Pipeline

New Pipeline Updates from Pepscan, Precigen, Inc. and Dignitana AB

July 1, 2019

Company Drug/Device Medical Condition Status
Cyxone T20K multiple sclerosis (MS) Phase I trial initiated enrolling healthy male volunteers in the Netherlands
NantKwest Inc. PD-L1 t-haNK solid tumors Phase I trial initiated
Pepscan clinical neoantigen peptides cancer Phase I trial initiated
I-Mab Biopharma TJC4 advanced malignant tumors Phase I trial initiated
Asieris Pharmaceuticals APL-1202 in combination with BCG (Bacillus Calmette Guerin) non-muscle invasive bladder cancer (NMIBC) Phase Ib trial initiated enrolling subjects in China
Precigen, Inc. PRGN-3006 UltraCAR-T relapsed or refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndrome (MDS) Phase I/Ib trial initiated
Syntrix Pharmaceuticals SX-682 in combination with KEYTRUDA (pembrolizumab) metastatic melanoma Phase I/II trial initiated enrolling 77 subjects at Massachusetts General Hospital and Dana Farber Cancer Institute
Minovia Therapeutics Mitochondrial Augmentation Therapy (MAT) Pearson syndrome Phase I/II trial initiated enrolling seven subjects
Xeris Pharmaceuticals, Inc. developmental ready-to-use glucagon Post-bariatric hypoglycemia (PBH) following bariatric surgery Phase II trial initiated enrolling 12 subjects with PBH
iLiAD Biotechnologies BPZE1 pertussis Phase IIb trial initiated
X4 Pharmaceuticals, Inc. mavorixafor (X4P-001) WHIM (Warts, Hypogammaglobulinemia, Infections and Myelokathexis) Phase III trial initiated enrolling 28 subjects in 20 countries
XW Laboratories Inc. XWL-008 narcolepsy Orphan Drug designation granted by the FDA
Aridis Pharmaceuticals, Inc. AR-501 lung infection associated with cystic fibrosis Orphan Drug designation granted by the FDA
LifeMax Laboratories, Inc. LM-030 Netherton Syndrome Orphan Drug designation granted by the FDA
Boehringer-Ingelheim
Eli Lilly and Company
empagliflozin chronic heart failure Fast Track designation granted by the FDA
Arrowhead Pharmaceuticals Inc. ARO-AAT alpha-1 liver disease Fast Track designation granted by the FDA
ANI Pharmaceuticals, Inc. Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 ml enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile Approval granted by the FDA
Regeneron Pharmaceuticals, Inc.
Sanofi
Dupixent (dupilumab) chronic rhinosinusitis with nasal polyposis (CRSwNP) Approval granted by the FDA
Dignitana AB DigniCap Delta chemotherapy-induced hair loss Approval granted by the FDA

 

New Pipeline Updates from Boehringer Ingelheim, OxThera AB and Amgen

June 24, 2019

Company Drug/Device Medical Condition Status
Cellular Biomedicine Group Inc. anti-CD20 CAR-T diffuse large B-cell lymphoma (DLBCL) Phase I trial initiated enrolling 12 subjects in China
Boehringer Ingelheim
OSE Immunotherapeutics SA
SIRPα antagonist monoclonal antibody BI 765063 (formerly OSE-172) advanced solid tumors Phase I trial initiated
Rocket Pharmaceuticals, Inc. RP-A501 Danon disease Phase I trial initiated enrolling 12-24 pediatric and young adult male subjects
BioNTech SE
Genmab A/S
DuoBody-PD-L1x4-1BB metastatic or unresectable malignant solid tumors Phase I/IIa trial initiated
Reistone Biopharma Company SHR0302 Ulcerative Colitis Phase II trial initiated
Reistone Biopharma Company SHR0302 Crohn’s disease Phase II trial initiated
Zydus Cadila Saroglitazar Magnesium Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH) Phase II trial initiated enrolling 104 subjects at 20 sites across the U.S.
InflaRx N.V. IFX-1 Pyoderma Gangraenosum (PG) Phase IIa trial initiated enrolling 12 subjects with moderate to severe PG at three sites in Canada
Corvidia Therapeutics Inc. Ziltivekimab (previously known as COR-001) advanced chronic kidney disease (CKD) Phase IIb trial initiated enrolling 240 subjects at 50 sites across the U.S.
Arena Pharmaceuticals, Inc. etrasimod 2 mg ulcerative colitis (UC) Phase III trial initiated enrolling subjects with moderately to severely active UC
OxThera AB Oxabact Primary Hyperoxaluria Phase III trial initiated enrolling 22 subjects at 10 sites across Europe and the U.S.
Torque TRQ-1501 relapsed or refractory solid tumors and lymphomas that express any of five tumor-associated antigens (PRAME, WT-1, SSX2, Survivin and NY-ESO-1) Fast Track designation granted by the FDA
Bio-Techne ExoDx Prostate IntelliScore (EPI) test prostate cancer Breakthrough Device designation granted by the FDA
Camurus CAM2029 acromegaly IND approval granted by the FDA
Triumvira Immunologics, Inc. TAC01-CD19 CD19-postive B-cell malignancies IND approval granted by the FDA
Amgen
Allergan plc
KAJINTI (trastuzumab-anns) HER2-overexpressing adjuvant and metastatic breast cancer Approval granted by the FDA
Amgen
Allergan plc
KAJINTI (trastuzumab-anns) HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma Approval granted by the FDA
Novo Nordisk Victoza (liraglutide) Type 2 diabetes in children and adolescents aged 10-17 years Approval granted by the FDA
Kowa Pharmaceuticals America, Inc. LIVALO (pitavastatin) heterozygous familial hypercholesterolemia (HeFH) in subjects eight years and older Approval granted by the FDA

