Harbinder Virdi

Virtual Pharma Rep(TM), a new company built by pharmaceutical industry veterans, today announced the release of Virtual Pharma Rep 360 Managed Care. This module builds on the existing Virtual Pharma Rep virtual sales platform of patent pending technology designed to significantly decrease the marketing, sales and educational expenses in the pharmaceutical sales and education process. Virtual Pharma Rep 360 Managed Care connects payors, providers and patients to a platform for low cost, efficient and effective communications with pertinent information in regards to preventative disease and lifestyle management. It increases proactive awareness of disease management and compliance, therefore reducing healthcare costs for patients and their families, as well as employer groups. Additionally, Virtual Pharma Rep 360 Managed Care provides a vehicle to convey important information to medical professionals and physicians with cost efficient updates on quality assurance targets and benchm...

Isotechnika Pharma Inc. (TSX: ISA) today announced that it has developed a portfolio of non- immunosuppressive cyclosporine analogue molecules (NICAMs) with potent cyclophilin inhibition. Cyclophilin inhibition has garnered considerable attention as a novel therapy in the treatment of a wide range of diseases including hepatitis C, stroke, and chronic neurological disorders such as Parkinson's, Lou Gehrig's, and Alzheimer's. Cyclosporine A is a well established cyclophilin inhibitor, however, its additional strong binding to calcineurin results in powerful immunosuppression and limits its therapeutic potential to transplantation and various autoimmune disorders. NICAMs do not bind to calcineurin yet retain the ability to inhibit cyclophilin.

Astellas Pharma, a Japanese pharmaceutical company, and Theravance, a US-based biopharmaceutical company, have reported that Astellas Pharma Europe submitted a marketing authorization application, or MAA, to the European Medicines Agency for telavancin. According to Theravance, telavancin is a bactericidal, once-daily injectable lipoglycopeptide antibiotic, for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia, and complicated skin and soft tissue infections in adults.  

The WebMD Health Corp. says it will provide increased access to the U.S. Food and Drug Administration's consumer health information. The announcement marks the second phase of the FDA's partnership with WebMD. It includes expanded content and multimedia tools at www.webmd.com/fda. WebMD said it will provide five new online FDA sections that will initially focus on allergies and asthma, children's health, diabetes, heart health and vitamins and supplements.  

Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today the completion of $50 million in equity financing. The round was led by Longitude Capital with participation from new investors Skandia and Silver Point Capital. Other current investors that participated in the financing include MPM Capital, LLC, AIG Investments' sponsored funds, Perseus-Soros Biopharmaceutical Fund, Blue Chip Venture Company, HealthCare Ventures, LLC, and Union Springs, LLC. Aquilo Partners, L.P., a life science investment bank, acted as the exclusive placement agent for the financing.

Forbes Medi-Tech Inc announced that the European Union (EU) has approved a health claim for plant sterols in free or esterified form. This recent Commission Regulation will enable products that incorporate Forbes patented cholesterol lowering ingredient, Reducol, to make a label claim that states 'Plant sterols have been shown to lower/reduce cholesterol. High cholesterol is a risk factor in the development of coronary artery disease'.

Wanbury Limited, the fastest growing pharmaceutical company in India, has reported net sales of Rs 86.38 crore for the quarter ended on September 30, 2009, compared to Rs 92.04 crore in the corresponding quarter of last fiscal. The net profit was Rs 2.95 crore, compared to Rs 6.57 crore in the corresponding quarter of last fiscal.

Sun Pharmaceutical Industries, a Rs 4,275 crore pharmaceutical major, has suffered heavy setback during second quarter ended September 2009 and its consolidated net profit declined by 11.5 per cent to Rs 453.81 crore from Rs 512.77 crore in the corresponding period of last year. Its net sales remained stagnant at Rs 1,185 crore as against Rs 1,178 crore in the last period. With fall in profits, its EPS nosedived to Rs 21.9 from Rs 24.8 in the last period.

Glenmark Pharmaceuticals, the research-led global integrated pharmaceutical company, has suffered a setback during the second quarter ended September 2009 and its consolidated net profit declined sharply by 31.1 per cent to Rs 80.89 crore from Rs 117.36 crore in the corresponding period of last year. This is mainly on account of significant higher interest cost. Its consolidated net sales increased by 5.5 per cent to Rs 590.33 crore from Rs 559.72 crore.  

The state watchdog says the Ohio insurance fund for injured workers is out $20 million because of problems with its prescription drug program. Inspector General Tom Charles says the Bureau of Workers' Compensation failed to take steps to recover $14.5 million in available rebates from drug manufacturers from 2005 to 2008. A report released Wednesday by Charles also found the bureau unnecessarily spent $5.5 million for drugs treating conditions not approved by the U.S. Food and Drug Administration. The report says the bureau has taken steps to recover rebates but still lacks procedures for changing its drug reimbursement policies. The bureau says it has taken several steps to improve its pharmacy program since 2007, when current administrator Marsha Ryan took over.  

Following its legal defeat in the patent infringement lawsuit against the US drug maker Forest Laboratories, Sun Pharmaceuticals plans to stop manufacturing or marketing the generic version of Alzheimer's drug, reported The Economic Times. According to the news source, the Indian pharmaceutical company will not manufacture the drug during the life of the patent, unless all asserted claims of Forest Laboratories's patent for Namenda have been invalidated. Forest's patent for Namenda expires in 2010. However, Forest Laboratories has filed an application to extend its Alzheimer's drug patents until 2013, the news source said. Forest Laboratories is also reportedly waging patent battles against Lupin, Orchid Chemicals & Pharmaceuticals, Wockhardt, and Ranbaxy in the US district court for patent violation of Namenda.  

