BioCentury | Sep 2, 2020
Regulation

Sept. 1 Quick Takes: House committee to subpoena AbbVie on pricing; plus Athenex, Harmony, AZ, BMS, Novo, and cancer trial guidance

...resubmitted NDA for Wakix pitolisant to treat cataplexy in adults. The PDUFA date for the HRH3...
BioCentury | Jul 22, 2020
Finance

July 21 Quick Takes: Royalty to reap risdiplam royalties; plus CureVac, Antengene, Citrine, Verona, Novartis, Amicus, Aslan, SAB, Gain

Royalty buys PTC royalty stream Royalty Pharma plc (NASDAQ:RPRX) is spending $650 million to acquire from PTC Therapeutics Inc. (NASDAQ:PTCT) about 43% its royalties for spinal muscular atrophy therapy risdiplam, to which the biotech's entitled...
BioCentury | Dec 4, 2019
Clinical News

Axsome plans Phase III trial for narcolepsy therapy following positive Phase II data

...August, FDA approved Wakix pitolisant from Harmony Biosciences LLC to treat excessive daytime sleepiness. The HRH3...
...and Vaughn was principal at Wyatt Pharma Consulting. Targets: GHB - Gamma hydroxybutyrate; HRH3 - Histamine H3 receptor Elizabeth...
BioCentury | Aug 15, 2019
Company News

Harmony crosses finish line with Wakix for narcolepsy

...which is the only approved narcolepsy treatment that is not a scheduled controlled substance. The HRH3...
...is approved for excessive daytime sleepiness and cataplexy. Targets: GHB - Gamma hydroxybutyrate; HRH3 - Histamine H3 receptor Elizabeth...
...Histamine H3 receptor Elizabeth S. Eaton, Staff Writer Wakix (Brand), BF2.649 (Compound #), pitolisant (Generic), Wakix (Other) Harmony Biosciences LLC Histamine H3 receptor (HRH3) Narcolepsy...
BioCentury | Jun 14, 2019
Product Development

Despite senior management shake-up, Novartis’ pipeline is primed to deliver

A string of departures at Novartis AG and strategic shifts by new CEO Vasant Narasimhan have produced a fairly thorough makeover of the executive committee he inherited in 2018. The team gains a pipeline that...
BioCentury | Feb 27, 2019
Clinical News

Novartis first partner in RWE collaboration for dermatology

PharmaSolutions Inc. announced on Wednesday that Novartis AG (NYSE:NOV; SIX:NOVN) will be the first biopharma collaborator in its TARGET-DERM real-world evidence generation program. TARGET-DERM will gather real world, de-identified patient-level data from electronic medical records...
BioCentury | Aug 31, 2018
Company News

JW grants Leo rights to atopic dermatitis candidate JW1601

JW Pharmaceutical Corp. (KSE:001060) granted Leo Pharma A/S (Ballerup, Denmark) exclusive rights to develop and commercialize JW1601 worldwide, excluding Korea. This year, JW expects to submit an IND in Korea for a Phase I trial...
BioCentury | Mar 16, 2018
Clinical News

Glenmark's Ryaltris meets in Phase III for seasonal allergic rhinitis

Glenmark Pharmaceuticals Ltd. (NSE:GLENMARK; BSE:532296) reported data from a Phase III trial in 1,180 patients with seasonal allergic rhinitis showing that twice-daily Ryaltris mometasone/olopatadine met the primary endpoint of improving average morning and evening patient-reported...
BioCentury | Dec 22, 2017
Clinical News

Glenmark's Ryaltris meets in Phase III for perennial allergic rhinitis

Glenmark Pharmaceuticals Ltd. (NSE:GLENMARK; BSE:532296) reported top-line data showing that twice-daily Ryaltris mometasone/olopatadine (formerly GSP 301) met the primary safety endpoint and a secondary efficacy endpoint in a Phase III trial to treat perennial allergic...
BioCentury | Dec 1, 2017
Clinical News

Auris misses in Phase III hearing loss trial

...betahistine AM-125. In 1Q18, the small molecule partial histamine H1 receptor (HRH1) agonist and a HRH3...
...III data Milestone: NA Allison Johnson AM-101 AM-125 brimapitide Keyzilen Auris Medical Holding AG Xigen S.A. c-jun N-terminal kinase (JNK) Histamine H1 receptor (HRH1) Histamine H3 receptor (HRH3) NMDA...
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