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Panel Backing for Prevnar 13 – Analyst Blog
Pfizer ( PFE) announced that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products advisory committee voted in favor (10 to 1) of data presented to support the safety and effectiveness of Prevnar 13, its 13-valent pneumococcal conjugate candidate vaccine. The favorable recommendation of the vaccine was based on data from 13 phase III studies carried out on more than 7,000 children.
Pfizer is seeking FDA approval for the vaccine to prevent diseases (including sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema caused by 13 Streptococcus pneumoniae (S. pneumoniae) in infants and young children. Although the FDA is not required to follow the advisory panel’s recommendation, it generally does so. The FDA is reviewing the Biologic License Application (BLA) for Prevnar 13, which has an action date of December 30, 2009. Though the FDA was initially expected to respond by September 30, 2009, the agency had pushed back the approval date then by 90 days.
Prevnar 13 is a new version of the currently available pneumococcal vaccine, Prevnar. Prevnar, one of the best selling vaccines worldwide, recorded sales of about $2.7 billion in 2008. While Prevnar treats illness caused by 7 strains of pneumococcal bacteria, the new vaccine is expected to block 13 strains including the original 7. It is estimated that Prevnar 13 would cover 92% of invasive pneumococcal disease, compared to 81% covered by Prevnar. The company is currently seeking approval for Prevnar 13 in about 60 countries spanning six continents.
Earlier, in September, Prevnar 13 received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP). A final decision is expected by the European regulatory authorities by year end. In addition, the vaccine is being studied in global phase III clinical trials for the prevention of pneumococcal disease in adults. Meanwhile, GlaxoSmithKline ( GSK) received European approval for its pediatric 10-valent vaccine, Synflorix (meant for children aged 6 weeks to 2 years), in March 2009 which will compete with Prevnar and Prevnar 13. However, GlaxoSmithKline does not have plans to launch the vaccine in the US Read the full analyst report on "GSK"Read the full analyst report on "PFE"Zacks Investment Research
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RxNews Recap for Wednesday 11-18-09
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.Affymax, Inc. (Nasdaq: AFFY), today announced that it intends to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering.Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced new pre-clinical data from its ALN-VSP program presented at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics International conference being held November 15 - 19, 2009 in Boston, Mass.BSD Medical Corporation (NASDAQ: BSDM) (www.bsdmedical.com) today provided an update on the U.S. Food and Drug Administration’s (FDA) review of the Company's Humanitarian Device Exemption (HDE) marketing submission for the Company’s BSD-2000 Hyperthermia System.Clinical Data, Inc. (NASDAQ: CLDA) today announced that it has enrolled the first patient in its initial Phase III trial of Stedivaze™, a potential best-in-class vasodilator for use in cardiac stress testing.Delcath Systems, Inc. (Nasdaq: DCTH) announced today the closing of its public offering of 9,775,000 shares of common stock priced to the public at $3.60 per share.CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.Depomed, Inc. (NASDAQ:DEPO) announced today that William Callahan has been promoted to vice president, Operations. Mr. Callahan joined Depomed in 2002 and most recently held the position of senior director, Operations.Exelixis, Inc. (Nasdaq:EXEL) today reported interim data from an ongoing phase 1 dose-escalation trial of XL147 (SAR245408) in combination with the EGFR inhibitor erlotinib in patients with advanced solid tumors.PPD, Inc. (NASDAQ:PPDI) today announced it has signed an agreement to acquire BioDuro LLC, a drug discovery outsourcing company that provides a broad range of integrated services to biopharmaceutical companies. The acquisition will expand PPD’s drug development capabilities in China.Pfizer Inc (NYSE:PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children. Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP), a specialty pharmaceutical company, today announced the pricing of a public offering of 5,500,000 shares of its common stock.Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today reported data from two nonclinical studies of voreloxin at the AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics Conference, which is being held in Boston, MA from November 15-19, 2009.Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today presented new data on the mechanism of action of elesclomol, a first-in-class oxidative stress inducer, at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston, Mass.Tongjitang Chinese Medicines Company (NYSE: TCM) (“Tongjitang” or the “Company”), a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced its financial results for the quarter ended September 30, 2009 and the repurchase of ordinary shares in a private transaction.YM BioSciences Inc. (NYSE Amex: YMI; TSX: YM), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, announced that results from a study evaluating nimotuzumab were presented today in a poster at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference in Boston, Massachusetts.
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