Sanofi resolves claims of delaying Lemtrada with $315M payment | Abbott recalls CentriMag ‚ÄčAcute Circulatory Support System | FDA warns Zydus Cadila plant over contamination risks
November 7, 2019
Aon Life Sciences Advisor
Top Stories
Sanofi resolves claims of delaying Lemtrada with $315M payment
Sanofi is paying $315 million to settle claims it delayed the launch of multiple sclerosis drug Lemtrada, which was developed by Genzyme, to avoid milestone payments to Genzyme shareholders. The company did not admit to any wrongdoing under the settlement.
FiercePharma (11/4) 
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Abbott recalls CentriMag ‚ÄčAcute Circulatory Support System
The FDA has categorized Abbott's recall of its CentriMag ‚ÄčAcute Circulatory Support System as a Class I recall as pump and motor issues with the device could lead to injury or death. The company is aware of 44 serious injuries and one death related to the recall.
MedTech Dive (11/4) 
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Liability and Safety
FDA warns Zydus Cadila plant over contamination risks
The FDA has issued the second warning letter in four years to Zydus Cadila's sterile manufacturing plant in Moraiya, India. A May Form 483 for the plant cited grimy aseptic equipment and methods that could lead to contamination.
FiercePharma (11/4) 
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Business and Market Trends
Industry hopeful for broader EU MDR corrigenda than originally expected
The medtech industry is hopeful that an expected EU Medical Device Regulation corrigenda, allowing surgical instruments four more years on the market before requiring compliance, will be broader than previously expected and will include additional products. Some reports have suggested that it could be expanded to include substance-based medical devices.
Medtech Insight (free registration) (10/31) 
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Canadian ambassador: Importing drugs won't cut prices in US
Importing drugs from Canada would do little to reduce prices in the US because demand in the US far outstrips the supply of prescription drugs in Canada, says Kirsten Hillman, Canada's acting ambassador to the US.
Reuters (11/1) 
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Government and Regulatory
Health Care and Policy
FDA describes maturity model pilot for firms with compliance issues
The FDA's Noncompliant Site Voluntary Improvement Program, a pilot for device makers with compliance issues modeled after the Case for Quality Voluntary Improvement Program, will feature several key differences, says Cisco Vicenty, the Case for Quality program manager in the FDA's Office of Product Evaluation and Quality. For example, the appraisal process will be specific to quality system issues at the manufacturing site and it may include quality metrics for specific products.
Medtech Insight (free registration) (11/4) 
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Company and Financial News
Stryker to buy Wright Medical for $5.4B
Stryker is acquiring Wright Medical for $5.4 billion in a deal expected to close in the second half of next year. "This acquisition enhances our global market position in trauma and extremities, providing significant opportunities to advance innovation, improve outcomes and reach more patients," said Stryker Chairman and CEO Kevin Lobo.
BioWorld MedTech (11/5) 
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