Pipeline

New Pipeline Updates from Janssen, Eli Lilly, Gilead and Lysogene

September 10, 2018

Company Drug/Device Medical Condition Status
Janssen Esketamine nasal spray Treatment-resistant depression in adults Submitted a new drug application to the FDA
EpicGenetics BCG (an inexpensive generic vaccine to prevent tuberculosis) Fibromyalgia Massachusetts General Hospital granted FDA approval for human trial
ARMGO Pharma, Inc. ARM210 (also known as S48168) Ryanodine Receptor Type 1 Related Myopathies (RYR1-RM) Granted Orphan Drug Designation by the FDA
Lysogene LYS-SAF302 Mucopolysaccharidosis Type IIIA (MPS IIIA) Granted Investigational New Drug (IND) clearance by FDA for Phase II-III (AAVance) trial in U.S.
Pfizer Oral Janus kinase 3 (JAK3) inhibitor PF-06651600 Alopecia areata, a chronic autoimmune skin disease that causes hair loss Granted Breakthrough Therapy designation by the FDA
ITF Pharma TIGLUTIK™ (riluzole) oral suspension Amyotrophic lateral sclerosis (ALS) Granted approval by the FDA
Baxter International, Inc. Actifuse Flow Bone Graft Substitute Orthopedic surgical procedures Granted clearance by the FDA
AstraZeneca/MedImmune Anifrolumab Moderate to severe lupus erythematosus (SLE) Flunked Phase III clinical trial
Horizon Pharma plc Teprotumumab Moderate-to-severe active thyroid eye disease (TED) Early completion of enrollment for confirmatory Phase III trial
SillaJen/Lee’s Pharmaceutical Holdings Oncolytic immunotherapy Pexa-Vec (formerly JX-594) Advanced liver cancer First patient enrolled in China in the Phase III PHOCUS clinical trial
Eli Lilly and Company Flortaucipir F 18, a Positron Emission Tomography (PET) imaging agent Predicting brain tau pathology and Alzheimer’s disease diagnosis Phase III trial successfully met two primary endpoints
Advicenne ADV7103 Distal Renal Tubular Acidosis (dRTA) Granted Investigational New Drug (IND) clearance by FDA for ARENA-2 Phase III clinical trial
Gilead Sciences and Galapagos NV Filgotinib, a selective JAK1 inhibitor Active ankylosing spondylitis (AS) in adults Phase II TORTUGA clinical trial met endpoint of greater improvements in AS Disease Activity Score (ASDAS)
Neumentum Non-opioid NTM-001 (pre-mixed bag ketorolac for continuous infusion) Moderately severe acute pain Completed dosing the first cohort of patients in its Phase I trial
PvP Biologics, Inc. Kuma062 Celiac disease Two first-in-human clinical trials initiated

New Pipeline Updates from Pfizer, Shire, Poxel and Compass Pathways

September 4, 2018

Company Drug/Device Medical Condition Status
Cycle Pharmaceuticals Ltd Ketorolac Tromethamine Tablets 10mg (as continuation treatment post IV/IM dosing of ketorolac tromethamine) Moderately severe acute pain Granted FDA approval of Abbreviated New Drug Application (“ANDA”)
Compass Pathways Psilocybin, the active ingredient in “magic mushrooms” Treatment-resistant depression Received FDA approval for Phase IIb Clinical Trial
Akcea Therapeutics Waylivra (volanesorsen) Familial chylomicronemia syndrome (FCS) Received Complete Response Letter from FDA
Poxel SA Imeglimin Type 2 diabetes Patient enrollment completed in TIMES 3 trial of the Phase III registration program
Ceterix Orthopaedics, Inc. NovoStitch® Pro Meniscal Repair System – size 0 suture cartridge Meniscal tears 501 (k) clearance granted by the FDA
Reflection Biotechnologies Limited RBIO-101 program (AAV.CYP4V2), an AAV-based gene therapy product Bietti’s Crystalline Dystrophy (BCD) Granted Orphan Drug Designation by the FDA
Berlin Cures BC 007, a DNA-based aptamer compound that binds to and eliminates functional pathogenic autoantibodies Cardiomyopathy Announced successful completion Phase I trial
Novaremed AG Lead compound NRD.E1, a novel, first-in-class, small molecule Diabetic neuropathy pain Announced funding goal reached to begin global Phase IIb trial
Promore Pharma AB LL-37 Venous leg ulcers Approval to start Phase IIb clinical trial in Sweden and Poland
Pfizer Tafamidis Transthyretin Cardiomyopathy Announced Phase III findings that therapy cut death risk by 30 percent in patients with distinct disease type
Ortho Dermatologics New Drug Application for ALTRENO™ (tretinoin 0.05%) lotion Acne vulgaris in patients 9 years of age and older Granted approval by the FDA
Kala Pharmaceuticals, Inc. INVELTYS™ (loteprednol etabonate ophthalmic suspension) 1% Post-operative inflammation and pain following ocular surgery Granted approval by the FDA
Biocodex DIACOMIT (stiripentol) Seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam Granted approval by the FDA
Dompé Oervate™ (cenegermin-bkbj ophthalmic solution) neurotrophic keratitis (NK) Granted approval by the FDA
Seqirus Next-generation cell-based vaccine manufacturing process at Holly Springs, N.C. Influenza Granted approval by the FDA
Shire Takhzyro (lanadelumab-flyo) injection Hereditary angioedema (HAE) in people 12 years of age and older Granted approval by the FDA

