Essentials of Clinical Research

Essentials of Clinical Research

Publisher:Springer

Language: English

ISBN: 1402084854

Pages: 360

PDF 2 Mb

Description: This book is designed to provide the “student” interested in clinical research a foundation upon which to build more advanced study. The book focuses on clinical trials, in contrast to the many excellent textbooks that address epidemiological research. With the recent interest in patient oriented research, this book should provide a knowledge base that is not necessarily covered in other texts. Chapters discussing the FDA’s role in clinical research, Data Safety and Monitoring Boards, Postmarketing studies, the use of placebo controls, and a focus on clinical trials illustrates this point. In addition, new types of clinical research are evolving, and as such, this book discusses genetic, pharmacoepidemiologic, and implementation research. Finally, chapters on tips on how to write a grant, the mentoring process, and how to present ones research results are unique to this book.

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Pharmacogenomics and Personalized Medicine

Pharmacogenomics and Personalized Medicine

By Nadine Cohen

Publisher: Humana Press

Pages: 528 2008-09-25

ISBN 1934115045 PDF 7 MB

With all the multitude of challenges facing the pharmaceutical research and development process, the industry is actively exploring the relationships between human genetics and drug responsiveness, susceptibility to disease and disease severity. In Pharmacogenomics and Personalized Medicine, leading experts from the pharmaceutical industry, the scientific community and the government provide guidance for conducting pharmacogenomic research from discovery to the market, while also presenting a realistic perspective on the challenges, practicalities and obstacles in its application. Focusing on DNA data and associated analytical methodologies, with a consideration for complementary RNA-based studies, this volume includes a wide array of vital, cutting-edge research.Comprehensive and timely, Pharmacogenomics and Personalized Medicine will assist novice and experienced investigators alike in the understanding of the current scientific challenges in applying pharmacogenomics to drug discovery and clinical development.

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ADVANCED DRUG FORMULATION DESIGN TO OPTIMIZE THERAPEUTIC OUTCOMES

ADVANCED DRUG FORMULATION DESIGN TO OPTIMIZE THERAPEUTIC OUTCOMES

By Roberr O. Williams III, David R. Taft and Jason T. McConville

Description:
Advanced Drug Formulation Design to Optimize Therapeutic Outcomes demonstrates how modern compound designs and conveying technologies crapper be utilised to meliorate take effectualness and communication outcomes in portion therapeutic categories or disease states.
This aggregation discusses nanoparticle systems for cancer treatments, and also presents selection bounds immono-regulation agents for surgery and the topical targeting of drugs, especially poorly liquid solvable drugs to wage enhanced therapeutic outcomes. In addition, it highlights areas of therapy display the most prospect for transformation in clinical outcomes via modern compound design.

Features:
*Addresses numerous modern compound and conveying technologies, including mucoadhesion, chronopharmaceutical conveying finished sharp conveying devices, targeted nanoparticle systems, and modern solubilization technologies with liposomal conveying
*Covers field therapeutic categories much as communicable disease, cancer, system disorders, and secretor disorders
*Includes pre-clinical or clinical evidence, display an enhanced therapy achieved with modern compound organisation
*Discusses difficult-to-treat tumors requiring therapy agents to transfer the murder mentality barrier, which is of portion welfare for rising the coverall effectualness of much drugs with nonindulgent side-effects when administered in broad doses.

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Haematology at a Glance

Haematology at a Glance

By Atul B. Mehta

Publisher: Blackwell Publishing

Number Of Pages: 122

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Neuroscience At A Glance

Neuroscience At A Glance
By Roger A. Barker, Stephen Barasi, M. J. Neal, M.j. Neal
Publisher: Blackwell Publishers
Number Of Pages: 128

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Medical Pharmacology at a Glance

Medical Pharmacology at a Glance

By Michael Neal

Book Publisher: Blackwell Publishing Professional

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IR and Raman Spectroscopy : Fundamental Processing

IR and Raman Spectroscopy : Fundamental Processing

This interactive course shows newcomers the decisive and central steps in IR and Raman spectroscopy, together with their processing. Using the latest version of the packaged BRUKER software, users can manipulate the data to meet their own special requirements for further evaluation, allowing them to do without automatic processing or expert help.

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HPLC: Practical and Industrial Applications

HPLC: Practical and Industrial Applications

HPLC: Practical and Industrial Applications, Second Edition is an important revision that expands and updates information in areas that have seen dramatic change since the first edition was published. References have been updated. Easy to read and comprehensive, the book is a "must have" reference for students and professionals in analytical and pharmaceutical chemistry.

