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.
The FDA has categorized Abbott's recall of its CentriMag Acute 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.
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.
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.
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.
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.
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.
Aon provides Life Sciences companies with end-to-end risk solutions, supporting organizations from the initial discovery phase to final product launch. The practice provides solutions across the Life Sciences for pharmaceutical manufacturers; generic and OTC pharmaceutical companies; biotechnology and biopharmaceutical companies; genomic and proteomic companies; drug delivery system; diagnostic substance companies; and medical device and equipment manufacturers.
Aon plc (NYSE:AON) is a leading global professional services firm providing a broad range of risk, retirement and health solutions. Our 50,000 colleagues in 120 countries empower results for clients by using proprietary data and analytics to deliver insights that reduce volatility and improve performance.