Category Archives: Sales

Fred Hassan: More Musings on the Biopharma Learning Curve

Hindsight can be a great teacher – but only if you have the self-awareness needed to adapt those learnings to the next business challenge, whose rough edges are by definition almost always “non-recurring.” In other words, because the circumstances of any setback are unique, the astute manager knows that recovery depends on recognizing that the […]
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Deep Breadth: GSK Doubles Down on COPD and Asthma

Will GSK be able to maintain its position in COPD and asthma, post Advair/Seretide? Despite a patent expiry in 2010, generic versions of Advair aren’t expected to appear on the market for two more years. It took FDA eight years to develop a blueprint for how generics manufacturers might establish an acceptable bioequivalence for Advair, […]
Also posted in Advertising, compliance, Emerging Markets, Europe, FDA, Global, Legal, R&D, Regulatory, Strategy | Tagged , , , , , , , , | 4 Comments

Ibrutinib's Breakthrough to Market

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.
Also posted in Biotech, FDA, healthcare, Market Access, Orphan Drugs, pricing, Regulatory, Strategy | Tagged , , , | 7 Comments

PharmExec's Orphan Drug Pipeline Picks

Orphan drugs were given short shrift in PharmExec’s 2014 Pipeline Report, but a couple of pipeline candidates targeting small populations did make the list, and are expected to earn big dollars in the next few years. In the US, private and government payers haven’t yet had the nerve to balk at rare disease drug prices. […]
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Belviq's Battle of the Bulge

Arena Pharmaceuticals’ and marketing partner Eisai’s Belviq – the first FDA-approved drug to treat obesity in over a decade – is making progress with payers and beefing up sales forces to target primary care physicians. DTC support began in September. Perhaps the most significant development in obesity of late is the recognition by payers – […]
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