Inhalable Drug Delivery Devices – Medical Devices Pipeline Assessment, 2019

GlobalData
221 Pages - GLDATA70590
$8,000.00

Inhalable Drug Delivery Devices are meant to administer medications that are to be inhaled deeply into the lungs. Drugs are delivered either by nasal or oral respiratory route. GlobalData's Medical Devices sector report, “Inhalable Drug Delivery Devices – Medical Devices Pipeline Assessment, 2019" provides comprehensive information about the Inhalable Drug Delivery Devices pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

The Inhalable Drug Delivery Devices Pipeline Assessment report provides key information and data related to:

Extensive coverage of the Inhalable Drug Delivery Devices under development

Review details of major pipeline products which include product description, licensing and collaboration details and other developmental activities including pipeline territories, regulatory paths and estimated approval dates

Reviews of major players involved in the pipeline product development.

Provides key clinical trial data related to ongoing clinical trials such as trial phase, trial status, trial start and end dates, and, the number of trials of the major Inhalable Drug Delivery Devices pipeline products.

Review of Recent Developments in the segment / industry

The Inhalable Drug Delivery Devices Pipeline Assessment report enables you to:

Access significant competitor information, analysis, and insights to improve your R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of Inhalable Drug Delivery Devices under development

Formulate market-entry and market expansion strategies

Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

The GlobalData Differentiation

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

The data and analysis within this report are driven by GlobalData Medical Intelligence Center (GDMIC) database. GDMIC gives you the key information required to drive sales, investment and deal-making activity in your business. It includes the following:

• 15,000+ data tables showing market size across more than 780 medical equipment segments and 39 countries, from 2009 and forecast to 2023

• 4,500+ industry-leading analysis and procedure reports covering growing sectors, market trends, investment opportunities and competitive landscape

• 56,000+ medical equipment company profiles

• 4,300+ company profiles of medical equipment manufacturers in China and India

• 2,000+ company profiles of medical equipment manufacturers in Japan

• 825+ companies’ revenue splits and market shares

• 1,900+ quarterly and annual medical equipment company financials

• 940+ medical equipment company SWOTs

• 21,500+ pipeline product profiles

• 34,500+ marketed product profiles

• 36,000+ clinical trials

• 36,500+ trial investigators

• 5,400+ reports on companies with products in development

• 33,000+ deals in the medical equipment industry

• 1,300+ surgical and diagnostic procedures by therapy area

• 50+ key healthcare indicators by country

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Scope
– Extensive coverage of the Inhalable Drug Delivery Devices under development

– The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities

– The report reviews the major players involved in the development of Inhalable Drug Delivery Devices and list all their pipeline projects

– The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage

– The report provides key clinical trial data of ongoing trials specific to pipeline products

– Recent developments in the segment / industry

Reasons to buy
The report enables you to:

– Formulate significant competitor information, analysis, and insights to improve R&D strategies

– Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

– Identify and understand important and diverse types of Inhalable Drug Delivery Devices under development

– Develop market-entry and market expansion strategies

– Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

– In-depth analysis of the product’s current stage of development, territory and estimated launch date

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1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 9

2 Introduction 10

2.1 Inhalable Drug Delivery Devices Overview 10

3 Products under Development 11

3.1 Inhalable Drug Delivery Devices – Pipeline Products by Stage of Development 11

3.2 Inhalable Drug Delivery Devices – Pipeline Products by Segment 12

3.3 Inhalable Drug Delivery Devices – Pipeline Products by Territory 13

3.4 Inhalable Drug Delivery Devices – Pipeline Products by Regulatory Path 15

3.5 Inhalable Drug Delivery Devices – Pipeline Products by Estimated Approval Date 16

3.6 Inhalable Drug Delivery Devices – Ongoing Clinical Trials 17

4 Inhalable Drug Delivery Devices – Pipeline Products under Development by Companies 18

4.1 Inhalable Drug Delivery Devices Companies – Pipeline Products by Stage of Development 18

4.2 Inhalable Drug Delivery Devices – Pipeline Products by Stage of Development 19

5 Inhalable Drug Delivery Companies and Product Overview 21

5.1 Acorda Therapeutics Inc Company Overview 21

5.1.1 Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 21

5.2 Baxter International Inc Company Overview 22

5.2.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.3 Bellerophon Therapeutics Inc Company Overview 23

5.3.1 Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.4 Breath Therapeutics Holding BV Company Overview 27