 

New Pipeline Updates from Genentech, Merck and Ivenix, Inc.

June 17, 2019

Company Drug/Device Medical Condition Status

Terns Pharmaceuticals, Inc.

TERN-101

non-alcoholic steatohepatitis (NASH)

Phase I trial initiated

OnKure, Inc.

OKI-179

advanced solid tumors

Phase I trial initiated

Purdue Pharma, L.P.

nalmefene hydrochloride (HCl)

opioid overdose

Phase I trial initiated

Goldfinch Bio, Inc.

GFB-887

kidney disease

Phase I trial initiated

Aerpio Pharmaceuticals, Inc.

AKB-9778

primary open angle glaucoma (POAG)

Phase Ib trial initiated enrolling 48 subjects

Adocia

ADO09

type 1 diabetes

Phase Ib trial initiated enrolling 24 subjects in Germany

Tolero Pharmaceuticals, Inc.

TP-0903

previously treated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)

Phase I/II trial initiated

Pharming Group N.V.

RUCONEST recombinant human C1 esterase inhibitor (rhC1INH)

pre-eclampsia

Phase I/II trial initiated

Noveome Biotherapeutics, Inc.

ST266

persistent corneal epithelial defects (PEDs)

Phase II trial initiated

Ivenix, Inc.

Ivenix Infusion System

infusion

510(k) clearance granted by the FDA

CorMatrix Cardiovascular, Inc.

Cor PATCH

cardiovascular disease

510(k) clearance granted by the FDA

Bolder Biotechnology, Inc.

BBT-059

Acute Radiation Syndrome (ARS)

Orphan Drug designation granted by the FDA

Palatin Technologies, Inc.

PL-8177

non-infectious intermediate, posterior, pan and chronic anterior uveitis

Orphan Drug designation granted by the FDA

Genentech

Rituxan (rituximab) in combination with glucocorticoids (GCC)

granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children two years of age and older

Priority Review granted by the FDA

SpeeDx Pty. Ltd.

ResistancePlus GC

N. gonorrhea

Breakthrough Device designation granted by the FDA

Xenikos B.V.

T-Guard

steroid-refractory acute graft-versus-host disease (SR-aGVHD)

IND approval granted by the FDA

Innovative Health Solutions, Inc.

IB-Stim

irritable bowel syndrome (IBS) in patients ages 11-18

Clearance granted by the FDA

Genentech

Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab)

diffuse large B-cell lymphoma (DLBCL)

Accelerated approval granted by the FDA

Merck

KEYTRUDA

metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC)

Approval granted by the FDA

Senseonics Holdings, Inc.

