AMZ002, a purified synthetic polypeptide, offers an alternative to existing FDA-approved treatment for epileptic seizures.
This product received both Rare Pediatric Disease and Orphan-Drug Designations.
This Phase III Clinical Trial is a randomized, open-label superiority study designed to evaluate the efficacy, and safety of AMZ002 in the treatment of infantile spasms.
In addition, this trial is one of the first to investigate co-primary endpoints assessing both the absence of spasms and resolution of hypsarrhythmia.
Amring Pharmaceuticals is a privately held pharmaceutical company that provides niche generics and value-driven brands to the market.
Amring is partnered with well-established global biopharmaceutical companies and is uniquely positioned to leverage its expertise in bringing biotechnology derived medicines, sterile manufacturing and other state of the art technologies to the marketplace.
Amzell B.V. is a specialist development pharmaceutical company which takes candidate drugs and devices either through to proof of efficacy or through to marketing authorization for further commercialization in partnership with leading niche-based commercial healthcare companies.
The company, based in Hoofddorp, The Netherlands, was founded in 2016.
Amzell has particular interest in developing well-characterized, active pharmaceutical ingredients using innovation platform drug delivery technologies to provide more effective drug delivery, increased efficacy, and improved safety and compliance.
Par Pharmaceutical starts shipping colchicine 0.6mg capsules
Padagis launces Brinzolamide Ophthalmic Suspension with CGT exclusivity
Novartis completes Sandoz Spin-off
Novartis completes Sandoz spin-off, focusing on innovative medicines
Hikma marks KLOXXADO two-year anniversary by surpassing 375,000 doses donated in the US
STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
Azurity Pharmaceuticals completes Slayback Pharma acquisition
Sandoz secures European approval for Tyruko biosimilar in MS treatment
Senores Pharmaceuticals introduces Nicardipine Hydrochloride Capsules USP, 20mg and 30mg in US
Lupin collaborates with Mark Cuban Cost Plus Drug Company and COPD foundation
Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling
Sandoz's Tyruko (natalizumab-sztn) gains FDA approval as first biosimilar for relapsing MS
Nephron Pharmaceutical names new chief procurement officer
Lupin Pharmaceuticals launches Tiotropium Bromide Inhalation Powder, 18mcg/capsule in US