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Archive for January 11th, 2010

Plastic surgery fat graft device PureGraft approved in US: Cytori

Monday, January 11, 2010 18:17

According to the American Society of Plastic Surgeons' most recent report of plastic surgery statistics, over 46,000 fat grafting procedures were performed in the United States in 2008. Currently, over 5,000 plastic surgeons are registered with the American Society of Plastic Surgeons.

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Serum Institute may launch nasal vaccine against H1N1 swine flu in India soon

Monday, January 11, 2010 17:58

Serum Institute may launch nasal vaccine against H1N1 swine flu in India soon The intra-nasal spray vaccine against H1N1 swine flu made by Serum Institute of India (SII), will undergo human trials soon, reports said. Serum Institute of India has been granted approval by the Drug Controller General of India (DCGI) to carry out clinical studies for the intra-nasal spray vaccine. Serum Institute is currently in the process of identifying 50  healthy adults to undertake first-in-man clinical trials in Pune, Delhi and Ahmedabad, reports said quoting company officials. A few of the Indian companies are currently in the process of launching made-in-India H1N1 swine flu vaccines at half the price of imported vaccines will hit the markets by March. Currently, the imported H1N1 swine flu is priced around Rs 300-400. But H1N1 swine flu vaccines produced by Indian companies may have a price of only Rs 50-100, reports said. Initially, the India made H1N1 swine flu vaccines were expected to be launched in India only by April this year. However, Indian companies have advanced their their schedule to launch the vaccine as early by March, reports said quoting V M Katoch, director-general, Indian Council of Medical Research (ICMR) and secretary to the Government of India, department of health research. In December, India placed an order with the French drug maker Sanofi Pasteur for supplying 1.5 million doses of H1N1 swine flu vaccine. Sanofi Pasteur’s 2009 H1N1 swine flu vaccine batches will be available in India in January. GlaxoSmithKline, which supplies Pandemrix, Baxter (Celvapan) and Novartis (Focetria) are the other multinational vaccine suppliers who have been competing to supply H1N1 swine flu vaccines in India. India’s health ministry has given approval to French drug maker Sanofi Pasteur for conducting pre-market trials of swine flu vaccine in the country, which is a mandatory condition for selling the vaccine in India. Initially, India was planning to import four million doses of the vaccine. Indian manufacturers will now supply the remaining doses. However, the health ministry cut it down to 1.5 million doses, in view of the possibility indigenously produced H1N1 swine flu vaccine to be made available by March. The health ministry has been trying to make the vaccine available in India for the last two months and had sped up regulatory approvals for studies to be conducted on the safety of the vaccine. Drug Control General of India has given approval to Zydus Cadila of Ahmedabad to carry out human studies of its H1N1 vaccine in India. Zydus Cadila was the first Indian company to file the clinical trial protocol with the DCGI pushing back other domestic rivals who are also in race to launch H1N1 swine flu vaccine in India. Zydus Cadila would have the vaccine ready by March, so the government would not need to import batches, according to government sources. Bharat Biotech, Panacea Biotech and Serum Institute of India are the three biotech companies assigned by the Indian government to develop H1N1 swine flu vacccine. New Delhi-based Panacea’s  egg based H1N1 vaccine is currently going through pre-clinical testing in animals. Bharat Biotech, Hyderabad, which is currently working on a cell-based vaccine, also expects its animal studies to start human studies by January. Probably Bharat Biotech would start the human studies of its H1N1 vaccine as early as  January, 2010. The clinical studies are expected to be complted by March, 2010, subject to regulatory approval and  Bharat Bio would launch its own vaccine by April 2010, if everything goes as planned. Cadila Pharmaceuticals and Biological E Ltd, Hyderabad are also working on H1N1 vaccines. Cadila Pharmaceuticals, another pharma major from Ahemedabad, is also developing an H1N1 Swine flu vaccine in callaboration with Novavax. CPL Biologicals Pvt. Ltd, the newly formed joint venture between Cadila Pharmaceuticals in India, expects to start producing H1N1 swin flu vaccine in next four months, Novavax Inc announced in a press release. GlaxoSmithKline (GSK), Novartis, Baxter International and Sanofi-Aventis are the multinational companies applied for test license to the DCGI for carrying out clinical trials in India for their version of swine flu vaccines. India has reported 1010 deaths confirmed by lab due to H1N1 as on January 6, 2010, as per the data available with the Union Health Ministry,. Maharashtra on top of the list with 282 lab confirmed death cases. After Maharashtra, the maximum number of people who have lost their lives due to this pandemic disease is in Rajasthan which has registered 152 cases till January 6, and is followed by its neighbour Gujarat with 134 lab confirmed death cases so far. Gujarat is closely followed by the southern state of Karnataka with 133 death cases. Delhi reported 73 deaths, Andhra Pradesh 52 , Kerala 34, Punjab 35 and Haryana 33. The states which were registered comparatively less number of deaths included Uttar Pradesh (16), Uttarakhand (13), Madhya Pradesh (11), Chandigarh (8), Tamil Nadu (7), Himachal Pradesh (7), Puducherry (6), Goa (5), Orissa (3) Chhattisgarh (2), Jammu & Kashmir (2), Mizoram (1) and Assam (1). However, no deaths were registered in some states like Bihar, Jharkhand, West Bengal, Nagaland, Manipur, Meghalaya, Andaman & Nicobar and Daman & Diu. http://www.dancewithshadows.com/pillscribe/indian-h1n1-swine-flu-vaccine-at-rs-50-100-per-dose-by-march/ The intra-nasal spray vaccine against H1N1 swine flu made by Serum Institute of India (SII), will undergo human trials soon, reports said.

