Can vaccines be preserved without refrigeration? new technology revelations-

Dr.Shruti Bhat, a Generics & specialty pharmaceutical expert, brings to you some highlights from current pharma business news-

Technology may allow vaccines to be preserved without refrigeration.

A new technology, developed by British firm Nova Bio-Pharma Technologies and tested at Oxford University, may represent a sea change in vaccine preservation -- minimizing the need for long-term storage in refrigerators or freezers, and improving access and global health as a result." The study, published in the journal Science Translational Medicine, found that "the technology, which utilizes special membranes stabilized with a sugar compound, was shown to preserve two different types of virus-based vaccines for four months at a temperature" of 113 degrees Fahrenheit or 45 degrees Celsius "with no degradation."

The researchers also found the vaccines could be stored for a year or more at 37 degrees Celsius with only minimal losses of vaccine.

Watson To Pay $47 Million For Drug To Prevent Premature Birth.

Watson Pharmaceuticals Inc. press reported that it will pay $47 million upfront for a Columbia Laboratories Inc. drug that is being developed for the prevention of premature birth." Watson will pay $45.5 million more if the drug, currently marketed as Crinone and Prochieve, "succeeds in clinical testing, gets approved, and reaches the market." The companies also are working "on a late stage clinical trial of Crinone for the prevention of premature birth in women with a short cervix."

Bristol-Myers Has 60 Potential Drugs In Its Pipeline.

Executives at Bristol-Myers Squibb Co. told analysts at a business briefing that the drug maker has 60 potential drugs in development, seven in late-stage studies." Bristol-Myers "said it expects future revenue from those medicines and growing sales from existing drugs to help offset an expected plunge in Plavix sales in 2012." The key drugs in development "include the blood thinner apixaban, organ transplant drug belatacept, cancer drug brivanib, diabetes drug dapagliflozin and skin cancer drug ipilimumab."

Glaxo Looks To Expand In India.

The Wall Street Journal reports that GlaxoSmithKline PLC seeks to expand in India through both acquisitions and core business growth, Glaxo CEO Andrew Witty said, "Opportunities will be evaluated based on a variety of factors, including the strategic nature of the fit."

Synta Pharmaceuticals To Restart Development Of Skin Cancer Drug.

Synta Pharmaceuticals Corp. announced that "it will restart development of its skin cancer drug candidate elesclomol," a decision reached "after consulting with the Food and Drug Administration." The company "said it expects to start at least one new clinical trial in the second half of 2010." The drug is designed to treat metastatic melanoma. The company halted a trial of elesclomol due to safety issues and an increased number of deaths among those on the medicine.

Roche Expects Increase In Sales From China.

Bloomberg News reports, "Roche Holding AG expects sales of drugs in China to account for about half of all pharmaceutical revenue from the Asia-Pacific region within three years, spurred by higher incomes and the nation's health reforms." Roche "is benefiting as higher incomes and cancer rates in the world's most populous nation spur demand for its Herceptin [trastuzumab] and Rituxan [rituximab] oncology drugs." Roche may also benefit from rising rates of heart disease and diabetes in the region if late-stage patient studies of two experimental drugs are successful.

Perrigo To Buy Orion Laboratories For $48 Million.

Perrigo Co., a maker of the over-the-counter drugs, "said it would buy Orion Laboratories for $48 million in cash, expanding its market in Australia and New Zealand." Perrigo "said the addition of Orion," which makes and distributes pharmaceutical products to hospitals, "will boost annual sales by more than $30 million and add to earnings in the first year."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.

Cabazitaxel May Improve Metastatic Prostate Cancer Survival...many more updates.

What efforts go behind the scene till a new drug hits the market? Do patients benefit ? Are they cured? How do we control health care costs? What are the new drugs in the making? To know more, visit http://www.drugsinthemaking.com/

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

Heartburn Drug Renamed To Avoid Medicinal Mix-Ups.
Press reports that, Takeda Pharmaceuticals will change the name of a heartburn drug that has repeatedly been confused by pharmacists with drugs meant to treat cancer and other ailments." The drug, Kapidex (dexlansoprazole), has been mistaken for "Casodex [bicalutamide], a prostate cancer drug, and Kadian [morphine extended-release], a narcotic pain reliever." The newly-named Dexilant will "begin appearing on store shelves in late April 2010.

