BioCentury | Jun 30, 2020
Regulation

Data Bytes: Drug approvals in Japan

...MT-6548, akb-6548) Tabrecta (capmatinib, INC280, incb28060) Entresto, sacubitril/valsartan (LCZ696) Mayzent, siponimod (BAF312) Seebri Breezhaler, glycopyrronium bromide (QVM149, NVA237, ad 237, seebri neohaler, Enurev Breezhaler, Tovanor Breezhaler...
BioCentury | Jun 14, 2019
Product Development

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

...III Indacaterol/glycopyrronium bromide/mometasone fuorate Once-daily combination of indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA), glycopyrronium bromide...
BioCentury | May 22, 2019
Clinical News

May 22 Clinical Quick Takes: Lilly's mirikizumab meets Crohn's endpoints; plus Novartis, 89bio and more

...Novartis AG (NYSE:NVS; SIX:NOVN), which said both doses of its once-daily asthma therapy comprising indacaterol, glycopyrronium bromide...
...next-generation technologies, including immune cell-based targeted cancer therapies and AI imaging diagnostics. Hongjiang Li, Staff Writer BIO89-100 (TEV-47948) indacaterol/glycopyrronium bromide/mometasone...
BioCentury | Jan 29, 2018
Clinical News

PTC gains on early data for SMA candidate

PTC Therapeutics Inc. (NASDAQ:PTCT) added $2.37 (10%) to $27.03 on Monday after it and partner Roche (SIX:ROG; OTCQX:RHHBY) reported preliminary data from the pivotal Phase II FIREFISH trial of RG7916 (RO7034067) to treat infants with...
BioCentury | Apr 28, 2017
Politics, Policy & Law

Access and innovation in Japan

...C) PMDA simultaneously approved an NDA for tofogliflozin from Kowa Co. Ltd.; (D) EC approved Seebri Breezhaler...
...Mundesine forodesine T cell lymphoma 3/29/17 Novartis AG (NYSE:NVS; SIX:NOVN) Cosentyx secukinumab Psoriasis 12/26/14 Seebri Breezhaler glycopyrronium bromide...
BioCentury | Sep 19, 2016
Clinical News

Indacaterol/glycopyrronium bromide: Additional Phase III data

...also markets the individual components of Ultibro Breezhaler in the EU. Novartis has rights to glycopyrronium bromide...
...Tokyo, Japan Vectura Group plc (LSE:VEC), Chippenham, U.K. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Indacaterol/glycopyrronium bromide...
...Pulmonary Molecular target: Adrenergic receptor beta 2 (ADRB2); Muscarinic receptor Description: Fixed-dose combination of glycopyrronium bromide (NVA237...
BioCentury | Sep 5, 2016
Strategy

Back to School 2016: Haste, not waste

As researchers in industry and academia rapidly unravel molecular disease mechanisms and drug developers become more adept at intervening in disease pathways with drugs targeted to specific populations, the current clinical development paradigm cannot keep...
BioCentury | Aug 8, 2016
Clinical News

Sialanar glycopyrronium bromide regulatory update

...EMA’s CHMP recommended approval of Sialanar glycopyrronium bromide from Proveca to treat persistent drooling and excessive salivation...
...of glycopyrronium bromide, a long-acting muscarinic receptor antagonist (LAMA). Proveca Ltd. , Cheshire, U.K. Product: Sialanar glycopyrronium bromide...
BioCentury | May 9, 2016
Clinical News

Glycopyrronium bromide regulatory update

...EMA’s CHMP recommended against approval of Sialanar glycopyrronium bromide from Proveca to treat persistent drooling and excessive...
...formulation of glycopyrronium bromide, a long-acting muscarinic receptor antagonist (LAMA). Proveca Ltd. , Cheshire, U.K. Product: Glycopyrronium bromide...
BioCentury | Jan 11, 2016
Clinical News

Indacaterol/glycopyrronium bromide/mometasone fuorate: Phase III started

...$3.8 million milestone payments each to Vectura and Sosei from Novartis. Vectura and Sosei co-developed glycopyrronium bromide...
...Tokyo, Japan Vectura Group plc (LSE:VEC), Chippenham, U.K. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Indacaterol/glycopyrronium bromide/mometasone...
...Muscarinic receptor Description: Once-daily combination of indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA), glycopyrronium bromide...
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