Pipeline

New Pipeline from Roche, Genentech, Allergan and AMO Pharma

June 18, 2018

Company Drug/Device Medical Condition Status
Alnylam lumasiran Primary Hyperoxaluria Type 1 (PH1) Phase I trial initiated enrolling 25 patients with PH1
Cynata Therapeutics CYP-001 steroid-resistant acute graft-versus-host disease (GvHD) Phase I trial initiated enrolling 8 patients with steroid-resistant acute GvHD
Vizuri Health Sciences VZU00025 osteoarthritis Phase II trial initiated
NeuroRx NRX-101 suicidal bipolar depression Phase IIb/III trial initiated enrolling 12 patients
Allergan atogepant episodic migraine pain Phase IIb/III trial initiated enrolling 795 patients
icotec AG BlackArmor Carbon/PEEK Interbody Cages adults and children with hemophilia A without factor VIII inhibitors 510(k) Clearance granted by the FDA
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA assay Lyme disease bacteria 510(k) clearance granted by the FDA
AbbVie and Roche Venclexta in combination with Rituxan (rituximab) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Approval granted by the FDA
Genentech Rituxan (rituximab) moderate to severe pemphigus vulgaris (PV) Approval granted by the FDA
Fujirebio Diagnostics Lumipulse G B•R•A•H•M•S PCT Assay bacterial infections Clearance granted by the FDA
DyAnsys Drug Relief reduce the symptoms of opioid withdrawal without narcotics Clearance granted by the FDA
Arcus Biosciences AB928 breast and gynecologic malignancies Clearance granted by the FDA
Nordic Nanovector Betalutin relapsed or refractory follicular lymphoma (FL) Fast Track Designation granted by the FDA
Ironwood Pharma olinciguat (IW-1701) sickle cell disease Orphan Drug Designation granted by the FDA
AMO Pharma AMO-04 Rett Syndrome Orphan Drug Designation granted by the FDA
Samus Therapeutics PU-H71 myelofibrosis Orphan Drug Designation granted by the FDA

Pipeline new from Royal Philips, Janssen, Mylan, and Curis

June 11, 2018

Company Drug/Device Medical Condition Status
Peloton Therapeutics, Inc. PT2977 (oral HIF-2α inhibitor) Treatment of von Hippel-Linau (VHL) disease-associated kidney cancer Phase II trial initiated enrolling 50 subjects in the U.S.
Viking Therapeutics, Inc. VK2809 Primary hypercholesterolemia and non-alcoholic fatty liver desease (NAFLD) Phase II trial initiated
Tricida, Inc. TRCA-301 chronic kidney disease patients with metabolic acidosis Phase III trial initiated enrolling 217 subjects in the U.S. and Europe
Janssen (part of Johnson & Johnson) esketamine nasal spray adults with treatment-resistant depression Phase III trial initiated
Camber Spine Technologies ENZA (Titanium Anterior Lumbar Interbody Fusion (ALIF) system autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 510(k) clearance granted by the FDA
Royal Philips Ingenia Elition 3.0T MR solution increased diagnostic performance 510(k) clearance granted by the FDA
Partner Therapeutics, Inc. Leukine adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrom of Acute Radiation Syndrome) Approval granted by the FDA
Mylan Fulphila (pegfilgrastim-jmbd) febrile neutropenia Approval granted by the FDA
Eli Lilly and Incyte Corporation OLUMIANT (baricitnib) adults with moderately-to-severely active Rheumatoid Arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies Approval granted by the FDA
Micronics, Inc. PanNAT STEC Test Shiga toxin-producing E. Coli (STEC) Clearance granted by the FDA
Chugai Pharmaceutical Co., Ltd. HEMLIBRA (U.S. generic name: emicizumab-kxwh) adults and children with hemophilia A without factor VIII inhibitors Priority Review Designation granted by the FDA
Pfizer Talazoparib germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC) Priority Review Designation granted by the FDA
Pfizer Xalkori (crizotinib) relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive Breakthrough Therapy Designation granted by the FDA
AutoGenomics, Inc. INFINITI Neutral Response Panel opioid dependency Breakthrough Device Designation granted by the FDA
Curis, Inc. fimepinostat (CUDC-907) relapsed or fractory (R/R) diffuse large B-cell lymphoma (DLBCL) Fast Track Designation granted by the FDA
Alnylam Pharmaceuticals, Inc. ALN-TTRsc02 Transthyretin-mediated amyloidosis Orphan Drug Designation granted by the FDA

