MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Diabetes: DOJ investigates Shires’ DermaGraft marketing

Diabetes: DOJ investigates Shires’ DermaGraft marketing

By

Shire plc logo

British biotech Shire (NSDQ:SHPGY) is under investigation by the U.S. Justice Dept. for marketing practices for its Dermagraft diabetic foot ulcer treatment, according to regulatory filings.

The company reported that the DOJ, in conjunction with U.S. Attorney’s Offices for the Middle District of Florida and Washington, D.C., launched civil and criminal investigations into the company’s sales and marketing practices.

"Shire is cooperating in these investigations," according to an SEC filing.

Dermagraft, which is cleared for treating diabetic foot ulcers, was owned by Smith & Nephew plc (NYSE:SNN), before the British health products giant abandoned it in 2005 after the FDA rejected it as a leg ulcer treatment. SNN then sold the rights to Advanced BioHealing in 2006.

Shire picked up Dermagraft in a $750 million buyout of Advanced BioHealing in June 2011.

The investigation was noted in Shire’s latest earnings report, in which the company posted profits of $238.4 million, or 41¢ per diluted share, on sales of $1.17 billion for the 3 months ended March 31.

Shire noted that it sold $48.8 million worth of the Dermagraft skin substitute during the 1st quarter. Since Q3 2011, Shire’s reeled in about $143.4 million from the regenerative medicine product ($50 million in Q3 2011, $55 million in Q4 and the $48.8 million logged in Q1 2012).

Shire did not immediately return requests for comment today.

SHPGY shares jumped 2% to $99.07 as of about 1:15 p.m. today.

In case you missed it

RSS From Medical Design & Outsourcing

  • Baxter, 3M, Abbott near the top of Newsweek’s most responsible companies list
    Several medtech, healthcare and life sciences companies, including big names like Abbott (NYSE:ABT), 3M (NYSE:MMM) and Baxter (NYSE:BAX), are among the 500 “most responsible,” according to Newsweek. The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with… […]
  • HHS reports 63-fold increase in telehealth use during pandemic
    A new study from the U.S. Department of Health and Human Services found a 63-fold increase in Medicare telehealth use during the COVID-19 pandemic. The report analyzed Medicare fee-for-service data from 2019 and 2020 and highlighted that people in urban areas were more likely to seek and use telehealth services than rural residents. In addition,… […]
  • Carlyle makes a significant investment in Resonetics
    Carlyle-managed funds have acquired a significant interest in medical device contract manufacturer Resonetics. Today’s announcement did not include the investment size, but the deal values Nashua, New Hampshire–based Resonetics at roughly  $2.25 billion. Carlyle joins existing investor GTCR as a meaningful shareholder in the company. Resonetics focuses on producing highly technical components for medical device… […]
  • Interpreting Pump Performance Curves
    Reading pump performance curves is crucial to proper pump selection. This piece reviews the creation and use of diaphragm pump performance curves to determine flow at given vacuum or pressure conditions. Included is a lesser-known method to interpolate pump performance when flow restrictions exist on both the inlet and outlet sides of the pump. Download… […]
  • BD elaborates on diversity and equity goals
    BD (NYSE:BDX) earlier this week outlined its efforts this year related to global inclusion, diversity and equity. Franklin Lakes, New Jersey-based BD released its 2021 Global Inclusion, Diversity and Equity (ID&E) Report, highlighting the progress it’s made in human health as part of its environmental, social and governance (ESG) strategy, according to a news release.… […]
  • How to protect medical devices from hidden cybersecurity risks
    Your software supply chain could be a cybersecurity risk. Here’s what you can do. Vince Arneja, GrammaTech The healthcare industry has been fighting a war on two fronts during the COVID-19 pandemic against the virus and an outbreak of cyberattacks. The Department of Health and Human Services says the sector reported a 9,851% increase in… […]
  • Integer completes $220M Oscor acquisition
    Integer Holdings (NYSE: ITGR) announced today that it has completed its purchase of Oscor — a deal that expands the capabilities of what was already one of the world’s largest medtech contract manufacturers. Integer said the acquisition would cost $220 million when it first announced its plans in October. Oscor is the creator and marketer… […]
  • Respira Labs seeks FDA clearance for its wearable lung monitor
    Respira Labs recently announced that it has developed a wearable device that continuously assesses lung function without the need for traditional pulmonary function tests. Mountain View, California-based Respira Labs designed its Sylvee wearable initially to assess chronic obstructive pulmonary disease, COVID-19 and asthma patients. It is embedded with speakers and microphones that measure the change… […]
  • Owen Mumford starts work on new production center in U.K.
    Owen Mumford this week announced that it has started building its new production facility in Witney, Oxfordshire in the U.K. Owen Mumford’s new Witney facility will stand as a production site for the company’s recently launched, next-generation auto-injector Aidaptus. The company has decades of experience creating its own drug delivery, blood sampling and rapid diagnostic… […]
  • FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron
    Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy. In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests,… […]
  • Traco Power launches THM 60WI DC-DC converters
    Traco Power today announced it has launched its THM 60WI series of quarter brick DC-DC converters. The Baar, Switzerlad-based company designed the DC-DC converters with ultra-wide input ranges and safety approvals for medical and industrial applications. Traco Power’s THM 60WI series of converters consists of 12 models with 9-75 or 18-75 Vin ranges with single… […]

Leave a Reply