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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
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
Baxter International said it will launch its hemophilia drug Obizur in the next few months, after the FDA approved the product late Thursday. Read More
The Australian government has authorized an independent review of the country’s drug approval process to remove or streamline areas of unnecessary, duplicative or ineffective drug regulations. Read More
The World Health Organization is seeking public comment on its long-held position that clinical trial sponsors should share their study data in a timely manner, pointing to recent research that finds many results are never published. Read More
European drugmakers say they support recent EU efforts to fight counterfeiting, but would like to see some changes to a provision that aims to catch fake products as they move across member-state borders. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval following its recent meeting, including products to treat intolerance to sunlight, ovarian cancer, oestrogen deficiency and hemophilia B. Read More
Drugmakers may soon have to report to the FDA how they decide when to launch a corrective or preventive action (CAPA) investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More
Generics giant Mylan confirmed its intention to merge with Abbott Laboratories and reincorporate in the Netherlands early next year, a move that comes as other U.S. pharma companies have abandoned their plans to move overseas in the face of new U.S. tax rules. Read More
A federal judge has struck down Mylan’s Paragraph IV ANDA challenge against Pfizer’s blockbuster cancer drug Sutent, ruling that the therapy’s patents are not invalid. Read More