Author Archives: Ben Comer

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 , , , | 7 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

Gov't Shutdown Halts FDA Product Submissions and Other Functions

Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown. Stephen King, a member of CDER’s communications team at FDA, said in an email that “no new regulatory submissions that […]
Posted in Biotech, compliance, FDA, healthcare, Legal, People, Regulatory, Safety, Strategy | Tagged , , , , , , , , | 1 Comment
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