New Pipeline Updates from Aravive Biologics, Biohaven Pharma and Sun Pharmaceutical

August 27, 2018

Company Drug/Device Medical Condition Status
Aravive Biologics, Inc. AVB-S6-500 Platinum-resistant ovarian cancer Granted Fast Track Designation by the FDA
Biohaven Pharma BHV-0223 Social anxiety and public speaking anxiety disorders Positive data from a proof-of-concept Phase III clinical trial
Sun Pharmaceutical Industries Ltd. Cequa (cyclosporine ophthalmic solution) 0.09 percent Keratoconjunctivitis sicca (dry eye) Approval granted by FDA
Lion TCR Pte. Ltd. LioCyx™ Relapsed liver cancer post-liver transplantation Approval granted by Health Sciences Authority (HSA), Singapore, for multicenter Phase I/II clinical trial
Taiwan Liposome Company, Ltd. TLC590, a proprietary BioSeizer™ liposomal formulation of ropivacaine Postsurgical pain Dosing of first patients in a Phase I/II trial
Teva Pharmaceuticals Generic version of EpiPen Auto-Injector Severe allergic reactions Approval granted by the FDA
BeiGene Ltd. Tislelizumab, an investigational anti-PD-1antibody, combined with chemotherapy as a potential first-line treatment Stage IIIB or IV squamous non-small cell lung cancer (NSCLC) Phase III clinical trial initiated
Eiger BioPharmaceuticals, Inc. Avexitide (formerly exendin 9-39) Post-bariatric surgical patients who experience post-bariatric hypoglycemia (PBH) Completion of enrollment in Phase II clinical trial
Escalier Biosciences, BV ESR-114 topical gel Mild-to-moderate psoriasis Phase I/IIa clinical trial initiated
Sangamo Therapeutics, Inc. SB-525, a cDNA gene therapy candidate Hemophilia A Positive preliminary data from the Phase I/II clinical trial
ADC Therapeutics ADCT-402 (loncastuximab tesirine) Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Phase II clinical trial initiated
Alexion Pharmaceuticals, Inc. ALXN1210, investigational long-acting C5 complement inhibitor Paroxysmal nocturnal hemoglobinuria (PNH) FDA accepted Biologics License Application (BLA) for approval
Merck & Co. Keytruda in combination with Alimta (pemetrexed) and platinum chemotherapy as first-line treatment Metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations Granted approval by the FDA
SPR Therapeutics SPRING endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems Pain Cleared by the FDA
Univision 360 Luminelle DTx Hysteroscopy System Hysteroscopy and cystoscopy Received 510(k) clearance from the FDA
Tolero Pharmaceuticals, Inc. Combination therapy with AbbVie’s venetoclax and Tolero’s investigational agent Relapsed/refractory acute myeloid leukemia (AML) Tolero Pharmaceuticals and AbbVie partner for trial

