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Spectrum Pharmaceuticals wants an extra four months of market exclusivity on its cancer drug Fusilev, arguing the FDA’s delay in approving the drug’s name entitles it to a revised approval clock. Read More
A trade group of small to medium-sized European brand drugmakers has criticized a Spanish government order that may allow biosimilars to be interchanged with their reference product in the same way that generics may be substituted for brands. Read More
Six months of additional pediatric exclusivity should be granted only to products that add a children-specific indication, and only if the drug sponsor receives a specific written request from the FDA for studies to support the label expansion, according to the American Academy of Pediatrics. Read More
Regulators in Brazil have unveiled the country’s first drug-tracking platform, a key piece of infrastructure that will connect Anvisa and drug registration holders as they implement the country’s 2013 National Drug Control System. Read More
Joining pharma’s global transparency movement, members of a pharmaceutical association in Greece have committed to disclosing details of their financial interactions with healthcare professionals and organizations. But a loophole in such voluntary industry codes could diminish the impact of the reporting, critics say. Read More
The FDA should make its consideration of ANDA first-filer status a far more public process, say generics firms that continue to seek more transparency and communications from the agency in general on the generic drug application process. Read More
The Therapeutic Goods Administration has adopted European Commission guidance on good pharmacovigilance practices for vaccines. The guideline includes recommendations on reporting reduced effectiveness or failure of vaccines and how to implement a recall or halt the distribution of problem batches. Read More