Please Give us your valued Feedback to serve you better.          Edition #2   March 30th - 2011                                                                  For a Browser View. Click Here                                                   Featured Article               At the end of this November, Pfizer Inc., the world’s largest Pharmaceutical company stands to lose a revenue stream of $10 billion a year when its patent on Lipitor (blockbuster cholesterol drug) expires. For Pfizer, replacing Lipitor is a huge challenge as the product used to account for more than 20 per cent of the company’s sales till last year. Now, the brand will begin facing generic competition from end of 2011. Over the past few years, Pfizer has been trying its level best to launch at least two potential blockbusters in place of Lipitor but failed in  late-stage human trials. One was a breast cancer drug, Sutent and another a lung cancer drug. The year 2011 also  marks the end of an era for the global pharmaceutical industry, which has been long relying on blockbuster drugs to keep it financially healthy. It is expected that nine of industry’s 10 blockbusters will be going off patent and face generic competition within next five years. What is disturbing this high profit making industry today is the prospects of an estimated 30 billion loss in revenue over the next ten years on account of expiry of patents. And there is very few promising molecules to replace these blockbusters in the pipeline. An important reason for the declining number of blockbusters for the global pharma companies is the tightened regulatory hurdles placed by the US FDA and the European authorities in clearing new drugs. The number of new drugs approved for marketing has been steadily falling despite rising public and private spending for research and development. Approval of new treatments by the US FDA has dropped from an average of more than 35 a year in the mid-1990s to just 20 in 2009. For the regulatory authorities, clearances have to be tight as increasing number of drugs are failing in the market after the marketing approvals are given. At least a dozen drugs had to be recalled from the global markets during the last 5 years. It is certainly a poor reflection on the integrity of the regulatory authorities. All these put enormous pressure on international pharmaceutical industry to reinvent itself and shed its dependence on blockbuster drugs. It is not very clear how they will do it. However, the primary concern for the companies now is to cut huge costs of R&D and protect the bottom line. Some are thus turning away from in house drug development and joining with universities and other companies to create new and more targeted medicines. By doing this, pharma companies hope to cut as much as 30 per cent of the R&D cost in the next few years. Cut in R&D costs is not probably the right answer for the current crisis as it kills the very progress and advancement of this industry. What is to be addressed urgently is how to raise the productivity in R&D in the pharmaceutical industry. Source :- Click here.          In This Issue        Global @ Podium Eisai's Erubilin gets EU approval for breast cancer Novartis completes acquisition of majority stake in Zhejiang Tianyuan   AHF: CA Controller Chiang Urges Gilead to Cut AIDS Drug Prices.         Indian @ Podium Not So Friendly Budget 2011 for Health Industry. Daiichi Sankyo to leverage Ranbaxy’s network to market products in Singapore Commerce Ministry to relax norms, may push deadline for barcoding for pharma exports. LifeCell brings menstrual blood stem cell banking to India        Events @ Podium NextGen - 2011 Medical Fair India March 25th-27th Bio Pharma Asia Convention InterpheX Expo , USA  Also-In-The-News@ Podium Why Politicians build educational trusts not Hospitals   Gujarat loses one language every 5 years: Linguist  NATO to control Libya No-Fly Zone. Radiation fears hit Japanese food.                                                                                 Eisai's eribulin gets EU approval for breast cancer The Japanese drugmaker has received approval from the European Commission for Halaven (eribulin) for the treatment of patients with locally advanced breast cancer who have progressed after at least two chemotherapy regimens.                                                                                                                   Novartis completes acquisition of majority stake in Zhejiang Tianyuan Novartis completed the transaction to acquire an 85 percent stake in the Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. This acquisition provides Novartis with an expanded presence in the Chinese vaccines market and...                                                                                                         AHF: CA Controller Chiang Urges Gilead to Cut AIDS Drug Prices.  I urge you to extend the supplemental agreement you already have in place with the state and provide additional pricing considerations that will translate into a cost savings for the program. Only by a shared responsibility to sustain this program can we ensure ADAP will serve all the people who rely on it.                                                                                       Not So Friendly Budget 2011 for Health Industry. The Indian health sciences industry has witnessed a Budget without much mention. Whilst there were a few positives for this industry, the industry wishlist largely remained unaddressed.                                                                          Daiichi Sankyo to leverage Ranbaxy’s network to market products in Singapore Daiichi Sankyo Company and Ranbaxy Laboratories announced the start of a synergistic initiative to leverage Ranbaxy’s presence in Singapore to market innovative products originally discovered by Daiichi Sankyo.                                                               