Archives June 2011

Recently we learnt from the newspapers, how easily one can set up many research establishments and a battalion of research workers for a paltry sum. Of course as this is medical research, we need guinea, pigs also. But that is not a problem. A dozen foreign companies are successfully making use of this system. The pharma companies are using 40 professors (a professor has his own assistants) and 18 hospitals in a single city alone. The modus operandi is to pay each professor about 50 lakhs of rupees with a share for the hospital. The doctors will be testing the particular medicine developed by the company in their hospitals with trials on the patients who do not know what medicines they are taking and for what purpose. During this process, in 2010 alone, some 25 patients lost their lives. The families of five victims were paid between 1.5 lakhs to more...

Lupin Ltd and Natco Pharma have formed an alliance to jointly commercialize generic lapatinib ditosylate tablets used for the treatment of breast cancer in the US market. Lapatinib ditosylate tablets are sold under the brand name Tykerb in the US market. The patent of Tykerb is with Glaxo. Natco had filed an Abbreviated New Drug Application (ANDA) seeking US Food and Drug Administration (US FDA) approval for marketing generic equivalent of Tykerb® in 250 mg tablets. Lupin, the 5th largest and the fastest growing top 5 generics player in the US (by prescriptions), the only Asian company to achieve that distinction along with Natco, believes that they are first-to-file an ANDA containing a Paragraph IV certification for Lapatinib. Tykerb® had sales of $113.6 million as of March 2011 according to IMS health.

Sproxil Inc, a world-class brand protection company recently announced the launch of its operations in India. With the help of its brand protection product, Mobile Product    Authentication™    (MPA™) the company will focus to check the growing drug counterfeiting in India. The announcement was made by Dr Ashifi Gogo, CEO, Sproxil Inc. It enables consumers to verify the authenticity of a pharmaceutical product by sending the unique code on the drug as a free text message to the manufacturers, in real time.  "Our MPA™ architecture combines secure interlocking technologies and makes counterfeiting unprofitable," said Dr Gogo. "This operation will be launched in Mumbai and Bengaluru initially, as more than 80 per cent of the Indian pharmaceutical manufacturers are based in the West and the South of India," said Dr Gogo. Brand and product pirates in Indian markets pose a significant risk to legitimate Indian manufacturers, leading to brand degradation, decrease in more...

Glenmark Pharmaceuticals has recently announced that it has received final approval from USFDA for its generic mupirocin ointment, used for the treatment of skin infections. The US subsidiary of Glenmark Generics has been granted a final Abbreviated New Drug Approval (ANDA) from USFDA for mupirocin ointment USP 2 per cent, the company said in a statement. Based on IMS health data for the 12-month period ending March 2011, mupirocin ointment, used in treatment of bacterial skin infection impetigo, garnered annual sales of $55 million and achieved a 9 per cent increase in growth compared to the same period last year. The ointment is available in a 22-gram tube. The company has 39 ANDAs pending for approval and has a portfolio of 68 products for distribution in the American market.

OncoTrack, an international consortium, managed by Bayer HealthCare Pharmaceuticals and the Max Planck Institute for Molecular Genetics launched one of Europe's largest academic-industry research projects to develop a novel approach for identification of new markers for colon cancer. Their prime objective is to establish new methods for systematic next generation oncology biomarker development, with the intention to generate top quality genomic and epigenetic sequence data from clinically well- defined tumours and their metastases. The data acquired from all phases of the project will enable OncoTrack to address important questions about the relationship between tumour genotype and phenotype, the project has collaborations with leading global pharmaceutical companies, such as AstraZeneca, Bayer HealthCare Pharmaceuticals, Merck, Pfizer and Roche Diagnostics, whose in-kind contributions to the project are around € 25.8 million. Dr David Henderson, Principal Scientist – Translational ^Sciences, Bayer HealthCare Pharmaceuticals, said, "We have assembled a team of clinicians, molecular scientists, bioinformaticians more...

