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A question-and-answer document released by the European Medicines Agency in September clarifies terms of engagement and expected outcomes for applicants to the agency’s adaptive licensing pilot program. Read More
Europe’s biotech industry is pressing regulators to update guidance on labeling of biosimilars to include information on both the reference product and the biosimilar. The current practice of assigning a generic label is insufficient due to the products’ unique scientific and regulatory status, companies say. Read More
The Canadian government is ratcheting up scrutiny of patent litigation settlements between brand and generic drugmakers in attempt to prevent antitrust deals that delay generic competition. Read More
The U.S. Trade Representative’s Office has launched a review of India’s intellectual property regime that will focus in large part on pharmaceutical IP issues, including the country’s policy of providing access to affordable medicines. Read More
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