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Topic: New chemical entities

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In the News (Sat 28 Nov 09)

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	Fall Health & Fitness
		New research is also identifying important differences in the way various patient groups react to drugs.
		The new field of pharmacogenomics is developing methods for discovering these key genetic differences that may influence the way patients respond to pain-relieving drugs.
		In the near future, physicians may be able to administer new types of anti-inflammatory drugs and new chemical entities that may modulate the causes of pain following injury to nerve tissue.
	www.washingtonpost.com /wp-adv/newsweek/fallhealth00/pain.html (833 words)

	Lupin - New drugs
		Lupin's research in new chemical entities uses not only the customary chemical synthesis route but also herbal based leads.
		Lupin has developed a new herbal drug of which the 'proof of concept' study had shown very good remission.
		In FY 2002-03, Lupin synthesized and screened nearly 500 new molecules for anti-inflammatory activity.
	www.lupinworld.com /r_d/newdrugs.htm (129 words)

	Frequently Asked Questions for New Drug Product Exclusivity
		A 5-year period of exclusivity is granted to new drug applications for products containing chemical entities never previously approved by FDA either alone or in combination.
		In this context, "new" is intended to convey a lack of prior use of a clinical investigation rather than any temporal requirement.
		A new chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Act.
	www.fda.gov /cder/about/smallbiz/exclusivity.htm (1165 words)

	Monthly Feature - June 2005 - Nanotechnology Aims to Improve Drug Synthesis
		Discovering a new drug to fight cancer is a major accomplishment, but figuring out how to synthesize that drug in large quantities and in pure form can often be as much of a challenge.
		Unfortunately, these chemical catalysts are not as specific as their enzymatic counterparts, and as a result, none of the 11 chemical reactions (in the case of tamoxifen's synthesis) is perfect — each chemical step produces the desired chemical and various byproducts that must be removed subsequently; in contrast, enzymes rarely generate byproducts.
		Zhou explained that chemical catalysts have always been nanoscale entities, but what is new is that chemists can now control the exact makeup of the catalyst at the atomic and molecular levels.
	nano.cancer.gov /news_center/monthly_feature_2005_jun.asp (1976 words)

	Drug development for neglected diseases: a deficient market and a public-health policy failure (Site not responding. Last check: 2007-10-13)
		For the period considered, the number of new chemical entities per million DALYs was 0·55 for infectious and parasitic diseases, compared with values two to three times higher (ranging between 1·25 and 1·44) for the main diseases of the high-income countries.
		Overall, the biggest advance in drug research and development and new chemical entity outputs for neglected diseases has been in malaria, for which four new chemical entities have been approved between 1975 and 1999, and 18 projects were in clinical development in 2001.
		The new approaches to antimalarial therapies rely mainly on artemisinin derivatives discovered in China in the 1970s, which are particularly effective in combination with other drugs in slowing the development and spread of drug resistance.
	www.malattiemetaboliche.it /articoli/drug_development_for_neglected.htm (5242 words)

	New chemical entity - Wikipedia, the free encyclopedia
		A NCE is a chemical molecule developed by the innovator company in the early drug discovery stage, which after undergoing clinical trials could translate into a drug that could be a cure for some disease.
		Synthesis of NCE is the first step in the process of development of a drug.
		Companies adopting this model of business would be able to generate high margins as they get a huge one-time payment for the NCE apart from entering into a revenue sharing agreement with the licensee company.
	en.wikipedia.org /wiki/New_chemical_entity (235 words)

	Untitled Document
		And only 15% of drugs approved during the period both used new chemical compounds as their active ingredients and were deemed by the FDA to provide significant improvement over existing medicines, a new study finds.
		The study found that the FDA approved 1,035 drugs in the period 1989 to 2000; 361 (35%) were new molecular entities drugs based on new chemicals acting in new ways to treat a disease.
		The NIHCM Foundation analysis of FDA data found that of the 361 drugs categorized by the FDA as new chemical entities between 1989 and 2000, 153 (15% of the total 1,035 drugs approved) were designated as priority drugs; the remaining 208 were put on a standard review track.
	www.nihcm.org /InnovationsPR.html (840 words)