5.4.1 Breath Therapeutics Holding BV Pipeline Products & Ongoing Clinical Trials Overview 27

5.5 Canigma A.L LTD Company Overview 30

5.5.1 Canigma A.L LTD Pipeline Products & Ongoing Clinical Trials Overview 30

5.6 Edixomed Ltd Company Overview 31

5.6.1 Edixomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

5.7 iDTx Systems, Inc. Company Overview 33

5.7.1 iDTx Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

5.8 Impel NeuroPharma Inc Company Overview 34

5.8.1 Impel NeuroPharma Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.9 Kanabo Research Ltd Company Overview 37

5.9.1 Kanabo Research Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

5.10 Mallinckrodt Plc Company Overview 39

5.10.1 Mallinckrodt Plc Pipeline Products & Ongoing Clinical Trials Overview 39

5.11 Medical Developments International Ltd Company Overview 40

5.11.1 Medical Developments International Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

5.12 Medspray BV Company Overview 45

5.12.1 Medspray BV Pipeline Products & Ongoing Clinical Trials Overview 45

5.13 NeuroproteXeon Inc Company Overview 47

5.13.1 NeuroproteXeon Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.14 Next Safety, Inc. Company Overview 50

5.14.1 Next Safety, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50

5.15 Nobilis Therapeutics Inc Company Overview 51

5.15.1 Nobilis Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.16 Sandoz International GmbH Company Overview 54

5.16.1 Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 54

5.17 Texas Tech University Health Sciences Center Company Overview 55

5.17.1 Texas Tech University Health Sciences Center Pipeline Products & Ongoing Clinical Trials Overview 55

5.18 University of Texas Health Science Center at Houston Company Overview 56

5.18.1 University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 56

5.19 Vectura Group Plc Company Overview 57

5.19.1 Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 57

5.20 Vero Biotech LLC Company Overview 61

5.20.1 Vero Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 61

5.21 VitalMIST Company Overview 63

5.21.1 VitalMIST Pipeline Products & Ongoing Clinical Trials Overview 63

5.22 Windtree Therapeutics Inc Company Overview 64

5.22.1 Windtree Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 64

6 Inhalable Drug Delivery Devices – Recent Developments 69

6.1 Apr 30, 2019: Windtree Therapeutics appoints Daniel Geffken to Board of Directors 69

6.2 Apr 26, 2019: AstraZeneca: Q1 2019 results 69

6.3 Apr 25, 2019: Baxter reports first-quarter 2019 results 71

6.4 Apr 23, 2019: Catalent invests $14 million at Its Eberbach, Germany Softgel facility 73

6.5 Apr 12, 2019: Inhalation Sciences wins place on prestigious EU-funded Life Science Investment Hotlist 74

6.6 Apr 11, 2019: Catalent Celebrates opening of second Shanghai facility to optimize global and local clinical supply solutions for China 74

6.7 Apr 05, 2019: JC Pharma plans stock exchange listing to develop CannatolRx 75

6.8 Apr 02, 2019: 3M Drug Delivery Systems relocates UK R&D to new, state-of-the-art facility 75

6.9 Apr 01, 2019: Inhalation Sciences receives new Contract Research order for DissolvIt 76

6.10 Apr 01, 2019: Vectura Group names Kevin Matthews to its board of directors 76

6.11 Mar 27, 2019: Mountain rescue study launches to investigate use of Penthrox (methoxyflurane) for trauma-related pain in hostile environments 77

6.12 Mar 27, 2019: AstraZeneca leads in the development of a new International Life Science Innovation Park in China 78

6.13 Mar 26, 2019: Breath Therapeutics announces initiation of global phase 3 trials for the treatment of bronchiolitis obliterans syndrome 79

6.14 Mar 26, 2019: AstraZeneca slash almost 100 jobs in manufacturing 'hammer blow' 80

6.15 Mar 26, 2019: Vectura Group 2018 preliminary results 80

6.16 Mar 20, 2019: Breath Therapeutics announces presentations at Upcoming Scientific Conferences 92

6.17 Mar 14, 2019: Eyepoint Pharmaceuticals reports fiscal period ended december 31, 2018 financial results and highlights recent clinical and operational developments 93

6.18 Mar 14, 2019: AstraZeneca: Appointment of M s. Sarah Wang as an additional director 95

6.19 Mar 14, 2019: Bellerophon provides business update and reports fourth quarter and full-year 2018 financial results 95

