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BI subsidiary Ben Venue is recalling a lot of acetylcysteine 10 percent USP, after a single glass particle was seen in a single vial of the drug. Read More
Swiss drug giant Novartis has bought Cambridge, Mass.-based CoStim Pharmaceuticals in a bid to gain access to CoStim’s cancer immunotherapy platform. Read More
India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, India’s Central Drugs Standard Control Organization (CDSCO) said Thursday. Read More
In another blow to Aveo’s oncology pipeline, Astellas announced it is ending a global partnership with the company to develop its troubled cancer drug tivozanib by August 11. Read More
The FDA has for a third time rejected Janssen and Bayer’s push to have their blockbuster blood-thinner Xarelto approved to treat patients with acute coronary syndrome (ACS). Read More
A drug to treat a rare congenital enzyme disorder developed by BioMarin Pharmaceutical became the first product approved by the FDA under its rare pediatric disease priority review voucher program. Read More
The FDA is investigating whether it is requiring drugmakers to present too much risk information in direct-to-consumer (DTC) television ads, which could lead to a potentially drastic departure from current marketing regulation. Read More
In the wake of a rash of infant deaths related to GMP-certified hepatitis B vaccines, China is renewing its push to have makers of vaccines, blood products and sterile injectables obtain a revised good manufacturing practice certificate. Read More
Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized good manufacturing practices (GMP) guidelines. Read More