Pharmaceutical News

news.
Date Posted: 23 October 2009

Quick-Med Technologies, Inc. (OTCBB: QMDT) announced today that the Food and Drug Administration has issued Guidance to support the classification of the Company’s NIMBUS® barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance on February 25, 2009 via FDA’s De Novo review process, a special clearance program for medical devices that are found to be “not substantially equivalent” to any predicate device. “This guidance is important because it now lets us pursue other planned medical device applications using our own bandage product as a predicate device” stated Ladd Greeno, CEO of Quick-Med Technologies, Inc. “And since we have significant patent protection using this molecule, we believe that other companies cannot make similar use of this guidance,” Mr. Greeno added. The newly issued guidance pertains to a wound dressing with permanently bound cationic biocide pDADMAC, a key component of the NIMBUS technology and one of the molecular entities covered in nine Quick-Med U.S. patents and patents pending and in 24 foreign counterparts. The guidance document specifies only the cationic biocide polyDADMAC; dressings with other cationic biocides are not within the scope of this guidance. BIOGUARD™ dressings, which were introduced in June by Quick-Med licensee Derma Sciences, Inc. (OTCBB: DSCI), are the first wound care products to feature the novel, FDA-cleared NIMBUS technology and subject of the Guidance. The dressings serve as a barrier to infection, kill germs absorbed into the dressing, and provide an optimum wound healing environment. The NIMBUS active agent maintains effectiveness even in the presence of large amounts of proteinaceous exudates. NIMBUS is unique in that it is the only non-leaching antimicrobial wound dressing, which the Company believes is an important distinction; other antimicrobial dressings rely on the release of chemicals to the wound bed that can impede the wound healing process. NIMBUS forms a sterile bacterial barrier that prohibits the transfer of microorganisms into the wound because the microbicidal agent is bound to the dressing. NIMBUS is non-toxic, long-lasting and not blocked by organics such as blood, exudates, urine and perspiration. By its design, NIMBUS poses minimal risk of bacteria developing resistance. Copies of the Guidance, which was announced in the Federal Register on October 16, are available on the FDA website at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm186571.htm. About Quick-Med Technologies, Inc.Quick-Med Technologies, Inc. is a life sciences company that is developing innovative technologies for the healthcare and consumer markets. Quick-Med is developing NIMBUS applications in several other advanced wound dressing formats including adhesives, foams, hydrogels, films, and hydrocolloids. For more information, see: www.quickmedtech.com. © 2009 Quick-Med Technologies, Inc. All rights reserved. NIMBUS® is a registered trademark of Quick-Med Technologies, Inc. BIOGUARD™ is a trademark of Derma Sciences, Inc. Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "expect," "plan," "believe," "anticipate," "intend," "could," "would," "estimate," and/or "continue" or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements involve risks and uncertainties, including those risks that are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"), which may be accessed at the SEC's Edgar System at www.sec.gov.
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Merck, Schering-Plough news.
Date Posted: 23 October 2009

Merck & Co., Inc. (NYSE: MRK) and Schering-Plough Corporation (NYSE: SGP) today announced that they have received clearance from the European Commission (EC) under the EC Merger Regulation for their proposed merger. “Approval from the European Commission marks a key milestone for the completion of our transaction with Schering-Plough,” said Richard T. Clark, chairman, president and chief executive officer of Merck. “We're making good progress towards our closing and look forward to creating a strong, global leader that will make a substantial difference to patients and health care around the world.” Integration planning teams from Merck and Schering-Plough are working together to ensure that the combined company will be well equipped to begin its first day of business as soon as the merger is completed. Merck and Schering-Plough continue to expect the transaction to close in the fourth quarter of 2009. About MerckMerck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com. About Schering-PloughSchering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com. Forward-Looking StatementThis news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the proposed merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s and Schering-Plough’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the proposed merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the ability to obtain governmental and self-regulatory organization approvals of the merger on the proposed terms and schedule; the failure to obtain the financing required for the merger; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; the possibility that the merger does not close, including, but not limited to, due to the failure to satisfy the closing conditions; Merck’s and Schering-Plough’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s and Schering-Plough’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions. Merck and Schering-Plough undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2008 Annual Report on Form 10-K, Schering-Plough’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6081331&lang=en
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AVANIR Pharmaceuticals, Inc. news.
Date Posted: 09 October 2009

AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced additional detailed results from the confirmatory double-blind Phase III STAR trial evaluating two doses of the investigational drug Zenvia™ (dextromethorphan/quinidine) compared to placebo in the treatment of pseudobulbar affect (PBA) among patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). Over the course of the 12-week study in the MS patient subset, Zenvia 30/10 mg met the primary efficacy endpoint by reducing PBA episode rates by an incremental 11.9% beyond placebo (p=0.0280). The lower dose Zenvia 20/10 mg group did not achieve a statistically significant reduction in PBA episode rates compared to placebo. These results were presented today during a late-breaker poster session at the 3rd World Congress on Controversies in Neurology in Prague, Czech Republic (Poster Number: 11). Efficacy Highlights – MS Cohort: Zenvia 30/10 mg dose met the primary endpoint in the subset of patients with underlying MS by significantly reducing PBA episode rates compared to placebo Both Zenvia groups demonstrated a numerical reduction in mean CNS-LS scores but did not achieve statistical significance versus placebo in this small subset of MS patients Zenvia 30/10 mg demonstrated relief of MS-related pain in the subset of MS patients with moderate-to-severe pain “PBA represents an area of high unmet medical need with no FDA-approved treatments currently available. Although the involuntary emotional outbursts of PBA cause considerable impairment for millions of individuals in the United States, it is under recognized and commonly misdiagnosed,” said poster presenter Daniel Wynn, MD, Director, Clinical Research, Co-Director, Consultants in Neurology Multiple Sclerosis Center and STAR Trial Steering Committee member. “If approved, Zenvia will be an important treatment option to ameliorate the profound distress caused by PBA among individuals afflicted with neurologic disease or injury and their caregivers.” “We were very pleased that Zenvia demonstrated significant improvement in PBA episodes in the MS sub-population as well as encouraging proof of concept data in MS-related pain,” said Randall Kaye, MD, AVANIR’s Chief Medical Officer. “This is especially exciting given that the STAR trial was not powered to detect an efficacy signal in such a small number of patients. These data provide additional insight into the clinical utility of Zenvia and help shape our plans for future drug development.” ADDITIONAL EFFICACY RESULTS An important pre-specified secondary endpoint was the reduction of pain associated with MS using the 11-point Pain Rating Scale (PRS). All MS patients enrolled in the study assessed their daily pain regardless of baseline pain level or use of concomitant analgesics. Mean pain scores in MS patients (all patients regardless of baseline pain score) were decreased from baseline across time in the Zenvia 30/10 mg group. Mean scores at days 15 and 29 showed trends for superiority of Zenvia 30/10 mg over placebo (p=0.0512 and p=0.0859, respectively). In an additional preliminary analysis that included only MS patients with moderate-to-severe pain at baseline (PRS score =4), mean PRS scores in the Zenvia 30/10 mg group were significantly lower than those in the placebo group on days 29, 57, and 84. Data from this important secondary efficacy endpoint are summarized in the following table: PRS Scores Across Time in MS Patients With Baseline Score =4 (ITT Population)aStudy Visit   Zenvia 30/10 mg n = 26   Placebo n = 22   p-valueb Baseline   5.62 (1.53)   5.85 (1.75)   0.33 Day 15   2.74 (2.66)   2.99 (2.54)   0.24 Day 29   2.42 (2.63)   2.92 (2.67)   0.01 Day 57   2.02 (2.49)   2.68 (2.57)   <0.0001 Day 84   …
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Bristol-Myers Squibb news.
Date Posted: 06 October 2009