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Johnson & Johnson net earnings jumps by 22.4% in 2008

Source: Pharmabiz

Johnson & Johnson (J&J) has generated higher net profit of US$ 12,949 million during the year ended 2008 as against $10,576 million in the previous year, a strong growth of 22.4 per cent. The net earnings include special items related to in-process research and development charges of $181 million and an after-tax gain of $229 million representing the net impact of litigation settlements in the fourth quarter. With improvement in profitability, the earning per share improved to $4.57 from $3.63 in the preceding year.

The company's sales increased only by 4.3 per cent to $63,747 million from $61,095 million. Worldwide pharmaceutical sales declined by 1.2 per cent to $24,567 million from $24,866 million in the previous year. Sales results reflect the strong performance of Velcade, a treatment for multiple myeloma; Remicade, a biologic approved for the treatment of a number of immune mediated inflammatory diseases; Risperdal Consta, an antipsychotic medication; and Topamax, an antiepileptic and treatment for the prevention of migraine headaches. Sales results of Risperdal were negatively impacted by generic competition and sales of Procrit were lower due to a decline in the market.

Worldwide, the medical devices and diagnostics segment achieved annual sales of $23.1 billion in 2008, representing a growth of 6.4 per cent.

J&J's sales in US declined slightly to $32,309 million during 2008 from $32,444 million in the previous year. However, its international sales improved by 9.7 per cent to $31,438 million from $28,651 million. Its sales in Europe increased by 7.3 per cent to $16,782 per cent and in Asia-Pacific and Africa improved by 13.9 per cent to $9,483 million.

William C Weldon, chairman and CEO, said, "I am extremely proud of J&J's accomplishments in 2008 and the way our people met our commitments. We delivered solid earnings growth and made significant progress in our research pipeline while continuing to invest in the future growth of our business. I am confident that we are well positioned for continued leadership and growth in health care." The company projected earning per share of $4.45 to 4.55 for the year 2009.

Mass Spectrometry: Instrumentation, Interpretation, and Applications

Mass Spectrometry: Instrumentation, Interpretation, and Applications

Description:

With contributions from noted experts from Europe and North America, Mass Spectrometry Instrumentation, Interpretation, and Applications serves as a forum to introduce students to the whole world of mass spectrometry and to the many different perspectives that each scientific field brings to its use. The book emphasizes the use of this important analytical technique in many different fields, including applications for organic and inorganic chemistry, forensic science, biotechnology, and many other areas. After describing the history of mass spectrometry, the book moves on to discuss instrumentation, theory, and basic applications.

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Principles of Fluorescence Spectroscopy

Principles of Fluorescence Spectroscopy

by Joseph R. Lakowicz

Publisher: Springer; 2 edition

ISBN-10: 0306460939

Pages: 725

File Size: 16 Mb

In the second edition of Principles I have attempted to maintain the emphasis on basics, while updating the examples to include more recent results from the literature. There is a new chapter providing an overview of extrinisic fluorophores. The discussion of timeresolved measurements has been expanded to two chapters. Quenching has also been expanded in two chapters. Energy transfer and anisotropy have each been expanded to three chapters. There is also a new chapter on fluorescence sensing. To enhance the usefulness of this book as a textbook, most chapters are followed by a set of problems. Sections which describe advanced topics are indicated as such, to allow these sections to be skipped in an introduction course. Glossaries are provided for commonly used acronyms and mathematical symbols. For those wanting additional informtion, the final appendix contains a list of recommended books which expand on various specialized topics.

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Handbook of Surface and Colloid Chemistry, 3 Ed

Handbook of Surface and Colloid Chemistry, 3 Ed

By K. S. Birdi

Publication: CRC

ISBN: 0849373271

Pages: 784

File type: PDF File Size: 17 Mb

The third edition of a besteller covers the latest advancements in this rapidly growing field. Focusing on analyses and critical evaluation of the subject, this new edition reviews the most up-to-date research available in the current literature. International contributors offer their perspectives on various topics including micellar systems, microemulsions, colloidal assemblies, thermodynamics of polymer solutions, oil recovery and production, and hydrogen bonding.In addition to the expanded treatment of several important areas, this book features new subjects including the hydrophobic effect, water purification, nanoscience, and nanotechnology.