Eversense Continuous Glucose Monitoring System

diabetes

Approval granted by the FDA

 

New Pipeline Updates from Immunovant, Minoryx Therapeutics and Bayer

June 10, 2019

Company Drug/Device Medical Condition Status
Cellenkos, Inc. CK0801 bone marrow failure syndromes, including aplastic anemia, hypoplastic myelodysplasia and primary myelofibrosis Phase I trial initiated
Xencor, Inc. XmAb22841 advanced solid tumors Phase I trial initiated
Alnylam Pharmaceuticals, Inc. ALN-AGT hypertension Phase I trial initiated enrolling 168 subjects
UCB
Neuropore Therapies, Inc.
UCB0599 Parkinson’s disease Phase Ib trial initiated
Amphera B.V. MesoPher pancreatic cancer Phase II trial initiated enrolling 10 adult subjects with surgically resected pancreatic cancer who have received adjuvant standard of care treatment
Immunovant IMVT-1401 moderate-to-severe active Graves' ophthalmopathy (GO) Phase II trial initiated enrolling eight subjects
Rejenevie Therapeutics AR-100 immune restoration therapy immunology Phase II trial initiated enrolling 20 healthy subjects 55 years of age or older in Freeport, Bahamas
Ironwood Pharmaceuticals, Inc.
Allergan PLC
MD-7246 abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D) Phase II trial initiated enrolling 400 subjects
Verona Pharma PLC metered-dose inhaler formulation of ensifentrine (RPL554) moderate-to-severe chronic obstructive pulmonary disease (COPD) Phase II trial initiated enrolling 36 subjects at two sites in the UK
Minoryx Therapeutics leriglitazone (MIN-102) Friedreich’s Ataxia Phase II trial initiated enrolling 36 subjects 12 years of age or older at numerous sites across Europe
GENFIT elafibranor nonalcoholic fatty liver disease (NAFLD) Phase II trial initiated enrolling 16 subjects with NAFL as identified with magnetic resonance spectroscopy (H-MRS)
Arcutis, Inc. ARQ-151 atopic dermatitis Phase IIa trial initiated
Akero Therapeutics, Inc. AKR-001 non-alcoholic steatohepatitis (NASH) Phase IIa trial initiated enrolling 80 subjects
Ansun Biopharma, Inc. DAS181 lower respiratory tract parainfluenza virus Phase III trial initiated enrolling immunocompromised subjects at sites in the U.S., Europe and Asia
Eyenovia Inc. MicroPine pediatric progressive myopia Phase III trial initiated enrolling 400 subjects ages three to 12 years of age
Incyte pemigatinib (INCB54828) cholangiocarcinoma Phase III trial initiated enrolling 432 subjects
Allergan plc
Gedeon Richter PLC
VRAYLAR (cariprazine) manic or mixed episodes associated with bipolar I disorder in adults sNDA approval granted by the FDA
Cadent Therapeutics CAD-1883 spinocerebellar ataxia (SCA) Orphan Drug designation granted by the FDA
Bayer Aliqopa (copanlisib) marginal zone lymphoma (MZL) Breakthrough Therapy designation granted by the FDA
Imara, Inc. IMR-687 sickle cell disease Fast Track designation granted by the FDA
NovoCure NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy malignant pleural mesothelioma (MPM) Approval granted by the FDA
AveXis Inc. Zolgensma (onasemnogene abeparvovec-xioi) spinal muscular atrophy (SMA) in children less than two years of age Approval granted by the FDA
Novartis Piqray (alpelisib) tablets in combination with the endocrine therapy fulvestran hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced or metastatic breast cancer in postmenopausal women and men Approval granted by the FDA
Novartis Jakafi (ruxolitinib) steroid-refractory acute GVHD in adult and pediatric subjects 12 years and older Approval granted by the FDA
Celgene Corporation REVLIMID (lenalidomide) in combination with a rituximab product (R²) previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) in adults Approval granted by the FDA

 

