المصدر : رويترز أكدت دراسة علمية أجراها علماء من جامعة اوكسفورد البريطانية و آخرين من جامعة سيدني في أستراليا إن العلاج المكثف للمرضى بعقاقير ستاتين لخفض الكوليسترول بشكل آمن يمكن ان يؤدي أيضا الى خفض كبير في خطر الاصابة بأزمات قلبية والجلطات مقارنة بالجرعات المعتادة. وقال العلماء إن المزايا التي تحققت لها صلة مباشرة ونسبية مع خفض البروتين الدهني منخفض الكثافة ( ال.دي.ال) حتى بين المرضى الذين انخفضت عندهم المستويات بالفعل، حتى مع المستويات المنخفضة جدا من كوليسترول ال.دي.ال.”. ولدى تحليل نتائج التجارب وجد العلماء أن العلاج المكثف خفض مشاكل الاوعية الرئيسية بنسبة 15 في المئة، وشمل هذا خفضا بنسبة 13 في المئة في حالات الوفاة ذات الصلة بالقلب وخفضا نسبته 19 في المئة في عدد المرضى الذين يحتاجون جراحة قلب مفتوح وخفضا نسبته 16 في المئة في الاصابة بالجلطات.
Continue reading …اللجنة الخليجية المركزية للتسجيل الدوائي توافق على تسجيل منتجات صيدلانية وشركات جديدة للأدوية
November 8, 2010 1 Commentانتهت الجهات الصحية في دول الخليج العربي، من تحديث وإجراء تعديلات على اللائحة المركزية للتسجيل الدوائي التي تضع شروطاً ومواصفات ومتطلبات موحدة للتسجيل الدوائي. وصرح الدكتور أمين الأميري المدير التنفيذي لشؤون الممارسات الطبية والتراخيص في وزارة الصحة الذي ترأس اجتماع اللجنة الخمسين في دبي مؤخرا أن اللجنة الخليجية المركزية للتسجيل الدوائي قد ناقشت، إعادة تسجيل 17 مستحضراً جديداً واستكمال تسجيل 75 مستحضراً، بالإضافة إلى النسخ النهائية من اللائحة المركزية للتسجيل المركزي ودراسة «الثباتية» ودراسة التكافؤ الحيوي. وأكد الأميري أن التعاون قائم ومستمر بين دول التعاون في ما يخص الملاحظات عن جودة وأمن أي منتج دوائي. وبحث الاجتماع موضوع، تسجيل 21 شركة جديدة وإعادة تسجيل الشركات الجديدة واستعراض تقارير زيارة 8 شركات، وكذلك تسجيل 16 مستحضراً تمهيداً للتسجيل.. حيث وافقت اللجنة على تسجيل شركة واحدة في الوقت الذي تمت فيه الموافقة على تسجيل 27 منتجا صيدلانيا استوفت متطلبات التسجيل والوثائق المطلوبة. وقال: إنه تم رفض تسجيل 48 مستحضرا لعدم استيفاء المتطلبات التي يستوجبها التسجيل. وأشاد الدكتور أمين الأميري، باهتمام دول مجلس التعاون الخليجي ومكتبه التنفيذي ببرنامج التسجيل الدوائي المركزي، مشيرا إلى أن هذا التعاون يأتي توحيداً للجهود والإجراءات والأنظمة المتبعة للدول الأعضاء والاستفادة من الخبرات المشتركة في سهولة توفير الأدوية ومنتجاتها. وأكد الأميري مجددا ضرورة مضاعفة الجهود الكفيلة بتوفير دواء آمن…
Continue reading …الهيئة العامة للغذاء والدواء تلغي تسجيل المستحضرات التي تحتوي محفزات مستقبلات بيتا طويلة المفعول بشكل منفرد [Long acting beta agonists (LABA)] قامت الهيئة العامة للغذاء والدواء بإلغاء تسجيل المستحضرات التي تحتوي على محفزات مستقبلات بيتا طويلة المفعول Long Acting Beta Agonists (LABAs) المتوفرة بشكل منفرد وذلك بناءً على قرار لجنة تسجيل شركات الأدوية ومنتجاتها بتاريخ 16/11/1431هـ. تم اتخاذ هذا القرار بعد مراجعة دراسة إحصائية (Meta-analysis) لعدد 110 دراسات إكلينيكية لتقييم استخدام محفزات بيتا طويلة المفعول بشكل منفرد على 60954 من مرضى الربو. أظهرت هذا الدراسة إزدياد فرصة حدوث مضاعفات الربو التي تتطلب التنويم في المستشفى لدى الأطفال والبالغين، وكذلك حدوث وفيات لدى بعض المرضى عند مقارنتها بالمستحضرات الأخرى (جدول 1). No LABA LABA الحالة n (n/N%) n (n/N%) 4 (.01) 16 (.05) حالات الوفاة 27 (.09) 44 (.15) حالات الوفاة/ التنفس الاصطناعي 299 (.97) 369 (1.22) التنويم في المستشفى 304 (.99) 381 (1.26) مضاعفات الربو 40 (.13) 51 (.17) مجمل الوفيات لجميع الأسباب قامت الهيئة بعدة استشارات مع جهات محايدة وفرق عمل داخلية لتقييم مدى ضرورة توافر هذه المستحضرات وكانت التوصية كما يلي: كان معدل زيادة في حالات نوبات الربو الشديدة، ومعدلات تنويم المرضى، المصاحبة لاستخدام المستحضرات التي تحتوي على LABAs بشكل منفرد لعلاج مرضى الربو يقدر بـ 2.8 حالة…