PARIS & LONDON(BUSINESS WIRE)Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE/LSE: AZN) announced today that the European Commission has granted marketing authorisation for ONGLYZATM in the 27 countries of the European Union. ONGLYZA is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycaemic control: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; or in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate. The marketing authorisation is based on data submitted from a comprehensive clinical development programme that included six core Phase III registrational trials and a Phase IIIB study comparing saxagliptin plus metformin with sitagliptin plus metformin. The registrational trials assessed the safety and efficacy of ONGLYZA and involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with ONGLYZA. ONGLYZA is the first medicine to be launched in Europe through the worldwide collaboration of Bristol-Myers Squibb and AstraZeneca to enable the companies to research, develop and commercialise select investigational medicines for the treatment of type 2 diabetes. Béatrice Cazala, Bristol-Myers Squibb’s president, Europe, and president, global commercialization, said: “The European Commission decision marks an important milestone in the alliance between Bristol-Myers Squibb and AstraZeneca. Our legacy in treating type 2 diabetes and cardiovascular disease, together with our knowledge and expertise, enables us to deliver to patients a medicine that will offer further choice for the treatment of this serious condition.” Ulf Sather, AstraZeneca’s regional vice president for Europe, said: “Diabetes is a growing epidemic currently affecting some 53 million people in Europe with the number of cases expected to increase. Today’s announcement is good news for those affected by type 2 diabetes and further demonstrates the commitment of AstraZeneca and Bristol-Myers Squibb to bring much needed options for the treatment of type 2 diabetes.” ONGLYZA belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to enhance the body's ability to decrease blood sugar (glucose) when it is elevated by acting on the natural hormones, incretins, thereby increasing insulin production, and by reducing the liver's production of glucose. The launch of ONGLYZA is expected to begin in the fourth quarter of 2009. About Type 2 Diabetes Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin (a hormone that is needed for the cells of the body to properly take up glucose). This leads to elevated blood glucose levels (hyperglycemia) that are sustained over time. Sustained hyperglycemia, the hallmark of diabetes, is associated with long-term complications that can affect almost every part of the body. The genesis of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role. There are two primary underlying causes associated with type 2 diabetes: the body does not produce enough insulin (insulin deficiency), and the cells are resistant to the effect of insulin (insulin resistance). Symptoms of type 2 diabetes develop gradually, and their onset is not as sudden as in type 1 diabetes. Symptoms may include fatigue, frequent urination, increased thirst and hunger, weight loss, blurred vision, and slow healing of wounds or sores. Some people, however, have no symptoms. Type 2 diabetes is most often associated with older age, obesity, family history of diabetes, previous history of gestational diabetes, physical inactivity and certain ethnicities. People with type 2 diabetes often are characterised with: insulin resistance, abdominal obesity, a sedentary lifestyle, having low HDL-C (“good”) cholesterol levels and high triglyceride levels and hypertension. According to the International Diabetes Federation (IDF), type 2 diabetes accounts for approximately 85 to 95 percent of all diabetes. The IDF says that across the world there are 246 million people with both types of diabetes. Taking a 90 percent figure for type 2, this equates to roughly 221 million people with type 2 diabetes globally. It is estimated there are more than 53 million people in Europe with type 2 diabetes. The International Diabetes Federation (IDF) recommends a haemoglob…
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test news.
Date Posted: 07 October 2009

test
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PROcellcare news.
Date Posted: 21 September 2009

Heiligkreuzsteinach / Heidelberg, Germany, September 17th, 2009 / b3c newswire / – PROdesign GmbH launches the innovative cell feeding station PROcellcare® based on a 96 well plate. The System has initially been developed by the licensing partner EMBL (European Molecular Biology Laboratory). PROcellcare® stands for a system, which supplies live cells (in vitro) under the microscope with biological nutrient and working solutions thus allowing the scientist/developer to execute efficient and automatic dispensing and controlling processes of the equipment (microscope, table and incubator) and also facilitating the online supervision of the cells over a long period of time during the continuous operation mode (24h/7). This instrument is presently being applied within different market segments covering the fields of research and development in molecular biotechnology (Live Cell Imaging). PROcellcare® has been filed for patent by the licensing partner EMBL in Europe and will be presented on a microscope OLYMPUS type IX81 for the first time to the general public on the Biotechnica 2009 (Halle 9, Stand E08), which takes place from October 6 to October 8, 2009 in Hannover. PROcellcare® The treatment of cells and cell cultures, however, is one of the most complex and time-consuming work processes in a Live-Sciences-laboratory. The testing of active agents in, and on cell culture systems as well as the effects caused on the cells over a certain period of time is becoming more and more important. Small and medium numbers of tests, cells are generally handled und feed manually. The methods, however, how cells are treated and cultivated in the laboratory have barely changed over the last 20 years. With this new PROcellcare® system it will now be possible to execute tasks on live cells in High-Throughput-Rates. This automatic cell feeding system allows the automated cell culture, the exchange of nutrient and working solutions, image and video analyses for basic works, such as the exchange of nutrient and working solution media, as well as for long-term tests (24h/7). Microtiter plate-based High-Throughput-Screening-Systems of live cells under the microscope OLYMPUS Typ IX81 are combined with a nutrient / rinsing and suction system, which will reduce today’s pipetting, handling and control processes to a minimum volume. PROcellcare® stands for a system, which supplies live cells (in vitro) under the microscope in the optical axis with biological nutrient and working solutions thus allowing the scientist/developer to execute efficient and automatic dispensing and controlling processes of the equipment (microscope and incubator). This instrument is presently being applied within different market segments covering the fields of research and development in molecular biotechnology (Live Cell Imaging). The system allows the supervision of the cells over a specific period of time (images and video analyses of cell reactions). The PROcellcare® system has been filed for patent in Europe and offers – within this particular price segment – a number of functions, up to now unknown on the market, for the freely configurable activation and control of pumps, engines as well as nutrient and working solutions supply systems. The user is offered a library of software functions, which helps him to configure his own working and cell culture environment as well as routines in accordance with his specific requirements.  
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LGC Standards news.
Date Posted: 22 September 2009

