Another blue-chip riser was Reckitt Benckiser, up 2.4% after agreeing to pay USD1.4 billion to settle a probe into former pharmaceuticals arm Indivior.The FTSE 100-listed consumer goods firm will pay up to USD1.4 billion to fully resolve all federal investigations into Reckitt in connection with Indivior's indictment and claims relating to state Medicaid programs for those states choosing to participate in the settlement.In September 2016, 35 US states and the District of Columbia filed a civil complaint against Indivior in relation to its ongoing legal privilege dispute with the US Federal Trade Commission. Indivior was wholly demerged from Reckitt, which makes Dettol disinfectant and Strepsils lozenges, in 2014. Suboxone is an opioid used to treat opioid addiction, acute pain, and chronic pain.Separately, Indivior shot up 26% after upgrading its guidance following a stronger than anticipated first half. Indivior - which did not mention the Reckitt announcement in its own on Thursday - now expects net revenue in a range of USD670 million to USD720 million, a sharp increase from previous forecasts of USD525 million to USD575 million. Net income is expected between USD80 million to USD130 million. Prior to this, the company had anticipated anything from a loss of USD40 million to income of USD10 million. The primary driver has been a market share outperformance from Suboxone Film, the company explained
Drug developers are free to ask for help from FDA at any point in the drug development process, including: Pre-IND application, to review FDA guidance documents and get answers to questions that may help enhance their research After Phase 2, to obtain guidance on the design of large Phase 3 studies Any time during the process, to obtain an assessment of the IND application Even though FDA offers extensive technical assistance, drug developers are not required to take FDA’s suggestions. As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design.