Pipeline

New Pipeline Updates from Vaxart, Elucent Medical and Aprea Therapeutics

April 22, 2019

Company Drug/Device Medical Condition Status
Vaxart, Inc. bivalent norovirus vaccine norovirus Phase Ib trial initiated
Zymeworks, Inc. ZW25 HER2-positive metastatic gastric, gastroesophageal junction, and esophageal adenocarcinomas Phase II trial initiated
Cortexyme, Inc. COR388 mild to moderate Alzheimer’s disease (AD) Phase II/III trial initiated enrolling more than 570 subjects at more than 90 sites across the U.S. and Europe
CStone Pharmaceuticals CS1001 in combination with oxaliplatin and capecitabine (XELOX) chemotherapy unresectable, locally advanced, or metastatic gastric adenocarcinoma (GC) and gastro-esophageal junction (GEJ) adenocarcinoma Phase III trial initiated in China
Alnylam Pharmaceuticals, Inc. lumasiran primary hyperoxaluria type 1 (PH1) Phase III trial initiated enrolling 8 subjects aged 6 years and younger
Ultragenyx Pharmaceutical Inc. UX007 long-chain fatty acid oxidation disorders (LC-FAOD) Rare Pediatric Disease designation granted by the FDA
Elucent Medical EnVisio Surgical Navigation System breast tumors 510(k) clearance granted by the FDA
Aprea Therapeutics APR-246 Myelodysplastic Syndromes (MDS) Fast Track designation granted by the FDA
Ultragenyx Pharmaceutical Inc. UX007 long-chain fatty acid oxidation disorders (LC-FAOD) Fast Track designation granted by the FDA
Janssen Pharmaceuticals Balversa (erdafitinib) locally advanced or metastatic bladder cancer Breakthrough Therapy designation granted by the FDA
Viracta Therapeutics, Inc. nanatinostat in combination with valganciclovir post-transplant lymphoproliferative disorder (PTLD), plasmablastic lymphoma, and angioimmunoblastic T cell lymphoma Orphan Drug designation granted by the FDA
Aprea Therapeutics APR-246 Myelodysplastic Syndromes (MDS) Orphan Drug designation granted by the FDA
Gelesis PLENITY (Gelesis100) weight management Clearance to market granted by the FDA
Circassia Pharmaceuticals, Inc. DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) chronic obstructive pulmonary disease (COPD) Approval granted by the FDA
Intact Vascular, Inc. Tack Endovascular System (6F) peripheral arterial disease (PAD) Approval granted by the FDA

 

New Pipeline Updates from Pfizer, Amgen and Synchron

April 15, 2019

Company Drug/Device Medical Condition Status
Immatics IMA203 solid tumors Phase I trial initiated enrolling 15 subjects with relapsed and/or refractory solid tumors for which no standard of care therapy is available
Concert Pharmaceuticals, Inc. CTP-692 schizophrenia Phase I trial initiated
National Institutes of Health (NIH) H1ssF_3928 flu Phase I trial initiated
Synchron, Inc. Stentrode in combination with BrainOS software severe paralysis Phase I trial initiated taking place at hospitals in Melbourne, Australia
Homology Medicines, Inc. HMI-102 phenylketonuria (PKU) Phase I/II trial initiated enrolling adults aged 18 to 55 years
NanOlogy NanoDoce (sterile submicron particle docetaxel suspension) bladder cancer Phase I/II trial initiated
Provention Bio, Inc. PRV-031 (teplizumab) recent onset type 1 diabetes (T1D) Phase III trial initiated enrolling 300 subjects aged 8-17 years with recent onset T1D at 80 centers worldwide
Pfizer IBRANCE (palbociclib) men with HR+, HER2- metastatic breast cancer sNDA approval granted by the FDA
Synspira Therapeutics SNSP113 cystic fibrosis (CF) Orphan Drug designation granted by the EMA
Aggredyne, Inc. AggreGuide A 100 ADP Assay testing cartridge platelet testing technologies Clearance granted by the FDA
Spry Health Loop System chronic obstructive pulmonary disease (COPD) Clearance granted by the FDA
Viiv Healthcare Dovato (combination of dolutegravir (DTG) and lamivudine (3TC)) HIV-1 in adults who had not received treatment before Approval granted by the FDA
Amgen Evenity (romosozumab-aqqg) osteoporosis in postmenopausal women at high risk of breaking a bone (fracture) Approval granted by the FDA