New Pipeline from Ivantis, Genentech, BeiGene and Endomag

August 20, 2018

Company Drug/Device Medical Condition Status
Amicus Therapeutics Galafold (migalastat) Fabry disease Approval granted by the FDA
Arbutus Biopharma Coporation and Alnylam Pharmaceuticals, Inc. ONPATTRO (patisiran) Hereditary transthyretin amyloidosis Approval granted by the FDA
Ivantis, Inc. Hydrus® Microstent, a microinvasive glaucoma surgery (MIGS) device Mild to moderate primary open-angle glaucoma in conjunction with cataract surgery Approval granted by FDA
Genentech Xlair® (omalizumab) Prevention of severe allergic reactions following accidental exposure to foods in people with allergies Breakthrough Therapy Designation granted by the FDA
Samsung Bioepis, Co., Ltd. SB26 ulinastatin-Fc (UTI-Fc) fusion protein Severe acute pancreatitis Phase I trial set to begin
Sesen Bio, Inc. Vicinium™ Non-muscle invasive bladder cancer (NMIBC) Granted Fast Track Designation by the FDA
BeiGene Ltd. Tislelizumab, an investigational anti-PD-1 antibody, combined with chemotherapy Potential first-line treatment for patients with Stage IIIB or IV squamous non-small cell lung
cancer (NSCLC)
Phase III clinical trial initiated
Eiger BioPharmaceuticals, Inc. Avexitide (formerly exendin 9-39) Post-bariatric surgical patients who experience post-bariatric hypoglycemia (PBH) Completion of enrollment in Phase II clinical trial
Izana Bioscience Namilumab Ankylosing spondylitis Phase II proof-of-concept clinical trial initiated
Rafael Pharmaceuticals, Inc. CPI-613 in combination with bendamustine Relapsed or refractory T-Cell Lymphoma Activation of a second clinical trial site for the Phase I study
Endomag Magtrace, the first non-radioactive, dual-tracer Lymphatic mapping in patients with breast cancer undergoing a mastectomy Granted premarket approval granted by the FDA
Cannabics Pharmaceuticals, Inc. Cannabics SR 5mg, daily for 3 months Advanced Cancer and Cancer Anorexia Cachexia Syndrome (CACS) Conclusion of trial announced; officials results are being evaluated
OrthoTrophix, Inc. TPX-100 Osteoarthritis Phase II trial results: improvements in function and cartilage in 55 percent of TPX-100 treated knees
Entasis Therapeutics ETX2514SUL Complicated urinary tract infections, including acute pyelonephritis (kidney infection) in adults Positive topline results from Phase II trial
Realm Therapeutics PR022 Atopic dermatitis Phase II trial failed to reach endpoint goals
INOVA Diagnostics, Inc. QUANTA Flash® HMGCR Aids in the diagnosis of idiopathic inflammatory myopathy (IIM), a group of conditions that affect the skeletal muscles Received FDA clearance

New Pipeline from BioCryst, Elite, PharmaMar and Vertex

August 13, 2018

Company Drug/Device Medical Condition Status
OncoPep, Inc. PVX-410, investigational multi-peptide cancer vaccine Smoldering multiple myeloma (SMM) Phase Ib trial initiated
SW Safety Solutions, Inc. Nitrile Exam Gloves with Low Dermatitis Potential Claim Skin irritation or sensitization Initial – Looking for Principal Investigator to head clinical study
Kyowa Kirin, Inc. Poteligo (mogamulizumabkpkc) injection Relapsed or refractory mycosis fungoides (MF) or Sezary syndrome after at least one prior systemic therapy Approval granted by FDA
Celltrion, Inc. Bevacizumab biosimilar ‘CT-P16’ Metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, and glioblastoma Phase III trial initiated
Apotex Inc. New generic potassium chloride oral solution Hypokalemia (low potassium blood levels) in patients who are on diuretics Approval granted by the FDA under a novel term called the Competitive Generic Therapy designation
Alector, LLC AL001, a human recombinant monoclonal antibody Frontotemporal dementia (FTD) Granted Orphan Drug Designation by the FDA
Pliant Therapeutics, Inc. PLN-74809 Idiopathic pulmonary fibrosis (IPF) Granted Orphan Drug designation by the FDA
Castle Creek Pharmaceuticals, LLC Diacerein 1% ointment (CCP-020) Epidermolysis bullosa simplex (EBS) Fast Track Designation granted by the FDA
Elite Pharmaceuticals, Inc. Generic methadone hydrochloride 5 mg and 10 mg tablets Severe pain, maintenance treatment of opioid addiction (heroin or other morphine-like drugs) Approval granted by the FDA
Alteogen Inc. ALT-P7, an antibody-drug conjugate (ADC) using a Trastuzumab variant form of antibody Gastric cancer Granted Orphan Drug Designation by the FDA
Vertex Pharmaceuticals Inc. Orkambi (lumacaftor/ ivacaftor) Underlying cause of cystic fibrosis in children ages 2 to 5 with the most common form of the disease Approval granted by the FDA
BioCryst Pharmaceuticals, Inc. BCX7353 Prevention of angioedema attacks in patients with hereditary angioedema Fast Track Designation granted by the FDA
PharmaMar Lurbinectedin Small cell lung cancer Granted Orphan Drug Designation by the FDA
Sensus Healthcare, Inc. SRT-100+, the next-generation Superficial Radiation Therapy solution Non-melanoma skin cancers (NMSC) and keloids Granted 501(k) clearance by the FDA
Armagen Inc. GT-184, an investigational enzyme replacement therapy (ERT) Mucopolysaccharidosis type IIIA (also known as Sanfilippo Syndrome A or MPS IIIA) Granted Orphan Drug Designation by the FDA
Shionogi & Co., Ltd Mulpleta®(lusutrom-bopag) Thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure Approval granted by the FDA

