• Regulatory NewsRegulatory News

    Amgen, Astellas Pay $125M to Settle DOJ Kickback Allegations

    Two more pharmaceutical companies on Thursday joined a heap of peers in settling allegations made by the Department of Justice that the companies used foundations to pay Medicare copays for their own products. Amgen and Astellas Pharma agreed to pay $124.75 million total ($100 million for Astellas and $24.75 million for Amgen) after they were accused of using multiple foundations to induce Medicare patients to purchase the company’s drugs. As far as the details of th...
  • Regulatory NewsRegulatory News

    ABPI Extends Astellas UK Suspension for 12 More Months

    The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety." Astellas was originally suspended in June 2016 for deception and was re-audited in September 2016 and April 2017, which "highlighted a lack of oversight and training of agency nurses who delivered patient support programmes, inc...
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    Why Don’t People Like Pharma Companies? Pfizer and Regeneron CEOs Discuss

    At the end of Thursday's Forbes healthcare summit in New York, some of the pharmaceutical and biotech industries’ top executives – from Pfizer, Regeneron, Eli Lilly, Gilead and Astellas – sat down and were presented with a simple question: Why don’t people like you? At first the conversation dovetailed away from the question, with John Milligan, CEO of Gilead, discussing his company’s hepatitis C cure Sovaldi (sofosbuvir) and the rapid increases in demand. “What happen...
  • Astellas Cardiac Stress Test Drugs Hit with FDA Warning

    The US Food and Drug Administration (FDA) has issued a new warning that Lexiscan (regadenoson) and Adenoscan (adenosine), two intravenously-administered drugs used during cardiac nuclear stress tests, are associated with "rare but serious" side effects that can result in heart attack and death. Cardiac nuclear stress tests are used to assess the body's capacity to circulate blood by capturing images of the heart during states of rest and physical activity. They are gener...
  • Astellas' Prostate Cancer Drug Receives Priority FDA Approval

    A new drug manufactured by California-based Astellas Pharma promises to help treat aggressive, late-stage prostate cancer that has evaded other treatments, the US Food and Drug Administration (FDA) said in a statement approving the drug on 31 August. The drug, Xtandi (enzalutamide), was approved under FDA's priority review program, and was reviewed in just three months-half the time allotted to FDA under the priority review program. Xtandi was subject to a clinical tri...
  • FDA Approves Astellas' Bladder Control Drug

    The US Food and Drug Administration (FDA) on 28 June approved Astellas Pharma Global Development's overactive bladder treatment drug Myrbetriq (mirabegron). The drug is used at the 25mg and 50mg dosage levels to reduce the severity of overactive bladder, which FDA explained is a condition in which the bladder muscle is uncontrolled. "Today's approval provides a new treatment option for patients with this debilitating condition," wrote Victoria Kusiak, deputy director of ...