Pipeline new from Atox, Dova, Sage, Zeto and Pfizer

June 4, 2018

Company Drug/Device Medical Condition Status
NeoImmune Tech, Inc. HyLeukin-7 brain cancer Phase I trial initiated enrolling up to 75 subjects
Atox Bio Reltecimod Abdominal sepsis and Stage 2/3 Acute Kidney Injury (AKI) Phase II trial initiated enrolling 120 subjects at approximately 50 level 1 trauma centers in the U.S.
Atox Bio Reltecimod Necrotizing Soft Tissue Infections (NSTI) Phase III trial initiated enrolling 290 subjects at approximately 70 level 1 trauma sites in the U.S.
Synedgen Catasyn Advanced Technology Wound Hydrogel wound care 510(k) clearance granted by the FDA
Novartis Promacta (eltrombopag) Severe aplastic anemia (SAA) sNDA approval granted by the FDA
Nektar Therapeutics NKTR-181 chronic lower back pain NDA approval granted by the FDA
Sage Therapeutics brexanolone (SAGE-547) postpartum depression (PPD) NDA approval granted by the FDA
MicroVention, Inc. Low profile Visualized Intraluminal Support (LVIS) and LVIS Jr. neuro stent devices wide-necked saccular intracranial aneurysms PMA granted by the FDA
Dova Pharmaceuticals Doptelet (avatrombopag) thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure Approval granted by the FDA
TherapeuticsMD Imvexxy (TX-004HR) moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), symptom of vulvar and vaginal atrophy (VVA) Approval granted by the FDA
BioMarin Pharmaceutical Palynziq (pegvaliase-pqpz) Henylketonuria (PKU) Approval granted by the FDA
Zeto, Inc. zEEG dry electrode electroencephalography (EEG) headset Approval granted by the FDA
Astellas Pharma Inc. gilteritinib Relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation Priority Review granted by the FDA
Pfizer Xalkori (crizotinib) Metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy Breakthrough Therapy Designation granted by the FDA
Pfizer tafamidis Transthyretin cardiomyopathy Breakthrough Therapy Designation granted by the FDA
Yamo Pharmaceuticals, LLC L1-79 autism spectrum disorder (ASD) Fast Track Designation granted by the FDA
Genea Biocells GBC0905 Facioscapulohumeral muscular dystrophy (FSHD) Orphan Drug Designation granted by the FDA

Pipeline new from Pfizer, Amgen, AstraZeneca, Abbott and Janssen

May 29, 2018

Company Drug/Device Medical Condition Status
Pfizer Inc. investigational RSV vaccine respiratory syncytial virus (RSV) Phase I/II trial initiated enrolling healthy adult volunteers in two age groups of 18-49 and 50-85
Acceleron Pharma Inc. sotatercept pulmonary arterial hypertension (PAH) Phase II trial initiated enrolling 90 subjects
Nabriva Therapeutics lefamulin moderate community-acquired bacterial pneumonia (CABP) Phase III trial topline results reported
Providence Medical Technology, Inc. DTRAX Spinal System posterior cervical fusion in patients with cervical degenerative disc disease 510(k) clearance granted by the FDA
CERENOVUS, part of the Johnson & Johnson Medical Devices Companies EMBOTRAP II Revascularization Device next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke 510(k) clearance granted by the FDA
Lannett Company, Inc. Dronabinol Capsules HIV aNDA approval granted by the FDA
AcelRx Pharmaceuticals, Inc. DSUVIA moderate-to-severe acute pain for adult patients in medically supervised settings NDA approval granted by the FDA
Amgen and Novartis Aimovig (erenumab-aooe) preventative treatment of migraine in adults Approval granted by the FDA
Nestlé Skin Health hyaluronic acid (HA) dermal filler Restylane Lyft correction of age-related volume loss in the back of the hands for patients over the age of 21 Approval granted by the FDA
AstraZeneca Lokelma (sodium zirconium cyclosilicate) treatment of adults with hyperkalemia Approval granted by the FDA
Sun Pharmaceutical Industries Ltd. and Churchill Pharmaceuticals, LLC YONSA (abiraterone acetate) in combination with methylprednisolone metastatic castration-resistant prostate cancer (mCRPC) Approval granted by the FDA
Abbott XIENCE Sierra coronary artery diseasen Approval granted by the FDA
Janssen JULUCA (dolutegravir/rilpivirine) two-drug regimen, once-daily, single-pill for the treatment of human immunodeficiency virus type 1 (HIV-1) infection Approval granted by the EMA
WAT Medical EmeTerm nausea-induced vomiting Clearance granted by the FDA
UTILITY therapeutics Ltd mecillinam (injectable) and pivmecillinam (oral prodrug) complicated urinary tract infections (cUTI) QIDP Designation granted by the FDA
Harmony Biosciences, LLC pitolisant cataplexy in patients with narcolepsy Breakthrough Therapy Designation granted by the FDA
bluebird bio, Inc. Lenti-D cerebral adrenoleukodystrophy (CALD) Breakthrough Therapy Designation granted by the FDA
Harmony Biosciences, LLC pitolisant excessive daytime sleepiness in patients with narcolepsy Fast Track Designation granted by the FDA
Berg, LLC BPM 31510 (ubidecarenone) Epidermolysis Bullosa (EB) Orphan Drug Designation granted by the FDA

