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Drugmakers seeking accelerated approval of a presurgical treatment for high-risk, early-stage breast cancer may consider conducting multiple trials rather than a traditional single trial, according to a new FDA guidance that aims to give sponsors an earlier indication as to the success of a drug candidate. Read More
A pair of lawmakers has launched a congressional investigation into dramatic price increases on some generic drugs, but GPhA dismisses the scrutiny as being so narrowly focused that it misses the overall savings from the industry as a whole. Read More
The Indian government is mulling a proposal from a research institute to launch an online registry of foreign and domestic drugs that would improve transparency and knowledge of distributed drugs. Read More
Branded drugmakers have expressed guarded optimism at the announcement of high-level intellectual property talks between the U.S. and India, hoping the discussions will resolve long-standing worries over a lack of effective patent protection by the Indian government. Read More
The UK’s healthcare cost watchdog has recommended against covering Roche’s leukemia drug Gazyvaro for chronic lymphocytic leukemia (CLL) patients who are ineligible for fludarabine-based therapy. Read More
Better postmarket surveillance of generic drugs and a greater understanding of the bioequivalence of hard-to-compare products will top the FDA’s regulatory science priorities under GDUFA in the new fiscal year, the agency said. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is seeking suggestions on prescription drugs that would be exempt from EU safety authentication requirements and nonprescription drugs that should bear the safety feature. Read More
Manufacturers that sell drugs in the European Union will soon have to make publicly available clinical trial data supporting approval of those products, under a landmark transparency policy adopted yesterday by the European Medicines Agency. Read More
The FDA expects to have standardized formats for ANDA data submissions in place and required for all filers by the first half of fiscal year 2017. Read More
European regulators are proposing changes to development guidelines of drugs treating the gastrointestinal disorders ulcerative colitis and Crohn’s disease to better understand how the products work in children as well as adults. Read More