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FDA Approves Investigational MS Trial
The stem cell research division of the Tisch MS Research Center of New York announced that the U.S. Food and Drug Administration (FDA) approved autologous, mesenchymal stem cell-derived neural progenitor cells (MSC-NPs) as an Investigational New Drug (IND) for an open label, phase 1 clinical trial in the treatment of multiple sclerosis.
FDA approves GlaxoSmithKline’s Tivicay, for the treatment of AIDS
August 14, 2013 | By Márcio Barra
GSK announced yesterday that the FDA has given green light for ViiV Healthcare’s Tivicay(dolutegravir) 50-mg tablets, an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs). It can be used to treat infected adults who have been treated with other drugs or are new to treatment.
Integrase inhibitors are a new class of antiretroviral agents that block HIV replication in the body by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). In short, they stop the virus from entering cells.
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Biocon Launches Psoriasis Drug In India; To File IND Application With US FDA This Fiscal
India’s Biocon on Saturday launched ALZUMAb, a novel biologic for the treatment of psoriasis, in India. Sreeja/IB Times
KIRAN MAZUMDAR SHAW, CHAIRMAN BIOCON
itolizumab is other name
| Jan 13: Biocon has received marketing approval in India. The company plans to file an investigational new drug application with the FDA seeking authorization for further human trials which will support regualtory approval in the US. | |
| Biocon is to seek pre-IND advice from the US FDA . | |
| On completing proof-of-concept PIII trials, Biocon will seek a licensing partner for itolizumab. The company has stated it expects to initiate licensing discussions during the 2010/2011 financial year |
Bangalore, India-based Biocon (NSE:BIOCON) announced Saturday the launch of its first biologic drug for the treatment of chronic psoriasis in India, and said it would file an investigational new drug, or IND, application with the U.S. Food and Drug Administration, or FDA, by the end of this fiscal year.
read all at
The drug, Alzumab, is the second biologic — a medicine created through a biological process and not through a chemical process — launched by the company, and is expected to serve about 1 percent to 2 percent of India’s population estimated to suffer from the ailment.
Itolizumab (INN, trade name Alzumab) is a ‘first in class’ humanized IgG1 monoclonal antibody developed by Biocon. It selectively targets CD6, a pan T cell marker involved in co-stimulation, adhesion and maturation of T cells. Itolizumab, by binding to CD6, down regulates T cell activation, causes reduction in synthesis of pro-inflammatory cytokines and possibly plays an important role by reducing T cell infiltration at sites of inflammation. A double blind, placebo controlled, phase III treat –Plaq study of itolizumab successfully met the pre-specified primary end-point of significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo.[2] Biocon has received marketing authorization for the drug from the Drugs Controller General of India (DCGI).
In my practice this product
Ixchelsis, a start-up company that has come out of Pfizer’s former R D site at Sandwich, UK, is progressing a treatment for premature ejaculation boosted by the backing of Eli Lilly.
Lilly, through its venture fund set up with TVM Capital Life Science, has
invested in Ixchelsis, made up of former Pfizer scientists and headed by Gary
Muirhead. The company is based on an oxytocin receptor antagonist called IX-01
originally discovered at Sandwich which the investors say “has the potential to
be the best-in-class pharmacological approach for the treatment of
PE”.
Ixchelsis, which is based at the Sandwich site, now called Discovery
Park, will collaborate with the autonomous early phase virtual drug discovery
arm of Lilly, known as Chorus. Dr Muirhead told PharmaTimes that the
TVM model will fund through to the agreed exit point, which is completion of
proof-of-concept and this requires about $14 million.
read all at
http://www.pharmatimes.com/Article/13-08-08/Lilly_backs_Ixchelsis_a_start-up_born_at_Pfizer.aspx
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Cancer
Cancer is a broad group of various diseases involving unregulated cell growth. It is medically known as a malignant neoplasm. In cancer, cells divide and grow uncontrollably and invade nearby parts of the body. The cancer may also spread to more distant parts of the body through the lymphatic system or bloodstream, it is called metastasis. However, not all tumors are cancerous. Some tumors do not grow uncontrollably, do not invade neighboring tissues, and do not spread throughout the body which are called Benign tumors.
There are more than 100 types of Cancers. Follow the link to know more:
http://www.cancer.gov/cancertopics/types/alphalist
Classification of Cancers:
There are five broad groups that are used to classify cancer.
- Carcinomas: These are characterized by cells that cover internal and external parts of the body such as lung, breast, and colon cancer.
- Sarcomas:These are characterized by cells that are…
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दुबलापन यानी दुबला शरीर या शरीर ऐसा जो हड्डियों का ढान्चा जैसा हो ; single chasis body ; very slim body ; skeleton body
दुबले आदमियों या दुबले लडकों या दुबली लड़्कियों या दुबली महिलाओं को आपने देखा होगा, कैसे लगते हैं देखने में ?
दुबले शरीर का होना अछ्छी बात है , एकहरा बदन हो तो यह बहुत अच्छा लगता है , फिल्मों के हीरो हीरोइनों को देखिये कोई भी आपको बहुत मोटा नही दिखाई देगा , सब इसीलिये अपने को maintain किये रहते हैं, किसलिये ?
आखिर छरहरा बदन भी कोई चीज होती है ? यही छरहरा बदन सब्को देखने मे अच्छा लगता है /
लेकिन अगर शरीर जरूरत से ज्यादा दुबला हो, skeleton जैसा दिखाई दे, तो फिर यह देखने वालों को अच्छा नही लगता /
आयुर्वेद में दुबले पतले लोगों के लिये महर्षि चरक ने लिखा है कि ” रूखा सूखा अन्न खाने वाले, अत्यधिक लन्घन यानी खाना या भोजन न खाने वाले, कम भोजन करने वाले, अधिक मेहनत करने वाले और कम खाना खाने वाले, ज्यादा जुलाब या enema…
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New Drug Approvals 