Championing measurement science and quality control in the Russian analytical market   LGC Standards has opened its first office in St Petersburg, Russia. This new office, coming only six months after a presence in China was established, demonstrates that LGC Standards continues to grow to support laboratory quality worldwide. Russia is widely recognised as a ‘pharmerging’ market, with a predicted growth rate in the pharmaceutical sector of 17% per annum to 2013 (Espicom – The Pharmaceutical Market: Russia, 2009.) The initial focus for the Russian team will be this sector, launching the LGC Standards range of 2400 reference standards for pharmaceutical impurities to support quality control. LGC Standards provides a range of products and services for measurement and laboratory control encompassing reference material distribution and proficiency testing, together with the production of pharmaceutical impurities and custom synthesis. For the first time the company will be able to support Russian laboratories directly by offering logistical and technical advice in their local language. The new office will be managed by Svetlana Buchaka, who has a PhD in Chemistry from St Petersburg State University and experience in both the industrial and academic sectors. Dr Buchaka will be attending the conference ‘Modern methods of analysis of pharmaceutical products’ in Moscow, 2-4 December 2009 to meet with potential customers. Dr Matthias Brommer, Director, LGC Standards said: “While Russia has its own metrological system for chemistry (GOST standards), there is increasing interest in the ISO metrological system widely used in the European Union, particularly for those industries seeking export opportunities into this market. With our new office in Russia, LGC Standards will be well placed to support these developments.” Dr Svetlana Buchaka, Head of Representative Office in St-Petersburg, said “We have Russian-speaking experts in our Russian and Polish offices who have a good understanding of both the GOST and ISO systems, and can advise Russian laboratories on the correct use of laboratory quality products and services under both systems.” The LGC Standards website is available in Russian at www.lgcstandards.ru  
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Vital Life news.
Date Posted: 22 September 2009

Immulina® is launching in the UK to help boost the nation’s immunity against the H1N1 (swine flu) virus. A completely natural food supplement, Immulina® supports the body’s natural defences and has been described as ‘the most powerful natural immuno-stimulatory product ever discovered’ . Immulina® will add value to the current supplement offering, driving sales and footfall within Pharmacy. Pharmacy is at the centre of maintaining their communities health & well being; therefore it is important that there are over the counter products available which meet the needs of the customer. Taken every day, Immulina® has been scientifically proven to support the body’s immune system by maintaining the function of the immune system cells. Evidence Dr. Lars Lindmark, CEO of Kasima Medical Development AB was involved in a recent concluded animal study conducted at the Louisiana State University School of Veterinary Medicine, Division of Biotechnology & Molecular Medicine (BIOMED). He comments, “The results are promising with regard to preventative effects and milder symptoms of H1N1 infection. Immulina® tested in mice, showed a significant reduction of both symptoms and lung tissue damage after being infected by the influenza virus H1N1, compared to placebo.” It should be noted that this trial did not test against the new swine-origin strain of H1N1 influenza A specifically, but demonstrated the potential for Immulina® to help manage the impact of H1N1 in general. The study leader, Professor Gus Kousoulas summarised the outcome of the research: “The experimental results collectively indicate a substantial effect of the nutritional supplement on ameliorating clinical symptoms and adverse pathological implication of influenza infection in the mouse model and lead us to believe that this micro algae compound may be able to boost resistance to H1N1 influenza”. Ingredients Each caplet contains a unique blend of a patented and proprietary extract based on a bioactive micro algae complex from Arthrospira Platensis and its special formulation means it is 20-25 times more bioactive than many other products². It also differs from antibiotics or anti-viral drugs by acting as a resistance booster. Immulina® is high in protein, vitamins, minerals and essential fatty acids and has been manufactured in a special process which preserves the natural nutrients of the raw material. H1N1 Autumn Outbreak As we approach the cold & flu season and having felt the impact of the H1N1 Virus this summer, Immulina offers pharmacists an opportunity to stock a natural solution to help prevent and ease patient’s symptoms and suffering. The swine flu vaccination is expected in October and will only be available to at risk groups leaving many people vulnerable to the virus. Latest statistics from the NHS indicate that 30% of the UK population will be affected by an autumn outbreak of the H1N1 virus. Mark Brewer, Brand Manager for Immulina® says, “Immulina® has been developed to help everyone boost their body’s natural defences against viruses like H1N1. The unique formulation gives the daily work-out for your immune system so you can meet the challenges of a busy and stressful life. This is a great opportunity for Pharmacy to add real value and to offer their entire customer base a scientifically proven natural solution.” Immulina® is available in packs of 30 caplets, which retail for £24.95. For more information please contact Vital Life on 0207 720 1441 or email info@vital-life.co.uk.
 
