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The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act. Read More
The Supreme Court appeared divided Monday on the constitutionality of the PTO’s patent re-examination process of inter partes review — in a debate with wide implications for drugmakers on whether patents are considered private property and if they can only be invalidated through a trial by jury. Read More
Type IB variations must be notified to the relevant national authorities or the EMA prior to implementation but they are not subject to formal approval. Read More
The Hatch-Waxman Act did not strike a good balance between generic access and brand-name innovation, according to public comments to the FDA from both PhRMA and the Association for Accessible Medicines — however the two groups disagree as to how. Read More
The UK’s competition watchdog agency claimed the drugmaker Concordia overcharged the NHS by millions for its hypothyroid medication liothyronine, also known as Cytomel, following price increases of almost 6,000 percent over a decade. Read More
Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug Development. Read More
A federal judge blocked Aegerion’s proposed $36 million deal to settle claims of illegal marketing tactics for its cholesterol drug Juxtapid, ordering the case to trial. Read More
The European Medicines Agency launched the new version of its EudraVigilance adverse event database Nov. 22, providing more tools for analysis. Read More