TAG and the TB CAB send open letter to Otsuka to expedite plans to develop a pre-approval access program for delamanid for patients in urgent need, determine if delamanid is safe to use with bedaquiline, and develop the drug for pediatric use as rapidly and safely as possible.
TAG and TB CAB issue an open letter to Janssen, bedaquiline’s sponsor, about the need to accelerate pediatric research, to determine the safety of using bedaquiline and delamanid together, and to support Janssen’s compassionate use program to provide access to bedaquiline for people in urgent need in places where the drug has not yet been approved.
TAG and TB CAB send letter to FDA and to the EMA to encourage crucial regulatory harmonization on endpoints for tuberculosis drug development, and to encourage Otsuka and Janssen to conduct necessary drug-drug interaction studies on bedaquiline and delamanid.
May 24, 2012 TO: Marco Cavaleri CC: Hans-Georg Eichler European Medicines Agency 7 Westferry Circus- Canary Whar London E14 4 HB United Kingdom RE: Conducting drug-drug interaction studies for bedaquiline (TMC207) and delamanid (OPC6783) Dear Dr. Cavaleri, We wish to draw…
TAG has previously expressed opposition to the PAVE100A vaccine trial involving the Vaccine Research Center’s DNA and Ad5 candidate(i). With the recent presentation by Dan Barouch of new macaque challenge data involving a DNA/adenovirus prime-boost regimen at the 2009 Keystone meeting(ii), we now must vociferously oppose the proposed descendant of PAVE100A, the HVTN 505 trial.
TAG and the TB CAB send open letter to Cepheid calling for price reduction for the GeneXpert machines and the Xpert MTB/RIF cartridges.
TAG and the TB CAB support South African advocates, doctors, and organizations in their call for early access to bedaquiline by sending an open letter to the South African Medicines Control Council (MCC).
As representatives of organizations that advocate for an evidence-based and robust response to global AIDS, we respond to your fiscal year 2013 budget request for the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)—the flagship bilateral AIDS program—with shock and dismay.
Letter sent in response to the press release issued by Sangamo BioSciences on January 9th 2012, the undersigned individuals and organizations are writing to express concern about the status of the SB-728-T development program.
TAG and other partner organizations issued this letter about their serious and unresolved concerns about the proposed clinical trial comparing stavudine at 20 mg to tenofovir.