	New Indian Patent Law, A Sell Off By Alternative Law Forum
		The term chemical ought to have been inserted so as to read any new chemical entity.
		The use of the phrase which does not result in the enhancement of the known efficacy is ambiguous, too broad and potentially allows for new forms of existing substances to become patented.
		It is quite possible to argue the procedure both ways, therefore, potentially delaying urgent new drugs that a developing or least developing country may require.
	www.countercurrents.org /gl-alf240305.htm (1785 words)

	HYLE 4-2 (1998): Modes of Chemical Becoming
		The kinds of chemical becoming discussed here may be interpreted to exemplify what a "harmony of features” (Neville 1989) or "fully reciprocal acting” (Leclerc 1972) might mean, and to extend classical ontology in interesting, and perhaps useful, ways.
		The fact that some chemical species react while others do not can be understood (in favorable cases) in terms of the chemical bonding (enthalpy) and degree of disorder (entropy) of the reactant and product states.
		In both these types of chemical system it is possible to investigate the component species or processes in as much detail as may be desired, so that rather complete understanding of those components can be attained.
	www.hyle.org /journal/issues/4/earley.htm (4224 words)

	The Consultant Pharmacist: May 1999 \| 1999 New Drug Review
		From potent new weapons for fighting arthritis, depression, and hypertension to new adjunctive therapies for dyslipidemia and Parkinson's disease, the host of new chemical entities approved by the FDA in 1998 hold great promise for improved care of many disorders common in the elderly.
		Here's a look at the new arrivals with the greatest potential applications in senior care-the advantages they offer, their side effect profiles and interaction potentials, and other information to facilitate safe, effective use in clinical practice.
		New positive antinuclear antibodies were demonstrated in 11% of patients on etanercept, compared with 5% receiving placebo, and new positive, double-stranded DNA was present in 15% of cases, as compared to 4% of the placebo group.
	www.ascp.com /publications/tcp/1999/may/99review.shtml (6462 words)

	An Introduction to Molecular Modeling
		Over the past few years, advances in the development of new mathematical models which describe chemical phenomena and development of more intuitive program interfaces coupled with the availability of faster, smaller and affordable computer hardware have provided experimental scientists with a new set of computational tools.
		As the nuclei are moved to new coordinates and molecular energies are re-calculated, a quantitative description of molecular energy is derived.
		Each of the methods described above are used to calculate the energy of a compound in a specific 3D orientation and to optimize the geometry as a function of energy (i.e., adjust the coordinates of each of the atoms and recompute the energy of the molecule until a minimum energy is obtained).
	www.netsci.org /Science/Compchem/feature01.html (3950 words)

	Chemical Biology at the Barnett Institute (Site not responding. Last check: 2007-10-13)
		The discipline of Chemical Biology can be described as the study of how chemical entities modulate biological systems through atomic, molecular, and cellular interactions with targets of defined genetic origin.
		Some of the relevant tools for this work include combinatorial/parallel library synthesis (where new chemical entities are produced), automated bioassays (where the biomolecular targets of small molecule candidates are screened) and microarray screening (where impact on genomic/proteomic expression is quantitated).
		Their group modeled a new family of agents based on a natural product skeleton and the first generation of agents showed promising selectivity and affinity.
	www.dac.neu.edu /barnett/Progr/ChemBiol.htm (219 words)

	CiteULike: The use of biodiversity as source of new chemical entities against defined molecular targets for treatment ... (Site not responding. Last check: 2007-10-13)
		The use of biodiversity as source of new chemical entities against defined molecular targets for treatment of malaria, tuberculosis, and T-cell mediated diseases--a review.
		The modern approach to the development of new chemical entities against complex diseases, especially the neglected endemic diseases such as tuberculosis and malaria, is based on the use of defined molecular targets.
		Chemical diversity is also driven by these forces, in an attempt to best fit the plant communities to the particular abiotic stresses, fauna, and microbes that co-exist with them.
	www.citeulike.org /user/cmmorel/article/610982 (896 words)

	Chemical & Engineering News: Latest News - Analyzing Protein Interactions
		A new technique could accelerate basic research and drug discovery by probing sets of compound-protein interactions all at once, rather than in a tedious one-by-one manner.
		The work "is remarkable in that it takes a fully fledged chemical genomics approach to the pharmacological targeting" of an enzyme family, comments Giulio Superti-Furga, director of the Center of Molecular Medicine at the Austrian Academy of Sciences, Vienna, on the Faculty of 1000 scientific review website.
		The new approach avoids the need "to piece together such insights from dozens of disparate papers that trickle out over years," says Shokat group postdoc Zachary A. Knight.
	pubs.acs.org /cen/news/84/i21/8421notw8.html (262 words)

	Inspire Awarded U.S. Key Patent for New Chemical Entities
		This is the company's first NCE patent and is the result of Inspire's in-house discovery efforts in the areas of chemistry and biology.
		This receptor is a key modulator of mucociliary clearance, the body's natural mechanism for cleansing the airways of the respiratory system and hydrating mucus membranes.
		This patent, in addition to other patents that have recently issued, strengthens our position as a leader in the development of novel therapies, based on new targets and new mechanisms of action, for the treatment of serious diseases that involve mucosal hydration.
	www.inspirepharm.com /May03-99news.html (440 words)

	New drug targets for kinetoplastid drug discovery
		Of the 1223 new drugs (new chemical entities) which entered the market between 1975 and 1996, only 11 were directed against parasites responsible for the diseases in TDR’s mandate.
		To consider ways of improving this situation, TDR's Drug Discovery Research team organized a meeting on new chemical leads for kinetoplastid diseases, which was held in Heidelberg in October 1999.
		Scientists who believe they have projects that are relevant to drug discovery for any of the kinetoplastid diseases, and for which molecular targets and/or lead molecules have been identified, are urged to contact Richard Pink for advice and information on TDR’s potential ability to advance the project.
	www.who.int /tdr/publications/tdrnews/news62/kinetoplastid.htm (628 words)

	GlaxoSmithKline: Annual Review 2004 - Delivering the pipeline
		New indications for Seretide/Advair made this important asthma medicine available for use by children aged 4 to 11 years.
		The best news in 2004 was the results from our clinical programme for Cervarix, a vaccine candidate against cervical cancer, which turned out to be even better than we had hoped for.
		The four other new products expected to be launched in 2005 are: Boniva a once-monthly treatment for osteoporosis, Avandaryl for type 2 diabetes, Entereg for post-operative bowel problems and Requip for restless legs syndrome.
	www.gsk.com /investors/reports/ar2004/annual-review-04/pipeline.htm (869 words)

	IMS Health - Pharmaceutical market intelligence (Site not responding. Last check: 2007-10-13)
		She believes: "The time has arrived for new drugs based on targeted medicine!" In her view, scale is the key to success in order to replicate and validate results.
		In his view, there is a need for greater partnering with the university sector to access new technologies.
		Perhaps one of the major factors discouraging companies from developing new antibiotics effective against drug resistant strains is the longer lead-times.
	open.imshealth.com /IMSinclude/i_article_20040323a.asp (1100 words)

	Access and Utilization of New Antidepressant and Antipsychotic Medications
		The entry of new chemical entities into the psychotherapeutic market in the coming years will profoundly alter the dynamics shaping access to and utilization of these products in much the same way the launch of the current generation of products changed the market within the last decade.
		However, even as these new agents are launched, the current group of antidepressants and antipsychotics will be nearing the end of their patent life.
		Second, new medications are recognized as a major factor in cost increases -- particularly in mental health (with a high incidence of new drugs available).
	aspe.hhs.gov /health/reports/Psychmedaccess/chap08.htm (2028 words)

	The Hindu : National : Public interest groups for limiting scope of patents
		NEW DELHI: Public interest groups, in their submissions to the Technical Expert Committee on Patent Issues have recommended limiting the scope of patents for pharmaceutical substances and the introduction of appropriate tests over micro-organisms.
		Its mandate is to examine if limiting the grant of patents to a new chemical entity and excluding micro-organisms from the patent regime are compatible with India's obligations under the Trade-Related Aspects of Intellectual Property Rights Agreement.
		The Affordable Medicines Treatment Campaign (AMTC) told the Committee that limiting patents to "new chemical entities" was compatible with TRIPS and necessary to address the country's public health concerns and for the survival of the domestic pharmaceutical industry.
	www.hindu.com /2005/08/29/stories/2005082905751200.htm (460 words)

	Public Citizen \| Congress Watch \| Congress Watch - Critique of the DiMasi/Tufts Methodology and Other Key Prescription ...
		DiMasi’s figure is the average RandD cost for "self-originated new chemical entities" (NCEs) — which are the most expensive class of new drugs.
		The RandD costs for all new drugs are detailed in Section II of Public Citizen’s July report.
		Applying the same methodology to the new DiMasi study, the average after-tax cash outlay for a self-originated NCE is approximately $240 million.
	www.citizen.org /congress/reform/drug_industry/articles.cfm?ID=6532 (1044 words)

	Forty Eight New Active Substances launched in 1998
		A total of 45 new active substances (NAS) were launched worldwide in 1998, slightly down on the 1997 total of 50 NAS, but on a par with the previous two years of 44 and 45 respectively, in 1996 and 1995.
		This situation should change as Japan has formally undertaken to reduce average review times for new drugs to one year from April 2000, and to accept foreign data in applications, under a bilateral agreement reached with the USA at the G8 meeting in summer 1998.
		The US FDA's accelerated approval process for drugs classified as having significant contribution over drugs already on the market or filling a niche not already satisfied means that the approval process in the US is accelerated at the final stages in the US, overtaking European first approvals.
	www.ims-global.com /insight/news_story/news_story_990719.htm (798 words)

	RDBC03 Biotechnology in Healthcare: Product and Market Review (Site not responding. Last check: 2007-10-13)
		While we are quite bullish on the sector's new product flow over the next several years, we believe it is prudent for investors to begin evaluating company assets beyond product pipelines.
		The discovery of new targets and scientific platforms gives biotech companies new pathways to combat diseases that have not been addressed by traditional small-molecule drugs.
		The expanding geriatic population is likely to increase the prevalence of poorly addressed serious illnesses such as cancer, blood disorders and viral infections suggesting that the demand for effective biologic drugs will remain strong in the coming years.
	www.bccresearch.com /editors/RDBC03.html (615 words)

	Investor's Business Daily: Breaking News
		The strategic initiative consists of an aggregate $8 million equity investment, which builds on its ongoing sponsored research arrangement, in which, on behalf of Kos, Triad is designing and synthesizing certain new chemical entities that regulate HDL (the "good") cholesterol.
		This alliance with Triad will broaden Kos' research and development efforts to include the discovery and synthesis of new chemical entities, leveraging Kos' existing competency in drug delivery and development.
		The sponsored research being performed by Triad, which began during the fourth quarter of 2003, represents Kos' first formal effort in the development of new chemical entities in key areas of therapeutic interest, particularly HDL cholesterol modulators.
	www.investors.com /breakingnews.asp?journalid=25804660 (1061 words)

	Rose-Hulman Ventures News
		This innovative product will allow chemists to optimize new chemical entities faster, shortening the product development time and increasing corporate revenues and profits.
		Often promising new chemical and pharmaceutical products get stuck in process development, where it can take 2-4 years to run a series of tests before the compound can be made in large enough quantities for commercialization.
		“Not only will this new chemical synthesizer help increase productivity and throughput in the labs, but it will also position Camile as the only company with a platform of products that can handle the work flow from drug discovery to manufacturing,” he said.
	www.rose-hulman.edu /Users/groups/RHV/HTML/news/camile.htm (544 words)

	The Hindu : Business : Sun Pharma's focus on new chemical entities
		Sun Pharmaceuticals' new research and development (R&D) centre, SPARC (Sun Pharmaceuticals Advanced Research Centre) in Vadodara was inaugurated
		While speaking on the occasion, Dr. Kalam highlighted the need to be up-to-date with the latest technological advancements globally, saying the onset of nanotechnology had helped in administering the right treatment to patients.
		The focus at SPARC will be New Chemical Entities (NCEs) and Novel Drug Delivery Systems (NDDS)." While Phase I trials for an NCE cost around Rs.
	www.hinduonnet.com /2004/12/16/stories/2004121602681800.htm (554 words)

	FasterCures: Biopharmaceuticals: The Innovation Pipeline Race
		While there is more corporate oversight and bureaucracy inherent in larger organizations, Dr. O'Bryan-Tear noted that large companies are inherently more risk-averse in their research agendas, as they have more opportunities to fail, based simply on the increased compounds they are researching.
		Where they previously provided funds to companies with a promising new chemical entitity, many are waiting for the compounds to reach mid-stage clinical trials, where the investment risk and the time to market are both decreased.
		The panelists concluded that, though the investment climate is increasingly risk-averse and new chemical entities face hurdles at every step of the development process, "targeted therapies are the future" and big pharma and small biotechs each possess individual strengths and weaknesses in their research and development protocols.
	www.fastercures.org /sec/biopharmaceuticals_innovation (735 words)

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