Close on the heels of international patent expert professor Carlos Correa's criticism of the revised Mashelkar Committee report, another international patent expert professor Brook K Baker has lambasted the Mashelkar Committee report stating that the revised version underestimates India's right to define patentability. For the second time, the Mashelkar Committee has misinterpreted India’s flexibility under international law to limit patents of pharmaceutical products to new chemical entities, or new medical entity involving one or more inventive steps (NCEs), professor Baker said.   Although the Mashelkar report slightly modified and extended its analysis, it has made three fundamental mistakes: it still incorrectly analyses India’s flexibilities under TRIPS to define pro-health standards of patentability; it fails to analyse key TRIPS-minimum patent standards, especially novelty and inventive step; and it incorrectly concludes that a NCE-only standard of patenta...

Cephalon, Inc and BioAssets Development Corporation (BDC), a privately held biopharmaceutical company, have signed an agreement that will provide Cephalon with an option to acquire BDC.   Under the terms of the option agreement, Cephalon will pay BDC an upfront payment of US$ 30 million and, assuming exercise of the option, an additional payment on the closing of the acquisition. BDC stockholders could also receive additional future payments related to regulatory and sales milestones. The option agreement is subject to customary closing conditions including the receipt of necessary BDC stockholder approvals.

Fortis Healthcare Ltd, one of India’s leading chain of private hospitals, has reported a better performance with revenues growing up by 21 per cent during the second quarter of the financial year, as per the consolidated results. The group having a network of 29 hospitals (including 13 satellite and heart command centres) with a capacity of 3300 beds, had operating revenues at Rs 190.5 crore, registering a growth of 21 compared to the same quarter last year. Operating EBIDTA grew by 44 per cent at Rs 29.8 crore, recording an increase of 250 bps in operating margin (as % to operating revenue). Consolidated net profit before exceptional items grew by 255 per cent to Rs. 13 crore, according to the release. The company executed an Agreement for acquisition of 10 hospitals (including two under construction) from Wockhardt Hospitals Ltd for Rs 909 crore during the quarter and raised Rs. 997 crore through its recently concluded rights Issue. The proceeds from the issue will be used...

Biotechnology company Amgen Inc. said Wednesday lower costs in its research and sales units pushed up third-quarter profit 24 percent, despite a continued downturn in anemia drug sales. Profit rose to $1.39 billion, or $1.36 per share, from $1.12 billion, or $1.05 per share, a year prior. Revenue fell 2 percent to $3.8 billion as sales of the anemia drug Aranesp continued slipping. Excluding charges, the company says profit rose to $1.49 per share. Analysts surveyed by Thomson Reuters, on average, forecast $1.27 in profit on $3.79 billion in revenue.  

BioMarin Pharmaceutical Inc has acquired Huxley Pharmaceuticals, Inc (Huxley), which has rights to a proprietary form of 3,4-diaminopyridine (3,4-DAP), amifampridine phosphate, for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS). Last week, the Committee for Medicinal Products for Human Use of the European Medicines Evaluations Agency adopted a positive opinion recommending approval of amifampridine phosphate for LEMS. If approved by the European Commission, amifampridine phosphate will be the first approved treatment for LEMS, thereby conferring orphan drug protection and providing ten years of market exclusivity in Europe. Huxley licensed the rights to 3,4-DAP from EUSA Pharma, which was developing the product after acquiring the rights from the original developer, Assistance Publique Hopitaux de Paris (AP-HP).  

Bharat Biotech International has inked a pact with the government of Orissa to set up the ‘Konark Knowledge Park’ at a cost of Rs 100 crore. This is the first public-private partnership (PPP) project conceived under a development alliance between the company and a state government. The project aims to boost investments in the areas of biotechnology and pharmaceuticals in Orissa.   The ground breaking ceremony was held at Mouza-Andharua, Bhubaneswar on 25 October, 2009 and was presided over by Orissa chief minister Naveen Patnaik.   The government of Orissa has allocated 64.86 acres. Out if this, 30 acres is for the Phase I and 24.86 acres for phase-II of the project. This will also include 10 acres for development of Biotech Incubation Centre through a special purpose vehicle for development of an integrated industrial park to attract biotechnology, pharmaceutical, and information technology industries in Bhubaneswar.  

Deccan Healthcare, an innovative products company in the Indian health and wellness market, has received a Rs 15 crore investment from Nexus Venture Partners, India’s leading venture capital firm.   Deccan Healthcare has developed, through intensive R&D, a variety of nutraceutical products which boost immunity and address chronic ailments. The key products include a flaxseed-based vegetarian Omega-3 which they sell under the OxyFlax and Nulife-ISB brand. It is useful for cardiac care, bone health, diabetes prevention, and is also anti carcinogenic and anti-inflammatory. Frost and Sullivan has touted flaxseed based Omega-3 as the next superfood in the making.  

