Anika Therapeutics Inc., of Bedford, Mass., said Sanofi SA unit Genzyme Corp., of Cambridge, Mass. (plaintiff), and Anika (defendant) filed a joint motion with the U.S. District Court for the District of Massachusetts to lift a stay and dismiss a patent infringement lawsuit concerning Monovisc, a single-injection treatment for osteoarthritis pain of the knee, which received FDA approval in February 2014. The court granted the parties’ motion and issued an order dismissing the litigation with prejudice on March 10. This final and unappealable order resolves the parties’ dispute and is another important milestone toward commercialization in the U.S., Anika said. Monovisc is marketed in the U.S. by DePuy Synthes, Mitek Sports Medicine (Mitek). Under the license agreement with Mitek, Anika will receive a milestone payment of $17.5 million upon an irrevocable resolution of the Genzyme litigation, allowing Mitek and Anika to make, use and sell Monovisc without infringing the Genzyme intellectual property. The agreement also calls for potential payments contingent on achieving certain performance and sales threshold milestones, in addition to product transfer and royalty fees.

Celsus Therapeutics plc, of London, said it held a pre-investigational new drug (IND) meeting with the FDA to discuss the regulatory pathway for the development of MRX-6 cream in atopic dermatitis, also known as eczema. The company plans to file the IND for MRX-6 with the FDA in the fourth quarter, and initiate phase II trials in the U.S. in the first half of 2015.

Cornerstone Pharmaceuticals Inc., of Cranbury, N.J., said its cancer metabolism-targeted therapeutic, CPI-613, demonstrated the ability to inhibit tumor cell growth in the published studies in Cancer & Metabolism. Clinical trials were initiated in 2008 and since then, the Cornerstone-sponsored trials have progressed steadily, moving into phase II trials in 2013, the company said. First-in-class CPI-613 is the lead drug candidate from Cornerstone’s Altered Energy Metabolism platform.

Formycon AG, of Martinsried, Germany, out-licensed its first biosimilar development project in a deal with Santo Holding GmbH, of Poecking, Germany. On behalf of Santo and its partners Andreas and Thomas Strüngmann, founders and former owners of the generics manufacturer Hexal AG, of Holzkirchen, Germany, Formycon will bring the first development project to market maturity.

Galena Biopharma Inc., of Portland, Ore., became the target of a federal securities fraud class action complaint in the U.S. District Court for the District of Oregon, filed by shareholder rights law firm Robbins Arroyo LLP. The complaint alleges that the company and certain of its officers and directors violated the Securities and Exchange Act of 1934 between Nov. 6, 2013, and Feb. 14, 2014. Galena is a biopharmaceutical company focusing on the development of oncology treatments. The complaint charges that an investor relations firm was hired by Galena to tout the company and misleadingly promoted its stock.

Islet Sciences Inc., of Raleigh, N.C., signed a binding letter of intent to acquire Brighthaven Ventures LLC (BHV), of Raleigh, N.C., a privately held pharmaceutical company developing the SGLT2 inhibitor remogliflozin etabonate for type 2 diabetes and non-alcoholic steatohepatitis, now in phase II development. In exchange for 100 percent ownership of BHV, Islet will issue 30 million shares of common stock to holders of BHV units. More shares of Islet common stock will be issued upon successful completion of development, regulatory and commercial milestones associated with the program.

Knopp Biosciences LLC, of Pittsburgh, disclosed a second collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) to investigate the eosinophil-lowering effects of investigational drug dexpramipexole. That follows an agreement made public in January under which NIAID will sponsor a phase II proof-of-concept trial of dexpramipexole in hypereosinophilic syndrome. Terms were not disclosed.

Medimmune, of Gaithersburg, Md., AstraZeneca plc’s global biologics R&D arm, said it entered a three-year translational and clinical research collaboration with the University of Texas MD Anderson Cancer Center to study therapies that boost patients’ immune systems to attack their cancers. The collaboration will fall under MD Anderson’s Moon Shots Program, an effort to dramatically reduce cancer deaths by targeting eight cancers employing the support of several new research platforms that provide infrastructure, expertise and technology. Through the collaboration, MD Anderson will evaluate several of the company’s immunotherapy molecules in a clinical setting in order to better understand how those molecules elicit immune responses. The hope is that data collected from those studies will be useful in shedding light on treatment-related changes to tumors, with the ultimate aim of identifying optimal combination therapies and developing biomarkers to guide and assess the safety and efficacy of Medimmune’s immunotherapy molecules. Financial terms related to the collaboration were not disclosed.

