Author Archives: Ben Comer

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, […]
Posted in Advertising, compliance, Emerging Markets, Europe, FDA, Global, Legal, R&D, Regulatory, Sales, 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.
Posted in Biotech, FDA, healthcare, Market Access, Orphan Drugs, pricing, Regulatory, Sales, Strategy | Tagged , , , | 8 Comments

Big Pharma's Second Life

Can big pharma solve its fixed cost problem by going virtual? Not entirely, but drug companies can get more out of their CRO partners by treating them less like avatars and more like equals, according to conference-goers at a CBI event in The Triangle. The problem with overbearing project mangers on the sponsor side of […]
Posted in Biotech, People, R&D, Strategy, Supply Chain | Tagged , , , , , | Leave a comment

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. […]
Posted in Global, Orphan Drugs, pricing, R&D, Regulatory, Sales, Strategy | Tagged | Leave a comment

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 – […]
Posted in Advertising, FDA, Global, healthcare, Market Access, Marketing, Patient Communication, People, pricing, Regulatory, Safety, Sales, Strategy | Tagged , , , , , , , , , , , , , , | Leave a comment
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