A U.S. Court of Appeals affirmation of a lower court ruling requiring the FDA to grant Eagle Pharmaceuticals Inc.'s bendamustine infusion product, Bendeka, seven years of orphan drug exclusivity appears to resolve a key piece of uncertainty that had troubled Eagle and others in similar circumstances.
The U.S. effort to deploy diagnostics for the novel coronavirus has been plagued by missteps by the CDC and the FDA from the outset, leading to delays and missed opportunities. The Trump administration declared a national emergency March 13, but concerns remain about how quickly the array of available tests can be conducted and whether there are enough testing supplies to handle the anticipated demand.
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax (nitric oxide) inhaled gas to treat COVID-19-associated lung complications. INOmax is marketed in the U.S. by the Staines-upon-Thames, U.K.-based company to treat full- and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.
The U.S. Securities and Exchange Commission (SEC) Thursday extended the public on-ramp for small companies that take longer than five years to generate $100 million in annual revenue, as well as some of the business development companies that invest in them.
LONDON – The World Health Organization (WHO) has officially declared COVID-19 a pandemic, but is pushing back strongly against countries giving up on stringent control measures.
HONG KONG – Cadila Healthcare Ltd. (Zydus Cadila) has won approval for its saroglitazar to be used as the treatment of non-cirrhotic nonalcoholic steatohepatitis (NASH) in India. The green light from the Drug Controller General of India (DCGI) makes saroglitazar the first drug in the world approved for this indication.
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