 

New Pipeline Updates from ACell, PellePharm and Merck

April 8, 2019

Company Drug/Device Medical Condition Status
Tizona Therapeutics, Inc. TTX-030 cancer Phase I/Ib trial initiated
Amylyx Pharmaceuticals, Inc. AMX0035 Alzheimer’s Disease Phase II trial initiated enrolling 100 subjects
Odonate Therapeutics, Inc. tesetaxel locally advanced or metastatic breast cancer (MBC) Phase II trial initiated
Poxel SA PXL770 non-alcoholic steatohepatitis (NASH) Phase IIa trial initiated enrolling 100 subjects with nonalcoholic fatty liver disease (NAFLD) who likely have NASH at sites in the U.S.
Biohaven Pharmaceutical Holding Company, Ltd. BHV-3500 migraine Phase II/III trial initiated
Hutchison China MediTech Limited surufatinib (HMPL-012 or sulfatinib) with capecitabine advanced biliary tract cancer (BTC) Phase IIb/III trial initiated
PellePharm, Inc. Patidegib Topical Gel, 2% Gorlin Syndrome Phase III trial initiated enrolling 150 subjects
Aldeyra Therapeutics, Inc. topical ocular reproxalap dry eye disease Phase III trial initiated enrolling 400 subjects with moderate-to-severe dry eye disease
ACell, Inc. Gentrix Surgical Matrix gastroenterological or plastic and reconstructive surgery 510(k) clearance granted by the FDA
ACell, Inc. Gentrix Surgical Matrix Thin urological, gastroenterological or plastic and reconstructive surgery 510(k) clearance granted by the FDA
ACell, Inc. Gentrix Surgical Matrix Plus gastroenterological or plastic and reconstructive surgery 510(k) clearance granted by the FDA
AstraZeneca and Merck selumetinib NF1 plexiform neurofibromas Breakthrough Therapy designation granted by the FDA
CSA Medical, Inc. RejuvenAir System moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB) Breakthrough Device designation granted by the FDA
Fera Pharmaceuticals Avaclyr (acyclovir ophthalmic ointment) herpetic keratitis NDA approval granted by the FDA
Intellirod Spine LOADPRO kyphotic correction surgery De Novo approval granted by the FDA
Immunocore Limited tebentafusp (IMCgp100) metastatic uveal melanoma (mUM) Fast Track approval granted
by the FDA
Clarus Therapeutics Jatenzo (testosterone undecanoate) hypogonadism Approval granted by the FDA
EMD Serono Mavenclad (cladribine) relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS) Approval granted by the FDA

 

