Monthly Archives: April 2012

U.S. Biosimilars Under Threat?

by D’vorah Graeser, Graeser Associates International While the FDA continues to develop its guidance for U.S. biosimilars, including a one-day public hearing on May 11, 2012, the basic legal underpinnings of biosimilars in the U.S. may be under threat, as the Supreme Court debates the healthcare law, a large chunk of which includes provisions for […]
Posted in Biotech, FDA, Guest Blog, IP, Legal, Regulatory, Strategy, Technology | Tagged , , , | 1 Comment

The Digital World is Changing Fast. Can You Keep Up?

by Ritesh Patel, global head of digital at Chandler Chicco Companies I’ve been doing this digital thing for some time now. I’ve been part of and witnessed many changes in our digital world. However, I have never seen such a swift pace of change and digital adoption of late. It’s stunning how quickly things spread […]
Posted in Agency Insight, Events, Guest Blog, healthcare | Tagged , , , | Leave a comment

Dare to Compare: Genzyme Bets on MS

Riding positive data on a late-phase multiple sclerosis drug, Genzyme execs talked up the company’s willingness to go head-to-head against Rebif, EMD Serono and Pfizer’s blockbuster beta interferon. Genzyme execs didn’t go so far as to reiterate former CEO Henri Termeer’s 2010 prediction of $3 billion plus in potential sales for Lemtrada (alemtuzumab), but they […]
Posted in Biotech, Events, FDA, Global, IP, R&D, Regulatory, Safety, Sales, Strategy, Technology | Tagged , , , | 1 Comment

GSK: A Rebuffed Suitor for the Moment

By Patricia Van Arnum. Last week Human Genome Sciences (HGS) rejected GlaxoSmithKline’s (GSK) unsolicited $2.59 billion bid for HGS or $13 per share.  Although rejecting GSK’s initial bid, HGS kept the door open for other suitors, including again GSK. HGS has authorized its board of directors to explore strategic alternatives for the company, including a […]
Posted in Deals, Guest Blog | Tagged , , , , | 1 Comment

Cracking the Adherence Nut: Drug Delivery

Chris Evans, West Pharmaceutical Services, and Ed Geiselhart, Insight Product Development, consider the importance of drug delivery systems in facilitating patient adherence. No two patients are alike, but drug-makers may not consider how different a single patient’s perspective can be when viewed over time. A patient’s progress through disease management is a journey, and perceptions […]
Posted in Guest Blog, healthcare, Patient Communication, patient compliance, patient education, Strategy | Tagged , , , | Leave a comment
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