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Clinical trial sites need to brush up on their good clinical practice training specs and shouldn’t expect sponsors to compensate them for doing so, says Christine Pierre, president of the Society for Clinical Research Sites. 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
Researchers approaching the FDA with new drug development tools, such as potential biomarkers or innovative trial designs, will now have a centralized place to bring their ideas for advice as the agency replaces its fragmented approach to considering such concepts with a new streamlined system. Read More
Belgian pharma giant UCB is divesting its U.S.-based specialty generics subsidiary Kremers Urban Pharmaceuticals in a $1.525 billion sale to a pair of private equity firms. Read More
India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings. Read More
German drug cost regulators have rejected Eisai’s latest request for brand level pricing on its anti-epileptic drug Fycompa, marking the second time the drug has failed to win the higher reimbursement level. Read More
A federal judge has dismissed claims brought by a group of pharmacies that Pfizer and Ranbaxy forged an illegal deal to delay generic competition to Pfizer’s cholesterol drug Lipitor, marking another victory for the manufacturers in the class action filing. Read More
The FDA oncology-drug advisory committee turned down Novartis’ investigational multiple myeloma drug Farydak by a 5-2 vote, citing safety concerns that largely overwhelmed benefits. Read More
A pharmacist advocate is urging manufacturers to provide more information on the reason for and expected duration of a drug shortage, so that healthcare providers can better plan for how the shortage will affect patient care. Read More
Drugmakers participating in an ISPE pilot program on quality metrics received new guidance on what data they need to collect, information that could provide a glimpse of the kinds of data that the FDA will start collecting next fall. Read More