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Regulatory
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Supreme Court passes on Athena patent case despite Solicitor General’s endorsement

Jan. 14, 2020
By Mark McCarty
The U.S. Supreme Court has declined to hear the case of Athena v. Mayo, which many hoped would ease the patent subject matter eligibility problem.
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Oxycodone pills and bottle

Rx opioid pipeline continues to flow despite enormous risks

Jan. 14, 2020
By Mari Serebrov
As a word to the wise in a week filled with FDA advisory committee meetings on potential new opioid drugs, the state of Oklahoma filed a lawsuit Monday against three distributors, reminding everyone in the U.S. opioid prescription supply chain of the risk of litigation and hefty penalties.
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Regulatory front for Jan. 14, 2020

Jan. 14, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Product image

Abbott gets FDA OK to start Mitraclip study in moderate surgical risk patients

Jan. 13, 2020
By Liz Hollis
Abbott Park, Ill.-based Abbott Laboratories has gained the U.S. FDA’s nod for a clinical trial that will compare the effectiveness of Mitraclip to open-heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery. The prospective, randomized REPAIR MR clinical trial is expected to enroll 500 patients.
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Flag of India

India extends med-tech registration deadline amidst regulations scramble

Jan. 13, 2020
By David Ho
HONG KONG – Indian authorities have apparently given medical device manufacturers a one-year extension to register for market authorization that was originally to be done by the New Year.
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Regulatory front for Jan. 13, 2020

Jan. 13, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Man piecing together a puzzle

Cognetivity wins approval for dementia diagnostic test

Jan. 13, 2020
By Nuala Moran
LONDON – Cognetivity Neurosciences Ltd. has received CE software as a medical device approval for its cognitive assessment tool, a five-minute test intended as a diagnostic aid to identifying the earliest stages of dementia.
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Regulatory front for Jan. 13, 2020

Jan. 13, 2020

The latest global regulatory news, changes and updates affecting biopharma.


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Regulatory front for Jan. 10, 2020

Jan. 10, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Abbott gets FDA nod for less invasive LVAD implant procedure, as it aims to broaden use

Jan. 10, 2020
By Stacy Lawrence
In the latest step toward making left ventricular assist devices (LVADs) easier and more accessible, the FDA recently approved a less invasive surgical approach for use with Abbott Laboratories’ latest LVAD, Heartmate 3. Now, rather than requiring risky open-heart surgery, the device can be implanted through an incision in the chest wall. Abbott gained Heartmate 3 in its 2017 acquisition of St. Jude Medical for $25 billion.
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