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News & Insights

Medical Device Tax Put on Hold for Two Years

January 11th, 2016

Medical Device Tax Put on Hold for Two Years When President Obama signed the omnibus spending bill last month, he also approved two years of tax relief for medical device manufacturers.  The spending bill included certain tax measures, including the medical device excise tax created by the Affordable Care Act […]

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Industry Struggles to Safeguard Medical Devices

November 30th, 2015

Industry Struggles to Safeguard Medical Devices Earlier this year in July, the Food and Drug Administration (FDA) published an advisory opinion to strongly encourage hospitals to stop using a certain type of infusion pumps that were particularly vulnerable to remote hacking. Since then, the issue of cybersecurity vulnerabilities with medical […]

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SEC Brings Over 800 Enforcement Actions in FY2015

October 26th, 2015

With the 2015 Fiscal Year (FY) now closed, the Securities and Exchange Commission (SEC) published its tally of enforcement actions.  Over the past year, the agency brought an incredible 807 enforcement actions covering a “wide range of misconduct.”  The SEC highlighted the “significant number of high-impact and first-of-their kind actions” […]

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Drug Pricing Probes Continue

October 19th, 2015

Drug Pricing Probes Continue  Over the past year, pharmaceutical drug prices have received increased scrutiny from industry stakeholders, politicians and regulators.  Emerging cancer treatments, Hepatitis C and blood pressure drugs have come under particular fire. After catching the attention of Democratic congressmen, United States (US) Attorneys from Manhattan and Boston […]

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Yale Study Calls for More Rigor Around Medical Device Testing

August 26th, 2015

Last week, Yale University’s School of Medicine’s Journal, The Journal of the American Medical Association, published a new study examining the testing process for high-risk medical devices.  Specifically, the study compared the number of premarket and postmarket clinical studies conducted by the Food and Drug Administration (FDA) as part of […]

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FCA Launches Financial Advice Review in Hopes of Regulatory Reform

August 26th, 2015

  The Department of Justice (DOJ) is currently developing a new counsel position within its Criminal Division.  Counsel will serve as a corporate compliance program expert.  News reports suggest that the new hire will come from within the agency.  The DOJ has confirmed that a candidate has already been selected […]

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FDA Raises Hacking Concerns for Medical Devices

August 10th, 2015

The Food and Drug Administration (FDA) recently released an alert warning that certain medical devices could be vulnerable to cyber attacks.  The alert singled out Hospira’s Symbiq Infusion System. The infusion pump connects to hospital systems over a wireless connection. The FDA strongly encouraged the discontinued use of such medical […]

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FDA Seeks to Ease Burden for Medical Device Approvals

July 29th, 2015

The Food and Drug Administration (FDA) published a blog last week on the agency’s recent efforts to reduce the hurdles to get medical devices approved.  The blog was authored by FDA Director of Reproductive, Gastro-Renal and Urological Devices, Ben Fisher, in the Office of Device Evaluation. The FDA is working […]

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EU Allows Big Pharma M&A with Strings Attached

March 30th, 2015

Zimmer Holdings, United States (US) based medical device company, agreed last year to acquire orthopedic-device manufacturer, Biomet, for $13.4 billion. The deal had been held up by the European Commission, who oversees antitrust issues. The European Union (EU) was concerned that the merger would drive up prices for orthopedic implants […]

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M&A Developments Continue in Pharma Space

March 2nd, 2015

Mergers and Acquisitions (M&A) developments in the pharmaceutical industry continue to unfold. Last year was a busy one for mergers and tax inversion deals, and 2015 is shaping up to look quite similar.  Already this year, Pfizer has closed a deal to buy Hospira for $17 billion.  In the most […]

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New Cancer Treatments Could Heat Up Market

February 23rd, 2015

The pharmaceutical industry has been abuzz in the past month over new developments in cancer treatment drugs.  In particular, immunotherapy is attracting the attention of big name investors, including Michael Milken and George Soros, and competing drug makers.  Bristol-Meyers Squibb recently introduced two new immunotherapy drugs, Yervoy and Opdivo, which […]

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TPP Could be Big Win for Big Pharma

February 17th, 2015

The Trans-Pacific Partnership (TPP) trade agreement, which would outline trade, regulatory and investment parameters between North American and Asian participating countries, is still under development. In the midst of negotiations, many of the agreement’s provisions have received negative attention from the media, consumer advocates and other stakeholders.  The TPP’s current […]

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