New Pipeline Updates from Eisai, Urovant Sciences and Novartis

April 1, 2019

Company Drug/Device Medical Condition Status
International AIDS Vaccine Initiative (IAVI) BG505 SOSIP.664 gp140 HIV Phase I trial initiated enrolling 60 healthy adult subjects in Seattle, Boston and Nairobi
Aerie Pharmaceuticals, Inc. netarsudil ophthalmic solution open-angle glaucoma or ocular hypertension Phase II trial initiated enrolling 208 subjects in Japan
DURECT Corporation DUR-928 (topical) mild to moderate plaque psoriasis Phase IIa trial initiated enrolling 20 subjects at multiple sites across the U.S.
Modra Pharmaceuticals B.V. ModraDoc006/r recurrent or metastatic HER-2 negative breast cancer Phase IIa trial initiated enrolling 24 subjects
Urovant Sciences vibegron overactive bladder (OAB) in men who are receiving pharmacological treatment for benign prostatic hyperplasia (BPH) Phase III trial initiated enrolling 1,000 male subjects with BPH who are also taking BPH medications but continue experiencing OAB symptoms
Breath Therapeutics L CsA i Bronchiolitis Obliterans Syndrome (BOS) Phase III trial initiated enrolling 110 subjects with BOS following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation at leading lung transplant specialty centers in eight countries
Novocure Tumor Treating Fields combined with paclitaxel recurrent, platinum-resistant ovarian cancer Phase III trial initiated enrolling 540 subjects
Eisai Co., Ltd. BAN2401 Alzheimer’s disease Phase III trial initiated enrolling 1,566 subjects with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild Alzheimer’s disease dementia (collectively known as early AD) with confirmed amyloid pathology in the brain
Zimmer Biomet, Inc. ROSA ONE Spine System minimally invasive and complex spine surgeries 510(k) clearance granted by the FDA
Genetesis, Inc. CardioFlux cardiac imaging 510(k) clearance granted by the FDA
Beckman Coulter DxH 520 hematology analyzer neonate, pediatric and critical care 510(k) clearance granted by the FDA
Enzyvant RVT-801 Farber disease Rare Pediatric Disease designation granted by the FDA
Promedior, Inc. PRM-151 Idiopathic Pulmonary Fibrosis (IPF) Breakthrough Therapy designation granted by the FDA
Impulse Dynamics Optimizer Smart System for delivering CCM therapy heart failure Breakthrough Device designation granted by the FDA
Lipella Pharmaceuticals, Inc. LP-10 cancer survivors with hemorrhagic cystitis resulting from pelvic radiation therapy and/or systemic chemotherapy IND approval granted by the FDA
Slayback Pharma LLC Hydroxyprogesterone Ca-proate Injection, USP 250 mg/ 1 ml preterm birth prevention ANDA approval granted by the FDA
Enzyvant RVT-801 Farber disease Fast Track approval granted by the FDA
Novartis Mayzent (siponimod) multiple sclerosis (MS) Fast Track approval granted by the FDA
BrightWater Medical, Inc. ConvertX Biliary Stent System biliary obstructions Approval granted by the FDA
Jazz Pharmaceuticals Sunosi narcolepsy Approval granted by the FDA

 

New Pipeline Updates from Genentech, Vaxart and Allergan

March 25, 2019

Company Drug/Device Medical Condition Status
Sutro Biopharma, Inc. STRO-002 ovarian and endometrial cancers Phase I trial initiated enrolling 160 female subjects with advanced relapsed and/or progressive ovarian, fallopian, primary peritoneal or endometrial cancer
Cytovation AS CyPep-1 HPV-induced warts Phase I trial initiated enrolling 58 subjects with cutaneous warts at the Centre for Human Drug Research in Leiden, the Netherlands
Innovent Biologics, Inc. IBI188 advanced malignant tumors Phase I trial initiated in China
I-Mab Biopharma TJM2, a humanized immunoglobulin G1 (IgG1) targeting granulocyte-macrophage colony-stimulating factor (GM-CSF) autoimmune and inflammatory diseases Phase I trial initiated enrolling 32 healthy subjects in the U.S.
Neurovive Pharmaceutical AB KL1333 mitochondrial disease Phase Ia/Ib trial initiated enrolling healthy subjects in the UK
Vaxart, Inc. norovirus GII.4 vaccine norovirus Phase Ib trial initiated enrolling 86 subjects
Infinity Pharmaceuticals, Inc. IPI-549 in combination with Tecentriq and Avastin (bevacizumab) front-line renal cell cancer (RCC) Phase II trial initiated
Infinity Pharmaceuticals, Inc. IPI-549 in combination with Tecentriq and Abraxane (nab-paclitaxel) front-line triple negative breast cancer (TNBC) Phase II trial initiated
Imugene Limited HER-Vaxx (IMU-131) HER-2 positive gastric cancer Phase II trial initiated enrolling 68 subjects with metastatic gastric cancer overexpressing the HER-2 protein at multiple sites across Asia, Eastern Europe and India
ImmunogenX Latiglutenase celiac disease Phase II trial initiated enrolling subjects at the Mayo Clinic in Rochester, MN
Xeris Pharmaceuticals, Inc. ready-to-use, room-temperature stable liquid glucagon Type 1 diabetes Phase II trial initiated enrolling 48 subjects with Type 1 diabetes who experience episodes of exercise-induced hypoglycemia (EIH) who receive daily insulin treatment via a subcutaneous infusion pump
Via Surgical Ltd. FasTouch Absorbable Fixation System soft tissue repair 510(k) clearance granted by the FDA
Aptar Pharma Bidose nasal spray device depression Breakthrough Therapy designation granted by the FDA
Aimmune Therapeutics, Inc. AR101 peanut allergy BLA approval granted by the FDA
Allergan plc AVYCAZ (ceftazidime and avibactam) complicated intra-abdominal infections (cIAI) in combination with metronidazole and complicated urinary tract infections (cUTI) in pediatric patients three months and older sNDA approval granted by the FDA
Genentech Tecentriq (atezolizumab) in combination with carboplatin and etoposide (chemotherapy) extensive-stage small cell lung cancer (ES-SCLC) Approval granted by the FDA
Sage Therapeutics, Inc. Zulresso (brexanolone) injection postpartum depression (PPD) Approval granted by the FDA
Regeneron Pharmaceuticals, Inc. and Sanofi Dupixent (dupilumab) adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable Approval granted by the FDA

