Intellipharmaceutics Cautions Over Financial Future
Company Reports First-Quarter Loss And Looks For New CFO
Intellipharmaceutics has cautioned over its financial future after the firm’s Aximris XR abuse-deterrent oxycodone hydrochloride extended-release tablets were rejected by an FDA committee earlier this year. The company has reported a net loss of $1.7m for the first quarter of 2020, as it looks for a new chief financial officer.
You may also be interested in...
Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.
As Prestige BioPharma announced plans for Phase I and Phase III trials of its PBP1502 proposed adalimumab biosimilar, as well as expected filing dates in the EU and US, the company outlined how it believes its proprietary technology will allow its Humira rival to compete aggressively on price.
The FDA has outlined how it has incorporated feedback on its GDUFA science and research priorities for FY2022 from a public workshop held earlier this year, across issues including harmonization of bioequivalence standards, nitrosamine impurities, and the use of AI to support generic drug development.