Lupin, a Mumbai based major pharmaceutical company, has recorded impressive performance during the second quarter ended September 2009 with significant growth in international business. It’s consolidated net profit jump by 38.6 per cent to Rs 160.30 crore from Rs 115.62 crore in the corresponding period of last year. The consolidated net sales moved up by 22.7 per cent to Rs 1,115 crore from Rs 908.37 crore. The earnings per share worked out to Rs 18.99 as against Rs 14.07 in the last period. The company’s international sales increased by 31.7 per cent to Rs 747 crore from Rs 567 crore in the similar second quarter of last year. Sales in India grew by 14.1 per cent to Rs 418.65 crore from Rs 367.05 crore.

Ranbaxy Laboratories has improved its bottom line during the third quarter ended September 2009 despite fall in sales by 18 per cent. It earned a consolidated net profit of Rs 117 crore as against a net loss of Rs 395 crore during the corresponding period of last year. It’s consolidated net sales declined by 18 per cent to Rs 1,721 crore from Rs 1,888 crore. Its standalone net sales, however, improved by 19.3 per cent to Rs 1,352 crore to Rs 1,133 crore in the corresponding period of last year. Trend in improvement of financial performance was aided by continued cost containment measures undertaken. The company returned to double-digit EBITDA margin, for the first time since Q2 ’08.

Pfizer Inc announced its support for several initiatives launched by the Public Health Foundation of India (PHFI) to strengthen public health through education, training, research, community empowerment and improved access to health services.   Included in this partnership, Pfizer will provide partial support to PHFI for establishing Centers for Strengthening Health Systems in the underdeveloped districts of Adilabad (Andhra Pradesh) and Ganjam (Orissa), where PHFI will undertake training and operational research to improve the availability and quality of health services and increase access for the currently underserved rural and tribal populations.   Through an unrestricted educational grant, Pfizer will also provide scholarships to 15 students undergoing training in the Diploma programmes offered by PHFI this year.

The European Union on Friday approved the proposed tie-up of U.S. drug makers Merck & Co. and Schering-Plough Corp. which would create the second-biggest global producer of prescription medicines. The EU's antitrust authorities said in a statement Friday that the "transaction would not significantly impede effective competition" in Europe. The $41.1 billion acquisition of smaller Schering-Plough will allow Merck to leapfrog to No. 2 worldwide in prescription medicine, just behind Pfizer Inc., which last week bought Wyeth for $68 billion. The new Merck-Schering company would have about $42.4 billion in annual sales. The two companies hope to fully close the deal in the fourth quarter after shareholders approved it on Aug. 7. The deal still needs approval from the U.S. Federal Trade Commission. The EU said the overlap would not pose significant problems in Europe even though both companies have operations in prescription pharmaceuticals.  

The Madras High Court, for the third time in a short span of 10 days, has granted stay on the controversial order of Drug Control General of India (DCGI) centralizing the issuance of Certificate of Pharmaceutical Products (CoPP) for exporters.   On October 23, the Madras High Court has granted the third stay on the DCGI order. The latest petition was moved by the Confederation of Indian Pharmaceutical Industries (CIPI) general secretary B Sethuraman said. The stay order granted to CIPI is significant as it will put at rest the speculation about the jurisdiction of the stay orders. Since the CIPI is a confederation of thousands of pharma units spread across the country, it will have a countrywide jurisdiction just on the lines of FDC issue.   In the first stay order dated October 13, 2009, the high court had granted stay on a petition moved by D I Dileep Kumar, the secretary of the Tamil Nadu Drug Inspectors Association. Again the Madras high court granted stay on the s...

Three teams of scientists from India are among those who will receive grants worth 100,000 dollars each from the Bill and Melinda Gates Foundation to pursue bold ideas for transforming health in developing countries. The Bill & Melinda Gates Foundation has announced 76 grants of US$ 100,000 each to pursue bold ideas for transforming health in developing countries. The grants support researchers in 16 countries, including three from India, with ideas as diverse as a developing an electronic nose to diagnose tuberculosis and using chocolate to help prevent malaria. Ranjan Nanda, K V S Rao and Virander Chauhan of the International Centre for Genetic Engineering & Biotechnology in Delhi will attempt to create a handheld 'electronic nose' that gathers and analyzes breath samples to diagnose tuberculosis in resource-poor settings while Abani Nag and Amiya Hati of Vivekananda International Health Centre in Kolkata will test whether liver ultrasounds and functional liver ...

Indian drug major Dr Reddy's Laboratories has reported 106.55 per cent growth in its net profit to Rs 217.3 crore for the second quarter ended on September 30, 2009 as compared with Rs 105.2 crore in the same period a year ago.   The company witnessed a fall of 21 per cent in its revenues from Germany during the second quarter of the financial year 2010 to Rs 220 crore from Rs 280 crore in second quarter of FY2009.   Ongoing reforms in the German generics pharma market, further tenders were announced by several of the public health insurance companies during the period. The company has participated or intended to participate in these tenders through its wholly-owned subsidiary betapharm. The final results of a majority of these tenders are yet to be announced. The results of these tenders may impact betapharm's business, a company release said.

Delhi-based Jubilant Organosys Limited posted revenues of Rs 933 crore, but slightly lesser than the previous year, and EBITDA of Rs 192 crore with a margin of 20.5 per cent for the second quarter of the year while positively reversing the fortunes in the net profits. Revenues for the quarter went down to Rs 933.1 crore during the quarter from Rs 940.5 crore during the corresponding period in the last fiscal. The EBITDA for the period under assessment stood at Rs. 191.7 crore against Rs 184.3 crore last year same quarter. The EBITDA margin improved by 90 bps to 20.5 per cent compared to 19.6 per cent during the previous year, according to a release from the company.