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Non-Hodgkin’s lymphoma vaccine BiovaxID to get fast-track review in US: Biovest

Monday, January 11, 2010 17:44

Non-Hodgkin's Lymphoma There are approximately 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the US with a comparable number in Europe. Despite the use of aggressive chemotherapy and recent advances in therapy such as monoclonal antibodies (Rituxan, TM), the disease is almost invariably fatal. Follicular lymphoma (FL) patients, in particular, can have an indolent but ultimately fatal clinical course. The median relapse time for FL patients is three years, with 90% of patients dying of a tumor-related mortality within 7 years of the date of diagnosis. The clinical course is usually characterized by a series of remissions and relapses. Good response rates are seen with treatments such as chemotherapy, radiation, lymphocyte transplantation, and monoclonal antibodies. However, following initial response to treatment, the cancer invariably returns and the majority of patients relapse with resistance to all available therapy. Related B-cell derived neoplasms include multiple myeloma (approx. 15,000 cases/year in the US and chronic lymphocytic leukemia (approx. 10,000 cases/year in the US). BiovaxID, Biovest's personalized lymphoma vaccine, has been granted Orphan Drug designation by US FDA.

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Nilotinib (Tasigna) of Novartis granted patent in India: Reports

Monday, January 11, 2010 17:39

Nilotinib (Tasigna) of Novartis granted patent in India Nilotinib (Tasigna) to treat blood cancer by Novartis AG, has been granted a patent in India, reports said. Novartis' leading blood cancer therapy Gleevec (imatinib) has been deneied a patent protection in India. Novartis is currently in a legal battle with Indian patent office questioning the validity of section 3 (d) of Indian Patent Actg on rejecting patent protection on Gleevec. Last year Novartis was also denied patent for a different form (alfa crystal) of Gleevec and a hypertension drug, which combined valsartan and amilodipine. Both applications were rejected citing Section 3(D) of the Patent Act. Niotinib is considered superior to imatinib in fighting a form of blood cancer called chronic myeloid leukemia. In studies Novartis unveiled in December last year, Nilotinib (Tasigna) showed superior efficacy over Glivec (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, according to a Novartis release. Both the drugs – nilotinib (Tasigna) and Glivec (imatinib) are oral pills developed by the Swiss drug major Novartis. Tasigna is a selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML. Following initial reports of resistance in the Glivec registration trials, Novartis scientists created Tasigna, just a year after the launch of Glivec. The first clinical trials began just 21 months after discovery. The drug received its first regulatory approval in the second-line indication in 2007. In a head-to-head comparison of nilotinib (Tasigna) and Glivec (imatinib) as initial treatment for this life-threatening blood cancer, Tasigna results showed statistically significant improvement over Glivec in every measure of efficacy, including major molecular response (MMR), complete cytogenetic response (CCyR) and prevention of progression to accelerated or blastic phase, Novartis announced while presenting the data at the 51st annual meeting of the American Society of Hematology (ASH), held in December, in New Orleans, USA. The clinical trial, Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients (ENESTnd), is a Phase III randomized, open-label, multicenter trial comparing the efficacy and safety of Tasigna versus Glivec in adult patients with newly diagnosed Ph+ CML in chronic phase. It is the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients. Designed to detect a difference in MMR between Tasigna and Glivec after 12 months of treatment, it is also the first registration study in which molecular traces of a key biomarker specific to Ph+ CML have been used as a primary endpoint for regulatory review. ENESTnd is being conducted at 220 global sites with 846 patients enrolled. Patients were randomized to receive Tasigna 400 mg twice daily, Tasigna 300 mg twice daily  or Glivec 400 mg once daily. At 12 months, fewer patients progressed to accelerated or blastic phase on Tasigna 300 mg twice daily than on Glivec 400 mg once daily. Tasigna was also well tolerated in patients. “The outstanding rates of response observed with Tasigna, combined with the very low rate of disease progression, strongly indicate that patients who begin their treatment with Tasigna may have long-term improvement of progression-free survival,” said Giuseppe Saglio, University of Turin, San Luigi Hospital, Orbassano-Torino, Italy, a member of the study management committee. Novartis now plans to file worldwide applications for approval of Tasigna as a treatment for adult patients with newly diagnosed Ph+ CML. Tasigna is currently approved in more than 80 countries including the European Union, United States and other countries for the treatment of adult patients with Ph+ CML in chronic phase or accelerated phase who are resistant or intolerant to prior treatment including Glivec. Headquartered in Basel, Switzerland, Novartis Group offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. In 2008, the Group’s continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the group. http://www.dancewithshadows.com/pillscribe/nilotinib-tasigna-to-beat-myeloid-leukemia-drug-glivec-imatinib-coming/ Nilotinib (Tasigna) to treat blood cancer by Novartis AG, has been granted a patent in India, reports said.