Novozymes Biopharma, of Bagsvaerd, Denmark, part of Novozymes A/S, said it is collaborating with Janssen Research & Development LLC, part of New Brunswick, N.J.-based Johnson & Johnson. Their agreement will enable Janssen to evaluate Novozymes Biopharma’s engineered albumin-based Veltis technology for potential drug candidates. Engineered human albumin in combination with a drug candidate offers the potential for tunable control of the therapeutic half-life, which provides an opportunity for reducing the dosing frequency.

Peregrine Pharmaceuticals Inc., of Tustin, Calif., said preclinical data presented at the Keystone Immune Evolution in Cancer symposium in Whistler, British Columbia, and the Keystone HIV Pathogenesis – Virus vs. Host symposium in Banff, Alberta, support the immune-stimulatory mechanism of action and therapeutic potential of the firm’s phosphatidylserine (PS)-targeting antibodies in both oncology and antiviral therapeutic areas. In a poster, data from studies conducted by Duke University and Peregrine researchers were presented that further characterize the mechanism by which the PS-binding antibody PGN632 inhibits the HIV infection of cells. Results revealed that PGN632 stimulates immune cells to link together and secrete molecules that block viral receptors used by HIV to infect cells. Furthermore, the immune-stimulatory mechanism of PS-targeting antibodies was further validated as study results showed that the antiviral mechanism of action was dependent on using the full length antibody rather than an antibody fragment that simply blocks PS. An oral presentation revealed data from studies demonstrating that PS-targeting antibodies override PS-mediated immune suppression in tumors and induce multiple downstream immune-stimulatory effects. Results showed a reduction of highly immunosuppressive myeloid derived suppressor cells (MDSC), increases in inflammatory cytokines, tumor-fighting M1 macrophages, mature dendritic cells and tumor-specific cytotoxic T-cells. Additionally, combination therapy studies utilizing a PS-targeting antibody with an anti-PD-1 antibody yielded enhanced therapeutic results in a preclinical model of melanoma, including delays and reductions in tumor growth compared to either antibody administered alone.

Pluristem Therapeutics Inc., of Haifa, Israel, said research findings showing that the company’s placental-expanded (PLX)-PAD cell therapy appeared to have an early beneficial effect on tendon healing following collagenase injury in a preclinical model were presented in a poster at the American Academy of Orthopedic Surgeons’ annual meeting. In addition, since these cells are immunoprivileged and are expanded ex vivo, its potential for off-the-shelf use is attractive relative to existing cell-based therapies. The biomechanical analysis of the study results showed that PLX-PAD treated tendons had significantly higher load-to-failure at the two-week time point following injection when compared to saline-treated patellar tendons.

Sucampo Pharmaceuticals Inc., of Bethesda, Md., said its European subsidiary received a notice of refusal to grant a type II variation for Amitiza (lubiprostone) 24 mcg for opioid-induced constipation from the UK’s Medicines and Healthcare Products Regulatory Agency. Amitiza was approved in the UK in 2012 for the treatment of chronic idiopathic constipation and associated symptoms in adults when response to diet and other nonpharmacological measures are inappropriate. Sucampo said it is reviewing the variation assessment report and intends to explore all available options for a path forward.

Taigen Biotechnology Co. Ltd., of Taipei, Taiwan, said the Taiwan Food and Drug Administration approved the new drug application (NDA) for Taigexyn (nemonoxacin) oral formulation for the treatment of community-acquired bacterial pneumonia. An NDA also was submitted to the China FDA in April 2013 and is under review. Taigexyn is a broad-spectrum, nonfluorinated quinolone antibiotic available for both intravenous and oral formulations.

The Pharmaceutical Research and Manufacturers of America (PhRMA), of Washington, and the National Minority Quality Forum said that they have launched a first-of-its-kind national campaign to help increase diversity in clinical trials. The “I’m in” campaign is designed to raise awareness about the importance of clinical research and encourage greater participation by diverse patient populations to help researchers develop potential new medicines. Partnerships with patient advocacy organizations, provider groups, individual physicians, clinical trials sponsors and researchers will help to drive campaign awareness and involvement. According to FDA data, African Americans represent 12 percent of the U.S. population but only 5 percent of clinical trial participants and Hispanics make up 16 percent of the population but only 1 percent of clinical trial participants. Inclusion of individuals of varied races, ethnicities, ages, gender and sexual orientation in clinical trials can help to prevent disparities in the evaluation of potential new medicines. The campaign will support the build-up of the National Minority Quality Forum’s Clinical Trial Engagement Network, a comprehensive, sustainable solution to help accelerate the inclusion of underrepresented populations in clinical trials. Authorized users will be able to simply and quickly identify potential clinical trial participants by utilizing zip code level mapping of disease clusters and simultaneously identifying and connecting points of care and community resources that can assist with site selection and patient recruitment.