All Pharmaceuticals articles – Page 3
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Experts: Where to start on your ESG journey
ESG directors from Tenneco and Amneal Pharmaceuticals shared best practices for businesses broaching the initial phases of environmental, social, and governance reporting at CW’s virtual ESG Summit.
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Akorn to pay $7.9M for Medicare false claims
Drug manufacturer Akorn Operating Company agreed to pay $7.9 million in a settlement with the Department of Justice for continuing to sell three drugs through Medicare when they were no longer covered under the program.
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Opioid cases against retail pharmacy chains yield compliance lessons
Two cases involving five retail pharmacy chains winding their way through court foretell a long and costly road ahead for all companies across the pharmaceutical supply chain battling litigation for their alleged roles in fueling the opioid epidemic.
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Bayer to pay $40M to settle long-running false claims suits
Bayer agreed to pay $40 million to settle allegations its sales team paid kickbacks to hospitals and doctors for prescribing its drugs and that the pharmaceuticals company downplayed risks regarding certain of its offerings.
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Mallinckrodt promotes VPs of compliance and legal to executive level
Mallinckrodt, a global pharmaceutical company, announced the promotions of its senior compliance and legal vice presidents to the executive level.
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Astellas promotes HR head to chief ethics and compliance officer
Pharmaceutical company Astellas announced the promotion of Head of Human Resources Katsuyoshi Sugita to chief people, ethics, and compliance officer, effective Oct. 1.
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SEC notifies five Chinese companies of HFCAA noncompliance
The Securities and Exchange Commission has notified five China-based public companies they could be delisted from U.S. stock exchanges if they do not allow their audits to be inspected by the Public Company Accounting Oversight Board.
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Mallinckrodt to pay $260M for False Claims Act violations
Pharmaceutical company Mallinckrodt agreed to pay approximately $260 million as part of a settlement announced by the Department of Justice for underpaying Medicaid rebates and violating kickback laws regarding its drug Acthar.
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The Cassava Sciences saga: Short sellers, ‘gaming’ the FDA, and the damaging ripple effects
The Federal Drug Administration’s decision last month to deny a citizen petition on behalf of short sellers with positions in Cassava Sciences stock highlights the damage the commonly exploited regulatory process can have on a company, regardless of innocence or guilt.
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Rocket Pharmaceuticals adds general counsel and chief compliance officer
Clinical-stage pharmaceutical company Rocket Pharmaceuticals announced the appointment of Martin Wilson as general counsel and chief compliance officer.
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Ex-Immunomedics CFO charged with insider trading
The SEC charged former Immunomedics Chief Financial Officer Usama Malik and his former romantic partner with insider trading. The Department of Justice also announced criminal charges for securities fraud.
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Cassava Sciences facing widening probe over short seller claims
The SEC has reportedly launched an investigation into Cassava Sciences regarding allegations made against the clinical-stage biopharmaceutical company and its experimental Alzheimer’s drug by a law firm representing anonymous short sellers.
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Compliance implications of drugmakers’ $447M False Claims Act settlements
Three pharmaceutical manufacturers—Taro Pharmaceuticals USA, Sandoz, and Apotex Corp.—will pay a total of $447.2 million for alleged violations of the False Claims Act related to price-fixing.
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Updated PhRMA Code addresses company-sponsored speaker programs
New voluntary standards issued by the Pharmaceutical Research and Manufacturers of America will soon take effect offering guidance related to company-sponsored speaker programs.
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Eiger BioPharmaceuticals adds chief compliance officer
Eiger BioPharmaceuticals announced the appointment of Erik Atkisson as general counsel and chief compliance officer.
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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).