Cabazitaxel May Improve Metastatic Prostate Cancer Survival.
According to a study presented at the Genitourinary Cancers Symposium, "cosponsored by the American Society for Clinical Oncology (ASCO), the American Society for Radiation Oncology, and the Society of Urologic Oncology," the Sanofi-Aventis prostate cancer drug cabazitaxel "increased survival by 30%...compared with the standard therapy of mitoxantrone" when "used as a second-line therapy" in men with metastatic disease. Researchers found that "men in the cabazitaxel group had a median survival of 15.1 months, compared with 12.7 months for men in the mitoxantrone group." The researchers noted that cabazitaxel's overall survival benefit was "consistent across subgroups."

FDA Approves Mylan Generic Gastrointestinal Drug.
Mylan Pharmaceuticals Inc. has received final Food and Drug Administration approval for 300-milligram Ursodiol capsules, the generic version of Watson Pharmaceutical's gastrointestinal drug Actigall."

Hydroxychloroquine May Help Delay Skin Damage In SLE Patients.
According to a study published in March issue of Arthritis Care & Research, "treatment with hydroxychloroquine (Plaquenil) may help delay the occurrence of skin damage in patients with systemic lupus erythematosus (SLE)." In a study of "580 patients who had not yet developed skin damage at baseline," researchers found that use of hydroxychloroquine "was associated with a longer time until integument damage -- defined as scarring alopecia, extensive skin scarring, and skin ulcers -- was present." Moreover, "the cumulative probability of damage at five years was 5% for those taking hydroxychloroquine, compared with 24% for those who were not on the drug."

FDA Approves Pre-Filled Injection Pens Of Somatropin.
The FDA approved pre-filled injection pens of the endogenous growth hormone disorder drug somatropin (Norditropin) for adult and youth patients." The Norditropin FlexPro "produces an audible click that tells patients the medication has been dispensed," and is a single-use device and does not require reconstitution to administer. The drug is indicated for children who have growth failure attributed to insufficient endogenous growth hormone, short children with Noonan or Turner syndrome, children born short who have not grown enough by two to four years, and adults with growth hormone deficiency due to pituitary disease, hypothalamic disease, surgery, radiation therapy, trauma, or those with childhood-onset growth hormone disorders.

FDA Approves Weekly Immune-Replacement Therapy.
CSL Ltd., the world's second-biggest maker of treatments derived from blood, won US clearance to sell Hizentra (IgPro20), "a weekly immune-replacement therapy for people with genetic disorders that lead to frequent infections." The drug "contains 20 percent immunoglobulin, or antibodies, and is intended as a replacement for CSL's older Vivaglobin product, which contains 16 percent and was previously the only self-administered immune treatment approved in the US." An FDA letter said that the drug Hizentra "did not raise concerns or controversial issues" that would warrant a review by outside advisers.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.


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Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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Is there a break through? Six Genes May Help Predict Paclitaxel's Effectiveness In Cancer Patients.

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

Leading the news...
Six Genes May Help Predict Paclitaxel's Effectiveness In Cancer Patients.
According to research published in The Lancet Oncology, "Scientists have developed a gene test which predicts how well chemotherapy will work in cancer patients." In a study of "829 genes in breast cancer cells," researchers "whittled down the possibilities to six genes which had an impact on whether a drug worked." The study "showed that these genes could be used to predict the effectiveness of paclitaxel in patients."

Researchers found that "if any of the six genes are 'faulty,' paclitaxel does not work and the tumor cells continue to divide uncontrollably, just as they would without treatment," The lead researcher Dr Charles Swanton, from the Cancer Research UK charity's London Research Institute, said that the "research shows it is now possible to rapidly pinpoint genes which prevent cancer cells from being destroyed by anti-cancer drugs and use these same genes to predict which patients will benefit from specific types of treatment."


"Painless" Vaccine Delivery Method Introduced In Japan.
Japanese researchers have unveiled a "painless new vaccine delivery system" consisting of "as many as 300 micro needles" that do not need to penetrate the dermis layer of skin. Professor Kanji Takada, of Kyoto Pharmaceutical University, said the "patient feels no discomfort and there is no bleeding”. It is hoped that the use of the microneedles, which dissolve after being pressed into the skin, will help alleviate some patient's fear of getting shots.


Scientists Say TB, Antiretroviral therapy should be administered concurrently to co-infected patients.
Clinicians with patients who have both HIV and tuberculosis infections should not defer antiretroviral therapy until TB treatment has been completed. In fact, the "benefit of concomitant treatment was so striking that a data safety monitoring committee stopped the sequential arm of the study within two months of completion of enrollment," according to researchers in South Africa. The findings published in the New England Journal of Medicine add "weight to World Health Organization guidelines," which favor "integrated therapy."


