For Celgene Corp., entering Japan proved a relatively brisk venture, said Jerome Zeldis, the company's chief medical officer, but China – where Celgene also has established itself, and is launching Revlimid (lenalidomide) this week – represents something more of a challenge for biotech and pharma firms. "I don't think any other company has ever walked into Japan, established a footprint and gotten to approval faster than we did," Zeldis said, noting that the Summit, N.J.-based firm gained
By Randy Osborne | BioWorld Today | Friday, June 14, 2013
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
By Randy Osborne | BioWorld Today | Thursday, June 13, 2013
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
By Mari Serebrov | BioWorld Today | Thursday, June 13, 2013
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
By Dave Silver | BioWorld Today | Thursday, June 13, 2013
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
By Anette Breindl | BioWorld Today | Thursday, June 13, 2013
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
By Jennifer Boggs | BioWorld Today | Thursday, June 13, 2013
By Randy Osborne Staff Writer CytomX Therapeutics Inc.'s oncology deal with Pfizer Inc. to develop Probody-drug conjugates (PDCs) gives the pharma giant rights to develop selected candidates in exchange for a potential $25 million up front, as well as $610 million if regulatory and sales milestones are met, and tiered royalties into the double digits on sales of resulting products. The $25 million "incorporates the up-front research funding and near-term milestone payments, as we move [PDCs
By Cormac Sheridan Staff Writer DUBLIN, Ireland – Royalty Pharma's bitter and protracted takeover battle for Elan Corp. plc will, one way or another, reach a climax next Monday when Elan shareholders vote on the company's recent M&A deals. Acceptance of those transactions, which requires a vote representing 50 percent of Elan's equity plus one share, would scupper Royalty's takeover bid. Rejection would signal the end of the road for Dublin, Ireland-based Elan, a company that has, over the years
For Celgene Corp., entering Japan proved a relatively brisk venture, said Jerome Zeldis, the company's chief medical officer, but China – where Celgene also has established itself, and is launching Revlimid (lenalidomide) this week – represents something more of a challenge for biotech and pharma firms. "I don't think any other company has ever walked into Japan, established a footprint and gotten to approval faster than we did," Zeldis said, noting that the Summit, N.J.-based firm gained