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Wednesday, February 04, 2009
News Novozymes Biopolymer wins Gold Innovation Award
Novozymes Biopolymer, part of Novozymes, won the Gold Innovation Award at CPhI worldwide conference in Frankfurt, Germany, for its novel form of hyaluronic acid (HA) HyaCare.
Traditionally, HA is derived from rooster combs or from strains of pathogenic Streptococcal bacteria, which allows for a high degree of contamination by animal proteins, viruses and end toxins present in the bacterial genome.  HyaCare is developed under animal-free conditions with no animal derived ingredients used at any stage of the manufacturing process. Novozymes Biopolymer developed this unique non-pathogenic method for producing HA by fermentation of a novel production strain, Bacillus subtilis. The Bacillus strain is a well-characterised, endotoxin free organism that is generally regarded as safe by the US Food and Drug Administration (FDA).
“HyaCare is a breakthrough in safety and purity and we are delighted to have won the gold award in recognition of this,” explained Kim Budolph Johansen, global business manager at Novozymes A/S. “HyaCare is the world's first hyaluronic acid that is 100 percent free of animal-derived raw materials and organic solvent remnants and as such has many advantages over existing methods of manufacture.”

Teva, Lonza announce strategic partnership
Teva Pharmaceutical Industries Ltd and Lonza Group Ltd have agreed to establish a joint venture to develop, manufacture and market a portfolio of biosimilars. Through this joint venture, Lonza and Teva aim to leverage their complementary capabilities to significantly advance their efforts to secure a leading position in the emerging biosimilars market.
“We had identified biosimilars as a major growth driver for Teva in our long-term strategy and have been augmenting our knowledge base, capabilities and infrastructure to position Teva as a leader in this market”, said Shlomo Yanai, president and CEO, Teva.
“We are excited to enter into this joint venture. The field of biosimilars is a natural extension of Lonza's existing life sciences portfolio, and represents the next strategic step for the company. With Teva we have found the right strategic partner to develop this new activity, which will deliver new opportunities for both companies. We are confident that our capabilities in the area of biologics manufacturing will add value to this joint venture; while at the same time, the agreement ensures that we will be able to continue to fully support the development of new technology and business of our existing innovator customers,” commented Stefan Borgas, CEO, Lonza.
The joint venture is expected to commence activities during the first quarter of 2009, subject to receipt of any applicable regulatory approvals.

Two more USFDA approvals for Strides Arcolab
Strides Arcolab Ltd (Strides) has announced the receipt of two Abbreviated New Drug Application (ANDA) approvals for Sterile Vancomycin HCL USP 500 mg; one g/vial and Sterile Vancomycin HCL USP five g/vial pharmacy bulk packages. The products are licensed to Akorn-Strides, LLC, which is a joint venture of Akorn Inc and Strides Arcolab Ltd that was formed in 2004.
“This is a very significant approval for the Akorn-Strides partnership and represents a tremendous opportunity in terms of its market size and profitability. Product launch is expected to happen in the first half of 2009,” said Ravi Seth, CEO, International Operations, Strides.
Strides also has a collaboration agreement with Aspen Pharmacare involving a range of products, territories and a joint venture (JV) in the oncolytic space in Bangalore. The joint venture has concluded a significant transaction with GlaxoSmithKline (GSK) to outlicense products for GSK's emerging market strategies in over 95 countries.

