Consistent with previously reported results, it showed a favorable safety profile and clinically meaningful efficacy...The new data also provided clinical confirmation of Neurocrine's pharmacologic modeling related to the elagolix dose-response continuum

BrainCells Inc., of San Diego, reported positive results from the first clinical proof-of-concept study of BCI-952, a combination of low-dose buspirone and melatonin, for the treatment of major depressive disorder...In addition, BCI-952 was well tolerated with a safety profile similar to placebo

Sebelius in May pledged $1 billion from already budgeted funds to be used for clinical studies and commercial-scale production of H1N1 vaccine antigen and adjuvants. (See BioWorld Today, May 26, 2009.) The new funding will be used to place additional orders for bulk H1N1 antigen and adjuvant on existing contracts awarded by the Biomedical Advanced Research and Development Authority to MedImmune Inc., Sanofi-Aventis Group, GlaxoSmithKline plc and Novartis AG, HHS officials said Monday...Many of the

Rigel Pharmaceuticals Inc., of South San Francisco, said that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis (RA) patients in THE TASKi2 Phase IIb trial of 457 patients treated for up to six months...Rigel added that the significant, early sustained efficacy, combined with a good safety profile, supported its plans to conduct partnership discussions for R788 and initiate a Phase III program in RA in the first half of 2010 with a corporate partner

Kasimov noted that he was "increasingly comfortable with lorcaserin's safety profile following the BlOOM data release at the American Diabetes Association meeting...Additionally with the proceeds, Allostera plans to complete preclinical studies and begin human clinical testing of its lead Allosteramer, APG2305, a drug candidate for autoimmune diseases such as psoriasis

The safety profile of Lucentis was consistent with previous experience, and no new adverse events related to Lucentis were observed in the study...Interim results in March showed that 12 evaluable head and neck cancer patients experienced a partial response and four had experienced stable disease ranging from two months to six months, for a clinical benefit of 75 percent

Data also demonstrated a good safety profile comparable to the one seen in previous studies with inhaled AAT...United Therapeutics Corp., of Silver Spring, Md., and Eli Lilly and Co., of Indianapolis, presented results of a pivotal 16-week study showing that once-daily tadalafil was generally well tolerated, improved exercise capacity and improved time to clinical worsening in patients with pulmonary arterial hypertension

In addition to demonstrating a good safety profile, Phase I data in NSCLC patients also showed that six of 19 patients had a clinical response on PT 107

Secondary clinical endpoints include time to clinical progression, safety and to measure changes in prostate-specific antigen blood levels...Ltd., of Osaka, Japan, has begun clinical testing in Japan of Relistor (methylnaltrexone bromide) subcutaneous injection, the first-in-class medicine approved in the U.S., Canada, the European Union, Australia and Latin American countries for the treatment of opioid-induced constipation

said Phase II/III data from the PROTECT-1 trial of Traficet-EN (CCX282-B) in patients with moderate-to-severe Crohn's disease demonstrated evidence of clinical efficacy in reducing disease severity as defined by a decrease from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points over the course of 12 weeks...Salix Pharmaceuticals Ltd., of Raleigh, N.C., reported data showing that Apriso (mesalamine) 0.375g extended-release capsules had a favorable safety profile in

Clinical Data Inc., of Newton, Mass., reported positive top-line results from the second of two Phase III trials of vilazodone for the treatment of major depressive disorder...Both treatments were well tolerated and had similar safety profiles

Database lock and unblinding of the full 48-week dataset has provided insight on the clinical benefits and safety profile of elagolix for the treatment of pain associated with endometriosis, the company said

raised $46 million in a Series C financing to continue clinical trials with the two antibiotic programs it licensed three years ago from Optimer Pharmaceuticals Inc...The drug has an established safety profile because it is marketed outside of the U.S., although Fernandes declined to specify the drug's name or maker

already has pulled in its second major round of venture funding, adding $30 million to support clinical testing in cancer and inflammatory disease...The program has moved into Phase I testing, and the company anticipates releasing early dose-escalation data at the upcoming American Society of Clinical Oncology meeting in Orlando, Fla., starting late this month...The new investor groups participating in the second closing are Yasuda Enterprise Development Co., Ltd., based in Tokyo, and Hunt BioVentures

Fovea Pharmaceuticals SA, of Paris, and its partner CombinatoRx Inc., of Cambridge, Mass., said results from a clinical proof-of-concept trial showed that Prednisporin (FOV1101) had the same efficacy and a better safety profile, with no increase in intraocular pressure, than Pred Forte (prednisolone ophthalmic) in patients treated for the signs and symptoms of persistent ocular allergic inflammation...Pulmatrix said it expects to advance PUR003 into multiple clinical studies to demonstrate its use

The randomized, double-blind, placebo-controlled, 299-patient study showed that rifaximin reduced the risk of clinical HE breakthrough episodes by 58 percent during the six-month dosing period (p < 0.0001...Rifaximin's safety profile was comparable to placebo...IDX316, a preclinical protease inhibitor, showed potent activity without cytotoxicity in vitro and bioavailability in animals supportive of once- or twice-daily dosing.

The researchers said the microfilter device is about three to five years from clinical use...Array BioPharma Inc., of Boulder, Colo., presented two abstracts showing both the clinical benefit of ARRY-543 in tumors that signal through multiple ErbB family members, and its efficacy in preclinical models when compared to, and combined with, Herceptin (trastuzumab), Xeloda (capecitabine) and Taxotere (docetaxel...Clinical trials are slated to begin later this year

The data also demonstrated the safety profile of Defibrotide showing no difference in adverse events between the prophylaxis and control arms...Data were presented at the Annual Clinical Genetics Meeting of the American College of Medical Genetics

Isotechnika previously reported that 0.4 mg/kg BID demonstrated both efficacy and an acceptable safety profile in their clinical trial of voclosporin in plaque psoriasis, which is in the range of the maintenance dose of voclosporin anticipated for use in kidney transplantation...In this trial, the combination of Zemiva imaging with initial clinical information resulted in improved sensitivity (85 percent) compared to the sensitivity of the initial clinical diagnosis alone (52.2 percent) (p < 0.0001