NEJM: Right-to-Try Laws Could Still Undercut FDA Authority, Even if Ineffective

January 22, 2018

While the versions of federal right-to-try legislation pending on Capitol Hill are expected to have a limited impact on access to experimental therapies — and, therefore, limited potential to increase harm to terminal patients — they still represent a broader effort to weaken medical product regulation and FDA oversight, according to a new piece in the New England Journal of Medicine.


FDA to Begin Publishing Clinical Study Reports & Possibly Select CRLs

January 22, 2018

A new FDA pilot program will publish information from sponsor-produced clinical study reports (CSR) — starting with documents volunteered by companies following a drug’s approval — as part of broader agency efforts to boost transparency in clinical trials and streamline the review process.


Twenty-One Drugs and Devices have Entered a New Trial Phase This Week

January 22, 2018

Company Drug/Device Medical Condition Status
Tetra Bio-Pharma PPP005 safety study Phase I trials planned in Canada
Constellation Pharmaceuticals CPI-1205 oncology Phase Ib/II trials initiated
CytRx Aldoxorubicin metastatic pancreatic cancer Phase Ib/II trials initiated enrolling 173 subjects
Transgene TG4010 MUC1 expressing tumors Phase II trials initiated enrolling 39 subjects
Ophthotech Zimura (avacincaptad pegol) autosomal recessive Stargardt disease (STGD1) Phase IIb trials initiated enrolling 120 subjects
MiMedx AmnioFix Injectable recalcitrant plantar fasciitis pain Phase III trials initiated enrolling 164 subjects
LivaNova Aortic Valve Implant reporting of reduced leaflet motion Post-Market trials initiated enrolling 230 subjects in the U.S. and Canada
Aspyrian Therapeutics RM-1929 locoregional recurrent head and neck squamous cell carcinoma Fast Track designation granted by the FDA
Centrexion CNTX-4975 pain associated with knee osteoarthritis Fast Track designation granted by the FDA
Concert Pharmaceuticals CTP-543 moderate to severe alopecia areata Fast Track designation granted by the FDA
Cour Pharmaceuticals TIMP-GLIA Celiac disease Fast Track designation granted by the FDA
Benitec BioPharma BB-301 oculopharyngeal muscular dystrophy Orphan Drug designation granted by the FDA
Helsinn, MEI Pharma pracinostat acute myeloid leukemia Orphan Drug designation granted by the EMA
Novartis Kymriah (tisagenlecleucel) relapsed or refractory diffuse large B-cell lymphoma Priority Review granted by the FDA, Accelerated Assessment granted by the EMA
ACON Laboratories, Innovus Pharma UriVarx Urinary Tract Infection test strips overactive bladder, urinary incontinence FDA administration clearance
AstraZeneca, Merck Lynparza (olaparib) deleterious or suspected deleterious gBRCAm HER2-negative metastatic breast cancer FDA approved
Avion Pharmaceuticals Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) oral contraceptive FDA approved
Boehringer Ingelheim Gilotrif (afatinib) metastatic non-small cell lung cancer with non-resistant EGFR mutations FDA approved
GlaxoSmithKline Fluarix Quadrivalent (Influenza Vaccine) flu in patients 3 years of age or older FDA expanded indication approved
Innovus Pharma Xyralid (DIN 02471434) pain and symptom relief for hemorrhoids Health Canada approved
Myriad Genetics BRACAnalysis CDx HER2-negative metastatic breast cancer with germline BRCA mutation FDA approved

Senate Committee Clears Azar’s Nomination for Floor Vote

January 22, 2018

The Senate Finance Committee advanced the nomination of ex-Eli Lilly exec Alex Azar to serve as HHS secretary, by a mostly party-line vote of 15 to 12. He is expected to be confirmed by the Senate as a whole in the coming weeks. “Mr. Azar is well-credentialed to lead such a critical department at a time America’s healthcare system is facing difficult challenges,” said committee chair Sen. Orrin Hatch (R-Utah). Sen. Tom Carper (D-Del.) was the lone Democrat in favor. Much of Azar’s confirmation hearings focused on the rising price of drugs, especially during his tenure as president of Lilly USA, with Azar himself agreeing that prescription costs are too high. Many Republicans touted his industry experience as a positive, saying he would an insider’s perspective to the role.


