May 2018

Briefs

Elligo Acquires Patient Identification Platform from ePatientFinder

May 29, 2018

Elligo Health Research announced Thursday that it was buying ePatientFinder’s technology platform, a move that Elligo officials said will “streamline patient identification and feasibility through automation using electronic health record data.” ePatientFinder has claimed its Clinical Trial Exchange was the “first and only” technology platform that linked up doctors, clinicians, sponsors and EHR providers. The platform is the largest of its kind and Elligo sees is acquisition as “a strategic opportunity … to expand our technology and network growth capabilities,” the company said in a news release. The deal comes just two months after Elligo announced that it had raised $16 million from venture capitalists to continue its goals of reaching the 97 percent of physicians who don’t regularly participate in clinical trials. Terms of the deal were not disclosed.

Pipeline

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
Trial Results

Nabriva Therapeutics Announces Positive Topline Results for Treatment of Bacterial Pneumonia

May 29, 2018

Nabriva Therapeutics announced positive topline results from its Lefamulin Evaluation Against Pneumonia (LEAP 2) clinical trial. In LEAP 2, lefamulin met the U.S. Food and Drug Administration (FDA) primary endpoint of non-inferiority (NI, 10.0 percent margin) compared to moxifloxacin for early clinical response (ECR)-assessed 72 to 120 hours following initiation of therapy in the intent to treat (ITT) patient population. Lefamulin also met the European Medicines Agency (EMA) primary endpoint for non-inferiority (NI, 10.0 percent margin) compared to moxifloxacin based on an investigator assessment of clinical response. LEAP 2 was a global, randomized, double-blind, double-dummy trial that compared the efficacy and safety of 600 mg of oral lefamulin twice a day for 5 days versus 400 mg of oral moxifloxacin once daily for 7 days in 738 patients (370 in the lefamulin arm and 368 in the moxifloxacin arm). The lefamulin arm enrolled 183 (49.5 percent), 145 (39.2 percent) and 40 (10.8 percent) patients with a Pneumonia Outcomes Research Team (PORT) class of 2, 3 and 4, respectively. The moxifloxacin arm enrolled 189 (51.4 percent), 133 (36.1 percent) and 42 (11.4 percent) patients with a PORT class of 2, 3 and 4, respectively.

CWMarketplace

May Top 10 Industry Provider Profile Page

May 29, 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.

Contract Research Organizations
Confidence Pharmaceutical Research

Confidence Pharmaceutical Research
Belarus, Europe
+1 401 965-3377
anna.ravdel@confidenceresearch.com

With 25 years of experience, Confidence Pharmaceutical Research is both a CRO and a vendor management organization, with a mission to help clinical trial sponsors run better trials.

CSSi LifeSciences

CSSi LifeSciences
Glen Burnie, MD
(415) 317-4903
jsergi@cssienroll.com

The CSSi LifeSciences™ mission is to deliver quality outcomes and improved efficiencies across the entire product lifecycle with the goal of improving quality health outcomes for patients.

ICON plc

ICON plc
Dublin, Ireland
+35312912000
enquiries@iconplc.com

Since our foundation in Dublin, Ireland in 1990, ICON’s mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

MedSource

MedSource
Houston, TX
(281) 286-2003
mwagener@medsource.com

Founded in 1997, MedSource is a full-service monitoring group that provides qualified and skilled CRAs, auditors and project managers to the pharma, biotech, device and CRO industry.

Promedica International

Promedica International
Costa Mesa, CA
(714) 460-7363 Ext. 17
thopton@promedica-intl.com

More than two decades of experience shapes PMI’s understanding of the many clinical and regulatory challenges facing healthcare providers and the healthcare industry today.

Institutional Review Board (IRB)
Biomedical Research Alliance of New York LLC

Biomedical Research Alliance of New York LLC
Lake Success, NY
(516) 470-6900
info@brany.com

BRANY provides IRB administration for more than 1,100 active research trials. It coordinates the study start-up process and manages study startup and research revenue tracking through study close-out.

Investigative Site Network
PMG Research, Inc.

PMG Research, Inc.
Winston-Salem, NC
(336) 608-3500
awright@pmg-research.com

PMG Research is an Integrated Site Network (ISN) of 12 clinical research facilities. Since its founding in 1979, PMG has conducted over 7,700 research studies.

Other Site Consortium
Wake Research Associates

Wake Research Associates
Raleigh, NC
(919) 781-2514
contactus@wakeresearch.com

Wake Research Associates, established in 1984, draws from a current patient and subject population of approximately 950,000. Wake Research has successfully conducted nearly 6,000 clinical trials.

Technology Solutions
DrugDev

DrugDev
Wayne, PA
(610) 650-1890
solutions@drugdev.com

Built around the largest global network of active opted-in investigators, DrugDev’s unified solutions suite optimizes site selection and startup, investigator payments and clinical operations.

Clinithink

Clinithink
Alpharetta, GA
info@clinithink.com

Founded in 2009, Clinithink is a clinical natural language processing (CNLP) software supplier that gives life sciences organizations and healthcare providers access to unstructured clinical narrative.