BC Week In Review | Jul 27, 2018
Clinical News

KemPharm's ADHD candidate meets in Phase III

KemPharm Inc. (NASDAQ:KMPH) said KP415 met the primary endpoint of improving classroom behaviors in the Phase III KP415.E01 trial to treat pediatric ADHD patients. The company reiterated plans to submit an NDA to FDA for...
BC Week In Review | Jul 13, 2018
Clinical News

FDA accepts resubmitted NDA for Ironshore's HLD200 for ADHD

The Ironshore Pharmaceuticals & Development Inc. subsidiary of Highland Therapeutics Inc. (Toronto, Ontario) said FDA accepted a resubmitted NDA for HLD200 to treat ADHD. The PDUFA date is Aug. 8. HLD200 is a modified-release formulation...
BC Week In Review | Jul 13, 2017
Clinical News

FDA approves Neos' Cotempla XR-ODT for ADHD

Last month, FDA approved an NDA from Neos Therapeutics Inc. (NASDAQ:NEOS) for Cotempla XR-ODT (methylphenidate XR-ODT) to treat ADHD in patients ages 6-17. The product is an extended-release oral disintegrating tablet formulation of methylphenidate using...
BC Week In Review | Dec 30, 2016
Clinical News

KP415: Preliminary Ph I KP415.101 data

Preliminary data from the open-label, crossover Phase I KP415.101 trial in 24 healthy volunteers showed that a single dose of 32 mg oral KP415 under fasted conditions was generally well tolerated with no serious adverse...
BC Week In Review | Dec 16, 2016
Clinical News

HLD200 regulatory update

FDA accepted for review an NDA from Highland’s Ironshore Pharmaceuticals & Development Inc. subsidiary for HLD200 to treat ADHD. The PDUFA date is July 30, 2017. Benjorna is a modified-release formulation of the generic methylphenidate,...
BC Week In Review | Oct 31, 2016
Company News

Acura, KemPharm deal

Acura granted KemPharm rights to develop and commercialize up to three immediate-release candidates using Acura’s version abuse-deterrent technology. KemPharm said it will develop KP415, a prodrug of methylphenidate and a ligand, to treat ADHD; KP201...
BC Week In Review | Aug 22, 2016
Clinical News

Methylphenidate XR-ODT: Phase I data

Neos said a 3-way crossover Phase I bridging trial showed that a single dose of Cotempla XR-ODT met the primary and secondary endpoints for establishing bioequivalence under fasting conditions. Subjects received a commercial scale formulation...
BC Week In Review | Jul 25, 2016
Company News

Teva, Impax, Allergan deal

Teva will sell a portfolio of generic products to Impax for $586 million. The deal includes 15 marketed generics, three approved products that have not yet launched, two products that are pending FDA approval and...
BC Week In Review | Jul 11, 2016
Clinical News

Benjorna: Phase III data

The double-blind, U.S. Phase III HLD-200-108 trial in 161 patients ages 6-12 with ADHD in a naturalistic setting showed that once-daily oral HLD-200 met the primary endpoint of improving ADHD-RS-IV total score during the last...
BC Week In Review | Feb 15, 2016
Clinical News

Dasotraline: Phase I data

Sumitomo Dainippon’s Sunovion Pharmaceuticals Inc. subsidiary reported data from a double-blind, double-dummy, placebo- and active-controlled, 6-way crossover, Canadian Phase I human abuse liability trial in 48 recreational stimulant users who had specific experience with cocaine...
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