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An Introduction to Medicinal Chemistry

An Introduction to Medicinal Chemistry
By Graham L. Patrick

`Review from previous edition ...presents a complex subject in a clear, readable manner. In places, it even manages to be amusing.' New Scientist`... informative, easy to read and the illustrations are particularly instructive ... mathematical principles are handled sympathetically and with more clarity than I have seen elsewhere ... this is a well produced, informative and readable book, and provides excellent value for money.' Education in Chemistry, November 1995"(The book is distinguished by) Professor Glenn's enormous breadth of knowledge about the great legal traditions of the world...the genuine effort towards an understanding of other cultures, and the great capacity of the author to express (himself) clearly and directly." Verfassung und Recht in Ubersee Summer 2001"Of interest not only to students of law, but to anyone concerned with intercultural dialogue." Verfassung und Recht in Ubersee Summer 2001"This book can be warmly recommended to students as an affordable introduction to medicinal chemistry". The Royal Society of Chemistry, 2002."Through appropriate graphics and very good explanations, this book allows the student to acquire a sound understanding of the development of medicines, even without having a previous strong grounding in biochemistry." Reto Mueller, Organische Chemie. Book DescriptionNEW TO THIS EDITION Updated throughout with the latest descoveries Five new chapters covering * the molecular structure of receptors and the mechanisms of signal transduction *combinatorial synthesis * the role of computers in drug design * adrenergics * drug discovery and drug development An Introduction to Medicinal Chemistry.

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Medicinal Applications of Coordination Chemistry

Medicinal Applications of Coordination Chemistry

By Chris Jones, John R. Thornback

Publisher: Royal Society of Chemistry

ISBN: 0854045961

Description:

Metals in pharmaceuticals have played an increasingly important role in medicine over the last century, particularly in cancer therapy and diagnostic imaging methods. Medicinal Applications of Coordination Chemistry focuses on the role that transition metals play in clinical applications.Medicinal Applications of Coordination Chemistry begins with a brief historical review and an introduction to the chemistry of d- and f- block metals. Subsequent sections discuss metallodrugs for a number of different applications, the design of new drugs and the relationship between structure and function. Key sections include diagnostic applications of metal compounds in anatomical and functional imaging, and therapeutic applications of metals compounds.This book is ideal for researchers in academia and industry and comes complete with examples of real life applications.

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Modern Analytical Chemistry

Modern Analytical Chemistry
by David T Harvey

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Illustrated Physiology

Illustrated Physiology
By B. R. Mackenna / Robin Callander
SIZE : 40 MB Language: English
FORMAT : PDF Pages : 325 pages
Edition : 6th edition ISBN : 0443050600
PRICE : $54.95
Description:
University of Glasgow, U.K. Introductory physiology textbook, for nursing and allied health students. Emphasis on illustrating physiology concepts with minimal textual information. New information on immunity, the autonomic nervous system, and the renal system. Softcover. Previous edition 1990.

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Global Pharmaceutical Marketing: A Practical Guide to Codes and Compliance

Global Pharmaceutical Marketing: A Practical Guide to Codes and Compliance
By Judith Grice

Worldwide, there are varying Codes of Practice/Conduct for the pharmaceutical industry that ensure the industry self-regulates to promote the appropriate use of medicines by operating in a professional, ethical and transparent manner and ensuring high standards.The aim of this book is to aid the understanding of the many pharmaceutical Codes of Practice/Conduct throughout the world. It contains an overview of the guidelines for the promotion of pharmaceutical products in all geographical areas.Each section includes a "general overview" providing a discussion on that particular Code of Practice and differences/similarities with other countries.

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Stockley's Drug Interactions 7th Edition

Stockley's Drug Interactions 7th Edition by Karen Baxter

ISBN: 0853696640

Pages: 1208

11,4 Mb

Description:

Stockley's Drug Interactions, produced within the Martindale Editorial Team under Karen Baxter, remains the world's most comprehensive and authoritative reference book on drug interactions.

*Contains detailed yet concise monographs
*Covers interactions between therapeutic drugs, proprietary medicines, herbal medicines, foods, drinks, pesticides and some drugs of abuse
*Based on published sources and fully referenced
*A typical monograph contains a summary, clinical evidence for the interactions under discussion, the probable mechanism, clinical importance and management
*Covers over 14,000 drug interactions
*Contains over 2,800 monographs
*Includes 17,600 references

Stockley's Drug Interactions provides the busy healthcare professional with quick and easy access to clinically relevant, evaluated and evidence-based information on drug interactions.

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USFDA OPENS INDIAN OFFICES

The US Food and Drug Administration opened its offices in New Delhi and Mumbai. The office will regulate quality of medicines from Indian drug makers sold in US. The office would also expedite the process for getting FDA's approval for Indian drug markers interested in exporting their medicines to US. The US department will send its 10 USFDA officials to India, besides 14 other location around the world including China, Europe & Latin America.

