Benitec Biopharma Ltd., of Sydney, Australia, said its subsidiary, Tacere Therapeutics Inc., submitted an application to the National Institutes of Health's Recombinant DNA Advisory Committee (RAC), comprising the full clinical trial protocol for its ddRNAi-based therapeutic, TT-034, in hepatitis C virus infection, as well as safety and toxicology data

Benitec Biopharma Ltd., of Sydney, Australia, said its subsidiary, Tacere Therapeutics Inc., submitted an application to the National Institutes of Health's Recombinant DNA Advisory Committee (RAC), comprising the full clinical trial protocol for its ddRNAi-based therapeutic, TT-034, in hepatitis C virus infection, as well as safety and toxicology data

The company said it expects an advisory committee meeting to be scheduled between late June and late July

The company said it expects an advisory committee meeting to be scheduled between late June and late July

Unigene Laboratories Inc., of Boonton, N.J., said that the outcome of an FDA Advisory Committee Meeting on March 5 regarding calcitonin salmon for postmenopausal osteoporosis will have a materially adverse effect on its finances and operations

AVEO Oncology Inc., of Cambridge, Mass., and Astellas Pharma Inc., of Tokyo, said the FDA's Oncologic Drugs Advisory Committee will review the new drug application for tivozanib for patients with advanced renal cell carcinoma during the morning session of its May 2 meeting...Titan Pharmaceuticals Inc., of South San Francisco, said the FDA's Psychopharmacologic Drugs Advisory Committee is scheduled to review the firm's new drug application (NDA) for Probuphine for the maintenance treatment of adults

At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...To date, almost 50 percent of planned patients have been enrolled in about 30 European centers...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

The FDA Blood Products Advisory Committee voted unanimously in support of questions by the FDA regarding Cangene Corp.'s Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G), agreeing that there is likely clinical benefit and an acceptable risk-benefit profile for the product, and that the studies support the proposed dosing in adults

In November 2012, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee panel recommended that a cardiovascular outcomes trial be conducted but voted 8-4 to approve the products with a post-approval cardiovascular outcomes trial commitment

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the FDA's Pulmonary-Allergy Drugs Advisory Committee recommended that clinical data included in a new drug application provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema

The company also said Thursday that a meeting with the FDA las month indicated that the agency could accept a new drug application filing for apaziquone based on the current Phase III data and likely would convene and advisory committee meeting

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the FDA's Pulmonary-Allergy Drugs Advisory Committee recommended that clinical data included in a new drug application provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema

According to a prospectus filed by Auxilium Pharmaceuticals Inc., of Malvern, Pa., the FDA will not review its supplemental biologics license application for Xiaflex in Peyronie's disease in an advisory committee meeting

In separate news, Janssen reported that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 late Thursday to recommend approval of canaglifozin, a selective sodium glucose co-transporter 2 inhibitor, to treat Type II diabetes in adults

Unigene Laboratories Inc., of Boonton, N.J., said the FDA scheduled an advisory committee meeting March 5 to discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis outweighs a potential risk of cancer

In separate news, Janssen reported that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 late Thursday to recommend approval of canaglifozin, a selective sodium glucose co-transporter 2 inhibitor, to treat Type II diabetes in adults

In December 2011, the Psychopharmacologic Drugs Advisory Committee split nearly down the middle, voting 9-8, with two abstentions, in favor of approval for single-dose Adasuve, administered via inhalation, with a risk evaluation and mitigation strategy (REMS) proposed by the FDA

Law firm Bronstein, Gewirtz & Grossman LLC is investigating whether Hemispherx Biopharma Inc., of Philadelphia, and its executives violated federal securities laws after the company's shares fell more than 27 cents, or nearly 43 percent, on Tuesday following unfavorable briefing documents posted by the FDA's Center for Drug Evaluation and Research in advance of Thursday's Arthritis Advisory Committee meeting to discuss chronic fatigue syndrome candidate Ampligen

The FDA's Center for Drug Evaluation and Research (CDER) posted briefing documents for the Arthritis Advisory Committee meeting scheduled for Thursday, Dec. 20, to discuss the new drug application (NDA) for rintatolimod injection (proposed trade name Ampligen) submitted by Hemispherx Biopharma Inc., of Philadelphia, to treat chronic fatigue syndrome (CFS