The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: PhRMA

Supreme Court Hears Oral Arguments in False Claims Act Whistleblower Case

The United States Supreme Court heard oral arguments today in a case we noted in June in which amici curiae PhRMA and BIO urged the Supreme Court to limit whistleblower suits under the False Claims Act (FCA). Feel like you were really there by reading the full transcript of the oral argument (pdf). Out loud. In [...]

Post-Vacation Brain Dump: Deal Developments

Some exciting deal news from the week: Neuromed, which licensed U.S. rights to its lead candidate Exalgo to Mallinckrodt after Merck dropped out, entered into an interesting stock-for-stock merger deal with Cambridge, MA-based CombinatoRx that we’ll discuss further in this coming Monday’s deal review. Paladin Labs made a deal with Wyeth for a bundle of products that [...]

PhRMA and BIO in the U.S. Supreme Court: False Claims Act Whistleblowers Beware

As PhRMA and BIO hoped it would, the U.S. Supreme Court has agreed to hear the appeal of a False Claims Act (FCA) case that could determine how easy it is to bring a whistleblower suit under the statute.  Noting the prevalence of healthcare fraud cases brought under the FCA, PhRMA and BIO filed a brief [...]

Wednesday Brain Dump: Things that Might Surprise You Edition

Things that surprised me this week: AstraZeneca’s CEO David Brennan, elected PhRMA’s new chairman, spoke in favour of comparative effectiveness research, calling it “a market requirement.” PolyCap, a combination of five off-patent cardiac and cholesterol drugs that costs $17 combined per month showed promising results in a 2000-person study in The Lancet. The Ebola researcher [...]

Trends in 2009: Shifting IP Constituencies as Innovator Pharma Buys Generics and Asia Turns to Innovation

Growing industrial and geopolitical realignment of economic interests has the potential to re-define intellectual property constituencies in 2009. 1.  Industrial realignment: the entry of innovator pharma companies into the generics business. This year has already seen Merck get into follow-on biologics by buying Insimed and Pfizer build its generics business with its Aurobindo deal.  As traditional innovator pharma [...]

News: FDA Off-Label Guidance

The FDA released updated guidance today on the use of journal articles to promote off-label uses.  Here is a link directly to the FDA guidance. Here is the Reuters story, which notes some Congressional (Waxman) and consumer (Public Citizen’s Health Research Group) opposition, and PhRMA support. One concern is that a permissive approach to off-label promotion [...]

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