AUROBINDO GETS APPROVAL FROM CANADA

Aurobindo Pharmaceuticals has received regulatory approval from Canada for a drug used in epilepsy. Aurobindo Pharmaceuticals has received approval from federal department Health Canada for Gabapentin capsules.

TARO REJECTED SUN OFFER

Taro Pharmaceuticals rejected Sun Pharma proposals to buy remaining stake in Taro Pharmceuticals. Sun Pharma owns 36% stake in Taro, on last week proposed to increase the offer price by 23% to $9.5 each as first opinion for all shareholders. Sun offered $9 each for non promoter sharholders and $8.25 each for promoter shareholders. The Israeli company's board has stated that it did not view the two options set forth in Sun's proposal as constructive or even 'in the ballpark.' Both Sun's merger proposal which signed in 2007 and its tender offer involved that represted a reduction from $10.25 that Sun paid for Brandes' 8% minority interest in Taro, the board rejected these two options.

Gene Therapy

Gene Therapy
Publisher:Greenwood Press
ISBN:0313337608
Pages: 216
Description:
Every day, newspapers and television news programs present stories on the latest controversies over healthcare and medical advances, but they do not have the space to provide detailed background on the issues. Websites and weblogs provide information from activists and partisans intent on presenting their side of a story. But where can students - or even ordinary citizens - go to obtain unbiased, detailed background on the medical issues affecting their daily lives? This volume in the Health and Medical Issues Today series provides readers and researchers a balanced, in-depth introduction to the medical, scientific, legal, and cultural issues surrounding gene therapy and its import in today's world of healthcare. Gene Therapy is organized to provide researchers with easy access to the information they need: BLSection 1 provides overview chapters on the background information needed to intelligently understand the issues and controversies surrounding gene therapy, such as the history of theories of the gene and recent developments in clinical trials BLSection 2 offers capsule examinations of the contemporary issues and debates that provoke the most heated disagreements and misunderstandings, such as whether or not humans should "tinker" with genetic material and who pays for genetic therapies. BLSection 3 includes reference material on stem cells, including primary source documents from important players in the struggle over gene therapy, a timeline of important events, and an annotated bibliography of useful print and electronic resources. This volume in the Health and Medical Issues Today series provides everything a student requires to understand the issues involved in gene therapy and provides a springboard for further research into the issue.

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BRS Physiology

BRS Physiology by Linda S Costanzo

Lippincott Williams & Wilkins

ISBN: 0781773113

pages: 352

Description:

Thoroughly updated for its Fourth Edition, BRS Physiology is an excellent aid for students preparing for the USMLE Step 1. The book concisely reviews key physiological principles and includes clinical correlations throughout to emphasize connections between basic physiology and clinical medicine. Numerous illustrations, tables, and flow charts help students visualize material quickly and aid in long-term retention. End-of-chapter USMLE-style questions and a comprehensive end-of-book exam test the student's problem-solving skills, and clearly explained answers guide the student through the correct steps in reasoning. This edition features increased coverage of pathophysiology, new questions, and a new two-color design and artwork.

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Gene Therapy Protocols Volume 2

Gene Therapy Protocols Volume 2
Pages: 314, 2008-04-24
ISBN: 160327247X, 6 MB

In Gene Therapy Protocols, Volumes 1 & 2, internationally recognized investigators describe cutting-edge laboratory techniques for the study of Production and In Vivo Applications of Gene Transfer Vectors (Volume 1) and Design and Characterization of Gene Transfer Vectors (Volume 2). The field of gene therapy has undergone remarkable advances, promising to impact human healthcare significantly in the twenty-first century. Today’s technologies can deliver genetic material safely and effectively to cells to slow or halt the progression of disease, and to help repair or regenerate damaged or lost tissues. In this second volume of Gene Therapy Protocols: Design and Characterization of Gene Transfer Vectors, readers will find a comprehensive resource of current and emerging methods for the processing and characterization of viral and non-viral gene transfer vectors, as well as promising approaches to design vectors for efficient, targeted and regulated gene delivery and expression. This second volume of the new and completely revised third edition of Gene Therapy Protocols will prove a necessary tool for graduate students and postdoctoral fellows and invaluable to basic and clinical researchers in both industry and academia.