Piramal Healthcare Limited has posted a 44.8 per cent increase in its net profit at Rs 1.0 billion in the second quarter of FY 2010 as compared to Rs 733.9 million in Q2 FY 2009.   Total operating income on consolidated basis for the quarter ended September 30, 2010 was up by 12.4 per cent to Rs 10.0 billion over Q2FY2009. Operating profit increased by 26.1 per cent to Rs 1.8 billion, operating profit margin for the quarter was higher at 17.9 per cent as compared to 16 per cent in Q2FY2009 and net profit was up by 44.8 per cent to Rs 1.0 billion as compared to Rs 733.9 million in Q2 FY2009. Earnings per share (EPS) for the quarter was up by 44.7 per cent to Rs 5.1 as compared to Rs 3.5 for during the same period last year. During the quarter, healthcare solutions (domestic formulations) division grew by 16.2 per cent as compared to industry growth of 12.4 per cent with sales of Rs 5.2 billion.  

Unichem Laboratories, a Mumbai based pharma company, has reported a marginal dip in net profit for the quarter ended September 2009. During the quarter, the company’s profit declined by 3.10 per cent to Rs 33.97 crore compared to the same period of last year.   The total income declined to Rs 174.65 crore for the quarter under preview against Rs 176.71 crore in the corresponding period of last fiscal, a company release said. The board of directors of the company have recommended an interim divided of 60 per cent for the current financial year ending March 2010.

Generex Biotechnology, a developer of drug delivery systems and technologies, has received its first purchase order for Generex Oral-lyn from Continental Pharm Laboratories, a pharmaceutical products distributor in Algeria. The order consists of 10,000 canisters of Generex Oral-lyn which will be filled by the company's Middle Eastern branch office, Generex Middle East and Northern Africa (MENA), located in Dubai Healthcare City.  

Swiss drug maker Novartis's generic drug subsidiary Sandoz has introduced two new generic products, reported Drug Store News. According to the news source, the company has launched topiramate sprinkle capsules, a generic version of Johnson & Johnson's epilepsy drug Topamax Sprinkle, and calcium acetate capsules, an authorized generic of Fresenius Medical Care's kidney failure drug PhosLo.  

VeriChip Corporation (VeriChip) has entered into a strategic partnership with the Diabetes Research Institute (DRI) to combine efforts on the further development of the glucose-sensing radio frequency identification (RFID) microchip in conjunction with VeriChip's development partner, Receptors LLC. VeriChip and DRI also intend to create a prospective, randomized, comparative clinical study that will seek to address the lack of appropriate, concise, and up-to-date patient health information available to both practitioners caring for diabetic patients and the patients themselves through the utilization of VeriChip's interoperable personal health record, Health Link, and an electronic medical record system.

EMD Chemicals Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, a leading supplier of assays, reagents, and chemicals for the life science and drug discovery market, announced today a research and commercial collaboration with MitoSciences Inc., a leading developer of antibodies and immunoassays for measuring mitochondrial and metabolic function, whose products are used by basic researchers, drug developers and clinicians. The new collaboration allows for co-development of high-quality multiplex immunoassay products for the WideScreenTM BeadPlexTM assay platform for the detection and profiling of mitochondrial toxicity and activity. This enables EMD Chemicals to expand its already extensive offering in the multiplex biomarker, drug discovery and drug development markets. Under the terms of the agreement, MitoSciences has granted EMD Chemicals exclusive rights to a large new offering of currently unlicensed monoclonal antibodies for monitoring mitochondrial toxicity and bioactiv...

Simcere Pharmaceutical Group, a developer of branded generic and proprietary pharmaceuticals, has signed an agreement with OSI Pharmaceuticals, a biotechnology company, to develop, manufacture and market its KDR/Kit inhibitor OSI-930 in China. According to Simcere, OSI-930 is an orally active inhibitor of two clinically validated targets: c-Kit and the vascular endothelial growth factor receptor-2. OSI-930 is designed to target both cancer cell proliferation and blood vessel growth in selected tumors. In preclinical studies, OSI-930 shows broad efficacy in tumor models representative of small cell lung cancer, glioblastoma, colorectal, renal, head and neck, non-small cell lung cancer and gastric cancers, said Simcere. OSI Pharmaceuticals has completed a Phase I dose escalation study of OSI-930 in healthy volunteers. A Phase I single agent dose escalation study in cancer patients has identified a recommended Phase II dose and a Phase Ib dose escalation study with erlotinib has a...

Endo Pharmaceuticals announced that it received a Complete Response letter from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Fortesta (testosterone) 2 per cent gel for men diagnosed with low testosterone (Low T), also known as hypogonadism. Endo is committed to bringing Fortesta to market to offer men another option for testosterone replacement therapy." In August 2009, Endo signed an agreement with UK-based ProStrakan Group Plc to acquire exclusive US rights to commercialize the testosterone 2% gel, branded variously as Tostran, Tostrex and Itnogen outside the US. The testosterone 2% gel is marketed across Europe by ProStrakan's own, in-house sales forces and is out-licensed by ProStrakan to Bayer Schering Pharma (BSP) in 147 countries.

