All Pharmaceuticals articles – Page 5
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Ex-Mylan employee pleads guilty to insider trading
Dayakar Mallu, a former IT manager at Mylan, pleaded guilty to criminal charges for his role in an $8 million insider trading scheme aided by an unnamed executive at the pharmaceutical company.
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Compliance takeaways from FDA’s final ‘intended use’ rule
The U.S. Food and Drug Administration’s “intended use” final rule reaffirms the agency’s wide latitude of discretion in establishing an off-label use case against pharmaceutical and medical device companies.
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Medvantx appoints chief compliance officer
Pharmacy services provider Medvantx appointed Darlene Mitchell as chief compliance officer.
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Connect Biopharma hires chief compliance officer
Clinical-stage biopharmaceutical company Connect Biopharma Holdings Limited named Jiang Bian general counsel and chief compliance officer.
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ICO’s first GDPR fine reduced on appeal
The U.K. Information Commissioner’s Office’s fine against pharmacy Doorstep Dispensaree for violations of the General Data Protection Regulation has been slashed approximately two-thirds on appeal to £92,000 (U.S. $126,000).
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Ironwood Pharmaceuticals names chief legal officer
Gastrointestinal healthcare company Ironwood Pharmaceuticals named John Minardo as senior vice president, chief legal officer.
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Compliance ramifications of proposed $26B opioid deal for pharma industry
Three major drug distributors and drugmaker Johnson & Johnson reached a proposed $26 billion multistate agreement for their alleged roles in fueling the nationwide opioid epidemic. The settlement imparts compliance lessons on the pharmaceutical industry at large.
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MEI Pharma appoints chief compliance officer
Late-stage pharmaceutical company MEI Pharma announced the appointment of Tina Beamon as chief compliance officer.
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FTC gearing up for aggressive oversight of antitrust, M&A
With a changing of the guard, the Federal Trade Commission is undergoing some major restructuring on the antitrust front. All told, it’s not just Big Tech and pharmaceutical companies that should be on alert.
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Eli Lilly names new chief ethics and compliance officer
Pharmaceuticals firm Eli Lilly announced the appointment of Alonzo Weems as senior vice president and chief ethics and compliance officer amid a series of executive-level transitions.
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Moderna adds chief legal officer
Pharmaceuticals and biotechnology firm Moderna announced the appointment of Shannon Thyme Klinger as chief legal officer, effective June 1.
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Novartis legal chief to resign
Swiss-based pharmaceutical firm Novartis announced Chief Legal Officer Shannon Thyme Klinger has decided to resign and return to the United States to take an executive role at a biotechnology company.
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Arcutis Biotherapeutics appoints chief compliance officer
Arcutis Biotherapeutics, a biopharmaceutical company, has appointed Courtney Barton as chief compliance officer and chief of staff. Barton will also serve as chief privacy officer.
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McKinsey to pay $573M for role in opioid epidemic
McKinsey & Company reached a $573 million settlement with 49 state attorneys general and the District of Columbia related to consulting services it provided to pharmaceutical companies that directly contributed to the opioid epidemic.
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Rare OIG Special Fraud Alert cautions the use of speaker programs
In a rare move, the U.S. Department of Health and Human Services’ Office of Inspector General issued a Special Fraud Alert warning of inherent fraud and abuse risks associated with speaker programs.
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Pfizer facing FCPA probes into China operations
Pharmaceutical firm Pfizer announced in a recent regulatory filing that it has received requests from the Department of Justice and the Securities and Exchange Commission regarding the company’s operations in China.
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Purdue Pharma case more than an $8B fine
Compliance officers in the pharmaceutical and healthcare industries should look beyond the $8 billion fine Purdue Pharma received from the DOJ and at the bigger enforcement trend highlighting the need for better oversight in the field.
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Mass. pharma company will pay $20.75M to settle FCA lawsuit
A Massachusetts-based pharmaceutical company will pay $20.75 million settle a whistleblower’s allegations that the company knowingly promoted misleading instructions for a skin lesion drug that caused doctors to submit false claims to Medicare.
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Bausch Health to pay $45M for misleading disclosures
The Securities and Exchange Commission charged Bausch Health (formerly Valeant Pharmaceuticals) and three former executives for improper revenue recognition and misleading disclosures in SEC filings and earnings presentations.
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Taro Pharma to pay $206M to resolve price-fixing charges
Taro Pharmaceuticals will pay a $205.7 million criminal penalty to resolve charges as part of the Justice Department’s ongoing investigation into the generic pharmaceutical industry.