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Gene and Cell Therapy

Gene and Cell Therapy: Therapeutic Mechanisms and Strategies, 3rd edition by Nancy Smyth Templeton

Publisher: CRC 2008-10 1160 Pages ISBN: 084938768X PDF 30 MB

This latest edition of Gene and Cell Therapy provides comprehensive coverage of all aspects of the tools and state-of-the-art technologies that are currently available in this field. Written by international leaders, this third edition features 12 additional chapters that address such new topics as gene and cell therapies for diabetes and cardiovascular disease, relevant nanotechnologies, siRNA therapeutics, dendrimers, clinical trials, human embryonic stem cell research, tissue engineering, and novel polymers. All chapters in the text have been substantially updated and revised to reflect the latest information available in the field.

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Lippincott's Illustrated Reviews : Pharmacology : 2nd Edition (Special Millennium Update)

Lippincott's Illustrated Reviews : Pharmacology : 2nd Edition (Special Millennium Update)

by Mary Julia Mycek, et al

Lippincott Williams & Wilkins Publishers; 2nd edition (January 2000)

ISBN: 0781724139

"A Faculty review:If you are looking for an easy to read, well illustrated book for your pharmacology studies, THEN STOP LOOKING!! This is the book for the dynamic reader who likes: Short and concise chapters. Self assesment questions by the end of every topic Perfect illustrations Maximum input with minimum of time loss If less reading and lots of quick learning sounds good to your ears, then don't look any further. Mark my words, this is the best "PHARMACOLOGY-TEACHER" in my town and yours."Warren Taylor.

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Introduction to Mass Spectrometry: Instrumentation, Applications, and Strategies for Data Interpretation

Completely revised and updated, this text provides an easy-to-read guide to the concept of mass spectrometry and demonstrates its potential and limitations. Written by internationally recognised experts and utilising "real life" examples of analyses and applications, the book presents real cases of qualitative and quantitative applications of mass spectrometry. Unlike other mass spectrometry texts, this comprehensive reference provides systematic descriptions of the various types of mass analysers and ionisation, along with corresponding strategies for interpretation of data. The book concludes with a comprehensive 3000 references.

This multi-disciplined text covers the fundamentals as well as recent advance in this topic, providing need-to-know information for researchers in many disciplines including pharmaceutical, environmental and biomedical analysis who are utilizing mass spectrometry.

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Drug Metabolism in Drug Design and Development

Drug Metabolism in Drug Design and Development provides a practical description of what happens during the drug design and development process and focuses on issues such as: what data are needed; what experiments and analytical methods are typically employed; and how to interpret and apply data. Emphasizing facts, detailed experimental designs, applications, and limitations of techniques, the book contains four parts that integrate the entire process: basic principles, experimental designs, analytical methods, and data interpretation and application.

*Identifies and explains protocols for those professionals who are new to industrial drug development.
*Brings users up to speed on the knowledge needed to conduct drug metabolic research.
*Integrates the theoretical and practical aspects of drug metabolism, drug design, and drug development.

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Drug maker Pfizer cutting up to 800 scientist jobs

AP
00:00 EST Wednesday, January 14, 2009

Pfizer Inc., the world's biggest drug company, is laying off up to 800 scientists this year in its latest effort to refocus disappointing research efforts and cut its massive overhead ahead of an anticipated crash in revenue. New York-based Pfizer plans to reduce its global research staff of about 10,000 people by 5 per cent to 8 per cent this year, company spokeswoman Kristen Neese said yesterday. "This is in line with our refocused research areas." Pfizer announced in September it was narrowing its research focus to six disease areas - Alzheimer's, cancer, schizophrenia, pain, inflammation and diabetes - and abandoning new research in other areas. PFE (NYSE) rose 23 cents to $17.59.
© The Globe and Mail

PHARMABIO WORLD EXPO

Start Date: 12-FEB-09 End Date: 16-FEB-09
Venue: Bombay Exhibition Centre - NSE Exhibition Complex
City / State: Mumbai/Maharashtra
Country: India

Event Profile:
Pharmabio World Expo, India's largest exhibition and conference for the chemical process and pharmaceutical industry, and the third largest in the world.

Highlights:
The international exhibition will spread over five days at the NSE Exhibition Complex, Goregaon (East), Mumbai. The four-day international conference will take place at the Renaissance Hotel, Powai, where 150 eminent speakers from 20 countries around the world will speak on matters of topical interest to the industry.

Visitor's Profile:
Industry professionals,Decision-makers and senior managers who have the authority to recommend purchase of equipment.

Exhibitor's Profile:
The agenda is designed for dissemination of information, discussions on new business models, strategy and future trends as also to provide an opportunity for interaction with global visionaries, business leaders and academia.