IMPORTANT :- Please click on this link for an event brief.  :  Click Here                 27th  -28th April, 2011           Venue:- ITC Maratha                Mumbai ,India            Details :- Click Here               28th  -31st March, 2011           Venue:- Marina Bay,sands           Singapore city,Singapore            Details :- Click Here          29th - 31st March,2011      Venue :- Jacob Javits,Covnention Centre      New York, USA     Details :- Click Here 22nd - 24th March,2011  Venue :- Dubai international Convention  Centre      Dubai, UAE     Details :- Click Here 12th-18th May,2011  Venue :- Dubai international Convention  Centre      Dusseldorf, Germany     Details :- Click Here Commerce Ministry to relax norms, may push deadline for barcoding for pharma exports. With the industry still opposed to the idea of implementing barcode in the proposed format for pharmaceutical exports from July 1, the Commerce Ministry is likely to relax the norms and implement it in a phased manner, depending on the suggestions from the industry gathered by March 31.                                                                                                                 LifeCell brings menstrual blood stem cell banking to India  On the 100th International Women’s Day, LifeCell International, pioneers in stem cell banking, launched LifeCell Femme — menstrual blood stem cell banking service in India.Menstrual blood banking has been pioneered by Cryo-Cell International..                                                                                             Why Politicians build educational trusts not Hospitals (Must Read) Have you ever wondered why many of our nearly 800 MPs and 4000+ MLAs from rural constituencies rush to establish educational trusts but show no interest in addressing the crying need for rural hospitals?                                                                                                             Gujarat loses one language every 5 years: Linguist Prof : Ganesh Devy , a celebrated Linguist and Sahitya Akademi award winner, whose contribution to the People's Linguistic Survey of India  has been indispensible. PLSI is an unofficial survey that has nearly 1,200 volunteers and is taking into account ..                                                                                                                        NATO to control Libya No-Fly Zone. Nato says it has agreed to take over responsibility from the US for enforcing the no-fly zone over Libya. Secretary General Anders Fogh Rasmussen said talks would continue on giving Nato a "broader responsibility", with a decision possible in the coming days.                                                           Radiation fears hit Japanese food. Fears of radiation contamination from a crippled Japanese nuclear power plant have prompted governments around the world to either halt food imports from Japan, or step up tests, nearly two weeks after a devastating earthquake and tsunami.                                                                  Copyright @  www.nationalpharmamachinery.com .  For any queries   Email here.                                                          To unsubscribe  clickhere

Pharma Podium , Edition #1

The pharma podium is a fortnightly newsletter by National Pharma Machinery      Edition #1, 15th March,2011                                                                                                 Featured Article   Personalised medicine is a “necessity not a luxury”, but there are numerous obstacles currently in place hindering true advancement in this area, industry has been told. Speaking at last week’s joint BIA/MHRA Personalised Medicine Conference, Sir Gordon Duff, chairman of the UK’s Commission on Human Medicines said there was no clear plan or leadership when it came to personalised medicines and this was particularly seen within the clinical trials landscape. “We tend to think of stratified medicine as new but stratification occurs on the market by trial and error – the patient says it doesn’t work so the doctor gives something else. But we need to understand how to do this at the development phase rather than in the clinic. We need to move upstream and stratify populations in clinical development with biomarkers. We need to stratify in Phase I and II and then on the market with a Phase III/IV type trial. As a result we’ll probably produce more and better drugs – that’s where we need to head.” But in order for this to work, Sir Gordon said there were several things that needed to change, including a need for a more adaptive approach to clinical trials, the use of all available information, early authorisation in exchange for post-market commitments and a risk-based approach to regulation. “Progress needs to be based on multiple convergent changes. We have progressed but not as a united front with all stakeholders. We need public involvement – an awareness and willingness to share data. We need healthcare systems – the NHS could be seen as one large clinical trial. In development, the model needs to change and there’s a need for collaboration. And regulators need to take on a facilitator role. We are at the beginning of a new era in convergent healthcare.” Dr Tom Lillie, international therapeutic area head, oncology, at Amgen, agreed, saying there was “great inequality” in the way healthcare was approaching personalised medicines. “It’s very disappointing we haven’t made more progress but our current trial and regulatory framework is not set up for that,” he said. He feared development of personalised medicines was currently quite risky with the emphasis being on “single agent activity” when a “combination approach was empirically desirable”. For example, different cancers have different genetic signatures, he said, and that points to combination therapy.  