Month: July 2013
InTeOp | 2012 | ISBN: 9535108375 9789535108375 | 154 pages | PDF | 8 MB
The current text deals with several, very important topics of modern, Analytical Chemistry, such as analytical method validation in biotechnology today, principal component analysis, kinetic methods of analysis using potentiometric and spectrophotometric detectors, the current status of Analytical Chemistry and where it may move in the future, peptide and amino acid separations and identification, and several other, related topics in this growing and increasingly important area of Chemistry, in general.
Serum Institute of India, a Pune-based manufacturer of vaccines, is planning on taking a promising vaccine – originally developed in Germany – and introducing it into the clinic. Studies have shown that the new vaccine is more effective and better tolerated than currently available options.
By signing a contract with Hannover-based Vakzine Projekt Management (VPM), Serum has secured the licence to the various patents and technologies related to the…
Kiran Mazumdar-Shaw, chairman and managing director of Indian biopharma giant Biocon propels company to clock revenue worth $121 mn
Kiran Mazumdar-Shaw, chairman and managing director, Biocon.
Kiran Mazumdar Shaw: She has the odd passion—artwork, horses—but it’s Biocon that really gives her joy
What do our other billionairesses like to splurge on? Kiran’s abiding passion, apart from her work, are horses and paintings—she particularly enjoys collecting the works of Yusuf Arakkal and S.G. Vasudev. Sailoja confesses she loves Louis Vuitton purses and diamond and gold jewellery. “But I haven’t bought any great jewellery for two years now,” she says. Shobhana admits to a weakness for designer watches and bags, as well as light, trendy and stylish fashion jewellery which is not necessarily very expensive. Ekta loves dressing up—but of course her biggest pleasure comes from watching her audience ratings soar.
For most, making billions is not what drives them. Sulajja, who recently sold a 15 per cent stake in her company to Anil Ambani’s Reliance Capital, could be speaking for…
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RBX2660-Rebiotix Receives FDA IND Approval to Begin Phase 2 Trial of Pioneering Microbiota Restoration Therapy
Rebiotix Receives FDA IND Approval to Begin Phase 2 Trial of Pioneering …
The Herald | HeraldOnline.com
Rebiotix Inc. announced today that the U.S. Food and Drug Administration has approved the company’s Investigational New Drug (IND) application to begin the Phase 2 clinical study of RBX2660 for the treatment of recurrent Clostridium difficile infection …http://www.heraldonline.com/2013/07/29/5064322/rebiotix-receives-fda-ind-approval.html
July 29 2013 | By Márcio Barra
Portuguese generic drug makers will now be able to introduce new generic drugs into the market every month and not just quarterly, in another move by the Portuguese Ministry of Health to increase the market share of generics and reduce state drug expenditure.
Ordinance n.º 103/2013 from 26 July 2013 , changes “the mechanisms of creation of homogeneous groups and respective reference prices, aiming to maximize savings resulting from a greater incentive for generics use and promote an increase of market share in line with the international commitments of the Portuguese State, “reads the preamble of the statute. This ordinance updates Decree-Law n. -A/2010 48, already amended by Decree-Law n.º 106 -A/2010 and Law n. º 62/2011.
According to the Ordinance, the calculation and publication of the reference price of new homogeneous groups created as a result of the market introduction of new…
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Kiran Mazumdar-Shaw, MD, BIOCON
Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw, MD, BIOCON
Biocon is looking at gaining market share and improving its margins with a greater focus on its product mixes and organizational efficiencies. Biocon Chairman and Managing Director Kiran Mazumdar-Shaw tells Financial Express that the company has outpaced the market, despite various challenges and that the pharmaceutical market needs to have a more robust regulatory set-up. Edited excerpts:
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July 29 2013 | By Márcio Barra
EMA’s CHMP 22-25 July 2013 saw 8 new drugs obtaining a positive opinion for a marketing authorization (MA). Here is the rundown of approvals:
Approved marketing authorizations for new drugs:
Giotrif (afatinib), Boehringer Ingelheim International GmbH – Giotrif is an antineoplastic drug for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations. The drug is the first irreversible ErbB family blocker, a group of receptor tyrosine kinases overexpress in many cancers. This is the third drug to target EGFR mutations in NSCLC, joining erlotinib (Tarceva) and gefitinib (Iressa).
The CHMP’s positive opinion for Giotrif is based on data from the pivotal trial LUX-Lung,comparing afatinib to chemotherapy with pemetrexed/cisplatin. Results from the study showed that patients taking afatinib lived for almost one year without their tumour growing again versus just over half a year for those treated with pemetrexed/cisplatin.
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