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ASTELLAS news.
Date Posted: 22 September 2009

DEERFIELD, IL, September 21, 2009 – Astellas Pharma US, Inc. (“Astellas”), in partnership with the National Science Teachers Association (NSTA), is pleased to welcome its second-year class of Chicago-area science teachers to participate in the 2009 NSTA New Science Teacher Academy. The national, year-long program connects new science teachers to a range of tools and resources, while providing the support needed to build a strong foundation for science in their classrooms. The 2009 Astellassponsored science teachers, known as Astellas-NSTA Fellows, include 15 new science educators from middle and high schools in Chicago and the surrounding Cook, Kane, Lake, McHenry and Tazewell counties. “As a young science teacher I’ve found that juggling my responsibilities, while at the same time instilling in students an interest in science, can be a daunting task,” said Alex Mendralla, an eighth grade teacher at Palombi Middle School in Lake Villa, IL. “I am extremely excited to be a part of an amazing program that understands those struggles and offers solutions to the various frustrations that new science educators encounter.”
Headquartered in Deerfield, IL, Astellas’ support of the NSTA and the New Science Teacher Academy is one of the key initiatives the company is undertaking to support the local community and the advancement of science in the classroom. “Science is not only the foundation of our business, it’s our passion. A renewed and continued interest in the field—particularly among our youth—is what will keep fresh ideas and innovation moving forward,” said Seigo Kashii, president and CEO of Astellas Pharma US, Inc. “Our ongoing commitment to the NSTA New Science Teacher Academy reflects our overall goal of fostering the advancement of, and inspiration in, science careers—jobs that are pertinent in building a brighter future for us all.” According to a 2007 study, roughly one in four new teachers in Illinois leave their teaching careers during their first five years and do not return1. In an effort to help address the issue of teacher attrition, the NSTA created the New Science Teacher Academy, a professional development initiative designed to help promote quality science teaching, enhance teacher confidence and classroom excellence, and improve teacher content knowledge. The program uses mentoring and other professional development resources to support new science teachers during the often challenging, initial teaching years and to encourage them to stay in the profession.
”The ability to learn and develop exceptional teaching skills throughout a teaching career can have a profound effect on the quality of the teaching force and the performance of students,” said Dr. Francis Eberle, executive director, NSTA. “We remained thrilled at the results we see each year and are grateful to have continued support from industry leaders, like Astellas, for this critical program.”
For more information about the New Science Teacher Academy, or to learn how to apply, please visit www.nsta.org/academy.
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Aesica Pharmaceuticals news.
Date Posted: 25 September 2009

Aesica Pharmaceuticals, an innovative and service-driven supplier of APIs, finished dosage forms and custom synthesis solutions, announce its licence approval for manufacturing controlled substances. Aesica's Cramlington, UK site has been recently granted a Home Office licence to allow manufacture and supply of substances listed in Schedule 2 of the Misuse of Drugs Act 1971. Granting of this licence followed a programme of investment carried out to enhance the security of the site and its buildings, and the implementation of special procedures for handling of controlled substances. These changes allow the Aesica Cramlington site to offer facilities for contract manufacture of controlled active pharmaceutical ingredients in quantities from a few kilogrammes in its GMP pilot plant to tonnes in one of its bulk API plants. The first contract-manufactured controlled drug for one of Aesica’s customers is already in production. Aesica can now offer such controlled drug manufacturing capability at two sites in the UK: Queenborough and Cramlington covering both active ingredient synthesis and manufacture and packaging of finished dosage pharmaceutical forms. Mr. Adam Sims, Commercial Director of Aesica, said: “This is a significant step forward for Aesica in terms of broadening our capabilities in line with our customers’ demand.” To learn more please visit Aesica at CPhI in Madrid, October 13th – 15th 2009, Stand No. 4B29 (Hall 4), Feria de Madrid, or please contact us directly: Europe: Maria Koustareva Marketing Manager Tel: +44 (0)191 218 1969 E-mail: maria.koustareva@aesica-pharma.com USA: Michael Staff VP, Business Development Tel: +1 201.960.1828 E-mail: michael.staff@aesica-pharma.com
 
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