New Pipeline Updates from Takeda, IO Biotech and Pfizer

May 27, 2019

Company Drug/Device Medical Condition Status
Inovio and CEPI INO-4500 Lassa virus Phase I trial initiated enrolling 60 volunteers
Compugen, Ltd. COM701 in combination with Opdivo (nivolumab) advanced solid tumors Phase I trial initiated enrolling 140 subjects at ten sites in the U.S.
Atriva Therapeutics GmbH ATR-002 influenza Phase I trial initiated enrolling 60 healthy volunteers in Belgium
Axovant Gene Therapies, Ltd. AXO-AAV-GM1 (also known as AAV9-GLB1) GM1 gangliosidosis Phase I trial initiated
Dicerna Pharmaceuticals, Inc. DCR-HBVS chronic hepatitis B virus (HBV) infection in adults Phase I trial initiated enrolling healthy volunteers (HVs) and subjects with non-cirrhotic chronic HBV infection
NeuClone Pharmaceuticals, Ltd. Stelara (ustekinumab) moderate to severe plaque psoriasis in adults and children 12 years or older, active psoriatic arthritis and moderate to severe Crohn’s disease in adults Phase I trial initiated enrolling subjects in Australia
ImaginAb, Inc. 89Zr-Df-IAB22M2C cancer Phase II trial initiated enrolling metastatic cancer subjects
IO Biotech IO102 in combination with KEYTRUDA (pembrolizumab) metastatic non-small cell lung cancer (NSCLC) Phase II trial initiated enrolling 96 subjects at more than 20 sites across the U.S. and Europe
Respivant Sciences RVT-1601 idiopathic pulmonary fibrosis (IPF) Phase IIb trial initiated enrolling 180 subjects in the U.S., Canada and Europe
Rigel Pharmaceuticals, Inc. fostamatinib disodium hexahydrate (fostamatinib) warm antibody autoimmune hemolytic anemia (AIHA) Phase III trial initiated enrolling 80 subjects in the U.S.
Perrigo, Co. Voltaren Gel, 1% (diclofenac sodium topical gel, 1%) osteoarthritis ANDA approval granted by the FDA
Mayne Pharma Group, Ltd. SORILUX (calcipotriene) Foam, 0.005% plaque psoriasis of the scalp and body in patients aged 12 years and older Approval granted by the FDA
Pfizer, Inc. Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults Approval granted by the FDA
UCB NAYZILAM acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older Approval granted by the FDA
Takeda GATEX (teduglutide) for injection pediatric patients one year of age and older with Short Bowel Syndrome (SBS) Approval granted by the FDA
Pfizer, Inc. Fragmin (dalteparin sodium) injection symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older Approval granted by the FDA

 

New Pipeline Updates from InflaRx, Transgene and Eli Lilly

May 20, 2019

Company Drug/Device Medical Condition Status
Tolero Pharmaceuticals, Inc. TP-3654 advanced solid tumors Phase I trial initiated
Tempest Therapeutics Inc. TPST-1120 advanced solid tumor malignancies Phase I/Ib trial initiated enrolling subjects with advanced solid tumors
ORIC Pharmaceuticals ORIC-101 in combination with nab-paclitaxel advanced solid tumors Phase Ib trial initiated
InflaRx IFX-1 ANCA-associated vasculitis (AAV) Phase II trial initiated enrolling 80 subjects at 60 sites across 12 European countries and Russia
Rigel Pharmaceuticals, Inc. fostamatinib disodium hexahydrate (fostamatinib) warm antibody autoimmune hemolytic anemia (AIHA) Phase III trial initiated enrolling 80 subjects in the U.S.
ReGenTree, LLC RGN-259 eye drops dry eye syndrome Phase III trial initiated enrolling 700 subject at 15 sites in the U.S.
Haemonetics Corporation 6s Hemostasis Analyzer System adult trauma 510(k) clearance granted by the FDA
Transgene TG4050 ovarian cancer IND approval granted by the FDA
Merz Americas XEOMIN (incobotulinumtoxinA) blepharospasm (involuntary blinking) sBLA approval granted by the FDA
AliveCor KardiaMobile 6L six-lead personal ECG device cardiovascular disease Clearance granted by the FDA
Genentech and AbbVie Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Approval granted by the FDA
EMD Serono and Pfizer, Inc. BAVENCIO (avelumab) in combination with INLYTA (axitinib) advanced renal cell carcinoma (RCC) Approval granted by the FDA
Eli Lilly and Company CYRAMZA (ramucirumab injection, 10 mg/mL solution) hepatocellular carcinoma (HCC) Approval granted by the FDA
Regeneron Pharmaceuticals, Inc. EYLEA (aflibercept) Injection diabetic retinopathy (DR) Approval granted by the FDA

 