Organizer:
Chemtech Foundation
26, Maker Chambers VI Nariman Point,
Mumbai, India.
Tel: +(91)-(22)-22874758
Fax: +(91)-(22)-22870502

Novartis donates $225,000 to Oklahoma State University Foundation

Source: Pharmabiz
North Carolina
Novartis Animal Health of Greensboro, North Carolina, has donated $225,000 to the Oklahoma State University Foundation to become the first industry partner of the university's National Center for Veterinary Parasitology, the company announced January 6.

The grant will help make the centre operational by providing support for laboratory renovations and related start-up costs, according to the foundation, OSU's principal fund-raising organization. Renovations are scheduled to begin in 2009 and graduate studies in 2010.

As a founding partner, Novartis will help guide and develop the centre as a member of its advisory board and interact with graduate students and residents in training.

Ultimately, OSU sees the centre becoming a national resource for diagnostic testing that will help train clinically oriented veterinary parasitologists.

"In the last several years, there has been a decline of veterinary parasitology training in the US," said Michael Lorenz, DVM, Dipl. ACVIM, dean of the Center for Veterinary Health Sciences. "The NCVP is an opportunity for us to continue training in the discipline of veterinary parasitology and to provide a source for national diagnostic testing."

Novartis Animal Health researches, develops and commercializes leading animal treatments that meet the needs of pet owners, farmers and veterinarians. Headquartered in Basel, Switzerland and present in almost 40 countries, Novartis Animal Health employs about 2,700 people worldwide.

Karnataka govt asks KDPMA to identify land for pharma SEZ

Source: Pharmabiz
Nandita Vijay, Bangalore
Karnataka Drugs and Pharmaceuticals Manufacturers' Association (KDPMA) is now aggressively scouting for land for the Pharma Special Economic Zone (SEZ). Initiative is subsequent to the meeting the Association had with Karnataka government officials with a proposal to have a dedicated SEZ.

To begin with the Association sent in a proposal to the Karnataka Health & Family Welfare secretary M Madan Gopal. The Association was then directed to meet the Economic Advisor to the Karnataka government, KV Raju who asked KDPMA to identify the land for the project.

"We want the Pharma SEZ to be located around 40 kilometres from Bangalore. We require an integrated and self contained complex which will have an advanced research centre and allied industry units to support the instrumentation needs in drug manufacture. Such an SEZ will require 1,000 acres, of which 500 acres will be taken up for development in the phase-I and remaining during the phase-II. The state government will need to provide the infrastructure which includes excellent road connectivity, regular water supply, uninterrupted power supply, a high-end Effluent Treatment Plant among others. Further, we insist on Bangalore primarily because it would be easy to get the required technical personnel to work here, Anjan K Roy, president, KDPMA and managing director," RL Fine Chem told Pharmabiz.

In the past, government had identified land at Hassan for a pharma SEZ. Although companies have invested here, there has been a serious reluctance by the qualified technical workforce to re-locate here. Therefore, we need to have easy access from Bangalore to allow the personnel to commute with no difficultly, added Roy.

"We have been lobbying hard for a separate SEZ for the pharma sector which is valued at Rs 3,500 crore, growing between 10-12 percent annually and generating a substantial chunk of exports too," said Jatish N Sheth, secretary, KDPMA and director, Srushti Pharmaceuticals.

Karnataka pharma has registered export earnings to the tune of Rs 1,750 crore ending December 2008. The major exporters are Strides Arcolab, Micro Labs, RL Fine Chem, Medreich, Bal Pharma, Anglo French, Bentley Remington, Lake Chem, Resonance Laboratories, Srushti Pharmaceuticals to name a few.

There have been several SEZs approved by the State government in Bangalore, but these are private initiatives for the information technology (IT) sector. Even the State government supported IT & BT Park at Rajajinagar Industrial Area, Bangalore has only IT companies setting up operations there.

In 2005, KDPMA went through two rounds of meetings with the ministers of health and industry apart from interactions with the senior officials from the directorate of industries & commerce for a dedicated Pharma SEZ in Bangalore. But the government preferred to offer Hassan which is a leading industrial town in the central part of the state. Although Bal Pharma, Medreich and Meyer have invested here, it has been extremely difficult to attract the right personnel. Therefore KDPMA is now insisting on Bangalore as the location to have access to the right resources.

The SEZ will provide the industry an integrated infrastructure for export production, expeditious approval mechanism and a package of incentives to attract foreign-domestic investments to promote export-led growth. Among the fiscal incentives are exemption from customs duty on goods imported, and no excise duty on goods brought from Domestic Tariff Area (DTA).

