FDA’s new Breakthrough Therapies designation sped Pharmacyclics/J&J’s ibrutinib (brand name: Imbruvica) through regulatory review in four months, based on Phase 2 studies. Pricing and access issues, though, may not get resolved so quickly. Read More
New and emerging technologies are noteworthy not simply for the excellent science behind them but also for the way they expose those raw edges of the industry’s business model. In biopharma today, disruptive changes to the model are being driven by two forces. The first is advances in basic science. The second is the accompanying — and often little noticed — process improvements that allow the new science to be adapted for patient use. It’s very simple: science is moving the agenda in all the areas that matter to Big Pharma — from regulation to finance to reputation. Read More »
By Peter O’Donnell.
The annual worldwide antibiotic awareness event — celebrated in Europe on November 15 — generated some alarming statistics, some reassuring statements from official sources, and some expressions of urgency from drug developers. But it was perhaps most compellingly marked by a plangent call for better medicines from an unusual source. Read More »
The pharmaceutical sector needs to shape up to deal with the big uptake in bribery and corruption enforcement actions — and not just in the USA, write Toby Duthie and David Lawler.
Most multinationals are already familiar with the Foreign Corrupt Practices Act (FCPA). US regulators have been aggressively prosecuting companies and individuals for bribery with increasing zeal for the past decade, with healthcare companies being specially targeted. Recently, leading manufacturers of orthopedic implants: Zimmer, Depuy, Smith & Nephew, Biomet and Stryker settled with US regulators regarding US public sector contracts under the False Claims Act (paying penalties totaling $310 million) and accepted that they had paid bribes (cash and in-kind) and kickbacks to doctors and consultants who had bought and recommended their products. More recently there have been a number of FCPA settlements in the sector which we list out below. However, a couple of companies in this sector received ‘declinations’ in this sector based FCPA investigation — that is undertakings that the US Government would not prosecute – for reasons we will discuss later. Often these FCPA cases have their ultimate provenance in US Anti-Trust, US Healthcare Fraud or False Claims Act prosecutions and are continuations in kind. Read More »
There has been a lot of talk lately that ‘Big Data’ is just BS. Peter Houston looks beyond the hype to reveal what companies should be focusing on.
Do you remember the first time you heard the phrase ‘Big Data’? Chances are, unless data’s what you do, it was last year. Big Data became big when the World Economic Forum in Davos discussed it and the US government spent $200 million on Big Data research projects.
Through the first couple of months of 2013, ‘Big Data’ was the marketing meme du jour, but as we hurtle ever closer to 2014, the promised miracle seems a little less miraculous.
I couldn’t make a marketing strategies conference in London this week, but following the event hashtag between meetings I caught sight of a “Big Data is Bullshit” tweet. That’s not the first time I’ve seen that phrase: Harper Reed, CTO for Barrack Obama’s 2012 re-election campaign said exactly that at higher educaton conference in October. He explained, “The ‘Big’ there is purely marketing. This is all fear … This is about you buying big expensive servers and whatnot.”
Compare that with Jon Kleinberg, a computer scientist at Cornell, reported in the New York Times just over a year earlier saying, “Big Data is a tagline for a process that has the potential to transform everything.” Read More »