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Injectables giant Hospira is launching its Remicade biosimilar Inflectra in at least 10 new European markets, nearly doubling the product’s presence on the continent. Read More
The FDA is seeking additional comment from industry on its highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More
The FDA is pushing ahead with efforts to spur development of hard-to-copy generics, this time sponsoring research into bioequivalence testing for long-acting periodontal drugs and developing methods for assessing generic, long-acting injectables. Read More
Australian regulators are calling for labels on six types of nonsteroidal anti-inflammatory drugs to include strong warnings about cardiovascular and liver risks associated with excessive or prolonged use. Read More
The proprietary name of a drug should include either the International Non-Proprietary Name or a description of its effects, and should be consistent across the product’s range, according to revised guidance from South Africa’s Medicines Control Council. Read More
India’s medicines authority has released a set of steps drugmakers must take to schedule presubmission screening meetings with drug reviewers — codifying an informal system that was launched several years ago. Read More
Australia’s research-based drug companies are urging the government to accept product approvals by trusted regulators in the U.S., EU, Canada and the UK with only minimal in-country review to speed access to breakthrough treatments. Read More
The White House released a joint statement by President Barack Obama and Indian Prime Minister Narenda Modi pledging to negotiate a harmonized approach to intellectual property protections and establish standard definitions for what is patentable. Read More
Manufacturers and industry groups are urging the Australian government to drop proposed requirements that would require larger type on drug labels and for labels to be made and applied in a way that prevents their being damaged when the product is opened. Read More
Indian officials are accusing U.S. Food and Drug Administration investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for Indian regulators to tag along on FDA drug manufacturing inspections as observers. Read More
Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named. Read More
The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More