FDA Seeks Comments on Cellular, Gene Therapy The FDA made available a draft document relating to preclinical assessment of cellular and gene therapy products providing guidance on the substance and scope of information needed to support clinical trials...The brief was filed in connection with an antitrust action against Warner Chilcott, alleging that Warner Chilcott maintained a monopoly for its antibacterial drug Doryx by reformulating the drug three times.

delafloxacin showed an 88 percent clinical response rate dosed at 300 mg twice daily, compared to 82 percent for Tygacil (tigecyline, Pfizer Inc...A separate Phase II trial in community-acquired pneumonia showed an 87 percent clinical response rate at 200-mg and 400-mg doses of oral delafloxacin...Shares of Rexahn (NYSE:RNN) fell 14 cents, or 30.3 percent, to close Thursday at 33 cents.

Top-line data from the PEARL-SC trial, presented in June, showed the drug missed its primary endpoint, defined as clinical improvement at 24 weeks in the SLE responder index, but further data showed that the BAFF inhibitor produced sustained and greater treatment effects vs

AiCuris GmbH, of Wuppertal, Germany, said it started the second clinical efficacy trial testing pritelivir (AIC316), its herpes simplex virus (HSV) drug, after data from the first study showed a high degree of efficacy against genital herpes...A Phase Ib study of ProHema achieved its primary objective of demonstrating safety and tolerability and established early clinical proof of concept, including trends of accelerated neutrophil recovery, improved 100-day survival and low rates of graft-vs.-host

Accera Inc., of Broomfield, Colo., started a clinical efficacy trial examining the effects of AC-1204 in patients with mild-to-moderate Alzheimer's disease (AD

regulators are happy to see a clinical response, whereas European regulators seek the more stringent outcome of remission...Proceeds will be used to advance the clinical development of EPI-743...The drug previously demonstrated efficacy in prostate, breast and ovarian cancer models, as well as in endometriosis, and the recent fundraising is expected to move VAL201 through first-in-human clinical trials.

Subcutaneous administration achieved efficient conversion to decitabine, resulting in an improved pharmacokinetic profile over the intravenous Dacogen (decitabine) formulation, and clinical responses were observed in the heavily pretreated population of patients with relapsed/refractory intermediate- or high-risk myelodysplastic syndromes or acute myelogenous leukemia

Using Electronic Data in Clinical Trials The FDA also is requesting comments on a revised draft guidance on the use of electronic source data in clinical trials...The document is designed to help sponsors, contract research organizations, data management centers, clinical investigators and others involved in capturing, reviewing and archiving electronic source data in FDA-regulated clinical trials to ensure the reliability, quality, integrity and traceability of the data

The Patient-Centered Outcomes Research Institute (PCORI) will award $12 million in funding through 14 contracts for studies addressing knowledge gaps in comparative clinical effectiveness research

CytoDyn Inc., of Portland, Ore., said it entered a clinical trial agreement with the Division of Infectious Diseases and HIV Medicine at Drexel University College of Medicine to conduct additional Phase II studies of PRO 140, a humanized monoclonal antibody targeting the CCR5 receptor for treating HIV infection...Pozen said it has now completed all the clinical trials intended for inclusion in a new drug application package, targeted for submission no later than the end of April 2013

Trial data showed clinical benefit, defined as partial response and stable disease of more than four months following up to eight cycles of treatment, at the maximum tolerated dose in 10 of 13 evaluable patients

Idera Pharmaceuticals Inc., of Cambridge, Mass., started a Phase I trial of IMO-8400, an antagonist of Toll-like receptors 7, 8 and 9, the second clinical candidate in Idera's autoimmune disease program...Insmed Inc., of Monmouth Junction, N.J., said the company's CLEAR-108 (CLinical Evaluation of Arikace) Phase III European and Canadian registrational study of Arikace (liposomal amikacin for inhalation) for cystic fibrosis patients with Pseudomonas aeruginosa lung infections has enrolled more than

Bayer Inc., of Deerfield, Ill., and the Population Health Research Institute said they started the COMPASS trial, the largest clinical study to date of oral anticoagulant rivaroxaban

The HCV program is on track for an investigational new drug application in the first quarter of 2013, and the company expects clinical proof-of-concept data by year-end 2013

The data, compared to month three, showed a further improvement in clinical symptoms linked to RA for patients in whom the Kinoid induced antibody (Abs) to TNF, compared to those without such antibody

The primary endpoint of the study is clinical benefit of AEZS-108...The study, conducted in 20 Asian patients at seven clinical trial sites, compared the outcome of a single intravenous dose of Zybrestat (15, 25, 35 or 45 mg/kg) with placebo...Based on outcomes for safety and tolerability, and measures of absorption, distribution, metabolism and excretion, Path will proceed to the next Phase of clinical trials in 2013

The data were presented during a late-breaking clinical trials session at the 9th International Congress of the Society for Melanoma Research in Hollywood, Calif

The Phase III study met its primary endpoint and demonstrated statistically significant protection against clinical and severe malaria in infants...In the trial, infants (ages 6-12 weeks at first vaccination) receiving the RTS,S vaccine candidate experienced one-third fewer episodes of both clinical and severe malaria and experienced similar reactions to the injection when compared to those who received the control meningococcal C conjugate vaccine

Although the trial was not designed to demonstrate efficacy, evidence of clinical activity was observed in some patients...Response evaluation to date among 30 evaluable patients showed 27 patients had stable disease or better for a 90 percent clinical benefit rate (nine partial response [30 percent] and 18 stable disease [60 percent...In the clinical trial (n = 39 patients), OMP-59R5 was generally well tolerated, with diarrhea as the main treatment-related and dose-related adverse event