Furthermore, there were too many studies generated on retrospective analysis, which slowed down development, cost more and was unsustainable, he said. There was general consensus that the current clinical trial framework did not fit with the development of genomic drugs and there was possibly the need for a “radical rethink” of how clinical trials should be done. However, Dr Ian Hudson, director of licensing division of the Medicines and Healthcare products Regulatory Agency, said there was flexibility in the system. “Companies need to talk to regulators for advice on what trials might be needed. We know large studies are impossible for many orphan diseases. I think regulators are more flexible than we are given credit for.” But Dr Eric Abadie, chairman of the European Medicines Agency’s committee for Medicinal Products for Human Use, acknowledged there were a lot of open questions with the answer ‘it depends’. For example, questions like, is retrospective biomarker identification adequate for regulation and are biomarker negative patients required in clinical trials? Likewise, Seren Phillips from the National Institute for Health and Clinical Excellence, said there were still a lot of issues to be resolved.  Source :- PHarma Times Reach us @Twitter (@npmachinery),        IN THIS ISSUE   Global News Insys Therapeutics, Inc. announced positive results form the pivotal phase III efficacy Trial. FDA turns down Salix' antibiotic for IBS Breaking the Taboo Associated with Hemorrhoidal Disease  Indian News DCGI to ask centre to increase drug inspectors under CDSCO to 500 Maharashtra FDA detects 25 not-of-standard drugs in February Health ministry assures on making PSU vaccine units fully GMP   compliant in 3 years Events & Expos Medical Fair India March 25th-27th Bio Pharma Asia Convention InterpheX Expo , USA Also In The News Acton Biotech offers full genome scan at Rs 20,000 How man 'lost his penile spines' World’s Richest Man’s wealth jumps up by 38% Material World :-  Reinvention of silk   Insys Therapeutics, Inc. announces positive results from the pivotal phase III efficacy trial. Insys Therapeutics, Inc. announces positive results from the pivotal phase III efficacy trial for patients utilizing the Fentanyl Sublingual Spray (SL Spray) technology to treat breakthrough cancer pain. All primary and secondary endpoints were achieved in the study, and the drug is the first product to ever show statistically significant pain relief.                                                                                             FDA turns down Salix' antibiotic for IBS   Salix Pharmaceuticals' antibiotic Xifaxan has failed to win favour with the US Food and Drug Administration for the treatment of irritable bowel syndrome.                                                                                                                                        Breaking the Taboo Associated with Hemorrhoidal Disease Experts assume that more than 50 percent of Americans over the age of 50 have had symptoms related to hemorrhoidal disease at some point in their lives(1). For Europe similar data have been reported(2) and a German study reveals that 20 percent of the patients suffered more than five years from hemorrhoidal disease before they finally got the right treatment.                                                                       DCGI to ask Centre to increase drug inspectors under CDSCO to 500 The office of Central Drugs Standard Control Organisation (CDSCO) may ask the Centre to increase the number of drug inspectors under it to 500 as the requirement of the regulatory staff will be much more with its increased responsibilities, according to Dr Surinder Singh, DCGI.                                                                                           Maharashtra FDA detects 25 not-of-standard drugs in February The Maharashtra Food and Drugs Administration (FDA) has detected 25 not-of-standard drugs during the month of February in the random sample testing. Seven of these products belong to the manufacturers of the tax-free state of Himachal Pradesh and 6 from Uttaranchal.                                                                                          Health ministry assures on making PSU vaccine units fully GMP   compliant in 3 years The health ministry has assured the Parliamentary Standing Committee on Health and Family Welfare headed by Brajesh Pathak that the three public sector vaccine manufacturing units would be fully GMP compliant within a period of three years for which revamping of the existing production facilities at each location is in progress.                                                                                                                                    Acton Biotech offers full genome scan at Rs 20,000  Acton Biotech has recently offered a full genome scan to identify potential health risk. This full genome scan will cost Rs 20,000 and the report will be ready in a month. According to the company, patients can give blood samples at collection centers in their respective cities and                                                                  How man 'lost his penile spines' Scientists believe men once had small spines on their genitalia such as those found in chimpanzees, cats and mice. Analysis of the genomes of humans, chimpanzees and macaques indicates that a DNA sequence thought to play a role in the production of these spines have been deleted in humans, but has been preserved in other primates.                                                                                       