New Pipeline from CeraPedics, Armagen, Endomag and Sensus Healthcare

August 6, 2018

Company Drug/Device Medical Condition Status
Clover Biopharmaceuticals, Inc. SCB-808 rheumatoid arthritis (RA) and other autoimmune diseases Phase I trial initiated
Arcus Biosciences, Inc. AB154 anti-TIGIT antibody Phase I trial initiated
CeraPedics P-15L Peptide Enhanced Bone Graft transforaminal lumbar interbody fusion (TLIF) surgery Phase I trial initiated enrolling 364 subjects
BioLineRx Ltd. AGI-134 patient-specific tumor neoantigens Phase I/IIa trial initiated
Avelas BioSciences, Inc. AVB-620 primary, non-recurrent breast cancer undergoing surgery Period II, Phase II trial initiated enrolling 31 subjects
Biohaven Pharmaceutical Holding Company, Ltd. trigriluzole (BHV-4157) mild-to-moderate Alzheimer’s disease (AD) Phase II/III trial initiated enrolling 292 subjects
Kala Pharmaceuticals, Inc. KPI-121 0.25% dry eye disease Phase III trial initiated enrolling 900 subjects
GE Healthcare and Lantheus Holdings, Inc. Flurpiridax coronary artery disease Phase III trial initiated enrolling 650 subjects
Progenics Pharmaceuticals Azedra adult and pediatric subjects 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy NDA approval granted by the FDA
United Therapeutics Corporation Remodulin pulmonary arterial hypertension (PAH) NDA approval granted by the FDA
Sensus Healthcare, Inc. SRT-100+ non-melanoma skin cancer and keloids 510(k) clearance granted by the FDA
Modulated Imaging Clarifi Imaging System peripheral vascular diseases, diabetic foot ulcers, burns, skin flaps and chronic wounds 510(k) clearance granted by the FDA
Daiichi Sankyo Company, Ltd. quizartinib relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) Breakthrough Therapy Designation granted by the FDA
Armagen Inc. GT-184 Mucopolysaccharidosis type IIIA (also known as Sanfilippo Syndrome A or MPS IIIA) Orphan Drug Designation granted by the FDA
Endomag Magtrace breast cancer PMA granted by the FDA
Hologic, Inc. Panther Fusion GBS assay Group B Streptococcus (GBS) Clearance granted by the FDA
Shionogi & Co., Ltd. Mulpleta (lusutrombopag) thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure Approval granted by the FDA
Roche cobas cervical cancer Approval granted by the FDA
Indivior PLC PERSERIS schizophrenia Approval granted by the FDA

