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The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. Read More
The Texas attorney general has sued AstraZeneca over allegations the company illegally pushed off-label uses of its antipsychotic Seroquel, a move that comes four years after AZ paid hundreds of millions of dollars to settle similar litigation nationwide. Read More
Regulators in Europe have proposed restricting access to certain information in a forthcoming clinical trials portal and database, but industry wants assurances that the system will be able to differentiate security access for different types of documents. Read More
The FDA approved Eisai’s Akynzeo to treat nausea and vomiting from chemotherapy, the latest success by the Japanese drugmaker to expand its portfolio of such products. Read More
Australian doctors and academics are asking their colleagues worldwide to ban all meetings with pharmaceutical sales reps for a year in a bid to reduce concerns over inappropriately pushed medications. Read More
The FDA has expanded market exclusivity from three to five years on all fixed-dose combination drugs that contain a new active ingredient, bowing to industry pressure for new incentives to develop the costly products. Read More
Millennium Pharmaceutical’s received another victory in its efforts to bolster the use of its blockbuster oncology drug Velcade, receiving FDA approval for a new indication for previously untreated patients with mantle cell lymphoma. Read More
A European regulatory committee is recommending stronger restrictions on the use of valproate drugs by women and girls, citing risks of malformations and developmental problems during pregnancy. Read More
A key European health committee didn’t find enough evidence to confirm that testosterone-replacement (TRT) products create higher heart attack risk, but it did agree with FDA advisors that labeling for such products should change. Read More
Drugmakers in Europe are calling for the establishment of a new clinical trial portal and database, rather than modifying existing systems, to meet requirements for a single, streamlined submission process for clinical trial applications. Read More