 

New Pipeline Updates from Genentech, Alvotech and Sonavex

March 18, 2019

Company Drug/Device Medical Condition Status
Rocket Pharmaceuticals, Inc. RP-L102 Fanconi Anemia (FA) Phase I trial initiated enrolling 2 FA pediatric subjects
Infinity Pharmaceuticals, Inc. IPI-549 triple negative breast cancer (TNBC) and renal cell cancer (RCC) Phase II trial initiated
Theravance Biopharma, Inc. TD-1473 moderately to severely active ulcerative colitis Phase IIb/III trial initiated
Biohaven Pharmaceutical Holding Company Ltd. troriluzole Spinocerebellar Ataxia (SCA) Phase III trial initiated enrolling 230 subjects at approximately 22 sites in the U.S.
Alvotech AVT02 moderate to severe chronic plaque psoriasis Phase III trial initiated enrolling 400 subjects at approximately 30 sites in Europe
Helsinn Group anamorelin advanced NSCLC with cachexia Phase III trial initiated
Santhera Pharmaceuticals AG Raxone Leber’s hereditary optic neuropathy (LHON) Phase IV trial initiated enrolling 197 subjects in 31 sites across nine European countries and the U.S.
Nvision Biomedical Technologies Vector Hammertoe Correction System foot and ankle procedures 510(k) clearance granted by the FDA
Sonavex, Inc. EchoSure blood flow monitoring 510(k) clearance granted by the FDA
Instrumentation Laboratory GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with Intelligent Quality Management (iQM) rapid basic metabolic panel (BMP) testing at the point of care for diagnosing acute conditions, such as kidney failure, insulin shock, respiratory distress and arrhythmias 510(k) clearance granted by the FDA
Purdue Pharma L.P. nalmefene hydrochloride (HCl) injection emergency treatment of known or suspected opioid overdose Fast Track designation granted by the FDA
Alkem Laboratories Limited Valsartan (generic Diovan) high blood pressure and heart failure Approval granted by the FDA
Aerie Pharmaceuticals, Inc. Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% open-angle glaucoma or ocular hypertension Approval granted by the FDA
Genentech Tecentriq (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albuminbound); nab-paclitaxel]) unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test Approval granted by the FDA
Pfizer, Inc. TRAZIMERA (trastuzumab-qyyp) human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma Approval granted by the FDA

 

