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If approved "the parliamentary panel voted 12-1 passing it" this will double from here. Only 1.4 billion market cap.
Posts: 4381 | From: houston | Registered: Mar 2006
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WASHINGTON, D.C. (TheStreet) -- Two drugs into October's FDA drug approval-palooza, and neither of them makes it across the finish line. More from Adam Feuerstein ESMO Preview: Cancer Stocks to WatchReaders Pick Drug Approval Winners & LosersBest and Worst Drug Stocks in Q3Market Activity Jazz Pharmaceuticals Inc.| JAZZ UPHuman Genome Sciences| HGSI UPVivus| VVUS UPHuman Genome Sciences(HGSI_) and partner Novartis(NVS_) said Tuesday that U.S. regulators declined to approve the hepatitis C drug Zalbin. As a result, the companies have decided to halt further development of the drug. The U.S. Food and Drug Administration also issued a complete response letter for Dyloject, an injectable pain reliever from Hospira(HSP_). "We intend to work with the agency to address the letter. We remain positive about Dyloject’s commercial potential," said Hospira spokesman Daniel Rosenberg, in an email. FDA is deciding the fate of 11 new drugs in October -- an almost unprecedented number of approval decisions in such a short time period. Just two business days into the month and the FDA is living up to its recent reputation as a regulator very hard to satisfy. The FDA's decision against Zalbin was not a surprise. In June, Human Genome Sciences warned investors that FDA had raised significant concerns about the long-acting form of interferon for the treatment of hepatitis C and as a result, approval was unlikely. Zalbin goes by the name Joulferon in Europe, and there, Novartis has already been forced to pull the drug from approval consideration by European regulators. Existing long-acting interferons for hepatitis C -- Roche's Pegasys and Merck's(MRK_) Peg-Intron -- are given as once-weekly injections. Zalbin, had it been approved, would have been injected twice-a-month, although the drug was plagued by side effect concerns and underwhelming efficacy. The FDA is currently reviewing a second Human Genome drug, Benlysta, as a treatment for lupus. Hospira took control of Dyloject after the drug maker acquired Javelin Pharmaceuticals for $141 million earlier this year. Dyloject is a new, injectable form of the non-steroidal anti-inflammatory drug (NSAID) ketorolac, which has been marketed in the U.S. in other formulations since 1990. Regulators in the U.K. recalled Dyloject this past summer, which threatened to deral the Hospira-Javelin deal from closing. Hospira's Rosenberg did not specify the FDA's concerns about Dyloject or how long the company believed it would take to respond to the agency's questions about the drug. Other new drugs under FDA review in October include weight-loss drugs from Arena Pharmaceuticals(ARNA_) and Vivus(VVUS_), a diabetes drug from Amylin Pharmaceuticals(AMLN_) and partners, a drug to treat opioid addiction from Alkermes(ALKS_) and a treatment for fibromyalgia from Jazz Pharmaceuticals(JAZZ_).
Posts: 4381 | From: houston | Registered: Mar 2006
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The FDA is set to give its ruling on Tuesday. Calls are still cheap. I would suggest taking a look at this one as if approved, this will fly. If denied, not good.
Posts: 4381 | From: houston | Registered: Mar 2006
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Alkermes, Inc. Announces FDA Approval Of VIVITROL For Prevention Of Relapse To Opioid Dependence 6:38pm EDT
Alkermes, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL (naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL is the non-narcotic, non-addictive, once-monthly medication approved for the treatment of opioid dependence. VIVITROL was approved by the FDA in 2006 for the treatment of alcohol dependence and should be used as part of a comprehensive management program that includes psychosocial support. The FDA approval of VIVITROL for the prevention of relapse to opioid dependence was based on data from a six-month, multi-center, randomized phase 3 study which met its primary efficacy endpoint and all secondary efficacy endpoints. Data from the intent-to-treat analysis showed that patients treated once a month with VIVITROL demonstrated statistically significant higher rates of opioid-free urine screens compared to patients treated with placebo (p<0.0002). VIVITROL was generally well tolerated in the study. The most common clinical adverse events experienced by patients receiving VIVITROL during the study were hepatic enzyme elevations, nasopharyngitis and insomnia.
quote:Originally posted by Ripler: Alkermes, Inc. Announces FDA Approval Of VIVITROL For Prevention Of Relapse To Opioid Dependence 6:38pm EDT
Alkermes, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL (naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL is the non-narcotic, non-addictive, once-monthly medication approved for the treatment of opioid dependence. VIVITROL was approved by the FDA in 2006 for the treatment of alcohol dependence and should be used as part of a comprehensive management program that includes psychosocial support. The FDA approval of VIVITROL for the prevention of relapse to opioid dependence was based on data from a six-month, multi-center, randomized phase 3 study which met its primary efficacy endpoint and all secondary efficacy endpoints. Data from the intent-to-treat analysis showed that patients treated once a month with VIVITROL demonstrated statistically significant higher rates of opioid-free urine screens compared to patients treated with placebo (p<0.0002). VIVITROL was generally well tolerated in the study. The most common clinical adverse events experienced by patients receiving VIVITROL during the study were hepatic enzyme elevations, nasopharyngitis and insomnia.
So.....Ripler....I see that you started on Allstocks on the same date I did...Exactley Mar. of 2006.
Posts: 4381 | From: houston | Registered: Mar 2006
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Alkermes shares rose 22 cents to $15.90 in premarket trading.
The Waltham, Mass., company is also one of the developers of Bydureon, a once-a-week diabetes treatment. The FDA is scheduled to make a decision on Bydureon next week, and Windley expects the product to win approval. If it does, Bydureon would probably become a larger contributor to Alkermes' sales.
Posts: 364 | Registered: Mar 2006
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How do you get FDA approval and go down for the day? I sold some calls when it didn’t pop the way it should have. Made money, still own some. On radar.
Posts: 4381 | From: houston | Registered: Mar 2006
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