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

House oversight committee to subpoena AbbVie for pricing documents The U.S. House Committee on Oversight and Reform disclosed plans to issue a subpoena to AbbVie Inc. (NYSE:ABBV) for documents regarding pricing strategies for autoimmune drug...
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

Axsome is readying for a Phase III trial next year of narcolepsy therapy AXS-12 after the candidate met the primary endpoint of a Phase II trial, sending the company's stock up $5.99 (15%) to $45.61...
BioCentury | Aug 15, 2019
Company News

Harmony crosses finish line with Wakix for narcolepsy

FDA approved Wakix pitolisant Thursday, almost two years after Harmony gained U.S. rights to the narcolepsy drug. During 2017-18, Harmony raised $295 million to push it through registration. In October 2017, Harmony Biosciences LLC (Plymouth...
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

Auris Medical Holding AG (NASDAQ:EARS) stock fell 49% Nov. 28 after the company said brimapitide (AM-111) missed the primary endpoint in the Phase III HEALOS trial. Neither tested dose of intratympanic brimapitide gel significantly improved...
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