6.20 Mar 14, 2019: AAP updates vaccine recommendations for 2019-2020 Flu season 97

6.21 Mar 12, 2019: Techniques for achieving high dose accuracy to be presented by Catalent Biologics experts at ISPE Aseptic Conference 98

6.22 Mar 04, 2019: Sunovion Pharmaceuticals appoints Dr. Antony Loebel as President and CEO 98

6.23 Feb 21, 2019: Inhalation Sciences Sweden year-end report 2018 99

6.24 Feb 21, 2019: Catalent Appoints Kay Schmidt to executive leadership team to lead new technical operations organization 100

6.25 Feb 19, 2019: Impel NeuroPharma names Jennifer L. Berman as vice president of marketing 100

6.26 Feb 19, 2019: Solutions for assay automation to be presented by Catalent Biologics At BEBPA US Bioassay Conference 101

6.27 Feb 15, 2019: Bristol pharmaceutical company Avara Avlon Pharma collapses putting 270 jobs at risk 101

6.28 Feb 15, 2019: Aradigm announces plans for reorganization under Chapter 11 of the U.S. Bankruptcy Code 101

6.29 Feb 14, 2019: AstraZeneca announces full-year and Q4 2018 results 102

6.30 Feb 05, 2019: Catalent reports second quarter fiscal 2019 results 105

6.31 Jan 31, 2019: Baxter reports 2018 fourth-quarter and full-year results 109

6.32 Jan 28, 2019: Bellerophon to Present Clinical Data Supporting Actigraphy as a Clinically Meaningful Endpoint to Detect Improvements in Pulmonary Fibrosis Patients 111

6.33 Jan 28, 2019: EyePoint Pharmaceuticals names David Guyer, M.D., to Board of Directors 112

6.34 Jan 22, 2019: Baptist Health Expands CORE Value Suite Roll-out Across Five Hospitals 113

6.35 Jan 09, 2019: AstraZeneca laying off 200-plus in Boulder, Longmont 113

6.36 Jan 07, 2019: Nobilis Therapeutics announces IND filing for a phase IIb clinical trial of NBTX-001 drug/device combination for treatment of posttraumatic stress disorder 113

6.37 Jan 07, 2019: Bellerophon announces top-line results from cohort 1 of the INOpulse phase 2b clinical trial for treatment of pulmonary hypertension associated with interstitial lung disease 114

6.38 Jan 07, 2019: AstraZeneca announces organisational changes 115

6.39 Jan 07, 2019: Aptamer Group and AstraZeneca sign agreement to explore feasibility of developing drug delivery vehicles 117

6.40 Jan 06, 2019: Impel Neuropharma announces positive phase 1 trial for INP105 for the treatment of acute agitation In Bipolar I Disorder and Schizophrenia 117

6.41 Jan 03, 2019: Amphastar Pharmaceuticals announces launch of Primatene MIST to nationwide retail pharmacies 119

6.42 Dec 21, 2018: NPXe Announces First Patient Enrolled in Phase III trial of XENEX Inhaled Xenon Gas Therapy 119

6.43 Dec 14, 2018: AstraZeneca: Non-executive Board changes 120

6.44 Dec 13, 2018: Update on UK GSK patent litigation 121

6.45 Dec 12, 2018: Lower-priced spacer chambers could compromise young asthma patients'' treatment 121

6.46 Dec 10, 2018: New data from the AEROSURF phase 2b clinical program shows AEROSURF appears to reduce incidence and severity of Bronchopulmonary Dysplasia in preterm infants with RDS 122

6.47 Dec 06, 2018: Baxter International names Patricia Morrison and Amy Wendell to its Board 123

6.48 Dec 06, 2018: Catalent celebrates 20 Years at Philadelphia Facility 124

6.49 Dec 04, 2018: Consort Medical delivers profit growth in the first half 124

6.50 Dec 03, 2018: Gentle treatment for premature babies with lung diseases 134

6.51 Nov 27, 2018: EyePoint Pharmaceuticals names Ron Honig, Esq., as SVP, general counsel & company secretary 135

6.52 Nov 26, 2018: Vectura announces results for late stage clinical asset VR475 in severe uncontrolled asthma 136

6.53 Nov 15, 2018: Inhalation Sciences third quarter report 2018 137

6.54 Nov 09, 2018: Vectura and Hikma to jointly develop generic versions of GSK’s Ellipta 140

6.55 Nov 08, 2018: Mallinckrodt earns International Standard ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) certifications for INOmax DSIR Plus Nitric Oxide Delivery Systems 141

