Insys files for bankruptcy protection, plans to sell most assets | Potentially dodgy stem cell trials threaten valid studies | FDA committees discuss possible restrictions for high-dose opioids
June 13, 2019
Aon Life Sciences Advisor
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Insys files for bankruptcy protection, plans to sell most assets
Insys Therapeutics filed for bankruptcy protection and said it would sell most of its assets. Founder John Kapoor and four former executives were convicted of racketeering, and the opioid maker agreed to pay $225 million to settle bribery allegations.
STAT (tiered subscription model)/Pharmalot (6/10) 
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Potentially dodgy stem cell trials threaten valid studies
The FDA has been cracking down on companies and clinics that market unapproved, unproven stem cell therapies, but some of the organizations' trials remain listed on clinicaltrials.gov, which critics say gives the firms undeserved credibility. Critics also say that charging participants, as some stem cell studies do, is unethical, and trials run by unapproved sellers threaten participation in valid studies that comply with federal regulations.
STAT (tiered subscription model) (6/11) 
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Liability and Safety
FDA warns drugmaker over lack of quality unit
Ingenue Care received an FDA warning letter after an inspection of its Norwalk, Calif., plant found it had no dedicated quality control unit. It also lacked written specifications for its drug products and documentation of active ingredients testing for identity and strength.
FDAnews (6/11) 
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Business and Market Trends
Pharmacy industry seeks relief from remuneration fees
A letter to President Trump from pharmacy and pharmacist organizations has urged him to provide relief from pharmacy direct and indirect remuneration fees. "We request your immediate help to address DIR reform this year in order to eliminate practices that drive up patient and government spending on drugs," the letter read.
Chain Drug Review (6/10) 
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Government and Regulatory
Health Care and Policy
Merck seeks info on risks of broadening cancer drug trial eligibility
Merck seeks info on risks of broadening cancer drug trial eligibility
(Kena Betancur/Getty Images)
Merck has raised concerns with an FDA goal, identified in a new draft guidance, for the inclusion of more patients with HIV, hepatitis B and hepatitis C in oncology drug trials. The drugmaker supports the inclusion of more patients from these groups but is asking the agency to probe into the possible adverse events that could occur.
FDAnews (6/7) 
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Company and Financial News
Dassault buys out Medidata for $5.7B
Medidata Solutions, which specializes in clinical trials, will buy France-based software developer Dassault Systemes in a $5.7 billion all-cash deal. The agreement will help Medidata make further inroads into the biopharma services sector.
FierceBiotech (6/13) 
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Schinecker appointed new head of Roche Diagnostics
Thomas Schinecker has been appointed as the new head of Roche Diagnostics, replacing Michael Heuer, who led the $13-billion-per-year business on an interim basis for several months. Roche CEO Severin Schwan noted Schinecker, who started working as a trainee for Roche Diagnostics in 2003, has "broad and international experience."
Reuters (6/11) 
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News from Aon
May 2019 Global Catastrophe Recap
May 2019 notable global catastrophic events include: Prolonged US severe weather and flooding prompts multi-billion-dollar insurance industry payout; Cyclone Fani makes India landfall and causes estimated $2 billion in direct economic cost; and significant flooding affects parts of the US, Poland, Germany, China and the Middle East. Read more.
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The Role of Data in Improving Well-being
Can health technology -- particularly wearable trackers and apps that can be conveniently accessed via mobile devices -- improve the world's well-being by promoting healthier lifestyles? While health is personal, the role of an employer is critical. By using the data from this new technology, employers can create and scale more targeted well-being programs that encourage better health decisions across their workforce. Learn more.
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