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The FDA wants to understand how patient perceptions of medications change when pharmacies switch from brand to generic products or between the same generics made by different manufacturers. 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 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
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
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
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city, as well as other India manufacturers. Read More
Drugmaker Chimerix said it may soon start testing its broad-spectrum antiviral drug brincidofovir against the Ebola virus, after the FDA this week approved the company’s emergency investigational new drug application. Read More
PhRMA is asking a D.C. federal court to once again strike down a price discount mandated by HHS for orphan drugs, when used to treat non-rare conditions at certain covered hospitals. Read More