Job openings, upcoming industry conferences and educational programs

January 22, 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.
Featured Jobs

Clinical Research Coordinator
Las Vegas , NV

Clinical Scientist
Syros Pharmaceuticals
Cambridge, MA

Senior Clinical Research Coordinator
Elligo Health Research
Cincinnati, OH

Clinical Project Manager
Leidos Biomedical Research, Inc.
Frederick, MD

Clinical Trials Assistant
Apex Life Sciences
Raleigh, NC

Research Study Coordinator
Mountain View, CA

Clinical Research Coordinator
Dorn Research Institute
Columbia, SC

Project Specialist
Premier Research
Durham, NC

Clinical Research Assistant
St. Josephs Hospital and Medical Center
Phoenix, AZ

Health Outcomes Research Advisor
CVS Health
Woonsocket, RI

Microbiology Clinical Trial Scientist
BioMerieux Inc.
St. Louis, MO

Asstiant Clinical Research Coordinator
UC Davis Health System
Sacramento, CA

Clinical Trials Data Analyst I
Baylor Scott & White Health
Temple, TX

Clinical Compliance Lead
Boehringer Ingelheim
Ridgefield, CT

Nurse Investigator
Oklahoma Board of Nursing
Oklahoma City, OK

Registered Nurse
The James J. Peters VA Medical Center
Bronx, NY

Clinical Trials Manager
Sterling-Hoffman Life Sciences
Newark, CA

Clinical Research Study Coordinator
Alpha Research Associates
Dayton, OH

Clinical Project Manager
Thor Life Sciences
Raleigh, NC

Clinical Regulatory Specialist
Phoenixville, PA

Upcoming Conference

FEBRUARY 7-8, 2018
Investigator Initiated Sponsored Research (IISR) 2018
CBI’s IISR 2018 is the only annual event dedicated exclusively to helping you and your organization improve your IISR Programs by providing innovative and forwardthinking approaches to support collaborative partnerships, promote proactive contracting, financial planning and integrate best practices in clinical operations for medical affairs excellence in the global expansion of clinical trials.
Boston, MA

FEBRUARY 13-18, 2018
Scope Summit for Clinical OPS Executives 2018
SCOPE will offer three days of indepth discussions in 18 different conferences, three plenary keynote sessions and interactive breakout discussions focused on advances and innovative solutions in all aspects of clinical trial planning, management and operations.
Orlando, FL

MARCH 6-8, 2018
FDAnews ICH E6 GCP InteractiveWorkshops
Get all the ICH E6 (R2) training you need with three days of hands-on workshops aimed at helping you understand and comply with new requirements.
Raleigh, NC

APRIL 4-5, 2018
Let’s Improve Clinical Trials Today!
The forum will discuss how we can bridge people and processes, technology and regulations.
Oxon Hill, MD

Trial Results

Novan’s SB208 Antifungal Program Presents Positive Phase II Results

January 22, 2018

Novan announced Phase II efficacy and safety data for SB208, a topical, silicone-based gel under development for the treatment of fungal infections of the skin and nails. In a Phase II double-blinded, randomized, vehicle-controlled, dose-ranging clinical trial, the tolerability, safety and antifungal activity of SB208 was evaluated in 222 patients with clinical signs and symptoms of tinea pedis, or Athlete’s Foot. Patients were randomized evenly to one of three active or vehicle treatment arms, applying either SB208 Gel (2%, 4% or 16%) or vehicle once-daily for two weeks, followed by a four-week post-treatment observation period. In the primary efficacy analysis of subjects with evaluable culture results, 61.3% (p=0.209) of patients treated with SB208 2%, 80.6% (p=0.002) of patients treated with SB208 4% and 74.2% (p=0.016) of patients treated with SB208 16% achieved negative fungal culture at day 14 versus 45.5% of patients treated with vehicle. The percentage of patients achieving mycological cure at the day 14 visit was 34.4% (p=0.305) of the patients treated with SB204 2%, 50.0% (p=0.009) of the patients treated with SB208 4% and 53.1% (p=0.010) of patients treated with SB208 16% versus 23.5% of patients treated with vehicle. At day 42, the highest mycological cure rates were observed in 58.8% of patients treated with SB208 16% (p=0.020 compared to vehicle).  The percentage of patients achieving clinical cure at day 42 was 14.3% of the patients treated with SB208 2%, 29.7% of the patients treated with SB208 4% and 25.0% of patients treated with SB208 16% versus 14.3% of patients treated with vehicle. The overall incidence of adverse events was low (nine subjects or 4%) and similar in all groups. None of the treatment emergent adverse events were determined to be related to the study medication, and no patients discontinued treatment or dropped out of the study due to an adverse event. Based on the positive data generated in this SB208 Phase II dose-ranging trial, Novan intends to evaluate potential partnerships to advance the antifungal candidate into later stages of development.


Government Shutdown Temporarily Ends or Delays Some FDA Work

January 22, 2018

Congress’s failure to pass a government spending bill last weekend means much — but not all — of the FDA’s work will stop until the government is funded. Firms should be aware that scheduled meetings with FDA will more than likely need to be postponed and rescheduled, said Steven Grossman, deputy executive director of Alliance for a Stronger FDA. “Certainly, medical product companies with near-term expectations — review meetings, initiating clinical trials, etc. — are faced with the possibility of slippage in their development timelines,” he said.

Three Questions

Three Questions: Zikria Syed, VitalTrax

January 22, 2018

CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Zikria Syed, co-founder and chief executive officer of VitalTrax, which has developed a clinical trial network called PatientWing that makes it easier for patients to find and enroll in clinical trials.


Tufts Study: New Data Slows Trials Down

January 15, 2018

While the burgeoning amount of data collected in clinical trials promises to add more depth and breadth to study endpoints, leading to better studies and better drug therapies, for now it’s doing more harm than good by increasing data management burdens.