New Pipeline Updates from Savara, AbbVie and Genentech

May 13, 2019

Company Drug/Device Medical Condition Status
Xencor, Inc. XmAb23104 advanced solid tumors Phase I trial initiated
Shattuck Labs, Inc. SL-279252 (PD1/OX40L) advanced solid tumors and lymphomas Phase I trial initiated
Alector, Inc. AL002 Alzheimer’s disease Phase Ib trial initiated
VivaQuant RX-1 Rhythm Express cardiac arrhythmias 510(k) clearance granted by the FDA
Imperative Care, Inc. ZOOM Aspiration System ischemic stroke 510(k) clearance granted by the FDA
LENSAR, Inc. LENSAR Laser System with Streamline IV micro radial incisions to optimize outcomes of refractive cataract procedures 510(k) clearance granted by the FDA
BioLineRx Ltd. AGI-134 solid tumors IND approval granted by the FDA
Phoenix Tissue Repair, Inc. PTR-01 recessive dystrophic epidermolysis bullosa (RDEB) Fast Track designation granted by the FDA
Savara, Inc. Molgradex autoimmune pulmonary alveolar proteinosis (aPAP) Fast Track designation granted by the FDA
Concept Medical, Inc. MagicTouch Sirolimus drug-coated balloon (DCB) catheter coronary in-stent restenosis (ISR) Breakthrough Device designation granted by the FDA
Vertex Pharmaceuticals, Inc. KALYDECO (ivacaftor) cystic fibrosis (CF) in children ages six months to less than 12 months Approval granted by the FDA
AbbVie, Inc. Mavyret (glecaprevir and pibrentasvir) tablets six genotypes of hepatitis C virus (HCV) in children ages 12 to 17 Approval granted by the FDA
Medtronic plc Attain Stability Quad MRI SureScan left heart lead CRT treatment for heart failure Approval granted by the FDA
Genentech Kadcyla (ado-trastuzumab emtansine) adjuvant treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and Herceptin (trastuzumab)-based treatment Approval granted by the FDA
Dr. Reddy’s Laboratories Ltd. Testosterone Gel 1.62% (20.25 mg/1.25 g pump actuation) testosterone deficiency Approval granted by the FDA
Boston Scientific VICI VENOUS STENT System iliofemoral venous obstructive disease Approval granted by the FDA

 

New Pipeline Updates from Bayer, Exelixis and Forbius

May 6, 2019

Company Drug/Device Medical Condition Status
Forbius AVID200 myelofibrosis (MF) Phase I trial initiated
Tetra Discovery Partners BPN14770 early Alzheimer’s disease (AD) Phase II trial initiated enrolling 255 subjects ages 55-85 in 60 sites across the U.S.
Axovant Gene Therapies, Ltd. AXO-Lenti-PD Parkinson’s disease Phase II trial initiated enrolling 60 subjects
3-V Biosciences, Inc. TVB-2640 non-alcoholic steatohepatitis (NASH) Phase II trial initiated enrolling 90 subjects in the U.S. and 25-30 subjects in China
OMEICOS Therapeutics OMT-28 persistent atrial fibrillation (AF) Phase II trial initiated enrolling 120 subjects at sites in four European countries
Exelixis cabozantinib (CABOMETYX) in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) versus nivolumab and ipilimumab previously untreated advanced renal cell carcinoma (RCC) Phase III trial initiated enrolling 676 subjects at 150 sites globally
I-Mab Biopharma and MorphoSys AG TJ202/MOR202 relapsed or refractory multiple myeloma Phase III trial initiated enrolling 291 subjects at sites in China and Taiwan
ACADIA Pharmaceuticals, Inc. pimavanserin major depressive disorder (MDD) Phase III trial initiated enrolling 280 subjects at sites in the U.S.
CoapTech, LLC PUMA-G System gastrostomy 510(k) clearance granted by the FDA
Purdue Pharma, L.P. nalmefene hydrochloride (HCl) injection emergency treatment of known or suspected opioid overdose Competitive Generic Therapy (CGT) designation granted by the FDA
Belite Bio LBS-008 (BPN-14967) atrophic age-related macular degeneration and Stargardt disease IND approval granted by the FDA
AVROBIO, Inc. AVR-RD-01 Fabry disease IND approval granted by the FDA
Finch Therapeutics Group, Inc. Full-Spectrum Microbiota (FSM) pediatric Autism Spectrum Disorder (ASD) Fast Track designation granted by the FDA
Bayer darolutamide non-metastatic castration-resistant prostate cancer (nmCRPC) Priority Review designation granted by the FDA
GlaxoSmithKline Benlysta (belimumab) intravenous (IV) infusion pediatric systemic lupus erythematosus (SLE) Priority Review designation granted by the FDA
United Therapeutics Corporation and XVIVO Perfusion, Inc. XPS and STEEN Solution ex-vivo lung perfusion (EVLP) PMA approval granted by the FDA
Samsung Bioepis Co., Ltd. ETICOVO (etanercept-ykro) rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis Approval granted by the FDA
Regeneron Pharmaceuticals, Inc. and Sanofi Praluent (alirocumab) reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease Approval granted by the FDA
Bausch Health Companies, Inc. DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% plaque psoriasis in adults Approval granted by the FDA