Pipeline new from Genentech, UCB, Pfizer, and Faxitron

May 21, 2018

Company Drug/Device Medical Condition Status
Entasis Therapeutics ETX0282 and ETX0282CPDP (combination of ETX0282 with cefpodoxime) Oral therapy for infections caused by multidrug-resistant (MDR) Gram-negative pathogens, including MDR and carbapenem-resistant Enterobacteriaceae (CRE) Phase I trial initiated enrolling healthy subjects from Australia
BioMarin Pharmaceutical Inc. Valoctocogene roxaparvovec Hemophilia A patients with pre-existing AAV5 antibodies Phase I/II trial initiated
Alkahest, Inc. ALK4290 and ALK4290-201 newly-diagnosed wet age-related macular degeneration and refractory wet age-related macular degeneration, respectively Phase II trials initiated
Regeneron Pharmaceuticals, Inc.and Sanofi DUPIXENT (dupilumab) moderate-to-severe atopic dermatitis in adolescents ages 12-17 Phase III trial initiated enrolling 251 subjects
MC10, Inc. BioStamp nPoint system data collection platform 510(k) clearance granted by the FDA
Caliber Imaging & Diagnostics Inc. VIVASCOPE System Reflectance confocal microscopy (RCM) devise 510(k) clearance granted by the FDA
CurveBeam LineUP Multi-extremity weight bearing CT system orthopedic extremity imaging 510(k) clearance granted by the FDA
Faxitron VisionCT fully enhances the clinician’s ability for detailed margin assessment by automatically taking images around the entire specimen and reconstructing a navigable 3D render in real time 510(k) clearance granted by the FDA
Turnstone Biologics MG1-HPV Human papillomavirus (HPV)-positive solid tumors IND clearance granted by the FDA
Amneal Pharmaceuticals, Inc. Generic Welchol (colesevelam HCI) 625 mg tablets Cholesterol aNDA approval granted by the FDA
US WorldMeds Lucemyra (lofexidine hydrochloride) mitigation of opioid withdrawl symptoms in adult Approval granted by the FDA
Pfizer Retacrit (epoetin alfaepbx) biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy or the use of zidovudine in patients with HIV infection Approval granted by the FDA
Genentech Actemra Active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age or older Approval granted by the FDA
UCB BRIVIACT (Brivaracetam) monotherapy or adjuctive therapy in patients four years of age and older with partial-onset seizures Approval granted by the FDA
BMG Pharma GelX oral mucositis Approval granted by the EMA
Castle Creek Pharmaceuticals diacerein 1% ointment (CCP-020) Epidermolysis bullosa (EB) Pediatric Disease Designation granted by the FDA
Immunicom, Inc. Immunopheresis therapy cancer tumors Breakthrough Device Designation granted by the FDA

