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From the Blogosphere
Updated FDA Calendar: Buying Cypress Bioscience
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The accompanying table [click to enlarge] includes a weekly update of 71 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Decision Catalyst Index. Since my article last week, the following action has taken place at FDA:
1.) Pain Therapeutics (PTIE) & King Pharma (KG) lost 21% and 7%, respectively, today after receiving a complete response letter from the FDA for their abuse-resistant form of controlled-release oxycodone, which is designed to deter the abuse and diversion of the blockbuster pain drug OxyContin sold by privately-held Purdue Pharma.
While deta...
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Updated FDA Calendar: Buying Cypress Bioscience
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The accompanying table [click to enlarge] includes a weekly update of 71 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Decision Catalyst Index. Since my article last week, the following action has taken place at FDA:
1.) Pain Therapeutics (PTIE) & King Pharma (KG) lost 21% and 7%, respectively, today after receiving a complete response letter from the FDA for their abuse-resistant form of controlled-release oxycodone, which is designed to deter the abuse and diversion of the blockbuster pain drug OxyContin sold by privately-held Purdue Pharma.
While deta...
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Updated FDA Calendar of 73 Decision Dates
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The accompanying table [click to enlarge or download] includes an updated calendar of 75 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index, which includes a full slate of expected action before year-end outlined in my previous article. The last few days have been busy for antibiotics at the agency, resulting in sharply lower stock prices for Targanta Therapeutics (TARG) and Theravance (THRX).
An FDA panel voted against Targanta's oritavancin, which has an upcoming decision in early December and sent shares crashing from 8 bucks before the dec...
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Updated 3-Month FDA Decision Calendar
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The accompanying table includes an updated calendar of FDA decisions expected to occur within the next three months. Most recently, the FDA continued its tough stance toward new antibiotic approvals and issued a complete response letter for ceftobiprole to Johnson & Johnson (JNJ) and its Swiss partner, Basilea Pharma (Switzerland: BSLN) – sending the latter down sharply to new lows on Wednesday with a sharp rebound of 30% by the end of the week, but still down by about 43% in the last year.
The FDA cited concerns over auditing and monitoring of clinical trial sites, which is similar t...
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Updated 3-Month FDA Decision Calendar
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The accompanying table includes an updated calendar of FDA decisions expected to occur within the next three months. Most recently, the FDA continued its tough stance toward new antibiotic approvals and issued a complete response letter for ceftobiprole to Johnson & Johnson (JNJ) and its Swiss partner, Basilea Pharma (Switzerland: BSLN) – sending the latter down sharply to new lows on Wednesday with a sharp rebound of 30% by the end of the week, but still down by about 43% in the last year.
The FDA cited concerns over auditing and monitoring of clinical trial sites, which is similar t...
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About Targanta Therapeutics Corp.
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