Ethics/Regulatory

EMA welcomes publication of the Clinical Trials Regulation

Friday, May 30, 2014 01:38 PM

The EMA welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union (E.U.). This legislation will foster European competitiveness and innovative capacity, and facilitate swifter development of new medicines for patients. In addition to simplifying clinical trial approvals, the regulation foresees transparency on the conduct of trials in the European Economic Area, from the point of their authorization to the publication of the results of those clinical trials.

More... »

Quest Diagnostics

WIRB-Copernicus Group launches oncology IRB to meet challenges of cancer research

Thursday, May 29, 2014 01:15 PM

By Ronald Rosenberg
CenterWatch Staff Writer

The WIRB-Copernicus Group (WCG), a large provider of regulatory and ethical review services for clinical research, has formed WCG Oncology, a new cancer-focused institutional review board, along with the WCG Oncology Expert Advisory Board, which includes James E. Rothman, Ph.D., the 2013 recipient of the Nobel Prize in Medicine and chairman of cell biology at Yale Medical School.  

More... »


Ombudsman concerned by EMA policy change for clinical transparency

Wednesday, May 21, 2014 01:31 PM

In a letter to the EMA, the European Ombudsman, Emily O'Reilly, has expressed concern about a significant change of policy concerning clinical trial data transparency. The European Ombudsman investigates complaints about maladministration in the E.U. institutions and bodies.

More... »

EMA, FDA release joint proposal for Gaucher research

Friday, May 16, 2014 12:49 PM

The EMA and the FDA have released a draft joint proposal to facilitate the clinical investigation of new medicines for the treatment of Gaucher disease in children. The document is released for public consultation until Aug. 31.

More... »

FDA approves WuXi’s manufacture of ibalizumab in China for use under a U.S. IND

Wednesday, May 7, 2014 01:32 PM

The FDA has approved the first batch of the ibalizumab (TMB-355) drug substance and sterile drug product, manufactured at WuXi PharmaTech's biologics facilities and developed by TaiMed Biologics for the treatment of HIV/AIDS infection. 

More... »

FDA proposes expedited access program for devices that address unmet needs

Wednesday, April 23, 2014 02:17 PM

The FDA has proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.

More... »

NHS England approves $13.5M in funding for hepatitis C drug

Thursday, April 17, 2014 11:16 AM

NHS England has approved a $13.5 million investment in Sofosbuvir for the treatment of hepatitis C. About 500 patients with acute liver failure, and/or awaiting liver transplantation, are expected to benefit from the decision to fund Gilead Sciences’ new drug.

More... »

Report: NHS financial crunch getting closer

Wednesday, April 16, 2014 01:23 PM

Financial confidence within the NHS is ebbing away, with a financial crisis looming in 2015-2016, according to the latest Quarterly Monitoring Report published by The King's Fund.

More... »

HHS Secretary Sebelius, proponent of clinical research, resigns

Friday, April 11, 2014 03:33 PM

By Ronald Rosenberg
CenterWatch Staff Writer

Health and Human Services Secretary Kathleen Sebelius—whose agenda included keeping clinical research a priority—has resigned on the heels of the Affordable Care Act (ACA) web site turmoil last October, even though more recently she had achieved the goal of 7.5 million registrations for coverage.

More... »

EMA, Australian regulators strengthen collaboration in orphan medicines

Wednesday, April 9, 2014 12:38 PM

In a meeting at the EMA April 4, the EMA’s executive director, Guido Rasi, and the national manager of the Australian Therapeutic Goods Administration (TGA), John Skerritt, announced the two regulators have agreed to share the full assessment reports related to marketing authorizations of orphan medicines, intended to treat rare diseases.

More... »

CWWeekly

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs