Welcome to DrugsInTheMaking.Com
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data. Drug recalls reached a record high 1,742 in 2009 — more than four times the amount in 2008. Bowman Cox, managing editor of the Gold Sheet told CNN Money that in light of the 296 recalls issued in the first six months of 2010, there could be 600 or more recalls this year. Why So Many Recalls? Analysts and legislators are examining the recall statistics to find sources and solutions to the pharmaceutical safety issue. 1. Drug repackaging : Advantage Dose, a now-defunct Shreveport, LA based drug re-packager, was responsible for more than 1,000 of the 2009 recalls. Companies like Advantage Dose repackage and re-label drugs into smaller units for resale or distribution to health care facilities. After excluding Advantage Dose from the count, there still remains a 50% jump in recalls from 2008 to 2009. 2. The generic rush : Gold Sheet’s Cox suggests that generic manufacturers cut drug design costs in their rush to be first to market after a branded-drug’s patent protection expires, decreasing quality. “The first generic applicant typically gets the lion’s share of the business for the new drug…the 180 day exclusivity… So they get the application. They make and market the drug, but they could still have problems down the road if they haven’t really understood the optimum way to make that drug(product).” One example of a design failure is Caraco Pharmaceutical Laboratories’ “tablet thickness” recalls in March 2009… Read more at http://www.pharm-education.com/2010/09/drug-recalls-in-usa-reached-record-high.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.comExpert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals. The nation’s drug makers have eliminated nearly 35,000 positions in the first half of this year, second only to government in cutting jobs. Government and non-profit sectors announced 98,776 job cuts this year to date, compared with 34,987 by pharmaceutical companies, and 26,181 by the retail industry, according to a new report by Challenger, Gray and Christmas, a Chicago-based outplacement consulting firm. The firm noted in a release that the pace of retrenchment has slowed compared to last year, when drug companies cut 51,000 jobs; retail 85,000; and government 102,000. And the report said more employers are confident looking ahead. Still, the industry faces the prospect of more job losses to support the bottom line as patents expire on prominent drugs within the next year. Read complete article at: http://pharmaceuticalcareerdevelopment.blogspot.com/2010/07/drug-makers-shed-35000-jobs-new-york.html  Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moieties, brings to you some highlights from current pharma and clinical business news, views and data. "Two drug makers with sometimes stormy pasts, Biovail and Valeant Pharmaceuticals International, said Monday that they had agreed to merge in a $3.2 billion deal." The new company "will retain the Valeant name," and "will focus on four areas, including treatments for the skin and for neurology, and is expected to have more than $175 million in savings by the second year... More at http://www.pharm-education.com/2010/06/pharma-industry-updates-biovail-and.html References- http://www.nytimes.com/2010/06/22/business/22drug.html?src=busln http://www.forbes.com/feeds/ap/2010/06/21/business-health-care-providers-us-biovail-valeant_7706755.html http://online.wsj.com/article/BT-CO-20100621-709413.html?mod=WSJ_World_MIDDLEHeadlinesAmericas http://www.bloomberg.com/news/2010-06-21/valeant-pharma-canada-s-biovail-corp-agree-to-merge-in-stock-transaction.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. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?  Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moieties, brings to you some highlights from current pharma and clinical business news, views and data. Glaxo CEO Plans To Announce Two "Small" Acquisitions Soon. GlaxoSmithKline Plc Chief Executive Officer Andrew Witty plans to announce two 'small' acquisitions soon, after walking away from five potential purchases or partnerships since October. In an interview ... Cheap Inhalable Measles Vaccine May One Day Replace Syringes. A cheap inhalable measles vaccine, developed by scientists at the University of Colorado-Boulder, "could soon be available to families that could pave the way for an end to treatment by syringe for children." Within a few weeks, "human trials of the treatment are scheduled to begin," and ... Teva Poised To Dominate Generic Drug Industry. The New York Times reported on Teva Pharmaceutical Industries, "an Israeli enterprise that, despite not being a household name, is the biggest generic drug maker in the world." The Times added, "Teva's size gives it huge advantages." In fact, ... Pfizer, Merck Post Large 1Q Revenue Increases, Lower Net Income. The world's two largest drug makers, Pfizer Inc. and Merck & Co., posted big revenue jumps but lower net income for the first quarter, as they enjoyed new revenue from big rivals acquired last year but ... Eli Lilly & Co. Sues Watson Pharmaceuticals To Block Generic Version Of Osteoporosis Drug. The Indianapolis Business Journal reported that "Eli Lilly and Co. sued Watson Pharmaceuticals Inc. to prevent the sale of a generic version of its osteoporosis drug Evista [raloxifene] in the United States." In its application ... Expiring Patents, Price Controls Expected To Slow Drug Sales. Pharmaceutical sales growth worldwide will slow this year due to expiring patents for blockbuster drugs and tighter price controls imposed by European governments." In fact, according to "health industry data firm IMS Health...global prescription drug sales growth" may "slow to between 4 percent and 6 percent compared with 7 percent in 2009. Pharmaceutical companies are expected to ... http://www.pharm-education.com/2010/05/pharmaceutical-r-business-news-updates.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. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?  Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma business news- Abbott Labs Completes Purchase Of Starlims. "Abbott Laboratories said Monday it completed its purchase of Starlims Technology" for $123 million, or $14 per share. Abbott said that Starlims will "increase its position in the diagnostic testing market. WHO: Drug-Resistant TB Killed 150,000 In 2008. The New York Times reported that the WHO announced data last week showing that "drug-resistant tuberculosis killed about 150,000 people in 2008, and half of all the world's cases are thought in be in China and India... Transgene Sells Novartis Option On Rights To Experimental Cancer Vaccine. Bloomberg News reported that French biotechnology company Transgene SA "sold Novartis AG an option on rights to the experimental TG4010 cancer vaccine in a deal that may fetch as much as $960 million... Pharmaceutical Industry Prepares For New Business Under Health Reform Law. The US drug industry fended off price curbs and other hefty restrictions in President Obama's healthcare law even as it prepares for plenty of new business when an estimated 32 million uninsured Americans gain health coverage... FDA clears Vytorin and Zetia of suspected link to cancer. The Los Angeles Times blog reported "Booster Shots" that after examining two previous studies, a Food and Drug Administration review committee has determined that it is ... Roche Seeks Acquisitions To Boost Its Research Programs. Roche Holding AG Chief Executive Officer Severin Schwan said he seeks acquisitions that will bolster the company's research programs, rather than 'mega-mergers' designed to add immediate revenue... Roche To Introduce At Least Six New Drugs By 2015. In a separate story, Roche also expects to introduce "at least six new medicines by 2015." Roche "wants to expand" the use of its cancer drugs "by testing them in different tumors and earlier in the disease." The company "also is seeking to expand beyond cancer and tap markets for conditions such as diabetes and diseases of the central nervous system." Pharmaceutical Thefts Becoming More Common. The $75 million heist at" Eli Lilly's "warehouse in Connecticut was just the most audacious example of a growing phenomenon: Thieves are stealing large quantities of prescription drugs for resale on the black market... Full article at http://www.pharm-education.com/2010/04/who-drug-resistant-tb-killed-150000-in.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 . What is the Future of medicine ? What are the lessons from 60 years of pharmaceutical innovation? 03/19/2010
 Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data. It’s the title of a very insightful analytical paper by Bernard Munos (Nature Reviews, Dec-2009). He applied statistical analysis techniques to the aggregate inputs and outputs of the pharmaceutical industry. The most stunning insights from his analysis are: 1. Average annual output of the industry is constant and has been so for 60 years, despite consistent increase in R&D investment ($50 billion/year). Practically, it means that the output of the industry is not depressed, as commonly thought, but simply reflects the innovative capacity of the established R&D model. In this light,new approaches, such as the open innovation paradigm, public-private partnerships and industry consortia hold a lot of promise. 2. If the NME (New Molecular Entity) output is constant, the only way to grow is to increase the number of companies, which goes contrary to the 2009 wave of large mergers & acquisitions (M&As). However, Bernard Munos’ analysis shows that, broadly speaking, the impact of M&A in the pharmaceutical industry on R&D is “1+1=1″... Solution? Bernard Munos’ recommendations point to the need to rethink process and culture. How do we bring in passion for discovery? Is it through good HR practises? Certainly not... and it doesn’t need management to pump in dollars either ! The answers are available for those interested to bring in a wave of change to their R&D’s systems, functioning and culture.... Reference- http://www.pharm-education.com/2010/03/what-is-future-of-medicine-what-are.html For detailed FREE white paper on this topic, register at www.drshrutibhat.com 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? Glaxo Looks To Expand In India. 03/09/2010
 Pharma business highlights Dr.Shruti Bhat, Generics and Specialty Pharmaceutical Expert. Technology may allow vaccines to be preserved without refrigeration... Watson To Pay $47 Million For Drug To Prevent Premature Birth. .. Bristol-Myers Has 60 Potential Drugs In Its Pipeline... Glaxo Looks To Expand In India... Synta Pharmaceuticals To Restart Development Of Skin Cancer Drug... Roche Expects Increase In Sales From China... Perrigo To Buy Orion Laboratories For $48 Million... Full article at http://www.pharm-education.com/2010/03/can-vaccines-be-preserved-without.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.  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.comExpert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. Do you have questions for the author?  Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma industry news. 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? Be competitive for today and miles ahead for tomorrow? A free technical whitepaper is available for interested readers who wish to know more about this very important topic. Also at http://www.pharm-education.com/2010/02/research-and-development-in-21st.html 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. Do you have questions for the author?  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 why read Pharma R&D, business news? Because it offers following benefits- 1. Enables investors to take “wise decisions”. 2. Assists Job seekers to realize “where to invest their career”. 3. Helps community to abreast themselves of new medicine introductions, availability of low cost generics and overall to think wise about “how they can control their health care costs”. Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma business news- Pfizer's Viagra patent partially rejected. "Pfizer Inc.'s patent on its impotence drug Viagra [sildenafil citrate] was partially rejected after the US Patent and Trademark Office said it wasn't different enough from a Chinese herb known as Horny Goat Weed." An agency appeals board "upheld the decision that an element, or claim, of the patent for a method of treating male erectile dysfunction didn't cover a new invention." Bloomberg News . Potential kidney transplant drug wins orphan drug designation from FDA. "Quark Pharmaceuticals Inc.'s potential treatment for kidney transplant patients won orphan drug designation from the Food and Drug Administration." The company "said QPI-1002 is a synthetic small interfering RNA, or siRNA, that blocks expression of a gene called p53 and, as a result, could protect normal cells from injury." QPI-1002 also "is in a Phase I/II study," and "is the first systemic siRNA drug to enter human clinical trials." The San Francisco Business Times. Lilly, Arkansas settle Zyprexa marketing suit for $18.5 million. Arkansas Attorney General Dustin McDaniel on Tuesday announced an $18.5 million settlement of a lawsuit with Eli Lilly & Co. over off-label marketing of the anti-psychotic drug Zyprexa [olanzapine]." The American Press. Spending on cancer drugs in UK is 40 percent less than in other European countries. NHS cancer patients have 40 percent less spent on their medicines than those in other European countries,according to a "report from the centre-right think tank Policy Exchange." The UK's Daily Mail. Roche ordered to pay $25 million in Accutane damages. Roche Holding AG "must pay $25.16 million in damages to a former user of its Accutane [isotretinoin] drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled." Bloomberg News. India's generic drug industry may attract more interest from larger companies. India's generic-drug industry has more FDA-approved facilities than any other country outside the US, which is boosting speculation that larger foreign pharmaceutical companies will join the industry. The Wall Street Journal. AstraZeneca purchases RA treatment from Rigel for up to $1.2 billion. AstraZeneca has signed a deal worth up to $1.2 billion with Rigel for its rheumatoid arthritis drug, called R788, which is "the furthest developed in a new class of oral drugs being tested for treating RA and is designed for patients who do not respond to the older drug, methotrexate." The Daily Telegraph (UK). Merck may seek approval to sell Gardasil for new uses. Merck's "Gardasil is about 89 percent effective in blocking cervical cancer, genital warts and lingering HPV infections in women aged 24 to 45." The American Press. New Medicare rules may help Affymax grab market share from Amgen. New Medicare rules "will cap fees for kidney dialysis, including the cost of anemia drugs, at about $250 per treatment starting on Jan. 1, 2011, and combine all services under one bill or 'bundle,' said Yaron Werber, a Citibank analyst. Bloomberg News. Affymax readies blockbuster alternative to Epogen . Affymax hopes to get an FDA approval for its experimental anemia treatment Hematide next year, and that could leave the developer perfectly positioned to take advantage of new Medicare rules capping the cost of kidney dialysis at $250. Bloomberg news. http://www.bloomberg.com/apps/news?pid=20601202&sid=a1meTJTyj3g8 Details at http://www.pharm-education.com/2010/02/potential-kidney-transplant-drug-wins.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. | AuthorShruti is a visionary leader,a result-oriented professional and a pharmaceutical scientist targeting path- breaking research and technologies of future.  ArchivesSeptember 2010 Categories |
