Clavis Pharma ASA, of Oslo, Norway, said that interim efficacy data from a Phase II trial showed promising clinical activity from a combination treatment of elacytarabine and idarubicin in patients with acute myeloid lymphoma who have failed cytarabine-containing, first-course chemotherapy...Verona Pharma plc, of London, said that its bronchodilator RPL554 showed sustained action in a Phase II trial in patients with asthma

Action Pharma A/S, of Arhus, Denmark, said that it has completed the last visit of its last patient in a Phase IIb study of AP214 for prevention of kidney injury in patients undergoing cardiac surgery...It will now proceed with compiling data from its eight clinical sites in the U.S

Acacia Pharma Ltd., of Cambridge, UK, started a Phase II study of APD515, an oromucosal formulation of a currently marketed drug, in xerostomia (dry mouth) in advanced cancer patients...Threshold Pharmaceuticals Inc., of Redwood City, Calif., initiated a clinical trial of TH-302 in combination with bevacizumab (Avastin, Roche AG) in patients with recurrent high-grade astrocytoma including glioblastoma

The findings were based on Kohl's correspondence with six big pharma companies and an inquiry into URL Pharma Inc.'s pricing of its gout drug Colcrys (colchicine) and Avarin Pharmaceuticals Inc.'s pricing of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), the first approved treatment for pseudobulbar affect. (See BioWorld Today, June 3, 2011.) In a letter to the pharma companies, which included AstraZeneca plc and Eli Lilly and Co., Kohl asked why "Americans pay, on average

Horizon Pharma Inc., of Northbrook, Ill., set terms for its proposed initial public offering...The specialty pharma firm is aiming to sell 5.5 million shares priced between $10 and $12 each...Proceeds will be used for clinical trials and general purposes

Novartis attributed its interest in Sorbent to CLP1001's promising clinical data...ZS Pharma also is developing an oral product for hyperkalemic patients based on its ZirSi crystal structure technology...Oragenics Inc., of Tampa, Fla., amended its line of credit with the Koski Family Limited Partnership, increasing the total amount from $5 million to $7 million.

For now the company's scientific founders, David Woodley and Mei Chen at USC, have just received a National Institutes of Health grant for a clinical study of the recombinant protein in epidermolysis bullosa patients...A.P. Pharma Inc., of Redwood City, Calif., entered a definitive agreement with new and existing investors to raise $24 million in a private placement of common stock and warrants...The company said the funds are an additional source of liquidity to fund its clinical development plans

Endotis Pharma, of Paris, enrolled the first patients in a Phase IIa trial of anticoagulant EP217609 and its specific antidote, avidin, to manage coagulation during open-heart surgery...Infinity Pharmaceuticals Inc., of Cambridge, Mass., said it is expanding its clinical program for IPI-926, an oral, small molecule designed to inhibit Smoothened, a component of the Hedgehog pathway

LifeCycle Pharma A/S, of Horsholm, Denmark, said lead candidate LCP-Tacro demonstrated noninferiority compared to Prograf (tacrolimus, Astellas Pharma Inc.) in a Phase III trial enrolling 326 stable kidney transplant recipients...Senesco Technologies Inc., of Bridgewater, N.J., said the FDA removed the clinical hold on the company's investigational new drug application for SNS01-T in multiple myeloma

Assistant Managing Editor Proving that big pharma firms aren't the only ones interested in the orphan disease space, venture investors are getting behind 2010 start-up Ultragenyx Pharmaceutical Inc...Funds will be used to prepare and submit a new drug application for lead product lomitapide in homozygous familial hypercholesterolemia (HoFh), complete clinical and nonclinical studies in HoFH, advance development of the drug in pediatric and adolescent patients and for general corporate purposes

Ambit Biosciences Corp., of San Diego, and partner Astellas Pharma Inc., of Tokyo, reported data from an interim analysis of a Phase II study of AC220, a selective FLT3 inhibitor, as a once-daily monotherapy in acute myeloid leukemia patients with FLT3-ITD activating mutations who have relapsed or are refractory to other treatments...Clinical response data was reported for 53 patients and showed a composite complete remission rate (CRc) of 45 percent, with the majority of CRc cases represented by

Although Oliver Fetzer, president and CEO of Cerulean Pharma Inc., said he thinks the existing regulatory framework is robust enough to evaluate the safety and efficacy of nanopharmaceuticals, he is encouraged by the thoughtful approach the FDA is taking in providing clarity for this innovative technology...A biotech on the leading edge of nanotechnology, Cerulean, of Cambridge, Mass., has been interacting with the FDA in bringing its nanopharmaceuticals into clinical development...The revision

The drug was previously included as part of a six-year option agreement with GlaxoSmithKline plc, but the big pharma passed on the compound in 2008...The South San Francisco-based firm raised $165 million a few months later to push cabozantinib through clinical trials. (See BioWorld Today, Dec. 6, 2010, and March 11, 2011.) The results of initial trials seemed to garner mixed feedback at ASCO...Astellas Pharma Global Development Inc., of Deerfield, Ill., said AGS-1C4D4 reduced tumor formation and

It was a really big discovery and generated a lot of interest in big pharma," he added...Proceeds will allow the firm to advance product candidates in its portfolio toward clinical development...Proceeds are expected to help complete the ongoing 240-patient trial of DCVax-L for the treatment of glioblastoma multiforme and advance other programs in the pipeline.

Adeona Pharmaceuticals Inc., of Ann Arbor, Mich., announced that analyses of a clinical study evaluating reaZin, a gastroretentive, sustained-release, once-daily oral tablet formulated from zinc (150 mg) and amino acid cysteine (100 mg) for treatment of Alzheimer's disease, indicated that the older the reaZin treatment patient, the greater the amount of cognitive benefit compared to the placebo patients of the same age...Celgene Corp., of Summit, N.J., and Acceleron Pharma Inc., of Cambridge, Mass

We have a network of pharma experts who all told us, if it was their compound it would be given the green light to go into clinical development...We'll get clinical proof of concept and then think about it...The company said it will use the funds to complete Phase IIa studies with lead Smac mimetic drug candidate, TL32711, in solid tumors and to initiate clinical studies in hematological cancers.

Based on those difficulties, in addition to the need to sharpen the toxicology profile and a potential requirement for an altered dosage, the companies opted to terminate clinical development of EVT 101...Pharma Two B, of Rehovot, Israel, said it is planning a Phase II study of combination therapy P2B001, in development to treat the early stages of Parkinson's disease

The New York-based big pharma, which paid $50 million in cash and equity up front and would have owed up to $390 million more in milestones, cited reprioritization as its reason to return rights last fall, despite the drug's impressive Phase II data in GBM. (See BioWorld Today, Sept. 7, 2010.) Analysts have estimated that the Phase III rindopepimut program could run Celldex about $50 million...Antares Pharma Inc., of Ewing, N.J., closed an underwritten public offering of 12.5 million shares of

PolyMedix Inc., of Radnor, Pa., presented new clinical and preclinical data at the 21st Annual European Congress of Clinical Microbiology and Infectious Disease/27th Annual International Congress of Chemotherapy, in Milan, Italy, related to the safety and efficacy of its lead defensin-mimetic antibiotic, PMX-30063, that the company said reaffirmed that PMX-30063 does not cause nerve damage at the tested doses and indicated that interactions with ion channels are the underlying mechanism of the