WASHINGTON – One company's gain could be another's loss if the FDA raises the financial resources threshold for user fee waivers for drugs and biologics.
A $165 million underwriting agreement may be the prescription Exelixis Inc. needs to get its cancer candidate, cabozantinib, through clinical development.
WASHINGTON – One of the intended casualties of the patent reform bill the Senate passed Tuesday is the years-long wait for the Patent and Trademark Office (PTO) to review a patent application.
WASHINGTON – Whether the U.S. Supreme Court's refusal to hear a pay-for-delay patent settlement case Monday will affect biologics depends largely on how the FDA shapes the biosimilar regulatory pathway in the future.
In an unrequired, head-to-head trial, Amylin Pharmaceuticals Inc. and Eli Lilly and Co.'s weekly diabetes candidate Bydureon came up short against Novo Nordisk A/S' daily Victoza.
WASHINGTON – Two government contracts that could be worth up to nearly $200 million each will inoculate Novavax Inc. and VaxInnate Inc. against some of the financial risks involved in getting their recombinant influenza vaccines through clinical development.
With the global biopharmaceutical market expected to hit $167 billion by 2015, some major conglomerates, known more for their electronics, are taking the plunge.
WASHINGTON – Hoping to reinvigorate the drug pipeline, especially for rare diseases, the National Institutes of Health (NIH) plans to open its National Center for Advancing Translational Sciences (NCATS) on Oct. 1.