Established norms of national flagship programmes like NRHM and RCH have been reportedly violated to import branded 'ready to use therapeutic food' (RUTF) like multi-micronutrient sprinkles into Madhya Pradesh and Bihar, by using the money usually earmarked for purchasing medicines and without approval of the Union Health Ministry, it is learnt.   As per the information, RUTF items costing Rs 11.5 crore was imported by UNICEF India into the country between August 2008 and January 2009. The same were supplied and used in Madhya Pradesh and Bihar to treat children with severe acute malnutrition, without concurrence of the Centre. This has prompted the Union Health Ministry to take a tough stand and ordered the shipments back and issue general direction to all State authorities. Significantly, the money usually earmarked for purchasing drugs was diverted for this purpose. Moreover, the Union Health Ministry was against such import of RTUF products. As per norms, disbursal of...

Biocon Ltd has posted a net profit of Rs 74 crore for the Q2 ended September 30, 2009 which includes earnings from its German subsidiary AxiCorp. The year-on-year growth was 192 per cent which is up by 47 per cent YoY. This is nearly a three-fold jump over the same period last year posted mainly by its clinical research organizations namely Syngene and Clinigene.   Consolidated total income of the company rose to Rs 592.35 crore during the September quarter from Rs 457.73 crore in the same period of the previous year. On a standalone basis, the company posted a whopping 86 per cent jump in second quarter net profit at Rs 62.36 crore. The total income during the second quarter increased to Rs 312.44 crore as against Rs 268.27 crore achieved in the same period of the previous year.

The Mumbai-based Sun Pharmaceuticals has agreed to stop manufacturing and marketing of its generic version of Namenda (memantine hydrochloride), the lucrative Alzheimer’s drug patented by Forest Laboratories with the resolving of the dispute between the two firms at the US District Court for the District of Delaware. According to reports, Sun Pharma has agreed to abstain from marketing or manufacturing 5 mg or 10 mg tablets during the life of the US Patent No. 5,061,703 ('703), entitled 'Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia', unless all asserted claims of the patent have been found to be invalid.   On the basis of this, the US District Judge Gregory M Sleet of the US District Court signed off on a stipulation and order resolving the dispute dismissing all claims and counterclaims without prejudice in the case. Though denied on any infringement of the '703 earlier, Sun Pharma lately admitted that its filing of an Abbreviated N...

SpectraScience, Inc, a San Diego-based medical device company, has engaged Bielderman BVBA, an experienced European contract research organization to manage the clinical process for its Barrett's esophageal cancer application under trial at certain European locations. The trial results will be used in the company's application to the Food and Drug Administration (FDA) for use in the United States.

Basilea Pharmaceutica Ltd announced that Toctino (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the Swiss regulatory authority Swissmedic. "We are delighted that this innovative Basilea drug received marketing authorization in our home market. Toctino is the first licensed treatment for patients suffering from severe chronic hand eczema who do not respond to potent steroid therapy," said Dr Anthony Man, CEO of Basilea. "We look forward to bring Toctino to patients and physicians in Switzerland soon." Basilea submitted a pricing and reimbursement dossier to the Swiss authorities. Toctino has been launched in Denmark, Germany and the United Kingdom for the treatment of adults with severe chronic hand eczema unresponsive to potent topical corticosteroids. Toctino has also received marketing authorization in Austria, Belgium, Finland, France, Lu...

The Biomedical Research Human Subjects Promotion and Regulation Bill, which has been lying in the cold storage for several years, will soon find its way to the Indian Parliament for its final nod as the Indian Council of Medical Research (ICMR) has taken the initiative to give the Bill its final shape. ICMR director general Dr Vishwa Mohan Katoch said that the ICMR has already started the review of the Bill to make the punishment part of the Bill more severe as a deterrent. "The Bill at its present form is weak as far as punishment is concerned. We are working on it to make the punishment more severe at par with the international laws in this regard," Dr Katoch said. He said that similar laws have been passed in about 35 countries in the world and the punishment is severe in all these countries, including US, Canada, European countries, etc. Though the proposed bill has been cleared by the Law Ministry way back in January 2006, it has been lying with the Health Ministry...

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, and VaxGen, Inc., a biopharmaceutical company, announced that they have entered into a definitive merger agreement pursuant to which OXiGENE will acquire VaxGen in exchange for common stock of OXiGENE. Upon closing of the transaction, VaxGen will become a wholly-owned subsidiary of OXiGENE, and VaxGen stockholders will become stockholders of OXiGENE. At the closing of the transaction, OXiGENE will issue approximately 15.6 million shares of common stock in exchange for all outstanding shares of VaxGen's common stock. The number of shares issued at closing will be subject to adjustment if VaxGen's net cash, as of a date shortly before the closing, as agreed by both parties, less certain expenses and liabilities, is greater or less than approximately US$ 33.2 million. Based upon the shares of common stock of OXiGENE and VaxGen currently outstanding and ass...

GVK Biosciences along with Wyeth Research won the prestigious European Outsourcing Award 2009 for the Best New Partnership. The award was received by Manni Kantipudi, president, GVK Bio at a ceremony held at the Intercontinental Grand, Madrid, on October 14. GVK Bio-Wyeth came out as winners amongst several competing entries. Earlier in the year, GVK Bio had filed its nominations under two categories 'Best New Product' and the 'Best New Partnership/Acquisition/Merger'. GVK Bio's entry for the 'Best New Product' was its innovative 'Clinical Biomarker Database' developed together with a Big Pharma and the US FDA. 'GVK Bio - Wyeth: Value co-creators' was GVK Bio's nomination for the 'Best New Partnership'. GVK Bio were declared finalists in both categories.

