Archives April 2011

Is it really a catch-22 situation when one tries to excel in innovation amid regulations? While one cannot overemphasize the criticality of innovation to sustain growth and expand application avenues, a robust regulatory framework ensures compliance as per prescribed norms. Some of the ground realities related to this came to the fore during the recently concluded Bangalore INDIA BIO 2011. .Although it is obvious to have such operational challenges during the drug approval process, the worrying factor is the extent and impact it has on the efficacy as well as competitiveness of India's biopharmaceutical pipeline in the global market. The intent is clear. India can and has the potential to play a major role in the global biotechnology space, especially when it is in this new emerging phase. However, as most in the industry feel, the existing regulatory environment has not been a great facilitator in this transition. Rather it more...

Dr Reddy's Laboratories has announced the opening of its newly expanded Chirotech Technology Centre at Cambridge Science Park, UK where Chirotech has been based for the last 20 years. Dr Anji Reddy, Chairman, and GV Prasad, Vice Chairman and CEO, Dr Reddy's Laboratories, inaugurated the new site in the presence of Chief Guest Dr Hamied, Chairman of Cipla and Honorary Fellow of Christ's College, Cambridge. Dr Reddy marked the occasion by planting a tree outside the facility. The new 33,000 sq ft facility built specifically for laboratories and offices and has been fitted to Dr Reddy's specific requirements for chemistry, biology and analytics. The new facility is part of the Custom Pharmaceutical Services (CPS) business and will offer these expanded services worldwide. Prasad commented, "Being located in this historic city and in one of the leading European centres for Science and Innovation makes it the ideal location to expand and more...

Pharma major, Lupin Ltd has said that its US subsidiary, Lupin Pharmaceutical, Inc (LPI) has received tentative approval for its  metformin hydrochloride extended-release tablets, 500 mg and 1000  strengths from the US Food and Drug Administration (FDA).  Lupin's melfonnin Hydrochloride extended-release tablets are the AB-rated generic equivalent of Andrx Labs LLC's TortameS® 500 mgand 1000 mg tablets. Fortamet® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Annual sales for Fortamel® in the US was $83 million for the 12 months ending December 2010, as per IMS Health data. Luph"! believes that it is the first applicant to file an Abbreviated New Drug Application (ANDA) for Fortamet® 500 mg and 1000 mg containing a Paragraph FV certification, under the provisions of the Hatch-Waxman Act The product will be entitled to 180 days of marketing exclusivity Speaking on the approval, more...

Dabur India Ltd, India's leading natural health care company, has entered into an agreement with Mumbai-based Ajanta Pharma Ltd to acquire their Over-The-Counter   (OTC) energizer brand I   '30-Plus', stated a press release, "We are very happy to announce the acquisition of '30-Pius' brand,. For every .acquisition that we make, we look at synergies, which can complement Dabur's  existing portfolio. The acquisition of '30-Plus' is part of an aggressive strategy to build capability on the OTC healthcare business and I am confident that this transaction will help us in our endeavour to further strengthen our portfolio in this category," said FD Narang, Group Director, Dabur India Ltd. 30-Plus, launched in 1990 as an herbal energizer capsule, is one of the oldest and strongest health care energiser brands in ' the country It was a key brand for Ajanta Pharmaceuticals and was endorsed by Bollywood veterans like Jeetendra. The capsule was positioned more...

Ranbaxy recently announced the launch of olanzapine tablets, the generic version of Zyprexa following its patent expiry. It will be introducing olanzapine tablets 2.5 ing, 5 mg, 7.5'mg and 10 mg and also orodispersables in 5 mg and 10 mg. Zyprexa is the innovator product of Eli Lilly and has a market size of $210 million. Ranbaxy has received necessary regulatory approvals from the Spanish Health Authorities to manufacture and market olanzapine in Spain. Pere-Lluis Sala, Manager, Ranbaxy, Spain, said, "The generic alternative will bring about significant savings for patients and the Spanish Health System, which has been encouraging generic prescription."

