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Singapore would ban all direct-to-consumer advertisements for prescription drugs under a set of proposed advertising rules scheduled to take effect late next year. Read More
Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development. Read More
European Medicines Agency evaluators have recommended labeling updates for Roche’s rare lung disease therapy Esbriet to include information on the drug’s mortality benefit. Read More
Novartis has sold its influenza vaccine business to Australian drugmaker CSL Limited for $275 million, the latest effort by Novartis to shift away from vaccines and focus on other types of products. Read More
The FDA warned a partially defunct compounder for a multitude of quality violations such as using soap and water to clean parts of the production facility. Read More
European drugmakers praised a plan to move medicines regulation from a tripartite of directorates led by health and consumers to a single directorate, industry, saying it will reduce organizational silos. Read More
To avert drug shortages, Health Canada has partially lifted an import ban on products from three Indian manufacturing facilities that were barred from doing business in the country due to quality violations. Read More
Mylan recalled 15,966 bottles of the blood pressure drug metoprolol succinate tablets due to a product mix-up, the third recall in the past five months involving generic versions of AstraZeneca’s Toprol-XL. Read More
FDA investigators are finding unprecedented data integrity problems at contract and active pharmaceutical ingredient manufacturers, even after they have been audited by the firms that hired them, an FDA official said. Read More