Post archive for ‘Company Commentary’
Dendreon Turns Reins Over to New CEO
Key Points Dendreon has made a sweeping change in management by bringing in John Johnson, who was serving as a board member, to be the new President, CEO and Chairman-elect of the Board of Directors. He immediately replaces Mitchell Gold as CEO and Richard Brewer has stepped down as Chairman of the Board. Mr. Gold […]
Gilead’s Offer for Pharmasset Follows Closely on the Heels of Roche’s Bid for Anadys: Could Achillion and Inhibitex Be Next?
Gilead (GILD) is certainly paying up for Pharmasset with its offer to buy the company at $137 per share ($11 billion), an 89% premium to last Friday’s close. Gilead will be paying for the acquisition with cash on hand and debt. Relative to alternatives such as investing money in short term debt instruments or doing […]
Transcept to Resubmit Intermezzo NDA; Hopes for a Class I Review
Resubmission of Intermezzo NDA Transcept Pharmaceuticals in a press release today (September 15) said that it plans to resubmit its NDA on Intermezzo following a meeting with the FDA. The key parts of the resubmission are: Transcept proposes to reduce the recommended Intermezzo dose for women from 3.5 mg to 1.75 mg, and to keep […]
Bristol-Myers Squibb’s Dapagliflozin Voted Down By Advisory Committee; What’s Next
Overview of Advisory Committee Meeting The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 6-9 against approval of dapagliflozin for the treatment of type II diabetes. This will almost certainly result in a Complete Response Letter from the FDA on the PDUFA date of October 28. As I pointed out in a recent report on […]