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The FDA unveiled six new draft guidances outlining its latest thinking on the rapidly evolving field of gene therapy — and Commissioner Scott Gottlieb said the agency plans to work with product sponsors to help make the development and approval of innovative gene therapies more efficient. Read More
Sponsors are required to submit the guides in cases where certain information is necessary to prevent adverse effects and where adherence to directions is essential to a drug’s effectiveness. Read More
AstraZeneca has agreed to pay $110 million to settle two lawsuits filed against it by the state of Texas alleging the pharmaceutical giant deceitfully marketed two of its drug products to Texas Medicaid providers. Read More
Insys announced Wednesday it reached an agreement with the Justice Department to pay $150 million over five years to settle allegations that it bribed doctors to prescribe its fentanyl sublingual spray Subsys. Read More
The FDA issued final guidance Wednesday on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances. Read More
CMS announced a new policy late Tuesday that will allow Medicare Advantage plans to use a “step therapy” approach to control prescription drug costs for patients in an effort to meet the administration’s promises of lower drug prices and better Medicare negotiation. Read More
An FDA advisory panel voted Wednesday in favor of the safety and efficacy of Paratek’s two NDAs for omadacycline tablets and omadacycline injection as treatments for community-acquired bacterial pneumonia (CAPB) and acute bacterial skin and skin structure infections (ABSSSI). Read More