New Pipeline from Dermtreat, Allergan, Pfizer, and LifeSignals

July 30, 2018

Company Drug/Device Medical Condition Status
Tolero Pharmaceuticals, Inc. TP-0184, an activin A receptor type 1 (ACVR1) advanced solid tumors Phase I trial initiated
Sangamo Therapeutics, Inc. SB-318 mucopolysaccharidosis type I (MPS 1, Hurler syndrome) Phase I/II trial initiated enrolling up to 9 adult subjects
Dermtreat Rivelin Clobetasol patch (Rivelin-CLO) oral lichen planus (OLP) Phase IIb trial initiated enrolling 240 subjects
Biohaven Pharmaceutical Holding Company Ltd. trigriluzole (BHV-4157) mild-to-moderate Alzheimer’s disease (AD) Phase II/III trial initiated enrolling 292 subjects
MED-EL USA BONEBRIDGE bone conduction hearing implant system individuals 12 years and older who have been diagnosed with conductive hearing loss, mixed hearing loss or single-sided deafness De Novo clearance granted by the FDA
CarboFix Orthopedics LTD. CarboClear Fiber Pedicle Screw System patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion 510(k) clearance granted by the FDA
Cepheid Xpert Xpress Flu/RSV test influenza A and B viruses 510(k) clearance granted by the FDA
Allergan plc AGN-241751 Major Depressive Disorder (MDD) Fast Track Designation granted by the FDA
Flashback Technologies CiperOx CRI M1 monitor detection and monitoring of acute blood loss Clearance granted by the FDA
LifeSignals LP1100 Life Signal Patch healthcare monitoring devices Clearance granted by the FDA
AbbVie and Neurocrine Biosciences, Inc. ORILISSA (elagolix) moderate to severe endometriosis pain Approval granted by the FDA
Ology Bioservices, Inc. and Rafa Laboratories Ltd. Atropine Autoinjector chemical nerve agent poisoning Approval granted by the FDA
Devicor Medical Products, Inc. Magtrace and Sentimag Magnetic Localization System (Sentimag System) for guiding sentinel lymph node biopsies breast cancer Approval granted by the FDA
Senseonics and Integrated Device Technology, Inc. Eversense Continuous Glucose Monitoring (CGM) System Diabetes Approval granted by the FDA
Pfizer Inc. NIVESTYM (filgrastim-aafi) neutropenia Approval granted by the FDA
Agios Pharmaceuticals ivosidenib (Tibsovo) specific gene mutation IDH1 found in patients with acute myeloid leukemia (AML) or those patients who have relapsed or do not respond to standard chemotherapy Approval granted by the FDA

New Pipeline from Adaptiiv, Zavation, Astellas, and Ironwood

July 23, 2018

Company Drug/Device Medical Condition Status
Blade Therapeutics BLD-2660 debilitating fibrotic diseases Phase I trial initiated
SOM Biotech SOM3355 chorea movements associated with Huntington’s disease Phase II trial initiated enrolling 30 subjects
Concentric Analgesics, Inc. CA-008 post-surgical pain Phase II trial initiated
Ironwood Pharmaceuticals, Inc. linaclotide irritable bowel syndrome with constipation (IBS-C) Phase IIIb trial initiated enrolling 600 adult IBS-C subjects in the U.S.
RDD Pharma RDD-0315 fecal incontinence in subjects with spinal cord injury IND clearance granted by the FDA
MaxCyte MCY-M11 (chimeric antigen receptor (CAR) therapeutic candidate) solid tumors IND clearance granted by the FDA
Stryker Corporation Surpass Streamline Flow Diverter unruptured large and giant wide neck intracranial aneurysms PMA granted by the FDA
Astellas Pharma Inc. and Pfizer Inc. XTANDI (enzalutamide) castration-resistant prostate cancer, including men with non-metastatic CRPC sNDA approval granted by the FDA
Adaptiiv 3D Bolus Software cancer 510(k) clearance granted by the FDA
Zavation Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage) cervical spine (C2-C7) and thoracolumbar spine (T1-L5) for partial or total replacement of a diseased, collapsed, damaged or unstable vertebral body 510(k) clearance granted by the FDA
Quidel Corporation Solana Bordetella Complete Molecular Diagnostic Assay detection of Pertussis (whooping cough) Parapertussis Infections 510(k) clearance granted by the FDA
Genentech TECENTRIQ (atezolizumab) in combination with Avastin (bevacizumab) chronic lymphocytic leukemia Breakthrough Therapy Designation granted by the FDA
Gamida Cell NiCord hematopoietic stem cell transplantation (HSCT) Orphan Drug Designation granted by the FDA
Inozyme Pharma INZ-701 ENPP1 Deficiency (GACI in infants and ARHR2 post-infancy) Orphan Drug Designation granted by the FDA
Vallum Corporation polyetheretherketone (PEEK) spinal interbody fusion device spinal fusion Clearance granted by the FDA
SIGA Technologies Inc. and U.S. Department of Health and Human Services’ BARDA TPOXX (tecovirimat) smallpox Approval granted by the FDA
Janssen Pharmaceutical Companies of Johnson & Johnson SYMTUZA darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults Approval granted by the FDA

New Pipeline from BioSight,Vidac Pharma, Zebra Medical Vision and Kolon TissueGene