Genentech Says Avastin Failed.

To Extend Survival Of Patients With Advanced Stomach Cancer.
Genentech reported that the combination of its blockbuster cancer drug Avastin [bevacizumab] and Xeloda [capecitabine] did not meet a late-stage goal of extending the lives of advanced stomach cancer patients." Genentech "said it will submit the data and hopes to present full results...at the 2010 American Society of Clinical Oncology's annual meeting." But, Genentech pointed out that the study did not reveal any new safety issues with Avastin.


Impax Receives FDA Approval For Generic Flomax.
Drugmaker Impax Laboratories Inc. reported that the Food and Drug Administration gave final approval to its generic version of the enlarged prostate treatment Flomax [tamsulosin hydrochloride]." The company "plans to start shipping the drug immediately." Impax "said it had reached a legal settlement last October with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals Inc." to launch its generic version.


FDA Rejects Ranbaxy's Generic Flomax.
Daiichi Sankyo Co., which controls 64 percent of Ranbaxy Laboratories Ltd., reported that the " FDA rejected its Indian unit's application for approval to sell the generic version of Flomax. The company was expected to launch its generic version March 2 under a patent settlement.

Reference-

http://www.drshrutibhat.com/2/category/drug%20research%20and%20technology%20updates/1.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
Do you have questions for the author?

Marketing Your Career -- Become a Proactive Job Seeker, know what is personal branding.

The global economic crisis has hurt all of us in various ways. If you’ve been laid off in recent months, or are unhappy with your present job or keen on a change of job, then you're feeling recession’s effects very directly. It’s discouraging to try to get a job while the news reports continue to announce massive new layoffs, and the resumes you send out lie buried in stacks on hiring managers' desks.

However, your job loss can be an opportunity to reassess your career, figure out what you want to do next, and take more control of your future.

Clearly, the days are gone when one company took care of you from graduation through retirement. While you may still meet people who’ve worked for one company for 30 or 40 years, their situation has little in common with ours. In fact, today’s average worker changes jobs every 3 years. Furthermore, hiring managers now prefer the worker who has changed jobs every 3 years. In the manager's eyes, that's the worker with broad experience. The worker who’s stayed with one company for 30 years is now a questionable bet, unless he or she moved around within the company, continuing to learn and grow.

Since you can't rely on a company to manage your career, you have to manage it yourself.

Coz..."If you don't have a plan, someone else will make your plan." And forming that plan for your career is a critical first step in creating the future you want. You need a strategy for the short term and the long term.

In essence, you need to figure out what you want to become, and develop a plan that will get you there. Your plan may change, but you do need one. That's strategy.

Now what about strategy execution? What do you do to get the job you really want? The answer? Marketing/ branding.

Marketing yourself, or proactive job searching, starts with identifying (1) what you can offer, (2) what distinguishes you from your competition, and (3) who your target market is. Marketing yourself is no different than marketing a product, but the product is you.

To effectively market yourself, you must develop a good understanding of your assets--your skills and personal traits. If you know your strengths, you can market yourself more effectively and with greater confidence, making your strengths available to companies that are looking for them.

You also need to understand the marketplace for people with your skills. This requires research. You may find that you need to go back to school or that people with your skills are employed in industries you hadn't thought of.

When you know your skill set and your market, your job search should rely on two important techniques: informational interviewing and networking.

One technique to apply to your job search is the informational interview. In the informational interview, you contact people who work in a field or company that interests you, and ask them questions to increase your knowledge and understanding. The interview can be done on the phone or in person. You can take this approach: "I'm exploring the kind of work I want to do, and I’d like to learn more about you and your work."

The informational interview is an extension of the research you’ve already done. These interviews should help you learn more about your field of interest and intelligently craft your career plan. You might make a connection through interviewing that leads to a job, but don't approach it that way. Instead, be a researcher. Always thank your interviewees for taking time to help you. If they’re interested, keep them updated on how things work out.

The second key tactic used by the proactive job searcher is networking. Networking is about meeting people--lots of them--and staying in touch. You should focus your networking on people who are in your field of interest. A good way to do this is to attend professional association meetings in your target field. Attend the meetings of these and similar organizations. Use the meetings to develop relationships with the members, and you will gradually build a powerful professional network.

Why do you need a professional network? Because the people in your network care about your success, just as you hopefully care about theirs. Many of them also recognize that helping each other is far more fruitful than treating others as hostile competitors.

Read full article...click http://www.drshrutibhat.com/2/category/personal%20branding/1.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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Innovative Strategies and Models for R&D Success.

