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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
The FDA is using President Trump’s mandate to shrink the size of the government’s regulatory footprint as an opportunity to re-examine how its rules may be misused to delay generic competition — and to clear the decks of older regulations that advances in science have made obsolete, a senior HHS official told lawmakers. Read More
In the first month of the GDUFA II program, the FDA sent 325 complete response letters to generics manufacturers — far more than the high of 190 seen in August the fiscal year before. Read More
The FDA is working to develop and finalize a handful of new guidances on bringing complex generics to market — including complicated medicines that may require alternate methods of establishing bioequivalence, as well as drug-device combination products that may be blocked by iterative patents. Read More
FDA Commissioner Scott Gottlieb once again chastised brand-name companies that slow-walk federal procedures and use regulations to delay the entry of generic competitors. Read More
Amgen leveled new biosimilar patent infringement litigation against Mylan, after the generics manufacturer submitted an FDA application for its version of the company’s Neulasta (pegfilgrastim) therapy earlier this year. Read More
A health plan for a carpenters’ union filed a class action lawsuit against Celgene, claiming the drugmaker engaged in anti-competitive practices to maintain its monopoly on Thalomid (thalidomide) and Revlimid (lenalidomide). Read More
FDA Commissioner Scott Gottlieb told lawmakers the agency will work to break the stigma associated with medication-assisted treatments for opioid dependence and addiction. Read More
A federal judge declined to block Maryland’s new law on generic drug price-gouging that went into effect Oct. 1, but said a challenge based on the law’s vagueness can proceed. Read More
The FDA is streamlining its communications with generics manufacturers, and outlined its procedures for relaying the status of an ANDA review in a new manual for staff. Read More
The FDA formalized its guidelines for sponsors seeking reconsideration of scientific or regulatory issues early in the approval process for generic drugs, issuing a guidance that also affirms the agency’s response-time pledges. Read More