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A federal judge has tossed out some conspiracy claims brought against Abbott and its spinoff AbbVie over an alleged coupon scheme to boost sales of their branded arthritis drug Humira and testosterone therapy AndroGel. 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
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
Pfizer and Ranbaxy have asked a federal judge to follow his own precedent and dismiss all remaining class-action lawsuits alleging the companies colluded to delay generic versions of Pfizer’s blockbuster cholesterol drug Lipitor. Read More
Canadian regulators plan to ratchet up scrutiny of patent litigation settlements between brand and generic drugmakers in search of antitrust deals that delay generic competition. Read More
FDA officials sought to clear up questions about what standards the agency will apply when approving biosimilars, emphasizing that manufacturers must prove their products are “highly similar” to the reference product in order to win a green light. Read More
The FDA late Tuesday unveiled a broad plan that will change the way it inspects drugmakers, approves recalls, issues and reviews enforcement decisions, screens imports and tests products for quality, with drugmakers likely to start feeling the impact by the end of 2015. Read More
The FDA extended an indication for AbbVie’s Humira to treat childhood arthritis in younger patients, marking another win for the drugmaker seeking to get as much out of the blockbuster biologic before its patents start expiring in two years. Read More
Bristol-Myers Squibb has withdrawn its NDA for a hepatitis C combination drug of Daclinza and asunaprevir, citing concerns of an insufficient target population. Read More
European regulators are greatly expanding a public database for reporting suspected adverse drug reactions, adding roughly 1,700 more products to the site, the European Medicines Agency said. Read More
Australian regulators are urging tougher warnings on the cardiovascular risks of over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs), as well as proposing new initiatives to better inform patients about CV risks associated with both the OTC and prescription-based painkillers. Read More