CHICAGO – Big pharmas and biotechs have been flirting with the concept of open innovation – collaborative sharing of data to speed up the drug development process – for years. In fact, it has been more hype than substance. Read More
CHICAGO – Officials from the China Food and Drug Administration (CFDA) stammered through a question-and-answer period in which the audience sought the agency's definition of an "innovative" drug, its stance on orphan therapies and its policy with regard to biosimilars, during the first day of the BIO 2013 International Convention here. Read More
CHICAGO – Improved technologies for molecular imaging agents and wider use of biomarkers may be moving the drug development industry away from the blockbuster model – and toward a niche market strategy where smaller patient populations are treated by more effective, targeted drugs – but that doesn't mean treating disease, particularly cancer, will get any less complex. Read More
While the development and approval of biosimilars, especially monoclonal antibodies (mAbs), are moving at a snail's pace in developed countries, the copycat drugs are racing forward in Asia and Latin America. Read More
LONDON – Horizon Discovery Ltd. is in line for undisclosed up-front and milestone payments, followed by a potential $75 million from AstraZeneca plc in a deal that signals a move-up for the company, from providing services and products to applying its genome-editing technology in-house to uncover novel targets. Read More
Continuing a flurry of 2013 dealmaking, nanomedicine firm BIND Therapeutics Inc. kicked off the BIO International Convention with a potential $199 million-plus deal with AstraZeneca plc to develop and commercialize an Accurin therapeutic based on a molecular targeted kinase inhibitor. Read More
Novo Nordisk A/S is the first taker for Kymab Ltd.'s second-generation transgenic mouse antibody platform Kymouse, providing all-important industry validation for the fledgling technology, as well license fees, development milestones and royalties on eventual product sales. Read More
• Advaxis Inc., of Princeton, N.J., said it entered a memorandum of understanding with FusionVax Inc., of Taiwan, under which Advaxis will, subject to a definitive agreement, exclusively license its lead clinical-stage product candidate, ADXS-HPV, to FusionVax for development in Asia. Read More
• Senesco Technologies Inc., of Bridgewater, N.J., completed the second cohort of its Phase Ib/IIa trial of SNS01-T. Two multiple myeloma patients and one diffuse large B-cell lymphoma patient have completed the study. Read More
• Merck and Co. Inc., of Whitehouse Station, N.J., entered into a nonexclusive deal with Bristol-Myers Squibb Co., of New York, to conduct a Phase II trial of a once-daily oral combination regimen consisting of BMS' NS5A replication complex inhibitor daclatasvir and Merck's NS3/4A protease inhibitor MK-5172 to treat chronic hepatitis C virus infection genotype 1. Read More
• Elite Pharmaceuticals Inc., of Northvale, N.J., entered a $10 million agreement with Lincoln Park Capital (LPC) Fund LLC to raise funds to develop abuse-resistant opioids and other drugs in its pipeline and for other corporate expenses. Read More
