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Sponsors with pending ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
UK regulators have fined Pfizer $14,000 for failing to explain a questionable claim meant to justify price increases on the generic seizure medication Epanutin. Read More
The FDA is proposing to extend review times to enable more communication between the agency and sponsors to increase the number of first cycle approvals for biosimilars. Read More
Drugmakers and trade groups overwhelmingly want lower user fees and a clearer review process for GDUFA as the FDA looks to renew the user fees before the Sept. 30, 2017 cut-off date. Read More
Generic drug applicants need to get their bioanalytics right when demonstrating bioequivalence to avoid costly delays or outright rejection by the FDA, an agency official warns. Read More
Members of the Senate Special Committee on Aging took Valeant Pharmaceuticals’ International officials to task over what they called the company’s practice of buying drugs with no generic competition and “jacking up” the prices. Read More
The House Appropriations Committee passed a fiscal 2017 agricultural appropriations bill in April that proposes a slight funding increase for the FDA, but still remains well below the agency’s funding request. Read More
The Office of Generic Drugs had a banner year in 2015, seeing more than 700 full and tentative approvals, the agency announced in April in its first-ever report on generics. Read More
FDA regulators are pushing back the clock on orphan drug reviews from 90 days to 120 days in an effort to keep pace with heavier-than-expected workloads. Read More
The UK’s drug pricing watchdog is backing coverage for Human Genome Sciences’ Benlysta as an add-on treatment for systemic lupus erythematosus. Read More
Amgen and Sanofi are the latest companies to climb on the pay-for-performance bandwagon after reaching agreements with insurer Cigna for their respective cholesterol drugs, Repatha and Praluent. Read More