Updates for: Warner Chilcott PLC (NASDAQ:WCRX), AstraZeneca PLC (NYSE:AZN), Dainippon Sumitomo Pharma (PINK:DNPUF), and Nanosphere, Inc. (NASDAQ:NSPH)
Warner Chilcott PLC
(NASDAQ:WCRX)
On 5/27/09, Warner Chilcott (NASDAQ: WCRX) announced that the FDA has filed for standard review (10 months) the new drug application (NDA) for WC 3016, a low dose oral contraceptive. The NDA for WC 3016 was submitted by its subsidiary, Warner Chilcott Company, LLC, on 3/26/09 for an estimated PDUFA decision date of 1/26/10.
AstraZeneca PLC
(NYSE:AZN)
On 7/30/09, AZN announced the company has submitted a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for an investigational drug, vandetanib (proposed brand name Zactima) 100 mg for use in combination with chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) in patients previously treated with one prior anti-cancer therapy. The U.S. and European submissions are supported by data from Phase 3 clinical studies evaluating the safety and efficacy of vandetanib 100 mg in combination with chemotherapy. Evaluation of vandetanib is ongoing, as monotherapy or in combination with other anti-cancer therapies in a range of tumour types, including thyroid cancer. Results from the ZEPHYR (300mg monotherapy study in EGFR failures in advanced NSCLC, Phase III) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer, Phase III) studies will be presented during 1H10. The estimated PDUFA action date is 1/30/10 for a priority (six-month) review and possible FDA decision for the Zactima NDA.
Dainippon Sumitomo Pharma
(PINK:DNPUF)
On 3/31/09, Sepracor (NASDAQ:SEPR) filed a NDA with the FDA for the use of Stedesa (eslicarbazepine acetate) as an adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. On 6/1/09, the FDA accepted the Stedesa NDA for a standard, 10-month review with a PDUFA decision date of 1/30/10. On 8/10/09, SEPR announced that it submitted an application to the Therapeutic Products Directorate (TPD) of Health Canada for eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. On 9/3/09, Dainippon Sumitomo Pharma (TYO:4506) (DNPUF.PK) announced that it was acquiring Sepracor for $2.6 billion to help expand its presence in the U.S. market.
Nanosphere, Inc.
(NASDAQ:NSPH)
On 11/5/09, NSPH reported quarterly operating results and announced that it has completed the clinical trials for the regulatory submission of its troponin assay and expects to make the filing with the FDA shortly. NSPH reported that it is awaiting FDA clearance for its hemochromatrosis assay.” On 10/13/09, NSPH announced that it received 510(k) marketing clearance from the FDA for its influenza A & B and respiratory syncytial virus (RSV) test and the Verigene SP System, with complete sample-to-result automation. The 1/31/10 date for this entry is an estimate for a possible FDA response on the pending 510(k) application for the hemochromatrosis assay, since the Agency does not issue decision date deadlines for medical device submissions.
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