6.56 Nov 08, 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma 142

6.57 Nov 08, 2018: AstraZeneca: Year-to-date and Q3 2018 results 144

6.58 Nov 07, 2018: Amphastar Pharmaceuticals announces reintroduction of Primatene MIST 146

6.59 Nov 07, 2018: Bellerophon provides business update and reports third quarter 2018 financial results 147

6.60 Nov 07, 2018: Impel NeuroPharma names Ellen A. Lubman as chief business officer 149

6.61 Nov 06, 2018: UDG Healthcare: Director declaration 2018 150

6.62 Nov 06, 2018: Consort Medical announces its board change 150

6.63 Nov 06, 2018: EyePoint Pharmaceuticals reports fiscal first quarter 2019 financial results and highlights recent clinical and operational developments 150

6.64 Oct 31, 2018: Baxter reports third-quarter 2018 results and updates financial outlook for full-year 2018 152

6.65 Oct 31, 2018: Vectura Group: Directorate change 154

6.66 Oct 30, 2018: EyePoint Pharmaceuticals appoints John Landis, Ph.D., M.S., to Board of Directors 154

6.67 Oct 23, 2018: Penthrox approved in Hong Kong 155

6.68 Oct 22, 2018: Vectura group has announced the board change 156

6.69 Oct 22, 2018: Softhale announces New Board Member 156

6.70 Oct 17, 2018: Camallergy Appoints Baxter Phillips III as Chief Executive Officer 156

6.71 Oct 11, 2018: Penthrox is approved in Saudi Arabia 157

6.72 Oct 09, 2018: Bellerophon provides update on INOpulse phase 2b clinical program for treatment of pulmonary hypertension associated with interstitial lung disease 158

6.73 Oct 09, 2018: Astrazeneca sues block Zydus Cadila bid generic nexium 159

6.74 Oct 02, 2018: PARI Pharma’s eFlow Technology device, LAMIRA, approved as the only nebulizer system to deliver Insmed’s ARIKAYCE 159

6.75 Sep 19, 2018: Inhalation Sciences receives

2.4 MSEK order from global corporation based in Europe 160

6.76 Sep 12, 2018: Consort to develop delivery device for opioid overdose drug 160

6.77 Sep 12, 2018: EyePoint Pharmaceuticals reports fiscal 2018 fourth quarter & full year financial results and highlights recent progress 161

6.78 Sep 11, 2018: Vectura Group: Interim Results 163

6.79 Sep 10, 2018: EyePoint Pharmaceuticals names Goran Ando as Next Chairman of Board of Directors 173

6.80 Sep 06, 2018: AstraZeneca: Directorate change 174

6.81 Aug 30, 2018: Penthrox Paediatric trial: Safety update 175

6.82 Aug 30, 2018: Catalent experts to discuss ways to accelerate biologics development and manufacturing at Bioprocess International Conference 175

6.83 Aug 29, 2018: Medical Developments International announce Penthrox Inhaler USA update 176

6.84 Aug 29, 2018: Impel Neuropharma announces first subject dosed in phase 1 trial evaluating INP105 for the treatment of acute agitation in bipolar I disorder and schizophrenia 177

6.85 Aug 28, 2018: Catalent announces fourth quarter fiscal 2018 financial results 178

6.86 Aug 24, 2018: Cadila Healthcare’s Biologics manufacturing facility successfully completes USFDA inspection 182

6.87 Aug 23, 2018: Mallinckrodt and NPXE announce FDA fast track designation for phase 3 trial of inhaled xenon gas therapy 182

6.88 Aug 22, 2018: Impel NeuroPharma announces first patient dosed in phase 3 trial evaluating INP104 for the treatment of Acute Migraine Headache 183

6.89 Aug 22, 2018: Inhalation Sciences publishes interim report for the second quarter of 2018 183

6.90 Aug 21, 2018: Vectura Group announces positive findings from its VR647 Phase II pharmacokinetic and mouthpiece methodology studies 185

6.91 Aug 16, 2018: Nu-Med optimistic about nitric oxide prospects after patent ruling 186

6.92 Aug 15, 2018: Eyepoint Pharmaceuticals appoints John Weet, Ph.D., as SVP, regulatory affairs & quality 187

6.93 Aug 14, 2018: Aradigm announces second quarter 2018 financial results 188

6.94 Aug 07, 2018: Bellerophon announces results of interim analysis of phase 3 INOvation-1 study evaluating INOpulse for treatment of pulmonary arterial hypertension 189

