September 2018

Briefs

Breast Cancer Trial Resumes

September 24, 2018

Mersana says it has worked out a new agreement with the FDA to resume recruiting patients for a clinical trial of its breast cancer drug months after one of the participants died.

Pipeline

New Pipeline Updates from AstraZeneca, Teva, Camurus and Ironwood

September 24, 2018

Company Drug/Device Medical Condition Status
inui™ Health In-home urine analysis platform, which includes a disposable test and smart phone app (iOS and Android) Kidney function, metabolic disorders and urinary tract infections (UTI) Granted 510(k) clearance and a Clinical Laboratory Improvements Amendments (CLIA) waiver by the FDA CE Mark certification
Camurus CAM2038 Chronic low back pain Met primary and first secondary endpoints; resulted in significantly improved relief of the average and worst pain intensity compared to placebo
Iterum Therapeutics plc Sulopenem Gram-negative, multi-drug resistant infections Initiated SURE 2 and SURE 3 Phase III clinical trials
AstraZeneca Pharmaceuticals LP FASENRA™ (benralizumab) Severe eosinophilic asthma Phase III extension BORA trial results show long-term safety and efficacy as an add-on maintenance treatment
Regeneron Pharmaceuticals, Inc. and Sanofi Dupixent® (dupilumab) mono-therapy moderate-to-severe atopic dermatitis Phase III trial demonstrated a significant improvement in signs and symptoms
Alnylam Pharmaceuticals, Inc. Patisiran Polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults APOLLO Phase III trial showed improved markers of cardiomyopathy
AstraZeneca Triple combination therapy PT010 COPD Seeking FDA approval after Phase III trial found it outperformed its dual-therapy rivals eight of nine times
Teva Pharmaceutical Industries Ajovy (fremanezumab) Migraine Granted approval by the FDA
Venture Heat® Infrared Heat Therapy using Far infrared Rays (FIR) Pain Granted approval by the FDA
Sebacia, Inc. Sebacia Microparticles Mild to moderate inflammatory acne vulgaris Granted clearance by the FDA
WAT Medical HeadaTerm Migraine Granted clearance by the FDA
AstraZeneca Lumoxiti (moxetumomab pasudotox-tdfk) Adults with relapsed or refractory hairy cell leukemia (HCL) who have had at least two previous therapies Granted clearance by the FDA
Ironwood Pharmaceuticals, Inc. Praliciguat (IW-1973) Heart failure Granted Fast Track designation by the FDA
Genentech Subcutaneous (SC) formulation of Actemra® (tocilizumab) Active systemic juvenile idiopathic arthritis (SJIA) in patients two year and up Granted approval by the FDA
STAAR Surgical Company PMA Supplement for the Visian Toric ICL Myopia with astigmatism Granted approval by the FDA
CWMarketplace

September 2018: Top 10 Industry Provider Profiles

September 24, 2018

CWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their products and services. To learn more about becoming an Industry Provider Profile page subscriber, contact Sales at (617) 948-5100.

Click on any provider to view the company’s complete online profile or search more profiles.

Pipeline

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