company executives described the company's latest deals on a conference call

company executives described the company's latest deals on a conference call

In addition to the Phase I and II trials that Ambit conducted involving more than 400 patients, company executives had good insight into the trials managed by Astellas through active participation in joint development committee meetings, he said

In fact, when Aubagio gained approval last year, RBC Capital Markets analyst Michael J. Yee said Aubagio was not viewed as a "meaningful competitor at all vs. BG-12, primarily due to weaker efficacy and safety concerns." (See BioWorld Today, Sept. 14, 2012.) No advisory committee meeting has been set for BG-12, and neither company executives nor analysts are giving much weight to citizen petitions filed by Teva Pharmaceutical Industries Ltd

and a recent issuance of options to company executives constituted a "dramatic change in circumstances," requiring the board to allow shareholders another chance to nominate directors and make proposals during the annual meeting 4/26/12 Anchen Pharmaceuticals (Irvine, Calif.) and TWi Pharmaceuticals Inc. (Taipei, Taiwan) Shire plc (Dublin, Ireland) Shire settled all pending litigation in connection with TWi's abbreviated new drug application for a generic version of Intuniv in attention deficit

At an investor roadshow in November, company executives said they would seek to drive sustainable growth for Humira through additional indications, increased penetration, geographic expansion and share gains and by leveraging growth in the anti‐TNF market

The FDA denied the application by a former drug company executive, Baldev Raj Bhutani, to terminate the permanent debarment, which followed Bhutani's guilty verdict in 1996 for conspiracy

Editor's note: In the third and final part of this article, we will look at the success that public stem cell companies have had on the capital markets YTD and speak with several company executives about whether the recent spate of positive clinical trial results will bring investors and pharmaceutical companies back off the sidelines to get more involved in stem cell research.

But now that company executives can be effectively banned from the industry for life as a result of such settlements, drugmakers "are becoming more willing to try to protect their rights," Andrews said. (See BioWorld Today, July 31, 2012.) And with settlements topping $1 billion in some cases, he added that drugmakers may find it cheaper to fight off-label charges on free-speech grounds than it is to settle. (See BioWorld Insight, May 21, 2012

But now that company executives can be effectively banned from the industry for life as a result of such settlements, drugmakers "are becoming more willing to try to protect their rights," Andrews said. (See BioWorld Today, July 31, 2012.) And with settlements topping $1 billion in some cases, he added that drugmakers may find it cheaper to fight off-label charges on free-speech grounds than it is to settle. (See BioWorld Insight, May 21, 2012.)

In 2010, for example, only C$80 million was raised by private Canadian companies focusing on the development of biopharmaceuticals and only three of the venture capital deals in 2010 raised more than C$10 million. (See BioWorld SnapShots 2010.) After weathering this severe shortage of venture capital, Canada's long-suffering biotechnology company executives and university researchers hoping to get their innovative projects funded may at last be rewarded for their patience

and a recent issuance of options to company executives constituted a "dramatic change in circumstances," requiring the board to allow shareholders another chance to nominate directors and make proposals at the annual meeting

and the recent issuance of options to company executives constitutes a "dramatic change in circumstances," requiring the board to allow shareholders another chance to nominate directors and make proposals at the 2012 annual meeting

Your perseverance is to be admired," Lazard Capital Markets analyst Bill Tanner told company executives on the firm's conference call, shortly after the FDA issued its own press release disclosing the approval

However, company executives "may identify an earlier meeting that would be appropriate" to present the CORRECT data, she added

Company executives said they hope to initiate Phase III trials in 2013. (See BioWorld Today, Aug. 12, 2011.) In the current Phase I trial, whose results were published in the Sept

Actions against company executives have been proposed as a way of giving teeth to laws prohibiting off-label promotion of drug products, but the move in this instance was criticized as being unfair given that Forest's settlement with the DOJ included no finding of knowledge of wrongdoing by Solomon

PBM Incentives In Dendreon's case, company executives said doctors are hesitant to prescribe Provenge because they are not yet comfortable with reimbursement for the $93,000 drug

Company executives appeared to be at a loss to explain what went wrong: The baseline population in both trials was similar, and although TIGER-2 was a longer study, measuring FEV1 at 48 weeks, Inspire Chief Medical Officer Charles Johnson said there was no treatment effect at 24 weeks either