Adverse Event Reporting: When TMI is Risky

October 15, 2018

As sponsors and sites have expanded their global reach, they’ve run into myriad local and regional regulations requiring them to report adverse events in their clinical trials. Hoping to simplify, many sponsors or sites have tried to create a one-size-fits-all form that sends out nearly automated alerts for nearly every single glitch.

FDA: Generic Skin Patch Trials

October 15, 2018

Generic drug developers that use patches, inhalers, eye drops or similar means to deliver meds should hold clinical trials to test for potential side effects of skin irritation and, in the case of patches, adhesion quality, the FDA says.

New Pipeline Updates from Akcea Therapeutics, Genentech, Eximo Medical and Valneva USA

October 15, 2018

Company Drug/Device Medical Condition Status
Akcea Therapeutics TEGSEDITM (inotersen) Polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults Granted approval by the FDA
Akcea Therapeutics AKCEA-APO(a)-LRx Cardiovascular disease (CVD) and elevated levels of lipoprotein(a), or Lp(a) Positive topline results from a Phase II clinical trial
Bausch Health Companies, Inc. BRYHALI™ (halobetasol propionate) Lotion, 0.01% Plaque psoriasis in adults FDA tentatively approved New Drug Application; final OK pending expiration of exclusivity for related product
Eximo Medical Ltd B-Laser™ Atherectomy System Peripheral artery disease (PAD) Granted 510(k) clearance by the FDA
YiSheng BioPharma Co. PIKA® rabies vaccine Rabies Granted clearance by the China FDA to proceed with a clinical trial
Genentech Hemlibra Hemophilia A patients without factor VIII inhibitors Granted approval by the FDA
Leadiant Biosciences, Inc. Revcovi™ (elapegademase-lvlr) injection Adenosine deaminase severe combined immune deficiency (ADA-SCID) in children and adults Granted approval by the FDA
Breckenridge Pharmaceutical, Inc. Roflumilast Tablets, 500mcg (generic for Daliresp® Tablets) COPD Abbreviated New Drug Application approved by the FDA
Valneva USA XIARO® (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) Japanese encephalitis Accelerated dosing regimen approved by the FDA
Eidos Therapeutics, Inc. AG10 amyloidosis (ATTR) Granted Orphan Drug designation by the FDA
Paratek Pharmaceuticals, Inc. NUZYRA™ (omadacycline) Community-acquired bacterial pneumonia; acute skin infections (ABSSSI) in adults Granted approval by the FDA
Poxel SA Imeglimin, an investigational therapeutic agent Type 2 diabetes Patient enrollment completed in the TIMES 2 trial of the Phase III registration program
Chugai Pharmaceutical Co., Ltd HEMLIBRA® (US generic name: emicizumab-kxwh) Hemophilia A without factor VIII inhibitors in newborns, children and adults Granted approval by the FDA
Genentech baloxavir marboxil Influenza type A/H3N2 and type B Phase III CAPSTONE-2 trial showed symptoms improved significantly faster in patients at high risk of serious flu who took the drug v. a placebo
Zealand Pharma A/S Glepaglutide Short bowel syndrome (SBS) First patient enrolled in a global Phase III trial

October 15: Job openings, upcoming industry conferences, webinars and training programs

October 15, 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.
Jobs via Kelly Services
More Jobs

Clinical Research Coordinator
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio

Associate Clinical Trial Supply Manager
East Hanover, NJ

Clinical Research Coordinator
Children’s Hospital Los Angeles
Los Angeles, CA

Clinical Trials Manager
Bedminster, NJ

Clinical Research Coordinator II
Emory University
Atlanta, GA

Sr. Director, Quality Assurance
Research Triangle Park, NC

Pharmaceutical Teaching Positions (April 2019)
International Education Services
Tokyo, Japan

Study Concierge, Virtual Trials
Research Triangle Park, NC

Upcoming Conference

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

NOVEMBER 1-2, 2018
SOPs and Policies for the 21 st Century: Why Less is More
Washington, DC

NOVEMBER 14-15, 2018
Conducting Advanced Root Cause Analysis & CAPA Investigations
Princeton, NJ

NOVEMBER 14-15, , 2018
Clinical Trial Risk and Performance Management Summit
Princeton, NJ

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

Training Programs

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

New Pipeline Updates from Amgen, Eli Lilly, Applied BioCode and Ocugen

October 8, 2018

Company Drug/Device Medical Condition Status
Paratek Pharmaceuticals, Inc. SEYSARA™ (sarecycline) Inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older Granted approval by the FDA
Clovis Oncology, Inc. Rubraca® (rucaparib) BRCA1/2-mutated mCRPC after androgen receptor (AR)-directed therapy and taxane-based chemotherapy Granted Breakthrough Therapy designation by the FDA
PharmAbcine, Inc. Bevacizumab (Avastin®) Recurrent glioblastoma Received “Study May Proceed Letter “ for IND application from the FDA; can initiate Phase II trials
Amgen KYPROLIS® (carfilzomib) Relapsed or refractory multiple myeloma FDA approved supplemental New Drug Application to expand prescribing information
Applied BioCode BioCode® Gastrointestinal Pathogen Panel on BioCode® MDx-3000 molecular system Tests for 17 most common bacteria, viruses and parasites that cause infectious diarrhea Granted 510 (k) clearance by the FDA
Eisai Co., Ltd. Fycompa (perampanel) Partial-onset seizures in pediatric patients with epilepsy 4 years of age and older Granted approval by the FDA for an indication expansion
Eli Lilly and Company Ultra Rapid Lispro (URLi) Type 1 and Type 2 diabetes Phase III clinical trials show met primary efficacy endpoint
Seattle Genetics, Inc. and Takeda Pharmaceutical Company Limited ADCETRIS (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) CD30-expressing peripheral T-cell lymphoma (PTCL), also known as mature T-cell lymphoma (MTCL) Phase III ECHELON-2 clinical trial met its primary endpoint
Acorda Therapeutics, Inc. INBRIJA, investigational inhaled levodopa OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen Releasing efficacy analysis from SPAN-PD, Phase III clinical trial
Five Prime Therapeutics, Inc. Bemarituzumab (FPA144), an isoform-selective FGF receptor 2b (FGFR2b) antibody, with chemotherapy Advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer First patient dosed in Phase III FIGHT pivotal trial
Ocugen, Inc. OCU310 Dry eye Initiated Phase III clinical trial
PTC Therapeutics Risdiplam (RG7916) Type 1, 2 and 3 spinal muscular atrophy (SMA) Interim data from open-label clinical trials show increases in developmental motor milestones
Veloce BioPharma, LLC VBP-926 (Povidone-Iodine) topical treatment Chemo-associated paronychia, or painful, inflamed nails, a chemo side effect Positive results of Phase IIb trial

October 2018: Research Center Profiles

October 8, 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.