Monthly Archives: April 2012

U.S. Biosimilars Under Threat?

By Guest Blogger | Published: April 27, 2012
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 biosimilars.
Posted in Biotech, FDA, Guest Blog, IP, Legal, Regulatory, Strategy, Technology | Tagged , , , | 1 Comment

Brennan Departure: What Now for AZ?

By Julian Upton | Published: April 26, 2012
AstraZeneca’s shares may have fallen by as much as 6.3% following news of David Brennan’s imminent departure — the biggest intraday decline since December 17, 2010, said Bloomberg — but analysts welcomed his retirement as a good thing. “This will be received positively,” said WestLB’s Mark Belsey. “It’s time for someone to reinvigorate the pipeline.” With [...]
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The Digital World is Changing Fast. Can You Keep Up?

By Guest Blogger | Published: April 26, 2012
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 and [...]
Posted in Agency Insight, Events, Guest Blog, healthcare | Tagged , , , | Leave a comment

Dare to Compare: Genzyme Bets on MS

By Ben Comer | Published: April 25, 2012
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 [...]
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 Guest Blogger | Published: April 25, 2012
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 potential sale. [...]
Posted in Deals, Guest Blog | Tagged , , , , | 1 Comment