GSK resubmits NDA for Solzira in restless legs syndrome

London
GlaxoSmithKline (GSK) and XenoPort, Inc announced that GSK has resubmitted the New Drug Application (NDA) to the US Food and Drug Administration (FDA) requesting approval of Solzira (gabapentin enacarbil) extended release tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

The FDA had requested that the data in a single study be reformatted. In addition, GSK conducted a review of other clinical studies taking this input into account. The withdrawal was not related to the content of the filing.

Solzira is a new chemical entity that is designed to improve upon the pharmacokinetics of gabapentin by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.

XenoPort is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilise the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs.

Govt to decide next course of action on price control on patented drugs soon

Source: Pharmabiz
Ramesh Shankar, Mumbai
Even as the recommendations by the high-powered panel, constituted by the Union chemicals ministry around two years ago for price negotiations of drugs patented abroad and marketed in the country, is getting inordinately delayed, the government will soon decide the next course of action on the issue.

"Concerned authorities in the department of pharmaceuticals and other ministries will meet soon, probably on January 12, to take the next course of action on this issue. Nobody knows what will be the next course of action. The government has to decide whether further study is needed on the issue or whether the government has to consult the stakeholders further, all these issues will be discussed in the proposed meeting next week," a senior official involved in the issue said.

The official said that the high-level panel under the joint secretary in the department of pharma did not finalize its recommendations so far even though the panel held several rounds of meetings with all the stake-holders during the last one year. Apart from hearing all the stake-holders, the panel is studying the systems existing in other countries on the issue. The panel was set up in February 2007 to suggest a mechanism on price negotiations of drugs patented abroad and marketed in the country. The panel held several meetings so far with industry associations, NGOs, concerned ministries and departments, but failed to come up with an amicable solution to the issue so far.

While the government aims to ensure that the drugs and medical devices patented abroad are made available at affordable prices to the common man in the country as and when the multinational companies launch them in India, the big pharma companies are opposing the government move to control the prices of patented drugs while introducing them in the country on the plea that it is discriminatory and will go against the spirit of patent protection.

The big companies argue that the government move will only prove to be counter-productive as the multinational companies will not launch their products in the country if such a restriction is imposed on them, creating a situation where the needy patients of this country will not have easy access to the latest products of the pharmaceutical industry. The research and development (R&D) is a highly capital intensive and highly risky business, and a company spends an average of one billion US dollar for a new drug to develop. The companies have to recover the money spent on R&D and also to continue the R&D activities, they argue.

Global pharma companies rush to India for legal offshoring expertise

Nandita Vijay, Bangalore

An increasing number of global pharma companies are keen to increase the legal off-shoring business with India because of the huge cost advantage. When legal offshoring is out-sourced from India, global majors save up to 40-50 per cent.

The growth in the sector is primarily attributed to the similarity in the legal system with US and UK. There is huge availability of qualified personnel which includes graduates, engineers, 79,000 lawyers and 5,000 PhDs. Companies can save up to 40-50 per cent of the costs by getting the processes done in India vis-à-vis a high cost locations.

Organized Indian Vendors in the legal space have existed since '80s and have now gained lot of process maturity. The government of India has also given considerable thrust to legal off-shoring, Rishikesh Mandilwar, Director- Market Expansion, Zinnov Management Consulting Private Limited told Pharmabiz.

The legal offshoring sector in the country is estimated at $600 million. Currently, a large percentage of business from US and EU are being offloaded to India.

India is extremely cost competitive and global pharma companies are capitalizing on the low cost advantage of process efficiencies, he added.

Some of the notable service providers in India engaged in the pharma legal offshoring space includes Evalueserve, Nishith Desai, T & T Consultants, Remfry & Sagar and SciTech Patent Art. Emerging countries like China, South Africa and Mexico are competing with India for a share of the Legal Processing Outsourcing (LPO) market.

Offshoring assignments for the pharma sector began with legal transcription, coding, indexing, document review. Over the years complexity and value of legal work outsourced to India has been increasing. Currently, Indian service providers are offering high end services like legal research, intellectual property and litigation services including IPR (intellectual property right) litigation.

Pharmaceutical domain is expected to face increased cost pressure and global pharma multinational companies are likely to offshore assignments more across the value chain. This ensures promising future for the pharmaco-legal domain, said Mandilwar.

Currently due to global economic slowdown and recession, companies across the globe are looking to cut costs and offshore their legal activities to low cost destinations like India. Some of the Indian vendors in the legal outsourcing space have seen an increase in their revenues.