Generic drugmakers, which have saved Americans hundreds of billions of dollars in the past decade with their low-cost, copycat medicines, don't think they should join other health industries to finance a health care overhaul. Under the Senate Finance Committee bill approved Tuesday, the generic drug industry would pay $460 million over a decade through additional rebates to the state-federal Medicaid program for the poor. "That would be very harmful to our industry and our consumers," said Kathleen Jaeger, the president and CEO of the Generic Pharmaceutical Industry Association. She said the higher discounts would result in fewer companies making generics, which could push prices higher. Brand-name drugmakers, which would pay $80 billion as part of the proposed health overhaul and support the Finance Committee bill, scoff at their rivals' complaints. "Generics are getting off pretty light while everyone else gets whacked," said Joe Kelley, a lobbyist...

arGentis Pharmaceuticals, LLC announced today that the company has added new members to its Scientific Advisory Board overseeing development of autoimmune related therapies. Dr. Arnold Postlethwaite, Chief Medical Officer and Chairman of arGentis Pharmaceutical's Scientific Advisory Board stated, "Our post Phase II data analysis, along with the discovery of a genetic marker highly associated with the induction of oral immune tolerance in systemic sclerosis patients, have opened the door for additional study and development of ARG201 as an effective immunoregulatory therapy. I am extremely pleased that my colleagues, Drs. Mayes, Furst, Steen and Wong will be joining me in advising arGentis Pharmaceuticals on these exciting developments and their paths to commercialization."  

IMS Health, the world's leading provider of market intelligence to the pharmaceutical and healthcare industries, announced the launch of IMS MIDAS Global Biologics, a powerful offering that enables the company's clients to make more confident decisions as they assess opportunities in the fast-growing, US$ 120 billion worldwide biologics market. MIDAS Global Biologics provides an unprecedented understanding of biologics at both the molecule and product level for deeper insights into market size, performance and changing biologics usage in more than 70 countries.

Pfizer and Wyeth announced that Pfizer has completed its acquisition of Wyeth following the receipt of regulatory approval from all government authorities required by the merger agreement and approval by Wyeth shareholders. Under the terms of the transaction, each outstanding share of Wyeth common stock has been converted into the right to receive $33 in cash (without interest) and 0.985 of a share of Pfizer common stock.   Effective as of the close of trading on October 15, 2009, Wyeth common stock will cease trading.   Pfizer and Wyeth will begin joint operations from October 16, 2009. The merger of local Pfizer and Wyeth entities may be pending in various jurisdictions and integration is subject to completion of various local legal and regulatory obligations.  

MakroCare, an international clinical services firm providing clinical research services and Qualitix Clinical Research Inc, a Taiwan CRO headquartered in Taipei, announced the signing of an alliance agreement to offer clinical research services in Taiwan, China and Japan.   Through the alliance, MakroCare - which has its current area of operations in USA, Europe and India - will expand its operations in Asia with a wide range of clinical research services. MakroCare and Qualitix both operate in key strategic regions of Asia and the relationship between the two companies now means that MakroCare can support clients that need services in Taiwan and China utilizing Qualitix's high quality resources and local know-how, comments the MakroCare officials. MakroCare, a global clinical services firm provides clinical research support to pharmaceutical, biotechnology, and medical device industries. The company, a knowledge and technology-driven Clinical Research Organization (CRO) pr...

In a verdict on the patent litigation between Roche Palo Alto and the Daiichi-Ranbaxy on the former's patent rights with crystalline valganciclovir, the active ingredient in anti-viral drug Valcyte, the District Court of New Jersey has ruled that Ranbaxy's generic version does not infringe the patent even as Roche's patent on the product is valid. The verdict is on a complaint filed by Roche alleging Ranbaxy of patent infringement of the former's US Patent No 6,083,953, following an Abbreviated New Drug Application filed by Ranbaxy on amorphous form of valganciclovir with the US Food and Drug Administration (FDA) in 2006. Roche argued that the amorphous form of valganciclovir would change to the crystalline form and thus will infringe the '953 patent. In its verdict issued of late, the Judge refused to agree with the argument stating that Roche failed to prove the spontaneous change of form in the generic product and that Ranbaxy's product contained crysta...

Global campaigns to fight diarrhoea - the second deadliest illness for children - must be re-energized to prevent the deaths of millions in the developing world, UNICEF and WHO said today as they released a new report on the disease. The report, diarrhoea: why children are still dying and what can be done, lays out a seven-point plan that includes a treatment package to reduce childhood diarrhoea deaths and a prevention strategy to ensure long-term results. The seven specific points are: Fluid replacement to prevent dehydration; zinc treatment; rotavirus and measles vaccinations; promotion of early and exclusive breastfeeding and vitamin A supplementation; promotion of hand washing with soap; improved water supply quantity and quality, including treatment and safe storage of household water; and community-wide sanitation promotion to reduce diarrhoea deaths.    

