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SemBioSys Demonstrates Functionality of its Safflower Produced Apo AI(Milano)

SemBioSys Genetics, Inc. (Calgary, Canada) has demonstrated that its safflower-produced Apo AI(Milano) is functional in a widely accepted animal model. The company has demonstrated that safflower Apo AI(Milano) increased cholesterol mobilization substantially in mice which, in conjunction with analytical and in vitro assays, indicates that safflower Apo AI(Milano) is physiologically and pharmaceutically comparable to microbially-produced Apo AI. In human trials, microbially-produced Apo AI(Milano) has been shown to remove plaque from arteries (plaque regression), and holds potential for addressing one of the greatest unmet medical needs today—the reversal of atherosclerosis. Apo AI is a naturally occurring human protein being developed as a cardiovascular therapy to stabilize and reverse atherosclerotic plaque deposition for the prevention and treatment of cardiovascular disease. Apo AI is the major apolipoprotein associated with HDL, which naturally removes plaque from arteries. If...

RNA Revolutionaries

"This is a gift from heaven." So said MIT biologist Phillip Sharp, Nobel laureate and founder of Alnylam Pharmaceuticals, to The New York Times in 2003. Sharp was rhapsodizing about RNA interference, or RNAi, the swift and efficient way a cell protects itself by dispatching tiny snippets of RNA to silence harmful gene expression. Researchers at Harvard had just succeeded in using RNAi to "turn off" a worm's genes, one at a time, to identify which causes obesity. And given that the human RNAi pathway is very similar to a worm's, this was yet another in a series of fast affirmations of RNAi's therapeutic promise. While gene silencing (through approaches such as antisense) has so far proved dicey, and RNA research has so far yielded a decade's worth of failed drugs, RNAi is sparking visions of a revolutionary technology spitting out one new highly specific compound after another—almost as fast as the Human Genome Project can name disease targets. Toda...

SemBioSys Demonstrates Functionality of its Safflower Produced Apo AI(Milano)

SemBioSys Genetics, Inc. (Calgary, Canada) has demonstrated that its safflower-produced Apo AI(Milano) is functional in a widely accepted animal model. The company has demonstrated that safflower Apo AI(Milano) increased cholesterol mobilization substantially in mice which, in conjunction with analytical and in vitro assays, indicates that safflower Apo AI(Milano) is physiologically and pharmaceutically comparable to microbially-produced Apo AI. In human trials, microbially-produced Apo AI(Milano) has been shown to remove plaque from arteries (plaque regression), and holds potential for addressing one of the greatest unmet medical needs today—the reversal of atherosclerosis. Apo AI is a naturally occurring human protein being developed as a cardiovascular therapy to stabilize and reverse atherosclerotic plaque deposition for the prevention and treatment of cardiovascular disease. Apo AI is the major apolipoprotein associated with HDL, which naturally removes plaque from arteries. If ...

Medicare Drug Coverage Under Fire

Physician pay-patch bill offers something for everyone without resolving reimbursement problems. Enough Republicans sided with Democrats last month to approve legislation canceling a scheduled 10.6% cut in Medicare fees for physicians. In doing so, the legislators tacked on dozens of provisions pleasing to beneficiaries and providers alike. The Medicare Improvements Act expands coverage of preventive services, cuts some co-payments and coverage caps, increases assistance for low-income seniors and boosts support for hospitals and providers in rural areas. There are goodies for speech pathologists, ambulance services, clinical labs, community health centers, and others. Biopharmaceutical companies have their share of gains and losses. One low-profile item prevents the Centers for Medicare and Medicaid Services (CMS) from imposing stricter payment caps on radiopharmaceuticals. The policy benefits Cell Therapeutics and GlaxoSmithKline and provides time for manufacturers to work with CMS ...

India's Bioinformatics Industry: An Engine for Global Growth

Bioinformatics is one of the fastest-expanding fields in India's biotechnology sector today. There are over 200 companies in Bangalore, Hyderabad, Pune, Chennai, and Delhi that are in some way involved in bioinformatics. Large IT organizations such as Intel, IBM, and Wipro are also getting into this sector in India. Just as important, over 300 college-level institutes across India now offer degrees in biotechnology, bioinformatics, and biological sciences. These facilities are educating millions of students annually. This educational base is creating a solid future for India's bioinformatics industry. Much of this growth is because of the linkages between IT and biotechnology. India's software engineers are established around the globe. This breadth of expertise is, in turn, creating an engine for global biopharmaceutical growth. In fact, because of India's global presence in bioinformatics, Indian scientists and bioinformatics professionals are in high demand. Today,...

EU Approach to Safety: Vox Populi or Vox Dei?

