 2018

Proteus Digital HealthProteus Digital Health announced earlier this month that Anthem‘s (NYSE:ANTM) executive chairman, Joseph Swedish, joined the company’s board of directors.

Swedish served as Anthem’s president & chief executive from 2013 until he was appointed executive chairman in 2018.

Get the full story at our sister site, Drug Delivery Business News.

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CardioFocus launches trial for next-gen HeartLight device

CardioFocusCardioFocus said today that it’s launching a clinical trial for the latest iteration of its HeartLight direct-visualization ablation device for treating atrial fibrillation.

A company representative told MassDevice.com that the 60-patient study of the HeartLight X3, the next generation of the HeartLight Excalibur balloon that won CE Mark approval in the European Union last September. The first cases in the study were performed by Dr. Petr Neužil of Prague’s Na Homolce Hospital.

HeartLight X3 is designed to allow electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural flexibility. The first HeartLight version won 510(k) clearance from the FDA in April 2016.

“The potential reduction in procedure times combined with a better assurance of gap-free lesion sets will help this device change the way PVI is performed,” Neužil said in prepared remarks. “I’m excited to be able to offer this breakthrough approach to my patients during this clinical evaluation phase.”

“CardioFocus is committed to establishing a new benchmark in the field of PVI by delivering leading technologies that provide positive patient outcomes and offer physicians efficient and effective treatment options,” added COO Burke Barrett. “We are encouraged by the initial positive feedback we have received on the HeartLight X3 System from Prof. Neužil and look forward to expanding this important clinical evaluation to additional European study sites and patients. Compared to our current system, HeartLight X3 holds the potential to accelerate the speed of pulmonary vein isolation threefold. This could lead to extraordinary decreases in procedure time. We are excited to continue to evaluate the system’s performance as part of this clinical evaluation.”

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Lilly touts Ph3 data for once-weekly Type II diabetes medication

Eli LillyEli Lilly (NYSE:LLY) touted data today from a Phase IIIb study of its once-weekly, injectable Type II diabetes medication, Trulicity.

The insulin-maker reported that its GLP-1 receptor agonist significantly improved blood sugar control in people with Type II diabetes when added to ongoing treatment with a SGLT-2 inhibitor.

Get the full story at our sister site, Drug Delivery Business News.

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Patent board rules Mohawk tribe is not immune to challenges over Restasis IP

AllerganThe U.S. Patent Trial and Appeal Board ruled last week that the tribal immunity granted to Native American tribes in the U.S. does not shield tribes from patent challenges.

The ruling is a setback for Allergan (NYSE:AGN); the pharmaceutical company transferred patent rights for its blockbuster eye drug, Restasis, to the St. Regis Mohawk Tribe last year in an attempt to avoid inter partes review.

Get the full story at our sister site, Drug Delivery Business News.

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Boston Scientific prices $1B debt offering

Boston ScientificBoston Scientific (NYSE:BSX) said last week that it expects to close a $1 billion debt offering today that’s earmarked for buying back some of its other debt.

Proceeds from the offering, of 4.0% senior notes due March 2028, are slated for the redemption of the remaining $600 million worth of the Marlborough, Mass.-based medical device company’s 2.65% notes due in October; the balance is pegged for repaying short-term debt and any expenses from the transactions, the company said.

Boston said earlier this month that an $861 million tax charge pushed it into the red during the fourth quarter and slashed full-year profits by 70%, but the company still managed to meet or beat Wall Street’s expectations.

Losses were -$615 million, or -45¢ per share, on sales of $2.41 billion for the three months ended Dec. 31, 2017, compared with Q4 profits of $124 million, or 9¢ per share on sales growth of 9.9%. Adjusted to exclude one-time items including the tax sting, earnings per share were 34¢, dead in line with The Street, where analysts were looking for sales of $2.38 billion.

Full-year profits were $104 million, or 8¢ per share, on sales of $9.05 billion, for a -70.0% bottom-line slide on sales growth of 7.9% compared with 2016. Adjusted EPS came in at $1.26, again even with analysts, who forecast sales of $9.01 billion.

The $861 tax charge, taken based on the passage of tax reform legislation last year, was partially offset by that same measure as it lowered the corporate tax rate, Boston Scientific said.

Adjusted EPS are expected to be between $1.35 and $1.39 this year on sales of $9.65 billion to $9.80 billion, the company said. First-quarter adjusted EPS are pegged at 30¢ to 32¢ on sales of $2.32 billion to $2.35 billion.

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Outsourcing administration of your safety oversight group

imarcYou may think your team has covered all the bases when it comes to protecting the safety of human subjects in your clinical trial. You have a team of monitors in place to review reports and ensure your trial follows safety protocols. However, every trial needs a system of checks and balances.

Your monitors are probably great at spotting inconsistencies in individual reports, but who is checking their work and evaluating cumulative safety data to determine whether it’s safe to continue the trial?  

When an adverse event occurs, who is investigating it and determining an appropriate course of action?

Enlisting an objective third party for safety monitoring gives your subjects and your study another layer of protection, adding credibility and consistency. There are several different types of safety monitoring groups, including:

  • Data safety monitoring committees or data safety monitoring boards
  • Clinical events committees
  • Medical monitoring groups

While each has a different focus, they all share a common goal: ensuring the safety of your patients and the integrity of your data. Your study may need one or all of these, depending on its scope and potential risks.

IMARC has developed a list of best practices for enlisting safety monitoring groups for the best results.

Download our checklist today to learn more about when and how to outsource safety monitoring.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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