Latest From GlaxoSmithKline PLC
Results of both its clinical trials showed significantly higher rates of smoking abstinence, but GSK adds first labeling for an NRT formatted as a Quick Start Guide and makese other label changes "to further assist consumers in how to use the spray dispenser." Similarity of mouth spray formulation's safety profile to other OTC NRTs is a key point in GSK's proposal.
What FDA describes as "real world" trial was "designed to include a broader patient population and without providing any verbal behavioral support," says GSK. "Historically, the FDA has not required OTC NRTs to demonstrate efficacy in naturalistic conditions," it says.
Dermatology-focused regenerative medicine firm Fibrocell has been reviewing strategic opportunities for more than a year; April’s FCX-007 license deal with Castle Creek results in buyout.
In briefing materials NDAC to consider NDA for first mouth spray delivery NRT, agency also questions whether GSK study data show product is safe for OTC access for consumers. DNDP notes the GSK's clinical trial "consistent with a prescription use setting" showed higher success second trial "designed to be consistent with typical OTC use."
- Therapeutic Areas
- Immune Disorders
- Infectious & Viral Diseases
- Metabolic Disorders
- Neurology, Nervous System
- Respiratory, Pulmonary
- Western Europe
- Company Type
- Big Pharma
- Parent & Subsidiaries
- Affymax NV
- AKE Pathologists
- Allen & Hanburys Ltd.
- American Medical Optics
- Block Drug Co. Inc.
- Bristol-Myers Squibb Pakistan Ltd.
- Burroughs Wellcome Co.
- Burroughs Wellcome Inc.
- Cellzome AG
- Center of Excellence for External Drug Discovery
- CNS Inc.
- Corixa Corp.
- Diversified Prescription Delivery
- Domantis Ltd.
- Galvani Bioelectronics
- Genelabs Technologies Inc.
- Glaxo Australia Pty. Ltd.
- Glaxo Canada-IAF Biochem Joint Venture
- Glaxo Group Research Ltd.
- Glaxo Hong Kong
- Glaxo Laboratories Ltd.
- Glaxo Research and Development Ltd.
- Glaxo Wellcome Inc.
- Glaxo Wellcome PLC
- Glaxo Wellcome SA
- Glaxo Wellcome SPA
- GlaxoSmithKline (China) Investment Co. Ltd.
- GlaxoSmithKline Biologicals SA
- GlaxoSmithKline Consumer Healthcare
- GlaxoSmithKline Inc.
- GlaxoSmithKline KK
- GlaxoSmithKline LLC
- GlaxoSmithKline Pharmaceuticals Ltd.
- GlycoVaxyn AG
- GSK Biologicals Shenzhen Co. Ltd.
- GSK Consumer Healthcare
- Human Genome Sciences Inc.
- ID Biomedical Corp.
- International Clinical Laboratories Inc.
- International Hydron Corp.
- Laboratorios Phoenix SA
- Lombart Optical of Virginia Ltd.
- Maxinutrition Group Holdings Ltd.
- Morrith SA
- Nanjing MeiRui Pharma Co. Ltd
- Nippon Glaxo Co. Ltd.
- Norcliff Thayer and Reheis
- Okairos AG
- Pathology and Cytology Laboratories
- Polfa Poznan SA
- Praecis Pharmaceuticals Inc.
- Puget Sound Institute of Pathology Inc.
- Reliant Pharmaceuticals Inc.
- Sachsisches Serumwerk GMBH
- Sirtris Pharmaceuticals Inc.
- SmithKline Beecham
- SmithKline Beecham Animal Health
- SmithKline Beecham Consumer Healthcare
- SmithKline Beecham Corp.
- SmithKline Beecham Healthcare Services
- SmithKline Beecham Pharmaceuticals
- SmithKline Beecham Pharmaceuticals R&D
- SmithKline Beecham Seiyaku KK
- SmithKline Bio-Science Laboratories
- SmithKline Diagnostics Inc.
- Softsite Contact Lens Laboratory Inc.
- Stiefel Research Australia Pty. Ltd.
- Tesaro Inc.
- Total Support Management Group
- ViiV Healthcare
- Visiontech Inc.
- Wellcome Biotechnology Ltd.
- Wellcome Diagnostics
- Wellcome Foundation Ltd.
- Zambeletti SPA
- Senior Management
Emma Walmsley, CEO
Simon Dingemans, CFO
David Redfern, Chief Strategy Officer
Hal Barron, MD, Pres., R&D & CSO
- Contact Info
Phone: (44) 20 8047 5000
980 Great West Rd.
Brentford, TW8 9GS
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