World’s Richest Man’s wealth jumps up by 38% Mexico's Carlos Slim has topped the latest Forbes magazine rich list, as his wealth grew by more than a third. The telecoms magnate's fortune rose by $20.5bn (£12.65bn) to $74bn, again beating Microsoft founder Bill Gates ($56bn) into second place                                                                  Material World :-  Reinvention of silk As some silk researchers see it, if spiders were gregarious vegetarians, the world might be a different place. For spiders are nature’s master silk makers, and over millions of years of evolution have developed silks that could be useful to people — from sticky toothpastelike mush to strong and stretchy dragline                                                                                         25th  -27th March, 2011   Venue :- Pragati Maidan   New Delhi, Delhi, India    Details :- Click Here        28th  -31st March, 2011     Venue:- Marina Bay,sands     Singapore city,Singapore     Details :- Click Here          29th - 31st March,2011  Venue :- Jacob Javits,Covnention Centre      New York, USA     Details :- Click Here 22nd - 24th March,2011  Venue :- Dubai international Convention  Centre      Dubai, UAE     Details :- Click Here 12th-18th May,2011  Venue :- Dubai international Convention  Centre      Dusseldorf, Germany     Details :- Click Here                    To Receive our subsequent mails ,White list our email address by adding to your contact list.                                                         If you want to  unsubscribe to The Pharma Podium  click here    For a Browser view click here.               All rights with NATIONAL PHARMA MACHINERY .Copying the design in any form is strictly prohibited. Authenticity of the  source  is not verified by National Pharma Machinery.http://www.nytimes.com/2011/03/08/science/08silk.htmlhttp://www.pharmabiz.com/NewsDetails.aspx?aid=61788&sid=1

The pharma podium is a fortnightly newsletter by National Pharma Machinery      Edition #1, 15th March,2011                                                                                                 Featured Article   Personalised medicine is a “necessity not a luxury”, but there are numerous obstacles currently in place hindering true advancement in this area, industry has been told. Speaking at last week’s joint BIA/MHRA Personalised Medicine Conference, Sir Gordon Duff, chairman of the UK’s Commission on Human Medicines said there was no clear plan or leadership when it came to personalised medicines and this was particularly seen within the clinical trials landscape. “We tend to think of stratified medicine as new but stratification occurs on the market by trial and error – the patient says it doesn’t work so the doctor gives something else. But we need to understand how to do this at the development phase rather than in the clinic. We need to move upstream and stratify populations in clinical development with biomarkers. We need to stratify in Phase I and II and then on the market with a Phase III/IV type trial. As a result we’ll probably produce more and better drugs – that’s where we need to head.” But in order for this to work, Sir Gordon said there were several things that needed to change, including a need for a more adaptive approach to clinical trials, the use of all available information, early authorisation in exchange for post-market commitments and a risk-based approach to regulation. “Progress needs to be based on multiple convergent changes. We have progressed but not as a united front with all stakeholders. We need public involvement – an awareness and willingness to share data. We need healthcare systems – the NHS could be seen as one large clinical trial. In development, the model needs to change and there’s a need for collaboration. And regulators need to take on a facilitator role. We are at the beginning of a new era in convergent healthcare.” Dr Tom Lillie, international therapeutic area head, oncology, at Amgen, agreed, saying there was “great inequality” in the way healthcare was approaching personalised medicines. “It’s very disappointing we haven’t made more progress but our current trial and regulatory framework is not set up for that,” he said. He feared development of personalised medicines was currently quite risky with the emphasis being on “single agent activity” when a “combination approach was empirically desirable”. For example, different cancers have different genetic signatures, he said, and that points to combination therapy.  Furthermore, there were too many studies generated on retrospective analysis, which slowed down development, cost more and was unsustainable, he said. There was general consensus that the current clinical trial framework did not fit with the development of genomic drugs and there was possibly the need for a “radical rethink” of how clinical trials should be done. However, Dr Ian Hudson, director of licensing division of the Medicines and Healthcare products Regulatory Agency, said there was flexibility in the system. “Companies need to talk to regulators for advice on what trials might be needed. We know large studies are impossible for many orphan diseases. I think regulators are more flexible than we are given credit for.” But Dr Eric Abadie, chairman of the European Medicines Agency’s committee for Medicinal Products for Human Use, acknowledged there were a lot of open questions with the answer ‘it depends’. For example, questions like, is retrospective biomarker identification adequate for regulation and are biomarker negative patients required in clinical trials? Likewise, Seren Phillips from the National Institute for Health and Clinical Excellence, said there were still a lot of issues to be resolved.  