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Diabebetic neuropathy drug SB-509 by Sangamo Bio reaches crucial human trials

Monday, January 11, 2010 16:31

Diabebetic neuropathy dru SB-509 by Sangamo Bio reaches crucial human trials SB-509, an experimental drug to treat diabetic neuropathy, by  Sangamo BioSciences is curently in human studies. SB-509 is an injectable plasmid encoding a DNA-binding zinc finger DNA-binding protein (ZFP) transcription factor (ZFP TF) designed to upregulate the endogenous expression of the gene encoding vascular endothelial growth factor (VEGF-A). VEGF-A has been demonstrated to have direct angiogenic, neurotrophic and neuroprotective properties. Data from Phase 1 and Phase 2 clinical trials in subjects with diabetic neuropathy (DN) have demonstrated a direct neuroregenerative effect of SB-509 treatment. IENFD is a validated, direct histologic measurement of small unmyelinated sensory nerve fibers in the skin, the primary sensory nerves involved in DN. IENFD also correlates with neuropathy severity in diabetes, nerve fiber densities derived from sural nerve biopsies and levels of vascular endothelial growth factor-A (VEGF-A). In subjects with more severe neuropathy, as judged by their baseline IENFD, a greater nerve regrowth response to SB-509 treatment was observed compared to regrowth responses in placebo-treated subjects. Sangamo's double blind, repeat-dosing, placebo controlled Phase 2b study, SB-509-901, is designed to finalize dose, schedule and primary and secondary endpoints for pivotal Phase 3 trials. SB-509 trial will involve a total of 150 subjects who will be randomized 1:1 between placebo and treatment groups. "The body of clinical data obtained in previous trials of SB-509 has enabled us to design a very focused Phase 2b study that will accrue subjects that we believe are most likely to show a significant response to SB-509 over the 180 day test period," commented Dale Ando, Sangamo's chief medical officer and vice president of therapeutics, in a press release. The data generated to date also demonstrated that SB-509 treatment resulted in statistically significant increases in nerve fiber density, nerve regeneration and an improvement in clinical outcomes such as NIS-LL and sNCV, he said. Diabetic neuropathy is a progressive degenerative disease that is one of the most frequent complications of diabetes, affecting between 14 and 16.5 million Americans in 2007. High blood glucose levels lead to nerve damage over time, primarily affecting peripheral nerves. Symptoms include numbness, tingling sensations and pain particularly in the toes or feet, which gradually evolve to loss of sensation and motor function as nerve damage progresses. Ulcers and sores may appear on numb areas of the foot as pressure wounds or injuries go unnoticed. Despite palliative treatment, these areas of trauma frequently become infected and this infection may spread to the bone, necessitating amputation of the leg or foot. More than 60 percent of non-traumatic lower-limb amputations in the United States occur among people with diabetes. In 2004, this translated to approximately 71,000 amputations. The Centers for Disease Control estimates that from 1980 through 2007, the number of Americans with diabetes increased from 5.6 million to 23.6 million and that of those about 60 percent to 70 percent have mild to severe forms of neuropathy. Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic development program is currently in Phase 2 clinical trials for evaluation of safety and clinical effect in patients with diabetic neuropathy and ALS. Sangamo also has two Phase 1 clinical trials to evaluate safety and clinical effect of a ZFP Therapeutic for the treatment of HIV/AIDS. Other therapeutic development programs are focused on cancer, neuropathic pain, nerve regeneration, Parkinson's disease and monogenic diseases. Sangamo's has developed a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN) for gene modification. Sangamo has established strategic partnerships with companies in non-therapeutic applications of its technology including Dow AgroSciences and Sigma-Aldrich Corporation. SB-509, an experimental drug to treat diabetic neuropathy, by  Sangamo BioSciences is curently in human studies.

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