6.95 Aug 06, 2018: Inhalation Sciences wins Contract Research order worth

0.6 MSEK from leading European inhalation company 189

6.96 Aug 06, 2018: Anvisa suspends sale and use of lots of nasal decongestant 190

6.97 Aug 01, 2018: AstraZeneca faces US DOJ probe for alleged funding of Iraqi terrorists 190

6.98 Aug 01, 2018: Bellerophon provides business update and reports second quarter 2018 financial results 191

6.99 Jul 31, 2018: Nu-Med Plus Approaches Landmark Certification to Speed New Nitric Oxide Medical Device Approval 192

6.100 Jul 26, 2018: Baxter Reports Second-Quarter 2018 Results and Increases Earnings Outlook for Full-Year 2018 193

6.101 Jul 25, 2018: Medical Developments International announce USA Update 195

6.102 Jul 23, 2018: Windtree announces completion of new design development for its Aerosol Delivery System (ADS) including successful performance testing 195

6.103 Jul 16, 2018: Penthrox approved in Italy, The Czech Republic and Spain 196

6.104 Jul 16, 2018: Impel NeuroPharma Strengthens Leadership Team With Appointment Of Lynn C. Gold As Senior Vice President Of Regulatory Affairs 196

6.105 Jul 16, 2018: Vectura Appoints Paul Fry as Chief Financial Officer and Executive Director 197

6.106 Jul 12, 2018: Catalent Appoints Marlene Leuenberger As General Manager Of New Drug Development Center Of Excellence 198

6.107 Jul 06, 2018: Aradigm Names Dr. Theresa Matkovits As Board Director 198

6.108 Jun 28, 2018: Baxter Releases 2017 Corporate Responsibility Report and Reinforces Its Commitment to Enriching Communities Around the World 199

6.109 Jun 26, 2018: EyePoint Pharmaceuticals Names Goran Ando As Board Director 200

6.110 Jun 26, 2018: Catalent Biologics Names Dr. Graham Brearley As General Manager of its Madison, Wisconsin Facility 200

6.111 Jun 25, 2018: Penthrox approved in Portugal and Switzerland 201

6.112 Jun 21, 2018: MedPharm Licenses Its MedSpray Technology to Virpax 201

6.113 Jun 14, 2018: Consort Medical delivered another year of good growth in revenue and profit 202

6.114 Jun 13, 2018: Catalent Pharma Solutions Names Paul Hegwood As New President Of Clinical Supply Services 205

6.115 Jun 01, 2018: Vectura Group Appoints Anne Whitaker As Non-Executive Director 205

6.116 May 31, 2018: Windtree Therapeutics'' Aerosolized KL4 Surfactant Preclinical Data in Influenza Presented at the 2018 American Thoracic Society Meeting 206

6.117 May 22, 2018: Windtree Receives $0.7 Million SBIR Grant in Continuing Support of the AEROSURF Phase 2b Clinical Trial Completion 207

6.118 May 21, 2018: Baxter Highlights Business Strategies and Innovation at 2018 Investor Conference 208

6.119 May 17, 2018: Catalent Completes $5.5 Million Phased Clinical Storage Expansion At Kansas City Campus 209

6.120 May 16, 2018: Bellerophon to Present Positive Results from Phase 2 Study of INOpulse for Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease at the American Thoracic Society 114th International Conference 210

6.121 May 16, 2018: EyePoint Pharmaceuticals Announces Appointment of Leonard Blum as Executive Vice President and General Manager, U.S. 211

6.122 May 15, 2018: Aradigm Reports First Quarter 2018 Financial Results 211

6.123 May 10, 2018: Bellerophon Provides Business Update and Reports First Quarter 2018 Financial Results 212

6.124 May 09, 2018: European Distribution Partnership between NeuroproteXeon and Linde 214

6.125 May 08, 2018: Bellerophon Reaches Agreement with FDA on Study Design of Phase 2b Trial of INOpulse for Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease 214

6.126 May 08, 2018: Inhalation Sciences’ new CEO Lena Heffler: science, sales, win-win 215

6.127 May 08, 2018: EyePoint Pharmaceuticals Reports Fiscal Third Quarter 2018 Results 216

7 Appendix 218

7.1 Methodology 218

7.2 About GlobalData 221

7.3 Contact Us 221

7.4 Disclaimer 221

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