Continue reading …المصدر: جريدة الشرق الأوسط 31 أكتوبر 21010 http://www.aawsat.com//details.asp?section=6&issueno=11660&article=593229&search=%C7%E1%CD%DF%E3%C9&state=true تصبح بموجبه ثاني أكبر مورد لأدوية الحقن في أميركا استحوذت مجموعة «الحكمة» الدوائية على أعمال شركة «باكستر» للرعاية الصحية في الولايات المتحدة الأميركية الخاصة بأدوية جنسية تعطي عن طريق الحقن متعددة المصادر بصفقة قيمتها 112 مليون دولار. وفي بيان لها أمس، قالت الشركة التي تتخذ من عمان مقرا رئيسيا لها وتعمل في عشر دول هي الأردن والسعودية والجزائر وتونس ومصر والبرتغال وإيطاليا والولايات المتحدة الأميركية وألمانيا وبريطانيا، إن عملية الاستحواذ الاستراتيجية للأدوية التي تعطى عن طريق الحقن متعددة المصادر تضيف إيرادات تقارب 180 مليون دولار سنويا وتعزز بصورة واسعة نطاق قاعدة صناعة الأدوية التي تعطى عن طريق الحقن لـ«الحكمة» عالميا. وأضاف البيان: «بعملية الاستحواذ هذه تصبح الحكمة ثاني أكبر مورد للأدوية التي تعطى عن طريق الحقن في الولايات المتحدة بحصة سوقية مجمعة تبلغ نحو 15 في المائة. وتحتوي الأدوية التي تعطى عن طريق الحقن متعددة المصادر على مجموعة شاملة ومتكاملة من المنتجات تتكون من 41 منتجا بقوة 150 جرعة وبأشكال متعددة عبر 23 مجالا علاجيا. ويشمل بعض المواد التي تؤخذ تحت الرقابة الطبية والتي تعد مكملا لمجموعة منتجات «الحكمة» لأدوية علاج السرطان، إضافة إلى إمكانية إعادة تحريك ملفات طلبات خاصة بتسجيل أدوية جنسية جديدة من شأنها أن تعزز مبيعات «الحكمة» مستقبلا. وجاء…
Continue reading …The US Food and Drug Administration (FDA) has approved clonidine hydrochloride, 0.1-mg and 0.2-mg, extended-release tablets (Kapvay; Shionogi Inc) alone or with stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric patients aged 6 to 17 years. The product is the first formulation of clonidine to be approved by the FDA for ADHD and also represents the first and only adjunctive treatment to stimulant therapy for the condition. “ADHD is a complex disorder that requires individualized treatment. While there are prescription treatment options available, many ADHD patients on stimulants do not achieve adequate control of symptoms,” explained Rakesh Jain, MD, MPH, director of psychiatric drug research for R/D Clinical Research in Lake Jackson, Texas, in a company news release. “Kapvay, when added to a stimulant, addresses an unmet need and improves ADHD symptoms beyond what is achieved by stimulants alone. This is a significant step forward for the treatment of ADHD to have an approved product for add-on therapy in our treatment armamentarium.” FDA approval was based on clinical data from 2 phase 3 studies, showing that twice-daily use of extended-release clonidine alone or with stimulants (methylphenidate or amphetamine) significantly improved ADHD symptoms in children and teenagers aged 6…
Continue reading …US regulators have granted Swiss drug giant Roche permission to market its veteran breast cancer drug Herceptin as a targeted treatment for advanced stomach cancer. Following in the footsteps of its European counterpart earlier this year, the US Food and Drug Administration has agreed that Herceptin (trastuzumab) is a safe and effective treatment for patients with metastatic cancer of the stomach or gastroesophageal junction. However, only patients with tumours expressing HER2 – a protein produced by a specific gene with cancer-causing potential – are eligible, and the approval also stipulates the drug should only be used if prior treatment for advanced disease has not been given. The FDA’s green light is based on solid results from a 594-patient Phase III study, known as ToGA, which showed that patients with HER-2 positive forms of the disease given Herceptin in addition to chemotherapy lived longer than those taking the latter alone. Roche’s drug improved overall survival by 37% compared to standalone chemotherapy (13.5 months versus 11 months, respectively), and in patients expressing high levels of HER2 the benefit was found to be even greater, with average survival of 16 months compared to 11.8 for the control arm. Commenting on the approval, Hal…
