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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