Theorem Clinical Research

Ethics/Regulatory

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.

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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.

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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. 

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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.

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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.

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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.

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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.

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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.

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Europe approves clinical trial transparency law

Monday, April 7, 2014 12:39 PM

Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with E.U. ministers and passed by Parliament. The law also facilitates cross-border cooperation to make clinical trials larger, more viable and more reliable, which should in turn boost efforts to develop special treatments (e.g. for rare diseases).

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Proposed health IT strategy aims to promote innovation, protect patients, avoid duplication

Friday, April 4, 2014 12:05 PM

HHS has released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.

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