GlaxoSmithKline will begin manufacturing its treatment for flu, Relenza, in China to supply China’s domestic market. GSK received approval of the drug in September from the SFDA. Relenza, like Tamiflu from Roche, aims at reducing both the severity and the duration of flu symptoms, though some resistance to the drugs seems to be evident. More details...
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Biogen Idec (BIIB) and Genentech, Inc., a wholly-owned member of the Roche Group (RHHBY.PK), announced that they have received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for Rituxan. The companies were seeking approval for the use of Rituxan (rituximab) plus fludarabine and cyclophosphamide (FC) in patients with previously untreated [...]
GlaxoSmithKline will begin manufacturing its treatment for flu, Relenza, in China to supply China’s domestic market. GSK received approval of the drug in September from the SFDA. Relenza, like Tamiflu from Roche, aims at reducing both the severity and the duration of flu symptoms, though some resistance to the drugs seems to be evident.[More...]
Biogen Idec (BIIB) and Genentech, Inc., a wholly-owned member of the Roche Group (RHHBY.PK), announced that they have received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for Rituxan. The companies were seeking approval for the use of Rituxan (rituximab) plus fludarabine and cyclophosphamide (FC) in patients with previously untreated and treated chronic lymphocytic leukemia (CLL).
Although the companies did not provide any details regarding the letter, they said that the agency has not asked them to submit any new data. Genentech and Biogen intend to work towards gaining final approval for the expanded indication and are planning to continue final label discussions with the FDA.
Rituxan is currently approved for the treatment of rheumatoid arthritis and non-Hodgkin’s lymphoma (NHL), a type of cancer. It contributes significantly to Biogen’s top line. Biogen receives a profit-split on U.S. sales of Rituxan from Genentech, plus a royalty on international sales and reimbursement on development work. In 2008, the company recognized $1,128 million (up 22%) in Rituxan revenues. To keep the solid growth up, both companies are working to expand Rituxan beyond its current use.
According to the American Cancer Society, CLL is the most common form of adult leukemia, accounting for one-third of all leukemia in the United States. About 90,000 Americans are living with CLL and it is estimated that more than 15,000 new cases will be diagnosed this year. Current treatments for CLL include Cephalon’s (CEPH) Treanda, GlaxoSmithKline’s (GSK) Leukeran and Bayer’s (BAYRY.PK) Campath.
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 [...]
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
Companies featured in this segment: Southern Company (NYSE:SO), Foster Wheeler (NASDAQ:FWLT), American Electric Power (NYSE:AEP), GlaxoSmithKline plc (NYSE:GSK), Diageo plc (NYSE:DEO), JPMorgan Chase & Company (NYSE:JPM), Northern Foods plc (LSE:NFDS)
Companies featured in this segment: Fluor Corporation (NYSE:FLR), American Electric Power (NYSE:AEP), Southern Company (NYSE:SO), ReneSola Limited (NYSE:SOL), POSCO (NYSE:PKX), Suntech Power Holdings Company Limited (NYSE:STP), Ormat Technologies Incorporated (NYSE:ORA), Sanofi-Aventis (NYSE:SNY), GlaxoSmithKline plc (NYSE:GSK), Novartis AG (NYSE:NVS), AstraZeneca plc’s (NYSE:AZN), Mitsubishi Corporation (OTC:MSBHY), Sharp Corporation (OTC:SHCAY), CSL Limited (ASX:CSL), Mumias Sugar Company Limited (NBO:MSCL), Athi River Mining Limited (NBO:ARM), Kenya Power & Lighting Company Limited (NBO:KPLA), Daewoo Engineering & Construction Company Limited (SEO:047040)
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