Abbvie Inc., of Chicago, reported results from the CONCERTO trial testing different predefined doses of methotrexate in combination with anti-TNF-alpha drug Humira (adalimumab) in moderate to severe rheumatoid arthritis. CONCERTO showed that, at week 26, a statistically significant increasing trend was observed in the proportion of patients achieving low disease activity with an increasing dose of methotrexate when used with open-label Humira. Results were presented at the European League

Although Amgen Inc.'s top-line data from TRINOVA-1, the first of three Phase III trials evaluating trebananib, also known as AMG 386, proved positive in ovarian cancer with regard to progression-free survival (PFS), whether this will be enough for approval remains in question. The company reported that a statistically significant difference was observed in PFS, with a 34 percent knock-down in the risk of disease progression or death (hazard ratio = 0.66, 95 percent confidence interval, 0.57, 0

Aphios Corp., of Woburn, Mass., said it entered joint research collaboration and commercialization agreements with Vivacell Biotechnology Espana SL, of Cordoba, Spain, to develop therapeutics for multiple sclerosis and other neurodegenerative diseases of the central nervous system. Researchers collaborating with Vivacell recently discovered a class of nonpsychotropic cannabinoids that appear to have multiple activities on key molecular targets involved in neuroinflammatory and neurodegenerative

The FDA etched a distinct line between orphan drug designation and exclusivity in a final rule released Wednesday, making it clear that getting the designation doesn't guarantee seven years of market exclusivity. A hypothesis of superiority is enough to get the designation when another drug has already been approved for the same orphan indication, but evidence of clinical superiority is needed for exclusivity, according to the rule, which amends the regulations issued in 1992 to implement the

Ablynx NV, of Ghent, Belgium, will make an oral and poster presentation for arthritis candidate, ALX-0061, at the Annual European Congress of Rheumatology in Madrid, Spain, showing a strong efficacy and safety profile for the drug in a Phase II study. Pooled data at 24 weeks of treatment demonstrated that ALX-0061 led to an improvement of 84 percent in ACR20 and 58 percent DAS28 remission. At all doses, the drug was well tolerated with no clinically relevant neutropenia, no clinically

Bristol-Myers Squibb Co., of New York, reported year two data from the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis Subjects With Background Methotrexate) trial of 646 patients comparing the safety and efficacy of the subcutaneous formulation of abatacept (Orencia) vs. adalimumab (Humira, Abbvie Inc.), each on a background of methotrexate (MTX), in biologic naïve patients with moderate to severe rheumatoid arthritis (RA). Results from the second year of

TAIPEI, Taiwan – Diminutive drug discovery firm PRISM Pharma Co. Ltd., of Yokohama, Japan, has closed a Series C round of funding of approximately ¥1.4 billion (US$15 million) with the funds earmarked for upcoming clinical trials for the company's investigative oncology drug PRI-724 in non-oncology related conditions, initially fibrosis. PRI-724 is the first drug candidate developed from the company's Protein Secondary Structure Mimetic (PRISM) library, a database of compounds compiled and

Researchers from the University of California at Berkeley have developed a method that allows them to better target gene therapy viral vectors via directed evolution. For now, they have used their method to make a vector that can more easily reach the back of the eye. But in theory, their method, which consists of multiple rounds of mutagenesis for directed evolution, could be used as a general method to develop viruses for tissues that have been challenging to reach with gene therapy. The

Atlanta's Emory University launched a new initiative to help bridge the ever-widening gap between the laboratory discoveries that trumpet the possibility of breakthrough medical treatments and the proof-of-concept data that are needed to entice significant industry investment – known as the dreaded "Valley of Death" in the landscape of drug discovery. Emory, which in 2009 established the Emory Institute for Drug Development (EIDD), now has set up DRIVE (Drug Innovation Venture at Emory LLC), an

Algeta ASA, of Oslo, Norway, and Avipep Pty Ltd., of Parkville, Australia, inked a collaboration to evaluate a targeted thorium conjugate based on combining Algeta's thorium-227 alpha-pharmaceutical payload with a next-generation antibody fragment, known as an Avibody, from Avipep that targets a number of solid tumor types. Avipep will provide access to an Avibody, and Algeta will provide access to chelation and conjugation technologies and its alpha particle-emitting payload. Both companies

Agios Pharmaceuticals Inc., of Cambridge, Mass., filed for an initial public offering (IPO) to raise up to $86 million to fund development of its pipeline in cancer and inborn errors of metabolism (IEMs), a subset of orphan genetic metabolic diseases. Agios's partner, Celgene Corp., of Summit, N.J., agreed to concurrently purchase an as-yet undetermined amount of common stock at the public offering price. Agios' two lead cancer programs target mutations in isocitrate dehydrogenase 1 and 2

Privately held Dermira Inc. lifted its veil of silence, at least partially, to disclose $35 million in new funding. The infusion came in a Series B financing that included Japanese dermatology specialist Maruho Co. Ltd., of Osaka, and existing investors Bay City Capital, New Enterprise Associates and Canaan Partners as well as a "related transaction" that CEO Tom Wiggans coyly sidestepped. "It's a very good deal with a very good company and allows us to really drive our programs forward

It's not every day that a multimillion-dollar market suddenly opens up, inviting all comers to the ground floor of competition. But that's exactly what happened when the FDA put out its "open for business" sign for biosimilars. Even before the agency issued its first draft guidances last year on developing biologic copies and began meeting with interested sponsors, drugmakers were weighing their opportunities, developing strategies for entering the field and seeking out partners to strengthen

Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it started a Phase II trial of Iclusig (ponatinib) in adults with metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The open-label study is designed to enroll about 45 patients and will provide initial data on the drug's efficacy and safety in patients with GIST following failure of prior tyrosine kinase inhibitor therapy. Patients whose tumors have an activating mutation in exon 11 of the cellular KIT, the primary

LONDON – The identification of the exact molecule on the insides of blood vessels to which malaria parasites stick will allow an immediate start on work to develop vaccines and new therapies for severe forms of malaria, the scientists who made the discovery predict. Research published in Nature showed that the malaria parasite, Plasmodium falciparum, binds to a human protein that plays a key role in regulating blood clotting and the response to inflammation. Thomas Lavstsen, assistant

For drug developers, it's hardly news that markets such as Brazil, Russia, India and China (BRIC) are not the once hoped-for promised land, and Frost & Sullivan has put together a report that outlines the reasons the situation may get worse. "I think the biggest challenge today for selling into BRIC for global companies is the need to understand customer segmentation and behavior – how to optimize this and ensure your product is customized to that need – trying to sell value beyond the product