Pharmacy

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...says Atulya Nath, CEO, Global Institute of Intellectual Property (GSIP). He discusses importance of patents and policy framework in the life sciences vertical, which is favoured towards domestic companies. Arshia Khan What is the importance of Intellectual Property (IP) in pharma and healthcare? IP protection boosts innovation. It goes without saying that a strong enforceable IP regime fosters research and encourages inventors to produce technology, which is both beneficial to the society at large and has commercial value for the innovator. With the coming-in of the TRIPS compliant product patent regime in India, effective 2005, India has come a long way in the field of establishing a patent system, which can boast to be at par with the rest of the world. IP protection for the pharma and healthcare sector in India assumes a great significance, since apart from the considerable size of our generic industry, innovator companies are also more...

The Alien Institute for Brain Science  has   recently  released  the  world's anatomically   and   genomically comprehensive human brain map. The mappings are the foundation for the Alien Human Brain Atlas, which is an online public resource, developed to advance the Institute's goal to accelerate understanding of how the human brain works and fuel new discovery among the global research community. While developing the Alien Human Brain Atlas, the Alien Institute characterized and mapped the biochemistry of two normal adult human brains. This has provided opportunities for scientists to study the brain with new detail and accuracy. The data reveals a remarkable 94 per cent similarity between human brains, establishing strong foundation for translational and clinical research. The data analysis from the two human brains also indicates that at least 82 per cent of all human genes are expressed in the brain. This highlights the great complexity of the human brain while more...

 Controlled-dose nebulizers are more expensive than jet nebulizers and may require supervision of a clinician. However, they have the added advantage that the quantity of drug received by the patient can be accurately controlled and measured.  Therefore, for small-scale trials they offer significant advantages. Nebulizers allow formulation in solution and so overcome some of the challenges of stabilizing the drug. However, fragile Active Pharmaceutical Ingredients (APIs) cab be denatured by conventional jet nebulizers. The drug is delivered as an aerosol created by a compressor blowing air through the solution or suspension at high speed. In contrast, a controlled-dose nebulizer uses vibrating mesh technology that is much gentler, and therefore less likely to damage the drug. New study trials have shown that controlled- close nebulizers might reduce formulation costs and facilitate early-stage efficacy trials.  Melbourn Scientific, a contract analysis and formulation company, has developed A rapid formulation screening service for poorly more...

A new Clinical Research Management System (CRMS) helps in improving the efficiency and efficacy of clinical research studies, enterprise-wide, by driving better management of treatment   plans, processes and protocols while also supporting research- billing compliance.                                        Centricity Research, developed by GE Healthcare, is the industry's first-enterprise- class CRMS. Centricity Research helps institutions conducting clinical or translational research manage the growing complexity of research processes and compliance requirements. Centricity Research has robust functionality, built on the foundation of the currently available Centricity Patient Protocol Management (CPPM) solution, to support both the institutions' and researchers' efforts in achieving compliance, enhancing safety, increasing subject recruitment and facilitating agency audits. Moreover, GE Healthcare has developed a strategic partnership with mdlogix (Medical Decision Logic, Inc), which developed its CRMS in collaboration with the Johns Hopkins University School of Medicine and other leading clinical research institutions.  

The capsule checkweigher by Bosch, KKE 3800, sets the   standard in the field of 100 per cent capsule weighing. Its precise gravimetric weighing technology and ergonomic design make them the ideal weigher choice tor capsule check weighing needs. The ultra high-speed capacity of the KKE 3800 is ideally suited for application with more than one capsule filler or for batch work. The checkweigher has an output of up to 230,000 capsules/hour. The Bosch KKE 3800 sets the standard in the capsule weighing field with 100 per cent accuracy and high output. The integrated current Good Manufacturing Practices (cGMP) and ASB technology 3 guarantees extremely high productivity   and the permanent positive guidance of the capsules guarantees maximum pharmaceutical security. Other highlights include easy accessibility, comprehensive production documentation and ease of cleaning. It has comprehensive production documentation and is controlled by industrial PC and 21 Code of Federal Regulations  (CFR)  Part 11-compliant 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.

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...


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