Food and Drug Administration (FDA)
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Depression affects almost 20 million Americans yearly and major depressive disorders affect nearly 300 million people worldwide. The annual market for these disorders is approximately $83 billion.
Researchers at Johns Hopkins, the University of California, San Diego, and the National Institute of Mental Health grew retinas in petri dishes, and discovered fundamental factors involved in the development of vision and color vision.
Things seem to have gone from bad to worse for Pennsylvania-based Trevena, Inc. This week the company saw a U.S. Food and Drug Administration advisory committee reject its intravenous pain treatment and now a class action lawsuit filed against the company claims Trevena executives have misled investors for years.
Ionis Pharmaceuticals is on a roll. Days after securing regulatory approval from the FDA for Tegsedi, the company inked a deal worth more than $700 million with pharma giant Roche to develop IONIS-FB-L for the treatment of complement-mediated diseases.
President Donald Trump signed a bill into law yesterday that requires pharmaceutical companies to provide details of biosimilar deals to the Federal Trade Commission (FTC) for antitrust scrutiny.
In May the FDA placed a hold on the trial and IND for CTX001, an investigational gene editing treatment, citing concerns over questions that had not been addressed in the IND.
In August, Pfizer filed with the U.S. Food and Drug Administration (FDA) accusing Amgen and Roche of using social media to mislead doctors and patients about biosimilars and their effectiveness.
Celgene Corporation presented data at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) held in Berlin, Germany with results from two Phase III trials.
Genentech, a Roche company, released data from a long-term clinical trial of Ocrevus in multiple sclerosis. Meanwhile, Novartis isn’t standing still on MS. Earlier this week the company announced that both the FDA and EMA had accepted its NDA and MAA, respectively, for siponimod.
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