The FDA requested comments on planned modifications to its MedWatch system that will impact existing forms used to report adverse events, including FDA 3500, 3500A and 3500B. Source: Drug Industry…
Representatives from the pharmaceutical and hospital industries agreed the 340B drug discount program needs reforms but disagreed as to what changes are needed in testimony before a Senate committee Thursday.…
A federal judge refused a motion by CIGNA to dismiss a class-action lawsuit alleging it artificially inflated the cost of prescription drugs. Source: Drug Industry Daily
Criminal and financial penalties against pharmaceutical manufacturers continued a downward trend in the past two years and financial penalties for unlawful promotion dropped dramatically since 2013, according to Public Citizen,…
Elizabeth Holmes, the founder of embattled biotech Theranos, and former company president Sunny Balwani have been charged with massive fraud by the U.S. Securities and Exchange Commission. Source: BioSpace
On April 23, the FDA’s arthritis advisory committee will take another look at Eli Lilly's re-submission for their moderate-to-severe rheumatoid arthritis drug. Source: BioSpace
IDEAYA Biosciences has raised $94 million in Series B funding to drive multiple clinical studies in 2019. Source: BioSpace
The Wall Street Journal speculated today that it won't be long before drug manufacturers start consolidating in order to improve their bottom lines. Source: BioSpace
Celgene has a deep pipeline and a $69 billion market cap, but it could consider going private in 2019 via a leveraged buyout. Source: BioSpace
A U.S. Food and Drug Administration announced their decision to slap a clinical hold on Solid Biosciences Inc.’s experimental gene therapy treatment for Duchenne muscular dystrophy. Source: BioSpace