Cognex is the world leader of image-based ID readers and is the only Company that can support all of your ID barcode and 2D code reading requirements. The company's DataMan® ID readers can read ID code fimbologies such as UPC, PDF and postal codes, 2D code symbologies such 25 Data Matrix and QR, or a mix of barcode and 2D codes simultaneously. The company is also the world's leader in the machine vision industry, having shipped more than 500,000 machine vision systems, representing over $2.5 billion in cumulative revenue, since the company's founding in 1981. Cognex's In-Sight® Track & Trace™ provides the latest approach to traceability that is less expensive to install, less complex to validate, and less costly to maintain. And as it can be combined with a wide variety of third party products, manufacturers have the flexibility to customize and scale the serialization solutions to best suit needs more...

In a recent study conducted by investigators at Queen's University and Almac Discovery Ltd reported that a   s recombinant protein and its peptide derivative that have been found to be potent inhibitors of blood vessel formation and form the potential for a new family of anticancer drugs. The investigators began by studying a recombinant form of the   protein FKBPL (FK506 binding protein like). They found that   this protein was a potent blocker of angiogenesis in multiple in   vitro and in vivo model systems. Also, they were able to isolate and then synthesize a 24-amino acid peptide (AD-01) that was responsible for the anti-angiogenic activity.                    Dr Tracy Robson, Professor - Pharmacy, Queen's University, said, "By understanding the anti-angiogenic potential of the natural protein, FKBPL, we have been able to develop small peptide-based drugs that could be delivered to prevent tumour growth by cutting off their blood supply. This is highly more...

Development of tools to study epigenetic processes is a major project undertaken by PerkinElmer, Inc. Now, PerkinElmer's epigenetic and post-translational screening tools cover nine different histone markers as well as the p53 tumour suppressor, with more than 15 validated enzyme assays to aid researchers developing novel drug compounds directed against several epigenetic enzymes, such as histone methyltransferases, demethylases, acetyltransferases and deacetylases. Dr Martina Bielefeld-Sevigny, Vice President and General Manager, Drug Discovery and Research Reagent Solutions Group, PerkinElmer, explained, "The development of novel therapies aimed at epigenetic drug targets has intensified over the last several years. PerkinElmer is excited to be in the forefront of this research by introducing a wide range of screening reagents that focus on assay selectivity, sensitivity and speed, factors which researchers indicate are critical requirements."

Sanofi-aventis has announced that it has received   marketing   authorization; from the European Commission for Jevtana'® (cabazitaxel) in combination with prednisone " prednisolone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. sanofi-aventis has also signed a new agreement with the World Health Organization (WHO) to donate $25 million to fight neglected tropical diseases, extending its decade-long partnership with the WHO for another five years. The agreement was signed by Christopher A. Viehbacher, Chief Executive Officer, sanofi- aventis, and Dr Margaret Chan, WHO Director-General, WHO headquarters, Geneva, Switzerland. Since the partnership in 2001, over 150,000 patients have been treated for sleeping sickness, a fatal disease if left untreated. The number of patients treated for sleeping sickness has dropped by over 60 per cent.

Investigators at the University of California, Los Angeles worked with the experimental drug NVP-BEZ235. This drug is an imidazoquinoline derivative and Phosphoinositide 3-Kinase (PI3K) inhibitor that inhibits PI3K and mammalian Target of Rapamycin (mTOR) kinase activity by binding to the ATP-binding cleft of these enzymes. PI3K and mTOR are members of a molecular signaling pathway, which once activated promotes ovarian cancer growth. Tumours with this pathway are more aggressive and more likely to metastasize. The   investigators   described   the drug's effect on cell proliferation in 18 ovarian cancer cell lines, including four pairs of  syngeneic  cisplatin-sensitive and cisplatin-resistant cell lines. They also evaluated the in vivo effects of NVP-BEZ235 on established tumour growth using an immunocompetent, transgenic murine ovarian cancer model. Results revealed that NVP-BEZ235 decreased cell proliferation in all ovarian cancer cell lines assayed and sensitized Cisplatin-resistant cells to the cytotoxic effects of cisplatin. Oral administration of NVP-BEZ235 resulted in more...