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Biotech News Company news Regular news within the Australian biotech industry. |
- AstraZeneca publishes 2005 annual reports
- Genetech receives FDA approval for Rituxan
- Genentech granted six-month priority FDA review for Lucentis for the treatment of wet age-related macular degeneration
- Genetech's Raptiva listed on the PBS for severe chronic plaque psoriasis
- GlaxoSmithKline granted European Commission approval for rotavirus vaccine
- GlaxoSmithKline granted temporary order preventing marketing of generic Flonase
- GlaxoSmithKline makes new R&D appointments
- Novartis and Alnylam to collaborate on RNAi therapeutics for pandemic flu
- Novartis to build chemical raw material facility in China
- Novartis receives FDA 'approvable letter' for Paget's disease drug
- Pfizer's Eraxis approved by FDA
- Pfizer granted preliminary injunction against Ranbaxy for generic Lipitor in Finland
- Somerset Pharmaceuticals receives FDA approval for Emsam patch
- Takeda successfully defends patent rights to ACTOS against ANDA filers
AstraZeneca publishes 2005 annual reports
28 February – AstraZeneca published its 2005 Annual Report, its 2005 Annual Review and its 2005 Corporate Responsibility Summary Report. [Source: Company announcement]
Genetech receives FDA approval for Rituxan
28 February – Genetech Inc and Biogen Idec Inc announced that the US Food and Drug Administration (FDA) has approved the antibody Rituxan (Rituximab) in combination with methotrexate in patients who have had an inadequate response to tumour necrosis factor antagonist therapies. Rituxan is the first targeted B-Cell therapy for the treatment of moderate-to-severe rheumatoid arthritis.
[Source: Company announcement]
Genentech granted six-month priority FDA review for Lucentis for the treatment of wet age-related macular degeneration
28 February – The FDA has accepted the Biologics License Application (BLA) for the use of Lucentis (ranibizumab) in the treatment of neovascular wet age-related macular degeneration. As part of the BLA filing, Genentech requested and has been granted a six-month priority review. Priority review is granted to products that are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease. New preliminary phase III MARINA data show the improvement in visual acuity endpoints in Lucentis groups was maintained at year two while patients in the control group continued to decline. At least 90 percent of patients treated with Lucentis maintained or improved vision compared to approximately 53 percent of those treated in the control arm at year two. The study is continuing in the United States, Europe and Australia.
[Source: Company announcement]
Genetech's Raptiva listed on the PBS for severe chronic plaque psoriasis
21 February – Genetech's Raptiva (efalizumab) will become available under the Pharmaceutical Benefits Scheme (PBS) from 1 April 2006 for the treatment of severe chronic plaque psoriasis for patients who have exhausted or had an inadequate response to other treatments. Raptiva will be available to patients who have a Psoriasis Area and Severity Index (PASI) score of greater than 15. Patients must achieve at least a 75 per cent improvement in their initial PASI score after 12 weeks of treatment to be eligible to continue treatment. Criteria have also been developed for the rare cases of severe chronic plaque psoriasis of the face, palm of a hand or sole of a foot. The listing of Raptiva will add around $171 million to PBS expenditure between 2005-06 and 2008-09.
[Source: Company announcement]
GlaxoSmithKline granted European Commission approval for rotavirus vaccine
27 February – The European Commission has granted GlaxoSmithKline approval for the use of Rotarix in the European Union. Rotarix is the first vaccine available to children for the prevention of gastroenteritis caused by rotavirus.
[Source: Company announcement]
GlaxoSmithKline granted temporary order preventing marketing of generic Flonase
24 February – The US District Court for the District of Maryland granted GlaxoSmithKline's (GSK) motion to set aside the FDA decision approving Roxane Laboratories' generic form of Flonase allergy treatment.
[Source: Reuters]
GlaxoSmithKline makes new R&D appointments
23 February – GlaxoSmithKline (GSK) announced appointments in its research and development (R&D) organisation taking effect from 27 February 2006. Allan Baxter was appointed as Senior Vice President, Medicines Development. Amber Salzman was appointed as Senior Vice President, Development Operations. Ronald Krall was appointed as Senior Vice President and Chief Medical Officer and will also chair the Global Safety Board. All three executives will report to Tachi Yamada, chairman, R&D, and upon his retirement on 1 June 2006, to his successor, Moncef Slaoui.
[Source: Company announcement]
Novartis and Alnylam to collaborate on RNAi therapeutics for pandemic flu
21 February – Novartis and Alnylam have entered into an agreement to collaborate to advance RNA Interference (RNAi) therapeutics for pandemic flu to initial clinical testing and, if successful, regulatory approval. The collaboration is in addition to a multi-year alliance signed in September 2005 that is focused on the discovery of innovative therapeutics based on RNAi across multiple disease areas in the Novartis research portfolio.
[Source: Novartis Company announcement]
Novartis to build chemical raw material facility in China
24 February – Novartis has commenced building a chemical raw material development and production facility in Suzhou City, Jiangsu Province, China. The project will cost US$83 million and is expected to be operational by the end of 2007.
[Source: People's Daily Online (English edition), Xinhua net]
Novartis receives FDA 'approvable letter' for Paget's disease drug
27 February – Novartis received an 'approvable letter' from the FDA for Aclasta (zoledronic acid) in the treatment of Paget's disease of the bone. The letter is a notification that the FDA is prepared to give marketing approval when certain conditions are met. The drug has already been approved in 41 other countries, including the European Union (EU), for the treatment of Paget's disease. Submission of the drug for treatment of osteoporosis in the US and EU is planned for 2007.
[Source: Company announcement]
Pfizer's Eraxis approved by FDA
21 February – The FDA has approved Pfizer's Eraxis (anidulafungin). The drug is used to treat certain infections caused by Candida, a yeast-like fungus that can cause serious infections in hospitalised patients or patients with compromised immune systems.
[Source: Company announcement]
Pfizer granted preliminary injunction against Ranbaxy for generic Lipitor in Finland
21 February – The Helsinki Court of Appeal in Finland has granted a preliminary injunction against Ranbaxy Laboratories Ltd that prohibits the manufacturer from marketing a generic version of Lipitor.
[Source: Reuters]
Somerset Pharmaceuticals receives FDA approval for Emsam patch
28 February – The FDA has approved Emsam (selegiline), the first skin (transdermal) patch for use in treating major depression. Bristol-Myers Squibb will market Emsam after approval in the United States.
[Source: FDA]
Takeda successfully defends patent rights to ACTOS against ANDA filers
21 February – The Takeda Pharmaceutical Company Limited (Takeda) was successful in the US in defending patent rights to ACTOS (pioglitazone HCl). A federal judge of the US District Court for the Southern District of New York ruled that a patent covering the active ingredient of ACTOS is valid and enforceable. The Court's ruling prevents the FDA from approving the Abbreviated New Drug Applications (ANDAs) filed by Alphapharm and Mylan, and thus prevents those generic manufacturers from selling pioglitazone tablets until the relevant patent expires in 2011.
[Source: Company announcement]
