Novartis has forged a merger agreement with The Medicines Company under which it will buy up the firm’s cholesterol drug inclisiran for a whopping $9.7 billion. Source: Drug Industry Daily
The FDA hit Florida stem-cell supplier RichSource Stem Cells with an untitled letter for unapproved claims relating to its RICHGEN stem cell product. Source: Drug Industry Daily
In a move to help sponsors of insulin biosimilar applications, the FDA spelled out the data and information needed to support immunogenicity assessments for insulin biosimilars or interchangeables in a…
President Trump has signed without fanfare a continuing budget resolution that will keep the FDA funded at the 2019 level until Dec. 20. Source: Drug Industry Daily
The FDA hit two Aurobindo facilities for serious violations of good manufacturing practices discovered during inspections in October. Source: Drug Industry Daily
CDER Director Janet Woodcock called for an overhaul of American drug manufacturing to offset the nation’s dependence on APIs made in China, India and elsewhere, in Oct. 30 remarks to…
The FDA cited an Eli Lilly facility in Puerto Rico, an Aurobindo plant in southern India and five other facilities for a wide range of GMP and other violations observed…
The FDA issued recent warning letters to manufacturing facilities in India, South Korea, China and the U.S., for a wide range of deficiencies, including inadequate testing. Source: Drug GMP Report
The FDA invited comments on a draft guidance that outlines the agency’s best practices for postmarket safety surveillance for drugs and biologics, including product quality issues (PQIs). Source: Drug GMP…
A key cause of U.S. drug shortages is the market’s failure to reward well-developed quality management systems, according to an analysis by an FDA-led interagency task force. Source: Drug GMP…