Category Archives: Sales

J.P. Morgan: Pharma's Agenda for 2014

Presenters at the 32nd annual J.P. Morgan Healthcare Conference talked up value-based pricing, emerging market strategies, complex generics and new technology, from bedside devices and genetic sequencers to first-in-class mechanisms of action. Company executives honed in on their chosen therapeutic areas and made the case for aggressive spending in R&D to bring the next generation […]
Also posted in Biotech, Corporate Responsibility, Deals, Emerging Markets, Europe, Events, FDA, Gene therapy, Global, IP, leadership, Legal, Manufacturing, Market Access, Orphan Drugs, People, pricing, R&D, Regulatory, Safety, Strategy, Technology | Tagged , , , , , , , , , , , , , , , , , | Leave a comment

Confessions of a Compliance Director

In anticipation of CBI’s (a PharmExec sibling company) 11th Annual Pharma Compliance Congress happening later this month, PharmExec spoke with a compliance director at a mid-sized pharma ($5 billion in annual sales) about life under a CIA, and the potential trigger issues for 2014. In an effort to promote candor and avoid overly circumspect responses, […]
Also posted in compliance, Corporate Responsibility, E-Media, Emerging Markets, FDA, healthcare, Legal, Marketing, Medical Education, pricing, Regulatory, social media, Strategy | Tagged , , , , , , , , , , , , , , | Leave a comment

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 […]
Also posted in healthcare, leadership, People, R&D, Strategy | Tagged , , , , , | 2 Comments

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
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