February 2019

Pipeline

New Pipeline Updates from Genentech, Medtronic and Biohaven Pharmaceutical

February 25, 2019

Company Drug/Device Medical Condition Status
Ocular Therapeutix, Inc. OTX-TKI (tyrosine kinase inhibitor implant) wet Age-related Macular Degeneration (AMD) Phase I trial initiated
Inhibrx, Inc. INBRX-105 PD-L1 expressing tumors Phase I trial initiated
Fusion Pharmaceuticals [225Ac]-FPI-1434 advanced solid tumors Phase I trial initiated enrolling up to 30 subjects
Five Prime Therapeutics, Inc. FPA150 (FPA150-001; NCT03514121) breast, ovarian and endometrial cancers that over-express B7-H4 Phase Ib trial initiated
Advaxis, Inc. ADXS-503 non-small cell lung cancer (NSCLC) Phase I/II trial initiated enrolling 50 subjects at up to 20 sites in the U.S.
Lipocine, Inc. LPCN 1144 non-alcoholic steatohepatitis (“NASH”) with biopsy Phase II trial initiated enrolling male hypogonadal biopsy-confirmed NASH subjects with grade F2/F3 fibrosis
Debiopharm International SA Debio 1347 solid tumors harboring an FGFR fusion (NCT03834220) Phase II trial initiated enrolling subjects with advanced or metastatic tumors whose cells show specific FGFR gene alterations, namely FGFR1, FGFR2 or FGFR3 gene fusions
Novus Therapeutics, Inc. OP0201 otitis media Phase IIa trial initiated enrolling 50 pediatric patients, 6 to 24 months of age, with acute otitis media
Biohaven Pharmaceutical Holding Company Ltd. troriluzole generalized anxiety disorder (GAD) Phase III trial initiated enrolling 372 subjects in 50 sites in the U.S.
Biohaven Pharmaceutical Holding Company Ltd. verdiperstat (previously BHV-3241) multiple system atrophy (MSA) Orphan Drug designation granted by the FDA
Ocugen, Inc. OCU400 NR2E3 mutation-associated retinal degenerative disease Orphan Drug designation granted by the FDA
Modis Therapeutics MT1621 thymidine kinase 2 deficiency (TK2d) Breakthrough Therapy designation granted by the FDA
Medtronic plc Personalized Closed Loop (PCL) insulin pump system diabetes Breakthrough Device designation granted by the FDA
Fujirebio Diagnostics, Inc. Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test Alzheimer’s Disease Breakthrough Device designation granted by the FDA
ARS Pharmaceuticals, Inc. ARS-1 severe allergic reactions that could lead to anaphylaxis Fast Track designation granted by the FDA
Foldax, Inc. Tria surgical aortic heart valve aortic valve disease IDE approval granted by the FDA
Genentech polatuzumab vedotin in combination with bendamustine plus Rituxan (rituximab) (BR) relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Priority Review granted by the FDA
Genentech entrectinib adult and pediatric subjects with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors who have either progressed following prior therapies or as initial therapy when there are no acceptable standard therapies, and for the treatment of subjects with metastatic, ROS1-positive non-small cell lung cancer (NSCLC) Priority Review granted by the FDA
Novo Nordisk Esperoct (turoctocog alfa pegol) formerly known as N8-GP hemophilia A BLA approval granted by the FDA
Merck KEYTRUDA (pembrolizumab) adjuvant treatment of subjects with melanoma with involvement of lymph node(s) following complete resection BLA approval granted by the FDA
Xellia Pharmaceuticals Premixed Vancomycin Injection in a Ready-to-Use (RTU) bag septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections in adult and pediatric subjects (one month and older) NDA approval granted by the FDA
Nexus Pharmaceuticals, Inc. Prochlorperazine Edisylate Injection, USP schizophrenia and severe nausea and vomiting Approval granted by the FDA

 

CWMarketplace

February 2019: Top 10 Industry Provider Profiles

February 25, 2019

CWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their products and services. To learn more about becoming an Industry Provider Profile page subscriber, contact Sales at (617) 948-5100.

Click on any provider to view the company’s complete online profile or search more profiles.

Pipeline

New Pipeline Updates from RDD Pharma, Pulmatrix and IntraBio

February 18, 2019

Company Drug/Device Medical Condition Status
ADC Therapeutics ADCT-402 (loncastuximab tesirine) plus AstraZeneca’s IMFINZI (durvalumab) advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL) Phase I trial initiated enrolling 75 subjects
Exelixis, Inc. XL092 cancer Phase I trial initiated
ReGenTree, LLC and Ora, Inc. RGN-259 dry eye syndrome Phase III trial initiated enrolling 700 subjects
LASEROPTEK Co., Ltd. PicoLO picosecond Nd:YAG laser dermatology and general and plastic surgery 510(k) clearance granted by the FDA
Grifols, S.A. Procleix Babesia assay blood screening 510(k) clearance granted by the FDA
Finch Therapeutics Group, Inc. CP101 recurrent Clostridium difficile (C. difficile) infection Breakthrough Therapy designation granted by the FDA
RDD Pharma, Inc. RDD-0315 fecal incontinence in spinal cord injury Fast Track designation granted by the FDA
Neurotech Pharmaceuticals, Inc. NT-501 (Renexus) macular telangiectasia type 2 (MacTel) Fast Track designation granted by the FDA
IntraBio, Inc. IB1001 GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease) IND approval granted by the FDA
Pulmatrix, Inc. Pulmazole (PUR1900) allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma IND approval granted by the FDA
Precigen, Inc. PRGN-3005 advanced-stage platinum-resistant ovarian cancer IND approval granted by the FDA
Janssen Pharmaceutical Companies of Johnson & Johnson Darzalex (daratumumab) split-dosing regimen multiple myeloma BLA approval granted by the FDA
Sanofi Cablivi (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression acquired thrombotic thrombocytopenic purpura (aTTP) in adults BLA approval granted by the FDA
Medtronic expanded indication for Pipeline Flex embolization device brain aneurysm Approval granted by the FDA
Orthofix Medical, Inc. M6-C artificial cervical disc cervical disc degeneration Approval granted by the FDA