Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., said the FDA agreed to an expedited development pathway for next-generation compound AVP-786, requiring only a limited preclinical package as part of the investigational new drug application. Upon completion of those studies, the company intends to proceed directly into human testing. AVP-786, a drug product consisting of a combination of deuterium-modified dextromethorphan and ultra-low dose quinidine, is in development for neuropathic pain

Although efficacy below AstraZeneca plc's standard caused the pharma firm to give up rights to fostamatinib, the spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis (RA) met important endpoints, and Rigel Pharmaceuticals Inc. could find another partner and explore new diseases with it. "It works, but maybe not as well as AstraZeneca had hoped, in terms of having a robust bone benefit, in particular," said Raul Rodriguez, president and chief operating officer for South San Francisco

The president is getting gruff with patent trolls, using his executive powers to waylay their frivolous lawsuits and urging Congress to pass legislation that would make trolling far less appetizing. Unlike patent intermediaries that foster the transfer of technology from inventors to businesses looking to develop products, the trolls – also known as patent assertion entities (PAEs) – stake their claim around patents for ideas that failed in the marketplace or they buy up hundreds of thousands of

Shares of Pluristem Therapeutics Inc. stumbled Tuesday on word that the FDA placed a clinical hold on the U.S. Phase II study (IND 15038) of its allogeneic cell therapy in intermittent claudication (IC), a subset of peripheral artery disease (PAD), following a serious allergic reaction that required the patient's hospitalization. Zami Aberman, chairman and CEO of the Haifa, Israel-based firm, said the allergic event was the first to occur among 74 patients enrolled to date in trials of its

A bit more than a year after handing in positive results in a Phase II study for AKB-6548 in chronic kidney disease (CKD), Akebia Therapeutics Inc., of Cincinnati, secured a $41 million Series C financing to fund ongoing development of the drug. Spread out over the next 18 months, the company will put the funds to work supporting preparations for Phase III studies, including a Phase IIb study in patients with anemia associated with CKD. "In 2012, we completed a 93-patient Phase II study, the

Debiopharm Group, of Lausanne, Switzerland, said it treated the first patients in a Phase I study of Debio 1143, a small-molecule neutralizing inhibitor of apoptosis protein, combined with carboplatin and paclitaxel in patients with squamous non-small-cell lung cancer, platinum-refractory ovarian cancer and basal-like/claudin low-triple-negative breast cancer. The study will evaluate the safety and tolerability of the drug, establish a maximum tolerated dose and establish dosing for a further

BEIJING – As manufacturers of biologics reflect on the price of foreign products in China, they say there must be a better way. For example, at a panel discussion on biosimilars and biologics at the ChinaBio Partnering Forum in Beijing last week, Michael Yu, president and CEO of Innovent Biologics Inc., of Suzhou, China, noted that Herceptin (trastuzumab, Roche AG) is even more expensive in China than in the U.S. And thus, it reaches about 4,000 patients in China, or only 1 percent of the 400

Antisense Therapeutics Ltd., of Victoria, Australia, said it is conducting a chronic, six-month primate toxicology study in China designed to underpin and validate plans to secure a partner to take second-generation antisense drug ATL1102 into a Phase IIb study in multiple sclerosis patients. Dosing in the preclinical study is set to be completed by the end of this year, with data on track to be reported early in 2014. Biotie Therapies Corp., of Turku, Finland, obtained an exclusive option to

German biotech received a badly needed boost this week with the news that GlaxoSmithKline plc was in-licensing MOR103, an antibody in clinical development in rheumatoid arthritis (RA) and multiple sclerosis (MS) at veteran antibody developer Morphosys AG, in return for an up-front payment of €22.5 million (US$29 million), plus another potential €423 million in milestones linked to its progress through clinical development, regulatory approval and sales. Martinsried, Germany-based Morphosys also

CSL Behring, of King of Prussia, Pa., dosed the first patient in Part 3 of its AFFINITY trial program. The open-label Phase I/III study is evaluating the efficacy, safety and pharmacokinetics of its recombinant coagulation single-chain Factor VIII compared with recombinant human antihemophilic Factor VIII (octocog alpha) for the treatment of hemophilia A.