In late February, the European Union announced it was launching a review of its rules on pharma-covigilance. It is not surprising that the EU should decide a review of pharmacovigilance is necessary. This is a constantly evolving discipline requiring constant alertness to how well it is meeting the objectives set for it. What is surprising is the way that the EU chose to justify it in the formal announcement. In a statement entitled "Strengthening Medicines Safety Monitoring," it said: "A public consultation shows that the current EU system of medicines safety monitoring (pharmacovigilance) needs rationalization and strengthening." This suggested a strange approach to medicines regulation, in which public consultation is to be the arbiter of whether pharmacovigilance rules are adequate. Should public consultations, by the same logic, also come to be the mechanisms for deciding on the requirements for clinical trials, or the authorization conditions for m...

The Clinical Side: Turn up the science

Clinical selling advice for specialty reps Jan 1, 2006 By: Jane Y. Chin Pharmaceutical Representative Whether you are a specialty representative in a primary care field or you're in a niche specialty pharmaceutical field, you are probably focusing your time on the specialists in your area. Specialists are protocol-driven physicians; they are usually at the cutting edge of their therapeutic area and treat "niche" patient populations or rare diseases. At the specialist level, medicine has become as much an art as a science. Dr. Clarence Foster, the director of kidney and pancreas transplant surgery at the University of California in Irvine, is a surgeon who is interested in knowing "who is raising the bar in transplant." For Foster, this may mean steroid-sparing procedures or working with living donors or with kidneys from 60-year-old donors -- in other words, highly experimental approaches to treating a disease. I asked Foster what he expects from his interactio...

The Clinical Side: The drug interactions maze

Making sense of this confusing topic Sep 1, 2005 By: Neil Berliner, M.D. Pharmaceutical Representative Many types of drug interactions can occur within the human body. Having a good working knowledge of this complex subject represents a huge opportunity for pharmaceutical representatives both to educate their customers and to better present their products. A drug interaction can be defined as an increase or decrease in the available amount -- and therefore the effect -- of a medication caused by another medication, food or chemical that is simultaneously present in the body. Sites of interaction There are four main sites of interaction in the body. The gastrointestinal tract. The gastrointestinal tract plays an important role in drug interactions. Some medications, such as cisapride, increase GI motility and therefore decrease the time other medications spend in contact with the lining of the stomach or intestines. This causes decreased absorption of those medications and an effective...

Community pharmacy unifies

Disparate community phar--macy groups have come together to present a united front on issues affecting the com-munity pharmacy sector. The Community Pharmacy Leaders Forum includes the Pharmacy Guild, Pharmaceutical Society, Life Pharmacy, Radius and Pharmacybrands. The development is significant considering all these parties have, at times, not seen eye to eye on major issues affecting community pharmacy – either due to personality clashes or philosophical differences. This fragmentation has left the community pharmacy sector in a weak position. “Many groups are doing good work in their own right, but they are divided on major issues which make us great to negotiate against. “The formation of the forum will immediately open doors and provide a listening voice at the highest level,” Radius pharmacy director, Mike Seymour, says. This unity, he says, will allow the guild to be more effective in negotiating contracts and also work more closely with the society on new funding platforms to ...

Pharmacy risk-sharing promotes savings - includes related article - Pharmacy Benefits Management: The Next Generation supplement

When the Ford Motor Co. sought bids on its $174 million pharmacy benefit, management knew it had the clout to ask for--and receive--a capitated rate from pharmacy benefit managers (PBMs). Chrysler recognized its clout, as well, and in the past two years, both auto makers have signed similar capitated PBM contracts. With the stroke of a pen, these self-insured employers set a precedent that other employers and employer groups may follow. The benefits offered by auto makers often serve "as a bellwether for other unions," says Beach Hall, a health care consultant in Detroit and former director of health plans at General Motors. Two aspects of the contracts stand out, he says. The first is that they introduced a managed pharmacy benefit in lieu of an indemnity drug program. The second is risk-sharing. Capitation and sharing risk have been used in medical care to ensure that managed-care organizations control costs. Employers prefer these arrangements because they can budget accu...

The truth about medical journals, and how drug companies exert heavy influence over published scientific articles

Can the medical journals be trusted to provide accurate, unbiased information about medicine even as they are almost entirely funded by drug companies? In her book, Vaccination , Peggy O'Mara writes that the current era of medical beliefs (or dogma) began to develop soon after Louis Pasteur's demonstration that some pathogens could be converted into vaccines. The medical community then decided to try the same method for all afflictions. Medical journals were soon afterward reporting the discovery of "miracle" vaccines for every disease under the sun, and drug companies were simultaneously advertising those vaccines on those very same pages. Medical journals rely on Big Pharma's ads to pay the bills Mainstream media has long depended on advertising revenue to cover its bills. The money generated by newspaper subscriptions doesn't even begin to scratch the surface of a daily paper's running costs. Television stations also rely on advertising clients to foot...