Despite the cost advantage for India and the interest indicated by the global pharma companies to offshore jobs from here, yet legal offshoring is yet to mature. This is because there is only small presence of large market players. It is also observed that the operations are of small scale for many companies. There is also a lack of conviction about data confidentiality and ability to handle higher complexity work, which are some of the other challenges in the pharma-legal off-shoring in the country, informed Mandilwar.

GOVT ACTION ON PHARMA FIRMS FOR BRIBING DOCS

In TIMES OF INDIA on 5th Jan,2009 given that, the department of pharmaceuticals has indeed taken note of the dubious practices reported by TOI on Dec 15, but in a surprisingly mild, almost apologetic tone. Joint Secretary wrote to various drug manufacturer associations on Dec 18 citing the TOI report, but the letter suggests he would be "greateful" if the associations acted on suggestions made by the department. The secretary had earlier hald a meeting of various pharma associations in Mumbai in which he made several suggestions to the industry. The letter admits:"the allegations cannot be in any way treated as ethical and something that could be endorsed by society in general. This also puts the pharma industry in a bad light since the enhanced promotional expenditure of pharmaceutical companies result in enhanced market price of drugs, which has to be borne by the consumer." Both the Organisations of Pharmaceutical Associations of India (OPPI) and the Indian Drug Manufacturers Association (IDMA) had released their own codes of conduct at the beginning of 2007. However, there is no single code applicable to all drug manufacturers, a fact that the letter points out. But again, this is followed up by a gentle nudge. The OPPI and IDMA codes also have detailed procedures for filing of complaints and these associations cliam that they take action against companies found to indulge in unethical marketing practices. However, the government has sought not details of complaints received by them or of what action was taken on these complaints.

DRL ADVANTAGE OVER RANBAXY ON IMITREX

The delay in Ranbaxy Laboratories getting approval from FDA for launching migrain and headache drug of GSK's Imitrex could turn out to be a gain for Dr.Reddy's Laboratories, which has already launched the drug in the US. Dr.Reddy's could end up gaining a major chunk of the estimated 80 million dollars sales from the drug by Ranbaxy in the first year of launch in the US. Dr.Reddy's launched the generic version of Imitrex last november. Ranbaxy has not got approval from USFDA for launching generic version of Imitrex after it came under the scanner of health regulator, which last year banned 30 of its generic drugs produced by Dewas and Poanta Sahib units. Dr.Reddy's laboratories launched the same in November last year after settling patent litigation with GSK thus becoming the first company to launch an authorised generic version of the drug.

COMPANIES CUT OUT GOODIES FOR DOCTORS

Pharmaceutical industry has agreed to a voluntary moratorium on branded goodeis-Viagra pens, Zoloft soap dispensers, Lipitor- that were meant to foster good will & encourage doctors to prescribe more of drugs. No longer will Merck furnish doctor with purplish adhesive bandages advange Gardasil a vaccine against human Papillomavirus.

DR.REDDY'S PRODUCTS FOR ALLEGEMEINE INSURANCE COMPANY

DR.REDDYS LABORATORIES has won the bid for marketing of its products from Allegemeine Ortskrankenkasse (AOK) tender. The insurance company called bids to buy 44 Active Pharmaceutical ingrediants out of 66 products, woth $ 3.5 billions. Dr.Reddy's subsidiary Betapharm won this bid for 7 products. Allegemeine Ortskrankenkasse provides insurance cover to about 24 million publicly insured Germans. The 64 products, which are on bid, represented sales of $ 2.98 billions in 2007. Dr.Reddy's contract with Salutas will be ended, which had problems on that contract, which was the supplier of most products.

DABUR HOLD BACK RETAIL EXPANSION PLANS

Dabur India has decided to freeze the expansion plan of its newly launched retail arm with an aim of capitalising more from further downside in retail rentals that the company is expecting. The company earlier looking at having 12 to 15 stores by the end of the year 2008-09, it has now temporarily halted the ramp up for 3 to 4 months and hopes that retail rentals would fall further.

RANBAXY GETS USFDA APPROVAL FOR GLIADEL

Ranbaxy Laboratories Limited announced that the company had received USFDA approval for marketing of Gliadel (polifepro 20 with Carmustine implant) Wafer for treatment of highly malignant gliomas & recurrent glioblastoma multiforme. Ranbaxy laboratories limited has signed license agreemetn withBioPro Pharmaceutical Inc, to promote and market Gliadel Wafers in India.

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