GlaxoSmithKline plc (GSK) has entered into a unique partnership with the UK Government, The Wellcome Trust and the East of England Development Agency (EEDA) to develop an innovative new biotechnology science park located at GSK's site at Stevenage. The project aims to create a world-leading hub for early-stage biotechnology companies. The campus will pioneer a new operating model of open-innovation that should strengthen and grow the UK bioscience sector. It is hoped that this campus, supported by Government, business and academia, will compete with those in Boston, California and North Carolina in the United States.

The Minister of State for Defence Dr M M Pallam Raju has sought the Argentine president Cristina Fernandes de Kirchner to ease the country's pharma import policy to allow easy access for Indian pharmaceutical companies to the Argentine market, in order to increase the pharma trade between the two countries. Expressing hope that the bilateral trade between the two countries are expected to strengthen with Argentina being a member of Mercosur Trade Bloc, the India Mercosur Preferential Trade Agreement, he informed that the Indian and Argentine companies are keen to cooperate in areas such as pharmaceuticals, biotechnology and manufacturing.  

DARA BioSciences, Inc., a development-stage biopharmaceutical company, announced today that the Company has entered into an Addendum and First Amendment to Material Transfer Agreement with America Stem Cell, Inc. (ASC), pursuant to which the Material Transfer Agreement between the Company and ASC dated March 24, 2008 was amended. Under the Material Transfer Agreement, the Company is providing ASC with dipeptidylpeptidase (DPPIV) inhibitors from its proprietary library which ASC is using to further its research and development program related to hematopoietic stem cell (HSC) transplants. Under the Material Transfer Agreement as amended, ASC is required to pay the Company a total of $250,000, in four equal installments over approximately three years, contingent upon ASC's receipt of a specified amount of grant funding for its HSC research and development program.  

Sosei Group Corporation, a biopharmaceutical company, today announces the assignment of the drug discovery programme, SD281 and its analogues, to Biocopea Limited, a UK biotechnology company and subsidiary of PepTcell Limited. These compounds, based on a metabolite of a well-known drug, were shown by Sosei to have pronounced anti-inflammatory properties. Sosei had positioned the compounds for intervention in inflammatory diseases such as Inflammatory Bowel Disease (IBD). Biocopea intends to develop the portfolio of compounds further using its specialized chemical design, specific disease models and immunology expertise. The deal means that a promising class of new chemical entities with a long remaining patent life can be taken forward by a partner committed to the development of new therapies for a variety of immune diseases. Under the terms of the assignment, Sosei will receive payments when the compounds are commercialized by Biocopea or its partners.  

Galapagos NV (Euronext: GLPG) announced today that it has expanded its global strategic alliance in metabolic diseases with an affiliate of Merck & Co., Inc to incorporate the development of new therapies for atherosclerosis. Galapagos will be responsible for the discovery and pre-clinical development of new small molecule candidate drugs based on novel Galapagos targets. The alliance will make use of Galapagos' proprietary target discovery platform for identification of novel targets in atherosclerosis, as well as in obesity and diabetes. After validation, targets will be selected by a joint steering committee and entered into screening and chemistry by Galapagos. Merck will have an exclusive option to license in each candidate for clinical development and commercialization on a worldwide basis. Upon exercise of such option, Merck will be responsible for the development and commercialization of the candidate drug. Galapagos may execute Phase I clinical studies and will hav...

Global pharma major Merck KGaA has acquired Bangalore Genei (India) Private Ltd by its wholly-owned Indian subsidiary, Merck Specialties Pvt Ltd. Bangalore Genei (India) Private Ltd (BGIP) founded by Dr Padmanabhan Babu in 1989 and acquired by the leading south India-based chemical major Sanmar Group, Chennai in December 2003. Now Merck bought over from the Sanmar Speciality Chemicals Limited (SSCL). No financial details were disclosed. By combining BGIP's activities with Merck's existing bioscience business, Merck will become one of the leading bioscience companies in India, a release issued here said. The Bangalore-based company BGIP specializes in the development, production, marketing and sales of products for proteomic and genomic research. With more than 100 employees, the company generated a total revenue of Rs 20.2 crore in FY 09, the release said.

Locus Pharmaceuticals, a privately held drug discovery and development biotechnology company in Blue Bell, Pennsylvania, has entered into a discovery research collaboration with Novartis. Locus will collaborate with Novartis to discover novel chemotypes on targets of interest to Novartis` select therapeutic areas.   "We are very excited about the opportunity to work with such a prominent pharmaceutical company to enhance their drug discovery efforts using the Locus technology," said Dr Joan Lau, president of Locus Pharmaceuticals. "The strength of the Locus discovery process lies not just with the technology, but also the integrated drug design team approach, uniquely customized for each project," she added.   Locus has developed and successfully applied a novel virtual fragment-based drug design (FBDD) platform into an integrated system for drug discovery. Driven by computational protein modelling and FBDD technology, Locus` technology supports rapid...

An anticipated loss of US$ 160 billion is estimated to Indian national income due to increasing heart diseases, strokes and diabetes between January 2010 until beginning of 2015, says a joint report of PWc and Assocham. The national loss on account of these diseases were estimated around US$ 100 billion between a period of 2005 onwards until beginning of the calendar 2009, it points out.   The report named Working Towards Wellness, some of the findings of which were released here recently, highlighted that due to tensions arising out of transitional liberalization in working and social life, number of people with hypertension in India is expected to see a quantum leap of nearly 127.5 million in next few years. The number of people that suffered hypertension in the process of being a part of liberalized economy for survival has been estimated at over 60 million until about 2009, says Assocham and PWC.   India's loss in terms of losing potentially productive years due to...