Source :- PHarma Times Reach us @Twitter (@npmachinery),        IN THIS ISSUE   Global News Insys Therapeutics, Inc. announced positive results form the pivotal phase III efficacy Trial. FDA turns down Salix' antibiotic for IBS Breaking the Taboo Associated with Hemorrhoidal Disease  Indian News DCGI to ask centre to increase drug inspectors under CDSCO to 500 Maharashtra FDA detects 25 not-of-standard drugs in February Health ministry assures on making PSU vaccine units fully GMP   compliant in 3 years Events & Expos Medical Fair India March 25th-27th Bio Pharma Asia Convention InterpheX Expo , USA Also In The News Acton Biotech offers full genome scan at Rs 20,000 How man 'lost his penile spines' World’s Richest Man’s wealth jumps up by 38% Material World :-  Reinvention of silk   Insys Therapeutics, Inc. announces positive results from the pivotal phase III efficacy trial. Insys Therapeutics, Inc. announces positive results from the pivotal phase III efficacy trial for patients utilizing the Fentanyl Sublingual Spray (SL Spray) technology to treat breakthrough cancer pain. All primary and secondary endpoints were achieved in the study, and the drug is the first product to ever show statistically significant pain relief.                                                                                               FDA turns down Salix' antibiotic for IBS   Salix Pharmaceuticals' antibiotic Xifaxan has failed to win favour with the US Food and Drug Administration for the treatment of irritable bowel syndrome.                                                                                                                                        Breaking the Taboo Associated with Hemorrhoidal Disease Experts assume that more than 50 percent of Americans over the age of 50 have had symptoms related to hemorrhoidal disease at some point in their lives(1). For Europe similar data have been reported(2) and a German study reveals that 20 percent of the patients suffered more than five years from hemorrhoidal disease before they finally got the right treatment.                                                                       DCGI to ask Centre to increase drug inspectors under CDSCO to 500 The office of Central Drugs Standard Control Organisation (CDSCO) may ask the Centre to increase the number of drug inspectors under it to 500 as the requirement of the regulatory staff will be much more with its increased responsibilities, according to Dr Surinder Singh, DCGI.                                                                                           Maharashtra FDA detects 25 not-of-standard drugs in February The Maharashtra Food and Drugs Administration (FDA) has detected 25 not-of-standard drugs during the month of February in the random sample testing. Seven of these products belong to the manufacturers of the tax-free state of Himachal Pradesh and 6 from Uttaranchal.                                                                                          Health ministry assures on making PSU vaccine units fully GMP   compliant in 3 years The health ministry has assured the Parliamentary Standing Committee on Health and Family Welfare headed by Brajesh Pathak that the three public sector vaccine manufacturing units would be fully GMP compliant within a period of three years for which revamping of the existing production facilities at each location is in progress.                                                                                                                                    Acton Biotech offers full genome scan at Rs 20,000  Acton Biotech has recently offered a full genome scan to identify potential health risk. This full genome scan will cost Rs 20,000 and the report will be ready in a month. According to the company, patients can give blood samples at collection centers in their respective cities and                                                                  How man 'lost his penile spines' Scientists believe men once had small spines on their genitalia such as those found in chimpanzees, cats and mice. Analysis of the genomes of humans, chimpanzees and macaques indicates that a DNA sequence thought to play a role in the production of these spines have been deleted in humans, but has been preserved in other primates.                                                                                       World’s Richest Man’s wealth jumps up by 38% Mexico's Carlos Slim has topped the latest Forbes magazine rich list, as his wealth grew by more than a third. The telecoms magnate's fortune rose by $20.5bn (£12.65bn) to $74bn, again beating Microsoft founder Bill Gates ($56bn) into second place                                                                  Material World :-  Reinvention of silk As some silk researchers see it, if spiders were gregarious vegetarians, the world might be a different place. For spiders are nature’s master silk makers, and over millions of years of evolution have developed silks that could be useful to people — from sticky toothpastelike mush to strong and stretchy dragline                                                                                         25th  -27th March, 2011   Venue :- Pragati Maidan   New Delhi, Delhi, India    Details :- Click Here        28th  -31st March, 2011     Venue:- Marina Bay,sands     Singapore city,Singapore     Details :- Click Here          29th - 31st March,2011  Venue :- Jacob Javits,Covnention Centre      New York, USA     Details :- Click Here 22nd - 24th March,2011  Venue :- Dubai international Convention  Centre      Dubai, UAE     Details :- Click Here 12th-18th May,2011  Venue :- Dubai international Convention  Centre      Dusseldorf, Germany     Details :- Click Here                    To Receive our subsequent mails ,White list our email address by adding to your contact list.                                                         If you want to  unsubscribe to The Pharma Podium  click here    For a Browser view click here.               All rights with NATIONAL PHARMA MACHINERY .Copying the design in any form is strictly prohibited. Authenticity of the  source  is not verified by National Pharma Machinery.http://www.nytimes.com/2011/03/08/science/08silk.htmlhttp://www.pharmabiz.com/NewsDetails.aspx?aid=61788&sid=1