Michael Loucks stepped down as acting US Attorney at the end of 2009, after a career that put him at the center of many of the largest health care fraud prosecutions in the pharmaceutical industry. We spoke to him about what happens next, for industry, for prosecutors-and for him.
Michael McCaughan
Michael Loucks, the single most prominent figure in the wave of pharmaceutical industry health care fraud prosecutions over the past...
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Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?
At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.
The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.
The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
