Shots: The US FDA has accepted the Allergan’s sBLA to expand the BOTOX prescribing information for treating detrusor (bladder muscle) overactivity associated with an underlying neurologic condition in pediatric patients aged 5 -17yrs who have an inadequate response to or are intolerant of, or for any reason unwilling to continue anticholinergic medication The sBLA is […]Read More
Shots: The two companies will advance the development program of a proposed biosimilar to BOTOX and BOTOX Cosmetic (onabotulinumtoxinA), under 351(k) pathways. The US FDA’s feedback during BIAM indicated that the 351(k) regulatory pathways for an onabotulinumtoxinA product is viable Following the advancement of the program, Revance will receive $30M as milestones and is eligible […]Read More
Shots: Revance is in discussion with Mylan regarding whether Mylan plans to move forward or not with the biosimilar to BOTOX program. The expected decision date for Mylan is Apr 30, 2020 or thirty days from the date that Revance provides Mylan with certain deliverables regarding the program In Sept’2019, the companies amended their agreement […]Read More
Revance to get $25M upfront, milestone payments upon achievement of additional clinical, regulatory and sales targets, plus sales royalties in all relevant markets and will be finalized till Apr 30, 2020 In Feb 2018, Revance and Mylan signed global collaboration and license agreement for the development and commercialization of a proposed biosimilar to BOTOX (onabotulinumtoxinA) […]Read More
Revance to get $25M upfront, milestone payments upon achievement of additional clinical, regulatory and sales targets, plus sales royalties in all relevant markets and will be finalized till Apr 30, 2020 In Feb 2018, Revance and Mylan signed global collaboration and license agreement for the development and commercialization of a proposed biosimilar to BOTOX (onabotulinumtoxinA) […]Read More
Shots: The FDA’s approval is based on P-III study assessing the BOTOX in 300+ pediatric patients aged 2-17yrs. being treated for lower limb spasticity. The study included patients with cerebral palsy, but the approved indication excludes lower limb spasticity caused by cerebral palsy due to marketing exclusivity by another company The approval marks the 11th […]Read More
Mylan to pay $5M up front in addition to $25M (according to 2018 deal), contingent payments ~$100M, ~$225M milestones on the achievement of specified clinical and regulatory milestones and royalties on sales of the biosimilar in Mylan territories The amendment is made in the extension of time for Mylan to develop and commercialize biosimilar of […]Read More
Shots: The approval is based on two P-III studies result assessing BOTOX (3-6 units/kg) in 200 pediatric patients with upper limb spasticity aged 2-17yrs. for 12wks. followed by a one-year extension study Additionally, sBLA for using BOTOX in treating pediatric patients with lower limb spasticity is under FDA’s review with its expected approval in Q4’19 […]Read More
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