After acknowledging in a conference call Friday that the FDA would not in all likelihood approve its lead product tivozanib for renal cell carcinoma (RCC), Aveo Pharmaceuticals Inc. said Monday it received a complete response letter (CRL) from the agency informing the biotech it will not approve in its present form the new drug application (NDA) for the product.
In the wake of the FDA's Oncology Drugs Advisory Committee (ODAC) 13-1 vote against the adequacy of AVEO Pharmaceuticals Inc.'s tivozanib, an inhibitor of all three vascular endothelial growth factor (VEGF) receptors, in renal cell carcinoma (RCC) there were several losers: patients, the company and its staff.
It's been a long time since we've witnessed 11 biotechs successfully completing their initial public offierings (IPOs) on the U.S. market during the first five months of the year. That number only usually accrues in the space of a year. In fact you have to go back to 2007 when 13 biotech IPOs were completed in the same period. The IPO market has certainly taken off big time this year and biotechs are rushing to take advantage of the favorable environment.
While partnering strategies can provide access to essential products and technology, mergers and acquisitions can achieve the same goals and also provide greater leverage and control of the acquired assets.
While partnering strategies can provide access to essential products and technology, mergers and acquisitions can achieve the same goals and also provide greater leverage and control of the acquired assets. With a wide variety of biotech companies that have promising candidate products in late-stage clinical trials, and pharma companies still needing to tweak their product portfolios, the expectation is that the next big pharma acquisition of a biotech company is only just around the corner.
Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. is gaining access to several key vaccine candidates targeted against major infectious diseases in the developing world such as dengue and hand, foot and mouth disease (HFMD), through its acquisition of Inviragen Inc., of Fort Collins, Colo.
By any measurement the U.S. biotechnology industry is the envy of the world. Perspectives on the reasons for the nation's dominance in this sector are provided by the latest Scientific American Worldview Scorecard, which for the past five years has been ranking countries on their global competitiveness in biotechnology. The 2013 edition reflects increased global competition and a growing list of countries being added to the rankings.
As regulators, payers and drug developers become more comfortable with their use, interest in companion diagnostics to help direct targeted medicines to the right patient populations has surged in the past couple of years. Drug companies are certainly recognizing that companion diagnostics, when co-developed with potential therapeutics, can assist in regulatory approvals.
Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. is gaining access to several key vaccine candidates targeted against major infectious diseases in the developing world such as dengue and hand, foot and mouth disease (HFMD), through its acquisition of Inviragen Inc., of Fort Collins, Colo.
