Government
The Pennsylvania-based company disagrees with the FDA’s analysis of its clinical data and will seek to work with the agency for approval.
In January 2019, the U.S. Food and Drug Administration (FDA) updated a 2015 draft guidance on rare diseases.
Amgen is suing Novartis, alleging a breach of the partnership and seeking to terminate the 2015 contract. Novartis, in response, filed a lawsuit accusing Amgen of inappropriately attempting to end the alliance.
The government charged the three companies with using charitable foundations they financially supported to finance copays of Medicare and Medicaid patients, which is a violation of law.
The U.S. Federal Trade Commission (FTC) won a suit against India-based scientific publisher, Omics International, alleging that the publisher operated hundreds of fake scientific journals with deceptive business practices.
The lawsuit alleges that Soon-Shiong acquired the promising cancer treatment in order to prevent it from coming to market and challenging revenues from Celgene’s Abraxane, a drug Soon-Shiong developed.
The current Spinraza cost is $750,000 for the first year and $375,000 for every year after for the life of the patient. It is approved for all forms of SMA.
According to the NIH, the experimental vaccine is designed to “teach the body to make protective immune responses against diverse influenza subtypes by focusing the immune system on a portion of the virus that varies relatively little from strain to strain.”
With the clock winding down on his tenure at the U.S. Food and Drug Administration, Commissioner Scott Gottlieb continues to take aim at a number of concerns he has raised over the past two years, including the dangers of vaping and unsanctioned use of stem cells.
Across the globe, pharma and biotech companies report deals and pipeline updates, with news from Boehringer Ingelheim, Metrion, Elvie, and more.
PRESS RELEASES