New Pipeline Updates from Forbius, Inovio and Janssen

March 11, 2019

Company Drug/Device Medical Condition Status
AOBiome Therapeutics, Inc. B244 pediatric patients with atopic dermatitis (eczema) Phase Ib trial initiated enrolling 36 subjects aged 2 to 17 years
Forbius AVID200 diffuse cutaneous systemic sclerosis (SSc) Phase Ib trial initiated
I-Mab Biopharma TJ107 (HyLeukin) advanced solid tumors Phase Ib/IIa trial initiated enrolling 58 subjects in China
Odonate Therapeutics, Inc. tesetaxel locally advanced or metastatic breast cancer (LA/MBC) Phase II trial initiated enrolling 125 subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive disease who have not previously received a taxane
Eidos Therapeutics, Inc. AG10 transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM) Phase III trial initiated enrolling 510 subjects with symptomatic ATTR-CM, associated with either wild-type or mutant TTR, with New York Heart Association Class I-III symptoms
Inovio VGX-3100 cervical dysplasia caused by human papillomavirus (HPV) Phase III trial initiated enrolling adult female subjects with HPV 16/18 positive biopsy-proven cervical HSIL, otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3
Acceleron Pharma, Inc. ACE-083 Charcot-Marie-Tooth disease (CMT) Orphan Drug designation granted by the FDA
Mitochon Pharmaceuticals MP-101 Huntington’s Disease Orphan Drug designation granted by the FDA
Celgene Corporation fedratinib myelofibrosis Priority Review granted by the FDA
NKMax America SNK01 refractory cancer IND approval granted by the FDA
Breckenridge Pharmaceutical, Inc. Imatinib Mesylate Tablets cancer ANDA approval granted by the FDA
Janssen Spravato major depressive disorder Approval granted by the FDA
Baxter International, Inc. eptifibatide acute coronary syndrome (ACS) Approval granted by the FDA
Adlon Therapeutics, L.P.m Adhansia XR (methylpheni-date hydrochloride) extended-release capsules CII Attention-Deficit/Hyperactivity Disorder (ADHD) Approval granted by the FDA

 

New Pipeline Updates from Agfa, Eisai and Axilum Robotics

March 4, 2019

Company Drug/Device Medical Condition Status
Phoenix Tissue Repair, Inc. PTR-01 recessive DEB (RDEB) Phase I/II trial initiated enrolling 14 subjects
Immunic AG IMU-838 relapsing-remitting multiple sclerosis (RRMS) Phase II trial initiated enrolling 200 subjects in more than 40 centers across four European countries
Debiopharm International SA afabicin (Debio 1450) staphylococcal bone and joint infections (NCT03723551) Phase II trial initiated enrolling 60 subjects with bone or joint infection (BJI)
Mycovia Pharmaceuticals VT-1161 recurrent vulvovaginal candidiasis (RVVC) Phase III trial initiated enrolling 180 subjects in 45 sites in the U.S.
Axilum Robotics TMS-Cobot TS MV Transcranial Magnetic Stimulation (TMS) for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode 510(k) clearance granted by the FDA
Agfa DR 800 multipurpose imaging system with tomosynthesis radiography, fluoroscopy, tomography and advanced clinical applications 510(k) clearance granted by the FDA
Imbrium Therapeutics L.P. and Mundipharma EDO GmbH etoposide toniribate relapsed refractory biliary tract cancer Orphan Drug designation granted by the FDA
Heron Therapeutics, Inc. CINVANTI (aprepitant) injectable emulsion intravenous (IV) use sNDA approval granted by the FDA
Eisai, Inc. labeling update for BELVIQ (lorcaserin HCl) obesity sNDA approval granted by the FDA
Alkermes plc and Biogen, Inc. diroximel fumarate (BIIB098) Multiple Sclerosis (MS) NDA approval granted by the FDA
Taiho Oncology LONSURF (trifluridine/tipiracil) adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neutargeted therapy Approval granted by the FDA
Spirosure, Inc. Fenom Pro asthma Clearance granted by the FDA
Bausch + Lomb LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% postoperative inflammation and pain following ocular surgery Approval granted by the FDA
BIOTRONIK Orsiro drug-eluting stent (DES) system coronary artery disease Approval granted by the FDA

 

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

 

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