All Pharmaceuticals articles – Page 5
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ArticleThe 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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ArticleCassava 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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ArticleCompliance 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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ArticleUpdated 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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ArticleEx-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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ArticleCompliance 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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ArticleICO’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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ArticleCompliance 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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ArticleFTC 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.