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Pharmaceutical companies developing new pediatric vaccines for diphtheria, tetanus and pertussis (DTaP) should conduct clinical trials using a single dosing schedule as a means to streamline the process, according to a new guidance from the European Medicines Agency. Read More
Drugmakers should develop assays, tests and other processes to identify and mitigate any impurities in their products that may cause cancer, according to a European Medicines Agency guideline set to take effect January 2016. Read More
Celgene’s psoriasis drug Otezla will soon be available to a new group of patients following the FDA’s approval this week of an extended indication. 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
A new bipartisan House bill would stop brandmakers from relying on a drug-control program to deny generics firms the batch samples they need to put together an ANDA. Read More
Seven generics firms are set to begin distributing licensed versions of Gilead’s blockbuster hepatitis C drug Sovaldi in 91 developing countries, as part of a deal to expand access to the expensive therapy. Read More
Connecticut’s attorney general has joined a growing chorus of voices urging the FDA to immediately approve a generic version of AstraZeneca’s acid-reflux drug Nexium, either by clearing first-filer Ranbaxy’s version or by finding that the Indian firm forfeited its exclusivity because of rampant delays. Read More
A federal judge earlier this month affirmed the FDA’s decision to approve generic versions of Hospira’s sedative Precedex under a pathway that allows manufacturers Mylan and Par to proceed with products that “carve out” the brand firm’s method-of-use patent in the drug’s labeling. Read More
The FDA warned an active pharmaceutical ingredient manufacturer for not paying its facility user fees. However, the company says it hasn’t made APIs since 2008. Read More
Generics makers with first-to-file ANDA status say they are frustrated by the FDA’s slow approval times, claiming their 180-day market exclusivity period is jeopardized by agency inaction. Read More