Bristol-Myers Squibb Co., of Princeton, N.J., and AstraZeneca plc, of London, said the FDA accepted for review and granted priority designation for the biologics license application for metreleptin in metabolic disorders associated with inherited or acquired lipodsytrophy. Under priority review, the FDA aims to complete its review within an eight-month review cycle. Metreleptin, a recombinant analogue of human hormone leptin, was developed by San Diego-based Amylin Pharmaceuticals Inc., which

The following data were presented at the American Society of Clinical Oncology meeting in Chicago. Ambit Biosciences Corp., of San Diego, presented data from its Phase II ACE study of quizartinib (AC220), a FLT3 inhibitor, including data from 176 patients with either relapsed acute myeloid leukemia (AML) or AML that was refractory to second-line chemotherapy or hematopoietic stem cell transplantation (HSCT). Of the 136 FLT3-positive patients, 35 percent were bridged successfully to a

Aerial BioPharma LLC, of Morrisville, N.C., said data from a Phase IIa trial evaluating the efficacy and safety of ADX-N05 for the treatment of excessive daytime sleepiness in adult subjects with narcolepsy will be presented at the SLEEP 2013 meeting in Baltimore this week. A total of 33 patients were randomized and completed both N05 and placebo periods in the double-blind, placebo-controlled, multicenter, crossover study. The average sleep latency across the four trials on the Maintenance of

Some advisory committee members may think they're listening to a broken record when they convene for the third time in seven years Wednesday to once again discuss the cardiovascular (CV) risk of GlaxoSmithKline plc's (GSK) diabetes drug Avandia and its open-label, noninferiority RECORD trial. But this time, they'll be listening to a version conducted by the Duke Clinical Research Institute (DCRI), which was hired by GSK to satisfy the FDA's 2010 demand for an independent readjudication of the

Arcturus Therapeutics Inc., of San Diego, said it raised $1.3 million in a seed funding round led by multiple high net-worth private investors from the U.S. and Canada. The company was founded this year to pursue RNA interference solutions for rare diseases. Inflection Biosciences Ltd., of Dublin, Ireland, said it entered a license agreement with the Spanish National Cancer Research Centre (CNIO) for exclusive, worldwide rights to develop and commercialize several kinase inhibitors for the

LONDON – Bergenbio AS has raised $6 million in a Series B round supported by all the existing investors, providing funding for a number of Phase I trials of its lead product BGB 324, a first-in-class AXL receptor tyrosine kinase inhibitor. AXL kinase is central to the cell-to-cell signal transduction process known as epithelial-mesenchymal transition (EMT), by which cancer cells escape to form metastases and also is involved in the development of resistance to chemotherapeutics, most notably

CHICAGO – For those already cowed by the genetic diversity of cancer, Charles Swanton, of the Institute for Cancer Research/Royal Marsden Hospital, had some depressing news at the American Society for Clinical Oncology's (ASCO) annual meeting. Such tumor diversity, he told the audience at a joint ASCO/AACR session on metastasis, does not just exist between tumors in different patients. The differences between tumors and metastases, and even within different regions of the primary tumor, may

Much-awaited data from Synta Pharmaceuticals Corp.'s mid-stage GALAXY-1 study left investors less than satisfied, as shares of the Lexington, Mass.-based biotech dropped 34 percent. But the company said results from the study, presented Monday at ASCO 2013, confirmed the patient population selected for the recently initiated pivotal trial testing heat-shock protein 90 (Hsp90) inhibitor ganetespib as a second-line treatment in patients with advanced non-small-cell lung adenocarcinoma. Analysts