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The Department of Health and Human Services (HHS) is pressing the Supreme Court to squash Pfizer’s appeal challenging the U.S. anti-kickback statute, filing a petition which lays out the department’s opposition to the patient assistance program Pfizer created to cover costs of its highest-priced drug. Read More
In this special report, Drug Industry Daily examines the current state of clinical research on Alzheimer’s disease interventions. Part one focuses on the array of anti-amyloid candidates, the controversy surrounding some and the prospects for others.Read More
The agency observed that the facility’s environmental controls were inadequate to prevent cross-contamination of non-beta-lactam and beta-lactam drugs such as penicillin, raising the risk of allergic reactions in patients. Read More
The new recommendation extends the drug’s use to people with a forced vital capacity of more than 80 percent of expected normal lung capacity. Read More
Over-the-counter (OTC) drug manufacturer Midlab of Athens, Tenn., was slapped with a six-observation FDA Form 483 for failing to validate its drug manufacturing processes and equipment and its water system, in addition to using expired raw materials. Read More
To clear up any confusion about what the FDA considers delaying, denying, limiting, or refusing a drug or device inspection, the agency released a draft guidance on Thursday. Read More
Vanda Pharmaceuticals has vowed to appeal a federal judge’s dismissal of several patent infringement claims aimed at Teva Pharmaceuticals and Apotex over their generic forms of its sleep disorder drug Hetlioz (tasimelteon). Read More
The FDA has revised a guidance issued in July on failure to respond to a Complete Response Letter (CRL) from the agency for an abbreviated new drug application (ANDA), updating it to include commitments it made for reauthorization of the Generic Drug User Fee Amendments (GDUFA III). Read More