Continue reading …New long-term data for Novartis’ once-yearly osteoporosis jab Aclasta/Reclast have cemented its safety and efficacy profile, showing that the drug preserves bone mass and slashes the risk of new spine fractures. Unveiling its findings over the weekend, the Swiss drug giant said women taking Aclasta (zoledronic acid) for six years cut their risk of new morphometric spine fractures by 52% versus those who stopped treatment at three years, and that in the latter group bone mineral density was seen to dwindle (though remained well above baseline levels), making a strong case for its long-term use. In addition, the multicenter, double-blind, randomised, placebo-controlled study, which involved more than 1,200 women aged 68 years or older, showed that the number of adverse events between the three- and six-year treatment groups were comparable, and that there was no long-term effect on renal function or increase in risk of osteonecrosis of the jaw or atrial fibrillation. “These new long-term data reconfirm Aclasta as an important therapeutic option for doctors when considering an osteoporosis medicine for their patients,” said Dennis Black, PhD, the study’s lead author and Professor of Epidemiology and Biostatistics at the University of California, San Francisco, commenting on the results. The data…
Continue reading …Allergan has received a boost with the news that regulators in the USA have given the green light to the firm’s wrinkle smoother Botox as a treatment for the prevention of chronic migraine in adults. The US Food and Drug Administration has approved Botox (onabotulinumtoxin A) for the prophylactic treatment of headaches in adults with chronic migraine, characterised by severe headaches on 15 or more days per month, lasting four hours or longer.Allergan noted that Botox is the first prophylactic to be given the thumbs-up by the FDA “specifically for this debilitated patient population”. When injected in the head and neck, Botox is expected to produce results lasting up to three months, the company said. The approval was based on the PREEMPT programme, the largest ever in chronic migraine, which consisted of two trials involving 1,384 adults from 122 study sites in North America and Europe. In both PREEMPT studies, patients treated with Botox experienced a significantly greater decrease in the frequency of headache days from baseline compared to those on placebo at the week 24 primary endpoint (7.8 and 9.2 fewer days versus 6.4 and 6.9 days). Also at week 24, Botox patients reported a total cumulative reduction in…
Continue reading …Johnson & Johnson has been told to pay $257.7 million by a jury in Louisiana for claiming that its antipsychotic Risperdal was superior to similar drugs and downplaying its link to diabetes. The healthcare giant’s Janssen Pharmaceutica unit stands accused of violating the state’s Medical Assistance Programs Integrity Law. Louisiana alleges that in 2003 and 2004, J&J sent ‘Dear Doctor’ letters to more than 7,500 healthcare providers in the state claiming that Risperdal (risperidone) was safer than other antipsychotics, such as AstraZeneca’s Seroquel (quetiapine) and Eli Lilly’s Zyprexa (olanzapine). The court stated that J&J made more than 27,000 similar marketing calls and was warned by the US Food and Drug Administration out making “false and misleading claims that minimised the risk of diabetes associated with Risperdal and overstated the drugs supremacy to rival medicines”. As such, the jury, in the city of Opelousas, has imposed a penalty of $7,250 for each of the 35,542 violations of the MAPIL. J&J intends to appeal the decision. Spokesman Michael Heinley told Bloomberg that “we believe the jury was not appropriately instructed on applicable legal standards and that critical and highly relevant evidence was excluded”. Louisiana Attorney General Buddy Caldwell said the verdict “sends…
Continue reading …Pfizer has boosted its bid to expand in emerging markets as well as in biosimilars by getting access to market four insulin products being made by India’s Biocon. Under the terms of the deal, Pfizer is paying an upfront fee of $200 million to Biocon. The latter, described by the drugs giant as “Asia’s premier biotechnology company”, is also eligible to receive development milestones of up to $150 million, as well as payments linked to Pfizer’s sales of biosimilars of Sanofi-Aventis’ Lantus (insulin glargine), Novo Nordisk’s NovoRapid (insulin aspart), and Eli Lilly’s Humalog (insulin lispro), plus a recombinant human insulin product. In return, