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.
Tuesday, January 13, 2009
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).
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.
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.
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.
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.
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