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.
October 15, 2018
The FDA released new guidance last week on how researchers can comply with both agency regulations and pending Common Rule revisions that protect human subjects in clinical 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.
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, 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.
Clinical Trial/Study Manager
Indianapolis, IN
Lab Supervisor
Indianapolis, IN
Laboratory Tech Assistant
San Marcos, TX
Health Program Representative
Denver, CO
Associate Principle Scientist Medical Communications
Gaithersburg, MD
Principle Clinical Research Scientist
Milpitas, CA
Clinical Program Manager
Cambridge, MA
SAS Programmer II
Warsaw, IN
Regulatory Affairs Specialist
Pittsburgh, PA
Triage Manager
Ridgefield, CT
Sr. Research Associate
San Francisco, CA
Associate Director
Cranbury Township, NJ
Medical Technologist
Beaumont, TX
Research Associate II
Seattle, WA
Clinical Research Coordinator
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio
Associate Clinical Trial Supply Manager
Novartis
East Hanover, NJ
Clinical Research Coordinator
Children’s Hospital Los Angeles
Los Angeles, CA
Clinical Trials Manager
Mallinckrodt
Bedminster, NJ
Clinical Research Coordinator II
Emory University
Atlanta, GA
Sr. Director, Quality Assurance
IQVIA
Research Triangle Park, NC
Pharmaceutical Teaching Positions (April 2019)
International Education Services
Tokyo, Japan
Study Concierge, Virtual Trials
IQVIA
Research Triangle Park, NC
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
NOVEMBER 1-31, 2018
Program Phlebotomy Training — Two Day Training
Various locations
October 8, 2018
A new study questions the use of progression-free survival as a surrogate endpoint in cancer clinical trials after finding it overlooks quality of life issues.
October 8, 2018
A Florida scientist is urging sponsors and care providers to do a better job of getting early-stage Parkinson’s sufferers into clinical trials before they start treatment.
October 8, 2018
Sponsors of atopic dermatitis drugs for children don’t have to wait to test a drug’s safety or efficacy on adults before beginning pediatric trials, the FDA says.
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 8, 2018
Research Center Spotlight is a monthly selection of clinical research centers who have Research Center 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 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.
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