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The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards — a further sign of the agency’s commitment to using quality metrics. Read More
The Medicines Company expects its Ionsys opioid pain patch to be available in the third quarter of this year, following FDA approval on Thursday. Read More
The Therapeutic Goods Administration is considering raising the maximum limit for classifying rare diseases and specific subsets of patients to broaden the scope of medications that qualify for orphan drug status. Read More
AstraZeneca’s acid-reflux drug Nexium was the highest-costing drug prescribed under Medicare Part D in 2013, totaling $2.5 billion, according to new data released by the Centers for Medicare & Medicaid Services. Read More
A federal judge has ruled that the FDA was right in approving generic versions of Otsuka’s blockbuster antipsychotic Abilify, despite exclusivity remaining on at least one indication, removing any final obstacles to market entry of those drugs. Read More
A slew of observations related to cleanliness and sterility at Patheon Manufacturing Services’ Greenville, N.C., facility have resulted in a Form 483. Read More
The FDA has warned a Kansas compounder for multiple GMP violations, including poor sterile drug manufacturing practices and using ingredients that aren’t FDA-approved. Read More