July 16, 2018

Company Drug/Device Medical Condition Status
OncoNano Medicine ONM-100 intraoperative imaging agent tumor acidosis for the detection of solid tumors Phase I trial initiated enrolling subjects in The Netherlands
BELLUS Health Inc. BLU-5937 chronic cough Phase I trial initiated enrolling 90 subjects in the U.S.
Aeromics, Inc. AER-271 cerebral edema Phase I trial initiated enrolling 78 healthy subjects in the U.S.
Tetra Discovery Partners BPN14770 Fragile X Syndrome Phase II trial initiated enrolling 30 adult male subjects, ages 18-45 years, in the U.S.
BioSight Ltd. BST-236 Newly-diagnosed Acute Myeloid Leukemia (AML) patients, either de novo or secondary to myelodys-plastic disorder (MDS) who are unfit for standard chemotherapy due to its severe toxicity Phase IIb trial initiated enrolling subjects in 25 medical centers in the U.S. and Israel
Vidac Pharma VDA-1102 Actinic Keratosis (AK) Phase IIb trial initiated enrolling 150 subjects in the U.S.
Citius Pharmaceuticals, Inc. Mino-Lok therapy in combination with systemic antibiotics Catheter Related Bloodstream Infections (CRBSIs) Phase III trial initiated enrolling 700 subjects in the U.S.
Kolon TissueGene, Inc. Invossa knee osteoarthritis (OA) Phase III trial initiated enrolling 1,020 subjects in the U.S.
Recursion REC-994 cerebral cavernous malformation (CCM) IND clearance granted by the FDA
Adagene, Inc. ADG-106 advanced solid tumors and non-Hodgkin lymphoma IND clearance granted by the FDA
Bausch + Lomb Loteprednol etabonate ophthalmic gel management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate NDA approval granted by the FDA
Zebra Medical Vision Coronary Calcium Scoring algorithm coronary artery disease (CAD) 510(k) clearance granted by the FDA
OCULOCARE medical Inc. Alleye mobile medical software application indicated for the detection and monitoring of age-related macular degeneration (AMD) 510(k) clearance granted by the FDA
Eagle Pharmaceuticals, Inc. BENDEKA (bendamustine hydrochloride injection, or bendamustine HCI) chronic lymphocytic leukemia Orphan Drug Exclusivity (ODE) granted by the FDA
OBI Pharma Inc. OBI-3424 Treatment of Hepatocellular Carcinoma (HCC) Orphan Drug Designation granted by the FDA
US WorldMeds, LLC LUCEMYRA (lofexidine) tablets First non-opioid medication indicated for mitigation of opioid with-drawal symptoms to facilitate abrupt opioid discontinuation
in adults
Approval granted by the FDA

New Pipeline from Prana, Poxel, Cellerant and Merck & Company

July 9, 2018

Company Drug/Device Medical Condition Status
Prana Biotechnology Ltd PBT434 Parkinsonian diseases Phase I trial initiated
Poxel SA Imeglimin Metabolic diseases, including type 2 diabetes and non-alcoholic steatohepatitis (NASH) Phase III trial initiated enrolling 403 subjects in the U.S.
Cellerant Therapeutics, Inc. romyelocel-L (human myeloid progenitor cells) serious bacterial and fungal infections in patients with de novo acute myeloid leukemia (AML) undergoing induction chemotherapy RMAT designation granted by the FDA
Merck & Company KEYTRUDA in combination with carboplatin-paclitaxel or nab-paclitaxel First-line treatment for metastatic squamous non-small cell lung cancer (NSCLC) Priority Review granted for sBLA by the FDA
Merz Neurosciences Xeomin (incobotulinumtoxinA) chronic drooling in adults with neurodegenerative diseases sBLA approved by the FDA
Compugen Ltd COM701 (first-in-class immunioncology therapeutic antibody targeting PVRIG in patients advanced solid tumors IND clearance granted by the FDA
Elite Pharmaceuticals, Inc. generic Percocet (Oxycodone Hydrochloride and Acetaminophen, USP CII) management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate aNDA approval granted by the FDA
Acadia Pharmaceuticals Inc. NUPLAZID (pimavanserin) capsule Parkinson’s disease psychosis Approval granted by the FDA
Pulmonx Inc. Zephyr Endobronchial Valve (Zephyr Valve) severe emphysema Approval granted by the FDA
Dermira Qbrexza excessive underarm sweating due to primary axillary hyperhidrosis Approval granted by the FDA
ReCor Medical Paradise Ultrasound Denervation System treatment of Hypertension Approval granted by the FDA
Alkermes plc Aristada Initio (aripiprazole lauroxil) schizophrenia in adults Approval granted by the FDA