 

New Pipeline Updates from Akorn, AbbVie and Merck

April 29, 2019

Company Drug/Device Medical Condition Status
Innovent Biologics, Inc. and Eli Lilly & Company IBI318 advanced malignancies Phase I trial initiated enrolling subjects in China
TC BioPharm TCB002 Acute Myeloid Leukemia (AML) Phase I trial initiated enrolling 9 subjects in Prague, Czech Republic
Innovent Biologics, Inc. IBI302 wet age-related macular degeneration (wet AMD) Phase I trial initiated enrolling 36 subjects
Vaxiion Therapeutics, Inc. VAX014 non-muscle invasive bladder cancer (NMIBC) Phase I trial initiated
Indalo Therapeutics IDL-2965 nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF) Phase I trial initiated
Galapagos NV, MorphoSys AG and Novartis Pharma AG MOR106 in combination with topical corticosteroids moderate to severe atopic dermatitis Phase II trial initiated enrolling 60 subjects
Forbius AVID100 EGFR-overexpressing Triple Negative Breast Cancer (TNBC) Phase IIa trial initiated enrolling 100 subjects
Evofem Biosciences, Inc. Amphora sexually transmitted bacterial infections Phase IIb trial initiated enrolling more than 850 female subjects who had been treated for chlamydia or gonorrhea in the preceding four months
TaiGen Biotechnology Company, Limited Furaprevir in combination with Yimitasvir chronic hepatitis C Phase III trial initiated enrolling 360 subjects with both cirrhotic and non-cirrhotic genotype 1 in China
GlycoMimetics, Inc. uproleselan Acute Myeloid Leukemia (AML) Phase III trial initiated enrolling 250 subjects with relapsed/refractory AML
Mallinckrodt, plc Acthar Gel (Repository Corticotropin Injection) Systemic Lupus Erythematosus (lupus, SLE) Phase IV trial initiated enrolling 172 subjects with persistently active SLE
Beckman Coulter Early Sepsis Indicator sepsis 510(k) clearance granted by the FDA
TELA Bio, Inc. Restella Reconstructive BioScaffolds reconstructive surgery 510(k) clearance granted by the FDA
Repro-Med Systems, Inc. HIgh-Flo Super26 Subcutaneous Needle Sets subcutaneous infusion of medications 510(k) clearance granted by the FDA
Akorn, Inc. Fluticasone Propionate Nasal Spray temporary relief of hay fever and other upper respiratory allergies in adult and pediatric subjects 4 years of age and older ANDA approval granted by the FDA
Akorn, Inc. Loteprednol Etabonate Ophthalmic Suspension, 0.5% post-operative inflammation following ocular surgery ANDA approval granted by the FDA
Moleculin Biotech, Inc. Annamycin relapsed or refractory acute myeloid leukemia (AML) Fast Track designation granted by the FDA
GENFIT elafibranor Primary Biliary Cholangitis (PBC) in adult subjects with inadequate response to ursodeoxycholic acid (UDCA) Breakthrough Therapy designation granted by the FDA
Viela Bio inebilizumab neuromyelitis optica spectrum disorder (NMOSD Breakthrough Therapy designation granted by the FDA
Knopp Biosciences, LLC dexpramipexole hypereosinophilic syndrome (HES) Orphan Drug designation granted by the FDA
NeuroSigma, Inc. Monarch eTNS System (Monarch) attention deficit hyperactivity disorder (ADHD) Clearance to market granted by the FDA
BAROnova, Inc. TransPyloric Shuttle (TPS) Device obesity Approval granted by the FDA
Boston Scientific Corporation LOTUS Edge Aortic Valve System severe aortic stenosis Approval granted by the FDA
AbbVie SKYRIZI (risankizumab-rzaa) moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Approval granted by the FDA
Merck KEYTRUDA in combination with Inlyta (axitinib) advanced renal cell carcinoma (RCC) Approval granted by the FDA
Teva Pharmaceutical Industries Ltd. generic naloxone hydrochloride nasal spray opioid overdose Approval granted by the FDA

 

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