September 2018


New Pipeline Updates from Amryt, Loxo Oncology, Bristol-Myers Squibb and Pfizer

September 17, 2018

Company Drug/Device Medical Condition Status
Amryt AP101 Epidermolysis Bullosa, a genetic disorder that causes skin and lining of internal organs to blister and tear Granted Investigational New Drug clearance by FDA to open U.S. sites as part of EASE Phase III clinical trial
Fibrocell Science, Inc. FCX-013 Moderate to severe localized scleroderma Granted Fast Track designation by the FDA
Loxo Oncology, Inc. LOXO-292 Metastatic RET-fusion-positive non-small cell lung cancer; RET-mutant medullary thyroid cancer Granted Breakthrough Therapy designation by the FDA
Genesys Spine AIS-C Stand-Alone System a first of its kind, non-screw based, zero-profile, direct-anterior interbody system Cervical spine surgery Granted FDA clearance
Perrigo Company plc OTC equivalent of Imodium® Multi-Symptom Relief (loperamide hydrochloride and simethicone tablets, 2 mg/125 mg) Diarrhea plus bloating, pressure and cramps Granted approval by the FDA
Concentric Analgesics, Inc. CA-008, a non-opioid therapeutic Post-surgical pain Granted Breakthrough Therapy designation by the FDA
physIQ AFib detection analytics engine Atrial Fibrillation Granted FDA 510(k) clearance
Foamix Pharmaceuticals, Ltd. FMX101, tpical minocycline foam Moderate to severe acne Met endpoints in Phase III trial
Merck KGaA and Pfizer Combination of Bavencio (avelumab) and Inlyta (axitinib) Advanced renal cell carcinoma Therapy significantly improved progression-free survival in Phase III trial
Vital Therapies VT-308 Severe alcoholic hepatitis Failed Phase III clinical trial
Gilead Sciences and Galapagos NV Filgotinib Moderate to severe active rheumatoid arthritis FINCH 2 Phase III trial successfully met primary endpoints
Bristol-Myers Squibb BMS-986165 Moderate to severe plaque psoriasis Hit efficacy endpoints in Phase II clinical trial
Amygdala Neurosciences ANS-6637 Alcohol use disorder Initiated Phase II clinical trial with NIAAA
Abeona Therapeutics, Inc. Gene therapy product ABO-101 (AAV-NAGLU) MPS IIIB (Sanfilippo syndrome type B) Initiated Phase I/II clinical trial in Spain
EpicGenetics, Inc. Tuberculosis vaccine, BCG Fibromyalgia Launching Phase II clinical trial with Mass General Hospital
Checkpoint Therapeutics, Inc. CK-101 (also known as RX518), a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (TKI) Non-small cell lung cancer Positive preliminary safety and efficacy data announced from an ongoing Phase I/II clinical trial

September 17: Job openings, upcoming industry conferences, webinars and training programs

September 17, 2018

Twice monthly, CWWeekly provides featured listings of clinical research job openings, upcoming industry conferences and educational programs from JobWatch, CenterWatch’s online recruitment website for both clinical research employers and professionals.

  For conferences, webinars, training programs and job postings, join the LinkedIn JobWatch group.
More Jobs

Experienced Clinical Research Coordinator
M3 Wake Research, Inc.
Raleigh, NC

Clinical Research Coordinator
Ohio State University Medical Center
Columbus, OH

Clinical Trials Manager
BTC Network
North Quincy, MA

Clinical Data Abstractor
TARGET PharmaSolutions
Chapel Hill, NC

Clinical Studies Coordinator
Wake Forest Baptist Medical Center
Winston Salem, NC

Monitor – Remote Contractor for Site Visits
Regenesis Biomedical, Inc.
Scottsdale, AZ

Clinical Research Associate
Technical Resources International, Inc.
Bethesda, MD

Clinical Research Coordinator
Diagnamics, Inc.
Encinitas, CA

Upcoming Conference

SEPTEMBER 27, 2018
Emerging Biopharmaceutical Therapies
Washington, DC

OCTOBER 9-10, 2018
Medical Device Complaint Management
Waltham, MA

OCTOBER 23-25, 2018
FDA Inspections Summit – 13th Annual
Bethesda, MD

DECEMBER 10-12, 2018
Design of Medical Devices Conference, China 2018
Beijing, China

Training Programs

OCTOBER 1-31, 2018
Program Phlebotomy Training — Two Day Training
Various locations


SEPTEMBER 19, 2018
Medical Device Software and Risk Management
Dan O’Leary will break down the FDA’s QSR section on design validation requirements.

SEPTEMBER 27, 2018
Safety Reporting in Global Clinical Trials: Maximizing Compliance, Minimizing Costs
Steven Beales and Kendra Hayden will introduce you to new efficiencies in safety reporting and demonstrate ways to cut safety reporting costs by > 50% and more.


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
Research Center Profiles

September 2018: Research Center Profiles

September 10, 2018

Research Center Spotlight is a monthly selection of clinical research centers who have Research Center Profile pages posted on Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their expertise and services in conducting and managing clinical studies. To learn more about becoming a Research Center Profile page subscriber, contact Sales at (617) 948-5100.