Pipeline new from Bonti, Amneal, Janssen, PaxVax and Genentech

May 14, 2018

Company Drug/Device Medical Condition Status
Nektar Therapeutics NKTR-358 systemic lupus erythematosus (SLE) Phase Ib trial initiated evaluating 50 subjects
Bonti, Inc. EB-001T elective abdominoplasty surgery Phase II trial initiated
Amneal IPX203 advanced Parkinson’s disease Phase III trial initiated to enroll 500 subjects
Prisyna, the oral care division of Synedgen Moisyn product line xerostomia 510(k) clearance granted by the FDA
C4 Imaging LLC HDR MRI Marker use prior to high dose rate (HDR) brachytherapy to accurately locate the position of the applicators that guide the placement of radioactive sources for the treatment of multiple cancers 510(k) clearance granted by the FDA
Palladio Biosciences. Inc. lixivaptan capsules autosomal dominant polycystic kidney disease (ADPKD) IND clearance granted by the FDA
Portola Pharmaceuticals Andexxa antidote for blood thinners rivaroxaban and apixaban Approval granted by the FDA
Janssen Pharmaceutical Companiesof Johnson & Johnson DARZALEX (daratumumab) in combination with VELCADE (bortezomib), a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone – VMP newly-diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) Approval granted by the FDA
PaxVax, Inc. Chikungunya vaccine prevention of the chikungunya virus Fast Track Designation granted by the FDA
Debiopharm International SA Debio 1347 (FGFR 1-3 Inhibitor) unresectable or metastatic tumors with a specific FGFR gene alteration Fast Track Designation granted by the FDA
Genentech Tecentriq triple combination with Avastain (bevacizumab), paclitaxel and carboplatin (chemotherapy) first-line treatement of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) Priority Review granted by the FDA

Pipeline new from Jazz, Wize Pharma, Stealth Biotherapeutics, Ocular Therapeutix and SCYNEXIS

May 7, 2018

Company Drug/Device Medical Condition Status
Ocular Therapeutix OTX-TIC (travoprost intracameral implant) glaucoma and ocular hypertension Phase I trial initiated
Galapagos NV and MorphoSys AG MOR106 moderate-to-severe atopic dermatitis (AD) Phase II trial initiated evaluating 180 subjects
ThromboGenics NV THR-317 administered in combination with ranibizumab (Lucentis, Novartis) Diabetic Macular Edema (DME) Phase II trial initiated enrolling 70 subjects
Wize Pharma, Inc. LO2A Symptomatic treatment of dry eye syndrome (DES) in patients with Sjögren’s syndrome Phase IV trial initiated enrolling 60 subjects in the Israel
Immusoft Corporation Immune System Programming MPS I (Mucopolysaccharidosis type I) Orphan Drug Designation granted by the FDA
Stealth Biotherapeutics elamipretide Leber’s hereditary optic neuropathy (LHON) Orphan Drug Designation granted by the FDA
Conavi TM Medical Inc. Novasight Hybrid System simultaneous imaging of coronary arteries with both intravascular ultrasound (VUS) and Optical Coherence Tomography (OCT) 510(k) clearance granted by the FDA
Jazz Pharmaceuticals Xyrem (sodium oxybate) oral solution cataplexy and Excessive Daytime Sleepiness (EDS) in pediatric narcolepsy patients sNDA filed with the FDA
Acceleron Pharma Inc. ACE-083 Facioscapulohumeral muscular dystrophy (FSHD) treatment Fast Track Designation granted by the FDA
SCYNEXIS, Inc. Oral SCY-078 vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC Fast Track Designation and Qualified Infectious Disease Product (QIDP) granted by the FDA

