| Genoptix Reports Solid Results for the First Quarter 2010 (PR Newswire) Genoptix, Inc. , a specialized laboratory services provider, today reported revenue of $47.4 million for the first quarter of 2010. Â Net income was $5.3 million, or $0.29 per diluted share for the first quarter of 2010. us.rd.yahoo.com |
Eli Lilly Retools Pipeline Eli Lilly's Chief Executive John Lechleiter is focusing more intently on developing new drugs for difficult-to-treat diseases, as patent protection for eight drugs will soon expire. online.wsj.com |
Waters Corporation Q2 2010 Earnings Call Transcript Title: Waters Corporation Q2 2010 Earnings Call TranscriptSymbol: WATCall Start: 8:30Complete Story » seekingalpha.com |
Forest Settles Criminal Investigation Over Illegal Drug Marketing: Biotech's Latest Mishaps The Burrill Report submits: Forest Pharmaceuticals (FRX) has agreed to pay more than $300 million to settle charges stemming from a multiyear criminal investigation by the U.S. Food and Drug Administration over illegal marketing of drugs. The FDA, working in coordination with the U.S. Department of Justice, said that Forest Pharmaceuticals entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection. The settlement included $164 million in criminal penalties. Charges against Forest were primarily for its marketing of Levothroid, an unapproved drug used for the treatment of hypothyroidism. Arena Pharmaceutical’s (ARNA) shares plunged nearly 40 percent after a U.S. Food and Drug Administration advisory committee rejected its proposed weight loss drug lorcaserin. The reviewers expressed concern that potential risks of long-term use outweighed its benefit of modest weight loss. A briefing document issued two days earlier noted that the drug caused cancer in lab rats and succeeded by just “a slim margin” in meeting the FDA’s expectations for weight management. That news spurred a sell-off that drove Arena's shares down 38 percent as investors fretted over how the FDA's Endocrinologic & Metabolic Drugs Advisory Committee would vote. The committee’s recommendation often guides the FDA’s final decision on whether or not to grant marketing approval. Complete Story » seekingalpha.com |
Approval of Questcor's Athcar Drawing Near Sheff Station submits:It seems that if the FDA is going to approve Athcar for Infantile Spasms that there is no better week than this upcoming one. The 39th annual Child Neurology Society meeting is scheduled to be held this week from October 13th-16th in Providence, R.I. This meeting recognizes and reviews new treatments and advancements for specialists who deal with children in the Neurology field. From previous conference calls hosted by Questcor (QCOR), the common theme was that many of their company executives hoped that the FDA would have approved their treatment for IS so that the new labeling change, information, and news of approval could be presented at this prestigious meeting.During the last conference call update shortly after the PDUFA decision date for approval of Athcar had to be delayed, the company was direct with shareholders that this delay was due to the FDA. If the FDA had needed greater than 3 months, then the PDUFA date decision would have been changed as opposed to delayed. The hope of QCOR management was that a decision would have been made before their largest conference meeting on October 13th where they hoped to unveil Athcar. Being that the PDUFA date was not changed by the FDA, that leads management to believe that the FDA is working hard to tie all the loose ends with regards to updating the labeling for Athcar. This should be approved fairly soon as we are 1 month past the PDUFA date. The importance of hitting the targeted PDUFA dates are important for FDA reviewers as they track all of time sensitive reviews in their yearly report updates.Complete Story » seekingalpha.com |