Piramal Life Sciences initiates phase-II trials of P276
Piramal Life Sciences Limited (PLSL) has announced that it has started phase-II trial in USA for its lead cancer compound P 276 to treat mantle cell lymphoma (MCL) and it is the second investigational new drug (IND) approved by the United States Food and Drug Administration (US FDA) for this compound.
MCL is a subtype of non-Hodgkin lymphoma that has 59,000 new cases in the United States each year. Despite the availability of novel agents, MCL remains an incurable disease, with a median survival of three to five years. High-dose chemotherapy followed by transplantation has resulted in improvement in response rates and survival compared with conventional therapy, but relapse is nearly universal and not all patients are candidates for this option of aggressive treatment. Therefore, there is still a need for a targeted, safe and effective therapy.
Dr Swati Piramal, vice chairperson, PLSL said, “ Piramal Life Sciences aims to reduce the burden of disease by finding new and affordable cures for unmet medical needs. It is a proud moment for Indian research and an important milestone because a drug discovered in India, with global patents is now being tested at world- renowned cancer hospitals in the USA.”
Dr Somesh Sharma, managing director, Piramal Life Sciences, stated, “ Piramal Life Sciences is committed to the its values - knowledge, action and care. We nurture breakthrough thinking and follow it up with dynamic, nimble-footed delivery to impact lives of millions of people. The initiation of phase-II clinical trials of P276 in mantle cell lymphoma patients in the US further highlights PLSL's capabilities in developing a compound to address unmet medical needs worldwide.”

TAKE Solutions revenues rise 21 percent
The board of directors of TAKE Solutions Ltd has announced that the company has posted a revenue of Rs 965 million for the quarter ended December 31, 2008 as against Rs 795 million for the same period last year, representing 21 percent year-over-year (YOY)  growth.
The flat YOY profit after tax of the company reached Rs 145 million as against the same amount during the corresponding quarter of FY 2008.  The total exceptional expenses written off during the quarter is Rs 24 million (net of tax). Excluding this cost, the third quarter net profit increased 17 percent YOY to Rs 169 million and earnings per share increased 16 percent YOY to Rs 1.40.   
Commenting on the company's financial performance Srinivasan, vice chairman, TAKE Solutions said, “In the current uncertain economic and business environment, we are happy to continue with our healthy performance. Our focus continues to be on maintaining acceptable level of margin. The strategic planning undertaken by TAKE Solutions in the niche sector we operate has helped us to focus on addressing customers' most critical business issues and as such we hope to continue to emerge even stronger than we are today”.

Dr Vineet Gupta gets Jean H Lubrano award
Dr Vineet Gupta, group medical director, HealthCare Global Enterprises Ltd. (HCG), has been awarded the prestigious Jean H Lubrano Distinguished Scholar Award for 2009 by the Harvard University/Dana Farber Cancer Center, Boston.  He is the first Asian to receive this award and joins an elite list of world's leading Oncologists, who have been Lubrano scholars in the past. Dana Farber Cancer Institute has been consistently voted amongst the top three cancer centers in the US.
Jean Lubrano Distinguished Visiting Scholar Award acknowledges the spirit of helping others and continuing the fight against cancer. The award acknowledges the contribution of Dr Gupta in furthering the cause of science and brings a respected clinician and researcher in women's cancers to Harvard University/Dana-Farber Cancer Institute, Boston in the hope of fostering education and collaboration.
Dr Gupta is widely recognized for his work in breast cancer and hematological diseases including leukemias and lymphomas. In the current position as the group medical director, he provides leadership to align clinical and research expertise of oncology professionals at HCG institutions. An alumnus of University of Delhi, Dr Gupta's initial training was at the famed Wayne State University and Barbara Ann Karmanos Comprehensive Care Center, Detroit. Later he was at the world renowned Moffitt Comprehensive Cancer Center in Tampa, USA.

