Nov 07, 2016
Merck provided substantial evidence of safety and effectiveness for the approval of bezlotoxumab in June 2016 to the FDA, and the administration’s Antimicrobial Drugs Advisory Committee voted 10 to 5 with 1 abstention to recommend its approval. In October 2016, bezlotoxumab commercialized as Zinplava, got approved b...
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Aug 29, 2016
Immune checkpoints are defined as the stimulatory or co-stimulatory molecules involved in the immune system. There are two kinds of checkpoint proteins found on T cells such as PD-1/PD-L1 and cytotoxic T lymphocytes (CTLA-4). The PD1/PD-L1 pathway is an adaptive immune resistance mechanism exerted by tumor cells in ...
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Jul 04, 2014
In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally. On 27 June 2014, the European Medicines Agency’s (EMA’s) Committee for Medicinal Produc...
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Nov 04, 2016
According to National Society of Health, approximately 26 million patients are suffering from heart failure worldwide, with the increased economic burden of USD 30.7 billion each year. The advent of a novel class of drugs, i.e., the angiotensin receptor-neprilysin inhibitor, gives hope to the patients. Neprilysin is...
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Nov 03, 2016
Medivir entered into an agreement with Karo Pharma to sell its subsidiary BioPhausia Medivir is set to sell is subsidiary, BioPhausia, to Karo Pharmafor for Skr908m ($100.9m). The agreement shows that this price will be on a cash and debt free basis, including a normalized working capital, with the transaction expec...
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Nov 01, 2016
Sun Pharma Announces US Launch of Authorized Generics for Benicar, Benicar HCT, Azor and Tribenzor Sun Pharmaceutical Industries Ltd announced that its wholly owned subsidiary has launched in US, the Authorized Generic (AG) versions for all strengths of Olmesartan Medoxomil tablets, Olmesartan Medoxomil-Hydrochlorot...
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Oct 28, 2016
Today's opportunity for Indian companies in biosimilars is not much different from that of the generics industry in 1984. According to Ministry of Commerce and Industry, India’s pharmaceutical export segment has more than doubled from $ 7.8 billion in 2008 to $ 16.5 billion in 2014. With biologic treatments int...
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Oct 26, 2016
Teaching parents of children with autism how to interact more effectively with their offspring brings the children benefits that linger for years, according to the largest and longest-running study of autism interventions. The training targeted parents with 2–4-year-old children with autism. Six years after the adul...
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