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PhRMA, pressed on all sides by critics of its members’ insulin-pricing policies, on Thursday made its public pitch to be part of the solution and not just the problem. Read More
Amgen and Astellas Pharma have agreed to pay nearly $125 million to settle federal allegations that they exploited charities to protect the prices of their favored drugs. Read More
In certain cases, the agency will request a comparison of the bispecific antibody to an approved monospecific product targeted against the same antigens. Read More
The authorities say Young prescribed 500,000 hydrocodone pills, 300,000 oxycodone pills, 1,500 fentanyl patches and more than 600,000 benzodiazepine pills in less than three years. Read More
The revised term would require a generic drug to contain the same active components in similar dosage forms as its Canadian reference product. Read More
The Canadian government on Wednesday announced a $60 million, seven-year plan to build a massive health database that backers hope will help the country come to grips with its opioid crisis. Read More
Drug sponsors can use complicated covariance analyses to help determine statistical significances or to help sharpen estimates of how well a treatment might work but they shouldn’t apply those analyses to anything in a clinical trial that might be affected by treatment, the FDA says in a new draft guidance document issued Wednesday. Read More