Apexigen Inc., of Burlingame, Calif., signed a manufacturing supply agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, under which the big pharma firm will provide cell line development with the high expression BI-HEX system, full process and method development, scale-up and clinical Phase I supply for APX005, a humanized monoclonal antibody designed to target CD40 for treating cancer...Gentium SpA., of Villa Guardia, Italy, inked an agreement with the National University Corporation

In other news, Bayer said its BAY 86-6150 is being investigated in a Phase II/III study, dubbed TRUST (TReatment with Unique recombinant rFVIIa STudy), and the recruitment of the first cohort is now complete...In other news, Viralytics is offering shareholders up to $15,000 worth of shares at 30 cents each in a new underwritten share purchase plan to fund the company's intravenous cancer trial and the continued clinical research and development of Cavatak, its lead oncolytic virus candidate

Akela Pharma Inc., of Vancouver, British Columbia, said it applied for voluntary delisting from the Toronto Stock Exchange, citing an inability to maintain the continuous listing requirements...Its expenses related to the terminations will be $280,000 in the fourth quarter

Ildong also agreed to pay Arena a $2 million development milestone if its planned clinical trials of temanogrel support continued development and either Arena or a licensee initiates a Phase IIb trial...Arena also is eligible to receive a royalty on net sales of temanogrel in South Korea, while Ildong is eligible to receive a share of future payments to Arena for licensing transactions and sales of temanogrel in other countries

The randomized, sham-controlled, blind trial will compare C3BS-CQR-1 to a sham therapy in at least 240 patients with a primary composite endpoint of mortality, morbidity, quality of life and other measures at nine months after the procedure...LEO Pharma A/S, of Ballerup, Denmark, said the European Commission granted marketing authorization for Picato (ingenol mebutate) gel as a treatment for actinic keratosis, a skin condition that can lead to squamous cell carcinoma if not treated...Following

oncology-focused company ND Independent research collaborations to deliver a number of monoclonal antibodies to partner-selected targets Financial terms were not disclosed 9/28/12 MedImmune Inc. (Gaithersburg, Md.) WuXi AppTec (Shanghai, China) ND Joint venture to develop and commercialize MED15117 for autoimmune and inflammatory diseases in China MedImmune will provide technical and development expertise, with WuXi providing the local regulatory, manufacturing, preclinical and clinical trial

An NDA previously submitted in Japan in 2010 was withdrawn and additional clinical trials performed to confirm efficacy and safety...In other news, Orexo said the FDA accepted for review its new drug application for Zubsolv, a sublingual formulation of buprenorphine and naloxone, and set a PDUFA date of July l6, 2013...Tiltan Pharma Ltd., of Jerusalem, said it enrolled the first U.S

The databank will serve as a one-stop repository for key information about clinical trial sites, allowing participating pharmaceutical companies to reduce time-consuming and sometimes redundant administrative work in identifying appropriate clinical trial sites...Earlier this year, Janssen and nine other companies joined forces to create TransCelerate BioPharma Inc., an initiative aimed at identifying and overcoming common drug development challenges to improve the quality of clinical studies. (See

Ironwood plans to initiate Phase I studies in healthy volunteers to assess the pharmacokinetics of IW-2143...CellAct Pharma GmbH, of Dortmund, Germany, said its topoisomerase inhibitor CAP7.1 showed promising safety and tolerability in heavily pretreated solid tumors...Immune Pharmaceuticals Ltd., of Herzlyia-Pituach, Israel, and EpiCept Corp., of Tarrytown, N.Y., entered a merger agreement, anticipated to close in the first quarter of 2013, that will create a combined company – Immune Pharmaceuticals

The company currently estimates that it will establish a reserve of between $7 million and $12 million, which will be used to pay all expenses (including operating expenses up until the dissolution) and other known, noncontingent liabilities, and includes reasonable provision for expenses of liquidation and contingent and unknown liabilities as required by Delaware law...The vaccine will be based on the company's Vaccibody DNA vaccine platform, which targets antigen-presenting cells and the grant

The defendants AstraZeneca AB, AstraZeneca LP, AstraZeneca Pharmaceuticals LP and Aktiebolaget Hassle, all subsidiaries of AstraZeneca plc, of London, will pay up to $11 million with approximately half of the settlement fund going to pay consumer claims and the other half to pay insurers and employee welfare benefit plans claims...Suvorexant is designed to target and block orexins, chemical messengers that help keep people awake

rights to market Bethkis (tobramycin inhalation solution) for the management of cystic fibrosis patients with Pseudomonas aeruginosa...XenoPort licensed worldwide rights, excluding Asian territories, to Horizant to GSK in 2007 for $75 million in cash up front, $65 million in milestones leading up to the filing of a new drug application and an additional $210 million in other development and regulatory milestones, plus as much as $290 million in sales milestones...Immune Pharmaceuticals Ltd., of

IL-17 mediated signaling is known to induce the expression of cytokines and other effectors in a variety of immunological diseases such as psoriasis and chronic obstructive pulmonary disease...Isconova AB, of Uppsala, Sweden, carried out a fully subscribed rights issue of about SEK50 million (US$7.4 million) to finance clinical trials in-house, increase production capacity and continue research in new indications for the adjuvant Matrix M. Shareholders representing 46.3 percent committed to

Those data explained a phenomenon concerning the role of aggregated oligomeric tau as an inhibitor of fast axonal transport, the mechanism by which newly synthesized membrane and other proteins made in the nerve cell body essential for neuronal membrane function and maintenance are provided to the synapse...Boston Oncology plans to oversee clinical trials and the development of manufacturing facilities for those therapies in various MENA markets

A couple of other candidates in the space "have had kind of the same profile," he added...In the U.S., Ambit holds an option to co-promote under a 50/50 profit-and-loss-sharing arrangement. (See BioWorld Today, Dec. 21, 2009.) Existing investor OrbiMed Advisors led the latest financing, with participation from other existing Ambit investors including Aisling Capital, Apposite Healthcare, Roche Ventures, GrowthWorks, MedImmune Ventures, Forward Ventures, GIMV and Radius Ventures...In other financing

IL-17 mediated signaling is known to induce the expression of cytokines and other effectors in a variety of immunological diseases such as psoriasis and chronic obstructive pulmonary disease...Ventrus has started to enroll in its second Phase III pivotal trial, with results expected early fourth quarter 2013, and assuming a successful outcome, expects to file an NDA late in the fourth quarter of 2013 with an anticipated PDUFA date at the end of 2014

The company laid groundwork for clinical trials in advance of the financing and plans to begin a "very substantial" randomized Phase II study in the U.S...The company also received $25.0 million from the sale of common stock in a private placement to strategic partner AstraZeneca plc, of London, that closed concurrently with the IPO, and $5.0 million from the sale of a convertible note to research collaborator Biogen Idec Inc., of Weston, Mass., which was converted into shares of common stock at

In other news, Cellectis said it signed two exclusive license agreements with Iowa State University granting the firm worldwide rights to inventions related to TAL effector-nucleases (TALENs) and monomeric TALENs...Pharma Two B Ltd., of Rehovot, Israel, completed a second round of financing for $8 million to develop its fixed-dose-combination product, P2B001, for Parkinson's disease and to complete a Phase IIb trial

AmVac said it expects to begin clinical trials before the end of 2013