In April, Aptalis Pharma Inc. (formerly Axcan Holdings Inc.), based in Mont-Saint-Hilaire, Quebec, agreed to acquire the outstanding shares of Mpex and lead candidate, Aeroquin, an aerosol formulation of levofloxacin in Phase III trials for the treatment of pulmonary infections in patients with cystic fibrosis...We've got a fully formed clinical group here, so we'll be doing the clinical work in house," Burgess said

The company said proceeds from the IPO would see the company through 2013 and allow it to advance the TVI-Brain-1 clinical program, though additional financing would be needed to complete clinical trials of the compound...Affiris is developing peptide vaccines, including a vaccine for Parkinson's disease set to start Phase I testing in early 2012.

Cardiome Pharma Corp., of Vancouver, British Columbia, said partner Merck & Co...Galena Biopharma Inc., of Lake Oswego, Ore., reported that data from Phase II clinical trials of its NeuVax vaccine showed that it may provide a meaningful clinical benefit in patients with less aggressive forms of breast cancer, and potentially keep them free of their disease...Rexahn said the firm plans to evaluate the Serdaxin clinical programs and possible paths forward

Auxilium Pharmaceuticals Inc., of Malvern, Pa., reported that clinical practice data from the TRiUS (Testim Registry in the United States) study showed that daily administration of Testim 1 percent (testosterone gel) resulted in significantly improved sexual function and increased total testosterone levels in men with hypogonadism...Clinical follow-up, completed three months after the administration of PLX-PAD cells, noted statistically significant improvements in several parameters, including

True, there has been only one pricing since the spring – specialty pharma firm's Horizon Pharma Inc.'s $49.5 million offering in July – but the fact that a couple of other platform biotechs have jumped in the queue – Merrimack Pharmaceuticals Inc...NanoViricides said it is moving toward an investigational new drug application filing for influenza candidate NV-INF-1.

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., reported positive results from the Ampion-In-Knee (AIK) clinical trial, showing the drug was well tolerated and reduced pain over and above steroids...The decision follows reports of laboratory abnormalities and adverse events in a subset of clinical trial participants...Solasia Pharma K.K., of Tokyo, reported that enrollment of a Phase I trial evaluating the safety and tolerability of darinaparsin injection (SP-02L) for the treatment of

Clavis Pharma ASA, of Oslo, Norway, established the cutoff level for defining hENT1 low vs...Low hENT1 levels have been correlated to poor clinical outcome with gemcitabine, the standard treatment for many solid tumors...PharmaGap Inc., of Ottawa, said it has chosen ovarian cancer as its target for clinical development of GAP-107B8

Galderma Pharma SA, of Lausanne, Switzerland, reported top-line results from a Phase IIb trial showing that CD07805/47, a topical gel in development for moderate to severe facial erythema of rosacea, was rapidly effective at reducing facial redness...Data, which resulted from a pooled analysis of five trials in postsurgical pain management, were presented at the American College of Clinical Pharmacy meeting in Pittsburgh

Complete cure is the primary clinical endpoint for the conduct of pivotal clinical trials seeking FDA approval, Topica said...Net proceeds will be used for clinical trials activities related to completion of enrollment and ongoing patient dosing for the trial testing davunetide in progressive supranuclear palsy, as well as for general corporate purposes and working capital

Following a handful of IPO pricings earlier in the year, activity dropped off over the summer, with only one company going public: specialty pharma firm Horizon Pharma Inc...Amarantus is developing products based on MANF, a protein that corrects protein misfolding.

Dynavax will manage early clinical development, with AstraZeneca providing approximately $20 million to cover the cost of clinical development activities through Phase IIa...Tranzyme Pharma, of Research Triangle Park, N.C., dosed its first patient in a Phase IIb, 12-week trial of TZP-102, its oral gastrointestinal (GI) motility drug candidate

Action Pharma A/S, of Aarhus, Denmark, released top-line results for its Phase IIb AP214 trial in patients undergoing major cardiac surgery, indicating that AP214 is safe, reduces kidney injury and improves 90-day outcomes on a composite end point (death, dialysis and kidney function) in patients undergoing cardiac surgery with cardiopulmonary bypass who are at increased risk of developing acute kidney injury...The study will evaluate the safety and tolerability of ALN-PCS in subjects with elevated

Bionomics Ltd., of Adelaide, Australia, said the higher dose level of 16 mg/m2 was cleared for BNC105, a vascular-disrupting agent that is being tested in a clinical trial in combination with mTOR inhibitor Afinitor (everolimus, Novartis AG) in patients with metastatic renal cell cancer...Niiki Pharma Inc., of Hoboken, N.J., reported interim data from a Phase I study of NKP-1339 in patients with metastatic solid tumors resistant to standard therapies showing that six of the first 24 patients

The company has completed seven clinical trials of the minimally invasive procedure, known as adipolytic therapy, enrolling more than 350 patients...The funding will be used for preclinical and clinical development and commercial efforts...The company has candidates in clinical development to treat nephropathic cystinosis, nonalcoholic steatohepatitis, Huntington's disease, aldehyde dehydrogenase deficiency and thrombotic disorder

Proceeds will be used to fund clinical trial activities relating to progressive supranuclear palsy drug davunetide, as well as for general administrative expenses, working capital and general corporate purposes...Proceeds are expected to help the specialty pharma firm expand its commercialization activities, prepare for the extension of its product line including Altrazeal Collagen and Altrazeal Silver and position it for negotiating with potential partners

Bionor Pharma ASA, of Oslo, Norway, reported results from a multinational Phase IIb, placebo-controlled multicenter study of Vacc-4x, a therapeutic HIV vaccine based on four synthetic slightly modified peptide sequences from conserved parts of the P24 capsid protein of the HIV virus...In July, the FDA approved the company's investigational new drug application for QLT091001, whose clinical trial application also has been cleared by the U.K. Medicines and Healthcare Products Regulatory Agency...The

Acceleron Pharma Inc., of Cambridge, Mass., said it started a Phase I study of ACE-536, a ligand trap designed to increase red blood cells and hemoglobin by inhibiting member of the TGF-beta superfamily involved in late stages of erythropoiesis...Under the firms' 2010 deal, Otsuka will contract with Acucela for early clinical development in exchange for an opt-in right to co-develop and co-promote the compound in the U.S...Ascendis Pharma A/S, of Copenhagen, Denmark, said a Phase II study of ACP-001

The study, initiated in April, enrolled 52 patients at clinical sites in the U.S., Canada, Jamaica, Egypt and Lebanon to evaluate the safety and tolerability of HQK-1001...Nektar Therapeutics Inc., of San Francisco, said its breast cancer candidate, NKTR-102, showed a high response rate and strong clinical benefit in a Phase II trial in metastatic breast cancer, even in subsets of patients with a poor prognosis...Tranzyme Pharma Inc., of Research Triangle Park, N.C., presented data from a Phase II

In patients who achieved clinical success but had recurrence, the mean degree of contracture had yet to return to pre-treatment levels after three years...marketing rights in Europe and Tokyo-based Asahi Kasei Pharma Corp...Nektar will present results from a Phase I single-ascending dose trial at the American Academy of Pain Management's Annual Clinical Meeting later this month