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St. Jude Adjusts Management Structure After Latest Results Disappoint

This article was originally published in The Gray Sheet

Executive Summary

Joseph McCullough will step down as group president of St. Jude Medical Nov. 1, and will soon retire from the company, according to an Oct. 26 filing with the Securities and Exchange Commission

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Earnings Calls In Brief

Stryker resolves one of four FDA warning letters: Stryker is one step closer to resolving its ongoing FDA compliance issues now that the agency has lifted one of four warning letters received since March 2007, the company reported Oct. 20. The orthopedic device maker's biotech division received the warning letter, which cited quality system and compliance violations, in April 2008 (1"The Gray Sheet" May 18, 2009). "We view this as an important first step in our goal of resolving all of the outstanding warning letters," CEO Stephen MacMillan said during the firm's third-quarter earnings call. Stryker initiated a three-year, roughly $200 million plan in 2008 to overhaul its quality standards (2"The Gray Sheet" Feb. 2, 2009). "The investments we're making seem to be paying dividends ... but we still have work to do," commented Katherine Owen, VP of strategy and investor relations. Stryker reported third-quarter sales were flat at $1.65 billion. The total includes a 5.5% increase in orthopedic implant sales to $1.02 billion, offset by a 7.7% dip in MedSurg equipment revenue to $637 million. "Clearly, reduced hospital capital spending continues to impact the MedSurg business," which makes up 39% of the company, noted CFO Curt Hartman

COVID-19 Lockdown: India Pharma Manufacturing Limps Along Amid Challenges

Pharma manufacturing is operating well below normal levels in India, disrupted by labor absenteeism and supply chain issues amid the ongoing lock-down in the country, though the government is actively engaged in addressing bottlenecks. A speedy recovery is vital not just for domestic supplies.

Moderna Stands Alone With Single-Antigen Approach To COVID-19 Vaccine

Moderna is pursuing a single-antigen strategy even though some of its mRNA vaccines have included multiple antigens; the SARS-CoV-2 spike protein likely provides the best antigen for developing immunity against the virus.





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