A new device from NeuroInterventions, Inc, is designed to minimize brain damage by dramatically speeding the delivery of post-stroke countermeasures. "Stroke is the third most frequent cause of death, and the number-one cause of permanent disability," said NeuroInterventions president and COO Michele Migliuolo. "When a clot blocks the flow of oxygen-rich blood in the brain, the 'window' for surgical help is only a few hours wide. Every second can mean a drop in brain function." So, driven by the emergency-room maxim, 'Time is brain', NeuroInterventions has developed groundbreaking technology that enables surgeons to reach and remove clots in much less time than conventional approaches.   "Even after a patient reaches a hospital, it can take up to 60 minutes just to introduce a conventional catheter through the femoral artery and steer it to the site, before you can deal with the clot," Dr Migliuolo says. Capable of dissolving or e...

The Medicines Company has filed lawsuits against Teva Parenteral Medicines, Inc, Pliva Hrvatska d.o.o. and APP Pharmaceuticals, LLC, and related entities in the United States District Court for the District of Delaware alleging patent infringement based on Abbreviated New Drug Applications seeking US Food and Drug Administration approval to market and sell generic versions of The Medicines Company's Angiomax product prior to expiration of US Patent No. 7,582,727 ("the '727 patent"). Each lawsuit alleges infringement of the '727 patent. As previously announced, the '727 patent was issued to The Medicines Company on September 1, 2009. The Medicines Company is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, awarded six new research contracts to discover and characterize novel adjuvants, substances that can be added to vaccines to enhance the protective immune response they induce.   "The goal of these awards is to find safe new adjuvants that will boost the effectiveness of vaccines," says NIAID Director Anthony S. Fauci, M.D. "Adjuvants can be used not only to enhance the immune response to a vaccine and thereby offer better protection but also to extend the vaccine supply if needed, enabling more people to be vaccinated with fewer doses."   Currently, the only vaccine adjuvant approved for use in the United States is an aluminum mixture known as alum.   NIAID has awarded a total of approximately $60 million over five years for these contracts. The awardees will identify novel compounds with the potential to be vaccine adjuvants. All comp...

Nyloxin Rx, which was developed by Nutra Pharma's drug discovery subsidiary, ReceptoPharm, is a prescription medicine launching in late-2009 for the treatment of severe (Stage 3) chronic pain. Nutra Pharma Corp, a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), intent to launch a prescription analgesic, Nyloxin Rx, for the treatment of severe (Stage 3) chronic pain. Nyloxin Rx is a prescription pain reliever produced by Nutra Pharma's wholly-owned drug discovery subsidiary, ReceptoPharm. Unlike Stage 2 pain, which interferes with both work and sleep, Nyloxin Rx is aimed at treating Stage 3 pain, which is the most severe pain that inhibits one's ability to fully function. Additionally, Nyloxin Rx does not rely on the use of opioids for its pain relieving action, but, instead, uses a novel mechanism from cobra venom peptides for treating pain

Brazos International Exploration has executed a letter of intent to merge with Epinex Diagnostics, a US-based biomedical device company. Brazos and Epinex expect to execute a definitive plan of merger on or before October 19, 2009. The letter of intent anticipates a merger between a wholly owned subsidiary of Brazos and Epinex in a transaction intended to qualify as a tax free exchange whereby Brazos will issue 16.2 million shares of its common stock to the shareholders of Epinex on a pro rata basis in proportion to their respective shareholdings of Epinex and cancel 4.3 million shares of its outstanding common stock. On closing, the shareholders of Epinex will acquire a majority position in the shares of Brazos in exchange for all of the issued and outstanding securities of Epinex, including stock options that will be cancelled in exchange for new stock option grants under a Brazos stock option plan. Brazos intends to close a $2.5 million financing concurrent with the closing of...

Locus Pharmaceuticals announced today that it has entered into a discovery research collaboration with Novartis. Locus will collaborate with Novartis to discover novel chemotypes on targets of interest to Novartis' select therapeutic areas. "We are very excited about the opportunity to work with such a prominent pharmaceutical company to enhance their drug discovery efforts using the Locus technology," said Dr. Joan Lau, President of Locus Pharmaceuticals. "The strength of the Locus discovery process lies not just with the technology, but also the integrated drug design team approach, uniquely customized for each project," she added.  

CyberKnife, the first and only whole body radio surgery system, is now proving to be a viable treatment option for Atrial fibrillation, behavioural disorders, obsessive compulsive disorders, depression, epilepsy obesity, besides Deep Brain Stimulation to treat Parkinson's and epilepsy.   The robotic surgery system, used to treat a variety of cancers, is now preferred for correcting abnormal heart rhythms. It is being recommended to replace the current invasive surgery with painless laser intervention. Further, CyberKnife's is an alternative to treat Trigeminal Neuralgia or facial nerve pain, Arteriovenous malformations or abnormal blood vessels in the brain and benign tumours such as Acoustic neuromas and meningiomas. These conditions are proving to show good response, said Dr John R Adler, professor, department of Neurosurgery, Stanford University Medical Centre, also the inventor of CyberKnife and founder of Accuray Inc a Nasdaq listed start-up.