Pipeline new from Pfizer, Sage, Polyphor, Mithra, Catalyst and QIAGEN

April 30, 2018

Company Drug/Device Medical Condition Status
AOBiome Therapeutics Ammonia Oxidizing Bacteria (AOB) intranasal spray episodic migraine Phase II trial initiated enrolling 303 subjects
Mithra Donesta Vasomotor Symptoms (VMS) in post-menopausal women Phase II top-line results announced evaluating 257 subjects
Concert Pharmaceuticals CTP-543 moderate-to-severe alopecia areata Phase IIa trial initiated evaluating 90 subjects
Aldeyra Therapeutics, Inc. topical ocular reproxalap allergic conjunctivitis Phase III trial initiated enrolling 300 subjects
Catalyst Pharmaceuticals, Inc. Firdapse (amifampridine phosphate) MuSK antibody positive Myasthenia Gravis (MuSK-MG) Phase III trial initiated enrolling 60 subjects in the U.S. and Italy
Pfizer Inc. TRUMENBA (Meningococcal Group B Vaccine) Active immunization to prevent invasive disease caused by Neisseria meningitides group B (MenB) in children ages 1 through 9 years Breakthrough Therapy Designation granted by the FDA
Lumendi, LLC DiLumen C2 second-generation endoscopic accessory indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment 510(k) clearance granted by the FDA
Varian Calypso Anchored Beacon transponder tumor detection 510(k) clearance granted by the FDA
Amerigen Pharmaceuticals Limited and Dipharma S.A. Miglustat 100 mg capsules Adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option aNDA filed with the FDA
Sage Therapeutics intravenous formulation of brexanolone (SAGE-547) postpartum depression (PPD) NDA filed with the FDA
Veloxis Pharmaceuticals A/S de novo indication of ENVARSUS XR (tacrolimus extended-release tablets) Prophylaxis of organ rejection in kidney transplant patients sNDA filed with the FDA
Abeona Therapeutics Inc. ABO-102 AAV-mediated gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA) RMAT Designation granted by the FDA
MeiraGTx Limited AAV-RPGR X-linked retinitis pigmentosa (SLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene Fast Track Designation granted by the FDA
Polyphor balixafortide (POL6326) in combination with eribulin patients with HER2-negative metastatic breast cancer who previously received at least two chemotherapeutic regiments in the metastatic setting Fast Track Designation granted by the FDA
QIAGEN PartoSure preterm birth FDA approved

Pipeline new from Pfizer, Amgen, Genentech, and King-Devick

April 23, 2018

Company Drug/Device Medical Condition Status
Pfizer, Inc. PF-06939926 Duchenne muscular dystrophy (DMD) Phase Ib trial initiated
Synlogic SYNB1618 Phenylketonuria (PKU) Phase I/IIa trial initiated
NovoCure Ltd. STELLAR mesothelioma Phase II top-line results announced evaluating 80 subjects
Fervent Pharmaceuticals FP-101 vasomotor symptoms Phase IIa trials initiated enrolling 112 subjects from across the southeastern U.S.
Janssen Pharmaceutical Companies of Johnson & Johnson esketamine major depressive disorder at imminent risk for suicide Phase IIa results announced evaluating 68 subjects
Glenmark Pharmaceuticals GBR 830 moderate-to-severe atopic dermatitis Phase IIb trials initiated enrolling 392 subjects
Amgen Aimovig (erenumab) migraine Phase IIIb final results announced evaluating 246 subjects
Genentech, Inc. HEMLIBRA (emicizumab-kxwh) hemophilia A without factor VIII Breakthrough Therapy Designation granted by the FDA
King-Devick technologies, inc. K-D Balance conditions that could affect balance 510(k) clearance granted by the FDA
Alkermes ALKS 54641 major depressive disorder NDA filed with the FDA
NeuroVive Pharmaceutical AB KL1333 inherited mitochondrial respiratory chain diseases (MRCD) Orphan Drug Designation granted by the FDA
Boehringer Ingelheim Pharmaceuticals, Inc. Praxbind (idarucizumab) patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding FDA approved

Pipeline new from Stealth Biotherapeutics, Translate Bio, Adynxx, and BiondVax Pharmaceuticals

April 16, 2018

Company Drug/Device Medical Condition Status
Abbott optical coherence tomography (OTC) high-risk, complex coronary artery disease Phase I trials initiated enrolling 3,650 subjects in North America, Europe and Asia
Translate Bio MRT5005 first-in-human clinical trial in patients with cystic fibrosis Phase I/II clearance given by the FDA
Adynxx Inc. brivoligide (AYX1) post-surgical pain Phase II results announced
GTx, Inc. enobosarm post-menopausal stress urinary incontinence (SUI) Phase II trials initiated enrolling 493 subjects at over 60 clinical trial centers across the U.S.
BiondVax Pharmaceuticals Ltd. M-001 universal flu vaccine Phase II trials initiated enrolling 9,630 subjects age 50 years and older across four-to-six countries over a period of two flu seasons
Therapix Ltd. THX-110 adult subjects with Tourette syndrome Phase IIa topline results announced
AbbVie upadacitinib moderate to severe Rheumatoid Arthritis Phase III topline results announced evaluating 37 subjects
Stealth Biotherapeutics elamipretide Barth syndrome Orphan Drug Designation granted
Clovis Oncology Inc. Rubraca (rucaparib) tablets adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy FDA approval granted