Over the last quarter of the twentieth century, medical research made substantial advances in defining our understanding of diseases, their etiologies, and the biochemical pathways through which they were mediated. Our understanding was further augmented by human genome research. As the pathways of disease were clearly identified, pharmaceutical research largely focused on a “lab to market” approach, which involved identifying/synthesizing molecules that could mediate a disease pathway, characterizing their various attributes, and then commercializing them. In several cases, new molecules had characteristics that were marginally different from others already on the market, and therefore, did not address any unmet clinical need. Commercial success was often determined by the intensity of the sales and marketing effort behind the product, which resulted in an “arms race” (a battle for maximizing share of voice by investing in larger and larger sales teams) and the emergence of “blockbusters.”

The last 10 years have seen a seismic shift in the dynamics of pharmaceutical sales and marketing. The return on investment in sales force expansion is shrinking, causing almost all major pharmaceutical companies to reduce their head counts. Further, it is increasingly evident that the market and regulators are interested in new therapies that address an unmet need rather than yet another product in an existing class of molecules with little or no clinical or economic benefit.

Over the last few years, most of the innovations in pharmaceutical development have been only incremental — for most indications, there are significant therapy options available and it is unlikely that a radically better “wonder drug” will become available soon. Consequently, a disproportionate amount of ongoing research and development (R&D) effort has gone into products already in the market to expand the spectrum of indications where they can be used. A look at the number of drugs approved by the US FDA over the years indicate 35 new drugs approved in 2005 as against only 20 last year.. The decline in approvals is a clear indication of how difficult it will be for pharmaceutical companies to continue to show revenue growth in future.

As they grapple with shrinking pipelines, stricter safety requirements of the regulator, and spiraling costs to bring a product to market, pharmaceutical companies need to ensure that their products genuinely fulfill an unmet market need. Therefore, it is imperative that the R&D effort follow a “market to lab” approach—one that reverses the conventional approach used over the last few decades.

Aligning the organization to the Goals of Clinical Development-
Clinical R&D is a complicated process involving several steps and multiple stakeholders, both internal and external, in a pharmaceutical organization. Over the last 50 years, the journey of a product from laboratory to the market has not only become more arduous and time-consuming, but also more risky. Furthermore, since more and more clinical development plans (CDPs) include global, multi-centric clinical trials, their formulation and execution are broken into several sub-elements, each of which have become the responsibility of different functional silos in a pharmaceutical company. Consequently, clinical R&D at present involves stakeholders from the strategic, marketing, sales, medical, R&D, clinical operations, regulatory affairs, documentation, and health economics teams.

Given that the collective objective of all the teams involved in the CDP is to achieve a desirable Target Product Profile (TPP) and therefore a superior product label, pharmaceutical companies must ensure that all stakeholders are aligned and share a common line of sight to the end objective. This is not always easy, but is a critical challenge that must be overcome. Failure to do so runs the risk of a CDP not being in step with current and future market needs, and oblivious to the competitive scenario in the future.

The essence of “claims-based R&D” lies in taking a backward “market to lab” approach so as to ensure that the CDP is designed to address specific unmet market needs. It also involves the systematic benchmarking of a product’s CDP to current and future competition while continuously evaluating scientific and market threats and opportunities. It involves the integration of multiple inputs to develop the CDP and then prospectively simulate the likely TPP of the product and a SWOT analysis vis-à-vis its inline and pipeline competitors.

The Process of Developing a CDP-
The process of claims-based R&D is iterative since it attempts to temper the desire to develop an “ideal” product with scientific and operational feasibility. With the ever-growing volume of information and data available in the secondary domain, it is now possible to pursue claims-based R&D to a far greater level of granularity than before. It also enables TPP simulation on a near real-time basis as pivotal information becomes available.

Customer Insights-
In an earlier era of pharmaceutical development, unmet market needs were determined almost exclusively from the opinions of physicians and medical key opinion leaders (KOLs). In the modern era, however, there has been a significant shift in the level of influence exerted by different stakeholders (customers) on the patterns of pharmaceutical consumption. These stakeholders (customers) include the patient, the payor, and the regulator.

While pursuing claims-based R&D, it is critical to ensure that the insights and opinions of all the key stakeholders (customers) are accurately captured so that the product(s) developed can genuinely claim to deliver a clinical and/or economic benefit.

These insights are most often captured through primary research and intelligence initiatives, which include engagement with physician groups, patient and caregiver groups, insurance agencies, etc. However, such initiatives can be effectively complemented by research of secondary sources of information such as online patient discussions boards and transcripts of regulatory proceedings.