TCG Lifesciences conferred with excellence award
TCG Lifesciences Ltd has been conferred with 'Excellence Award' and its managing director, Swapan Bhattacharya won the Udyog Rattan award, by the Institute of Economic Studies (IES) for the outstanding achievements in the field of life sciences and contribution in India's industrial development.
The awards were presented by B P Singh, Governor of Sikkim in the presence of Dr Bhishma Narain Singh, former Governor of Tamil Nadu and Dr G V G Krishnamurthy, former election commissioner of India at the award ceremony in New Delhi.
Commenting on his achievement Bhattacharya said “I am honored to receive this prestigious award and I humbly accept it on behalf of the entire TCG Lifesciences family without whose dedicated and relentless team effort this achievement would not have been possible. I would like to thank IES for bestowing this honor.” Bhattacharya, is a B Tech from the Indian Institute of Technology, Kharagpur, an MS from Virginia Polytechnic Institute and State University, and a M B A. from Kellogg School of Management, Northwestern University. He was presented the Lester Cunningham Award for academic excellence at Northwestern.  
The Institute of Economic Studies was established in 1980 by a group of economists, parliamentarians and industrialists. The organization works on studying various aspects of economy and economic development. The institute closely monitors various facets of economy and individual contribution of various companies and business leaders.

Suven's revenue up by 21%
Hyderabad-based Suven Life Sciences, a biopharmaceutical company specializing in Central Nervous System (CNS) diseases, announced its unaudited financial results for the quarter ended December 2008. The revenues for the nine months period stood at Rs 106.42 crore compared to Rs 87.8 crore for the corresponding previous period, registering a growth of 21.1 percent.
Suven's major thrust on innovative R&D in drug discovery continued with a total spending of Rs 25.9  crore for the nine months period.
Suven's clinical candidate SVN-502 targeted for cognition in Alzheimer's and Schizophrenia is undergoing Phase 1 clinical development and the results are expected this month. SUVN-502 has attracted many big pharma from USA, Europe and Japan who would like to partner with Suven for development and commercialization. Suven's other molecules, SUVN-504 (obesity) and SUVN-507 (cognition in Alzheimer and schizophrenia) are in the advanced stage of pre-clinical studies and the same is expected to reach IND stage in fiscal year 2009-10.

OPPI's initiative to improve cold chain facility
The Organisation of Pharmaceutical Producers of India (OPPI) takes initiative to improve the cold chain management at Mumbai and New Delhi airports, where 80-90 percent of the export and import trade of pharmaceuticals take place. OPPI delegation met with the senior officials of GVK in Mumbai and GMR in Delhi, who are the custodians of the respective airports.  
OPPI highlighted some of the bottlenecks at the airports that include authorities not being able to assure cold room space despite getting advance notices from the companies about the possible unloading of large consignments of temperature sensitive products. Some of the other gaps include improper training and refresher courses for some of the handling staff who handle such products at the airport. Storage of Pharmaceutical products along with meat and food products is against the GMP norms.
To bring in learnings in this area, OPPI organized a seminar with support from Mumbai International Airport Ltd (MIAL) on, cold chain management of pharmaceutical products at Sahar Air Cargo Complex, Mumbai, for various stakeholders, including porters and supervisors.

ORG IMS reports IPM monthly sales growth
ORG IMS, one of the leading solution providers to the pharmaceutical and healthcare industries, announced that its integrated pest management (IPM) sales growth has reached 13.1 percent. The value growth for the preceding 12 months combined (from December 2007 – December 2008) is 9.8 percent when compared to corresponding previous 12 months. As per SSA ,the IPM December 2008, minimum alternative tax value stands at Rs 34,118.4 crore.
The reflections showed some significant change among the top 20 companies in month of December 2008 as compare to November 2008. Sanofi Aventis entered among the top 10 with value growth of 22.2 percent. USV entered among the top 20 companies, having gained three ranks as compared to the month of November 2008, it has recorded a growth of 37.3 percent. Pfizer and Dr Reddy's Labs have gained one rank each, currently positioned at rank 12 and rank 15 respectively.
ORG IMS reflections captured some major movers and shakers when it came to products. In the month of December 2008, Becosules has gained nine ranks, having leapt from rank 16 in the month of November 2008 to rank seven in the month of December 2008. The other products that have shown a significant gain in ranks are Seroflo (rank 16) and Zinetac (rank 17), having gained four and five ranks respectively. Zinetac has thus entered among the top 20 products for the month.

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