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The Office of the U.S. Trade Representative is conducting a review of India’s intellectual property regime that focuses in large part on pharma IP issues, including access to affordable medicines. Read More
Oversight of the EU’s medicines policy will remain under the health directorate, in an about face from plans, announced in September, to shift responsibility to the industry directorate. Read More
The European Medicines Agency is expanding its public database for reporting suspected adverse drug reactions, adding roughly 1,700 additional products to the site. Read More
European drug safety officials last week recommended lower dosing levels on Amgen’s angina drug Procoralan to lessen risks of heart problems, including heart attacks and excessively low heart rates. Read More
The FDA wants to know how differing levels of exposure to a drug advertisement affect a person’s perception of a product’s risks and benefits. Read More
Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development.
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Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age, as more women than men suffer from migraines, according to FDA draft guidance on trial design expectations for the pain drugs. Read More
The FDA is strengthening its bioresearch monitoring program as part of a sweeping plan to overhaul its approach to inspections and regulatory monitoring. Read More
A federal court decision this fall granting orphan drug marketing exclusivity to Depomed’s post-shingles pain drug Gralise will stand, after the FDA withdrew an appeal filed earlier this week. Read More
The entire class of prescription and over-the-counter proton pump inhibitors do not require a boxed warning, but some prescription PPIs should contain a medication guide, the FDA said in response to a long-waiting citizen petition. Read More