Full article... http://www.drshrutibhat.com/2/category/business%20news/1.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.


Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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Research and development in the 21st century: Web-enabled innovation comes of age.

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma industry happenings globally.

Web-enabled research and development? But of course. The Internet, built by researchers has been used to extend their reach for nearly 30 years. High-tech organizations that live and die by new product development have exploited the Web to speed communications and share information.

More recently, but just as enthusiastically, biotech and pharmaceutical companies have turned to Web-enabled research and development (R&D) processes. But the landscape of Web-enabled research and development is changing. New tools and approaches may now enable organizations to make their R&D processes faster, more reliable and also more innovative.

What have also evolved are two clearly different approaches to Web-enabled research and development: For pharmaceutical and biotech companies, it is how the Web can be used to supercharge a research hotbed. For high-tech computer, communications and electronics companies, the focus is on using the Web to create a seamless product-development process.

Within these two different approaches lies the potential of Web-enabled capabilities to smooth the handoff between research and development. This potential has caught the attention of C-level executives who recognize the need to champion what is, for many companies, a fundamentally new way of developing products.

Looking ahead, executives at pharmaceutical and biotech companies and at high-tech companies may be able to make even bigger strides by learning from one another. By evaluating and adapting the innovative approaches each industry is using, they can stimulate research and streamline development through the Web.

Wish to Improve your research and development performance? A free technical whitepaper is available for interested readers to know more about this very important topic.

Disclaimer- The views and opinions expressed in this article are meant to stimulate thought and discussion. As each business has unique requirements and objectives, these ideas should not be viewed as professional advice with respect to your business.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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Three Major US Drugmakers Create Asian Cancer Research Group.

The pharmaceutical business is yet another dynamic venture, present globally and extremely important to research scientists, investors and the entire community at large. As in any other business, the success of any pharma company lies on 2 factors- investment potential and risk taking ability. In addition, the R&D portfolio becomes a huge numerator to ensure successful profit quotient.

So what efforts go behind the scene till a new drug hits the market? Do patients benefit ? Are they cured? How do we control health care costs? What are the new drugs in the making? To know more, visit http://www.drugsinthemaking.com

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

FDA warns against using four asthma drugs as stand-alones or for extended periods.

The Los Angeles Times reported that the FDA "on Thursday called for putting new limits on powerful and long-lasting bronchial drugs" containing both long-acting beta agonists, commonly called LABAs, and inhaled corticosteroids, in "a move designed to lower the risk of complications leading to hospitalization or even death." The agency "said patients should use products containing only the corticosteroids or other asthma-relieving medication whenever possible." Meanwhile, "patients who cannot control asthma symptoms any other way should use LABAs for the shortest possible time, but the drugs should never be used alone in treating asthma in adults or children, the agency said."

FDA Clears Drug To Treat Respiratory Symptoms Of Cystic Fibrosis.
The Food and Drug Administration has approved for marketing Gilead Sciences, Inc.'s "drug Cayston [aztreonam for inhalation solution] as a treatment for respiratory symptoms of cystic fibrosis, the company said Tuesday." The company "said it plans to make the drug available by the end of next week." The San Francisco Business Times reported that "Cayston, administered three times a day over a 28-day period, treats the bacteria Pseudomonas aeruginosa, which causes mucus to build up in the lungs and digestive tract of cystic fibrosis patients," and which is also "the single greatest cause of death for CF patients."

FDA Panel Recommends Approval Of Xifaxan To Treat Hepatic Encephalopathy.
A Food and Drug Administration panel "recommended Salix Pharmaceutical's drug Xifaxan [rifaximin] be approved to treat" hepatic encephalopathy, which is "brain damage caused by liver failure." In a 14-to-4 vote, the panel found that "the drug's benefits warrant its approval. In a separate vote, the panel also voted 14-4 in favor of the drug's safety." The agency will consider its panel's vote when it makes a final decision anticipated by Mar. 24. Reuters also noted that the FDA has already approved Xifaxan to treat travel-related diarrhea.

Three Major US Drugmakers Create Asian Cancer Research Group.
Three major US drugmakers, Eli Lilly and Co., Merck & Co., and Pfizer Inc., said Tuesday they have formed a not-for-profit company in Asia to focus on cancer research and treatments." The Asian Cancer Research Group will "focus on the most commonly diagnosed cancers in Asia, including lung and gastric cancers." The companies aim to "create an extensive database that will be made available to researchers."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.

Do you have questions for the author?