For   new   biologicals and   biosimilars, the innovative Spedia NMR™ technology from Spinnovation Biologies provides a real advantage for optimizing cell cultures, monitoring and standardizing manufacturing processes in preparation for larger scale production. Within the past four months, this has been validated by 37 companies developing biologies or delivering services to this industry. This premium Nuclear Magnetic Resonance (NMR) analysis service rapidly identifies a wide selection of feed components, metabolites and toxic compounds in culture media. By comparing media profiles from different cell culture batches, Spedia-NMR™ identifies how a cell consumes and metabolizes the media along the culture process. This allows the composition of the media to be fine-tuned to improve cell viability, reach highest yields of biologic product and perform rapid process troubleshooting. Talking about the value of Spedia-NMR™ in biotech companies, Dr Frederic Girard, CEO, Spin ovation, explained, "In a short term, Spedia-NMR™ will fill the gap in knowledge more...

Goose, a Hyderabad-based leading innovator of business reengineering solutions, has new    regulatory packaging guideline, detect counterfeit and protect their brand reputation. Procon™ Tracker is a new addition to Goose wide range of Procon solutions adopted by several leading global pharma companies to increase business processes efficiency. Procon™ Tracker features robust encrypted serialization and package authentication capability designed to ensure consumer safety, reduce counterfeiting & diversion and therefore meet multiple stakeholder expectations throughout the product supply chain from the point of manufacturing to consumer end. The Procon™ Tracker supports pedigree (an electronic record keeping requirement) and is capable of multi-printer interface. It also supports automated and manual lines with added competency to work offline when there are no bar code capable printers. Deb Pattnaik, Founder, Goose, said that the recent directive from the government to pharma industry to implement track and trace automatic identification process to offset counterfeits opens an opportunity more...

Today, a pharma company's strategy towards becoming a diversified global healthcare leader involves increasing innovation in R&D. However, with the large spent seen in the marketing segment, a question that looms is whether the spending in marketing more than R&D? Chandreyee Bhaumik A recent study by two York University researchers estimate that the US pharma industry spends almost twice as much on promotion as it does on R&D. The researchers' estimate is based on the systematic collection of data directly from the industry and doctors, which shows that the US pharma industry has spent 24.4 per cent of the sales dollar on promotion, versus 13.4 per cent for R&D, as a percentage of US domestic sales of $235.4 billion. IMS Health (IMS) and CAM Group (CAM), two international market research companies that provide the pharma industry with sales/marketing data and consulting services, aided the researchers in their estimate. Further, the more...

...says Angelos Orfanos, President, Life Sciences and Healthcare, DHL and Global Customer Solutions (GCS). A member of the GCS Global Senior Management Team leading the DHL Life Science Steering Committee, he discusses the importance of warehousing management in the pharma supply chain in light with the one that DHL has. chandreyee Bhaumik   What is your business mantra? We have undertaken a lot of commercial responsibilities. We take care of warehousing, express and freight that are considered to be the pillars of logistics. Thus, we offer customized solutions for logistics along with the required training and best access. We have always been following the 'Strategy 2015' that encompasses our approach in its entirety. Further, for the last few years since the pharma industry has shown stable growth, we have been inclined to make considerable investment in this sector. We hope that this will help us in accelerating the success of more...

...says Dr K V Krishnan, Practice Head, Life Sciences, Mindteck. With a doctoral degree in Analytical Spectroscopy and an experience of over 29 years in the life sciences vertical, one of the leaders at Mindteck shares his expertise on the present and future industrial scenario. Parita Dholakia   Tell us how Mindteck helps a pharma company in achieving performance optimization along with cost reduction. Mindteck works in all areas of life sciences, with a strong focus on pharma industry. We provide a strong set of product engineering and IT service offerings to our clients in pharma business. Our offerings are comprehensive and cover software development, electronic design and independent verification & validation apart from other support services. Our technical solutions help life science companies to: • Reduce product development cycle time and quicker time to market • Increase productivity by enhancing the engineering bandwidth within the organization • Meet the more...


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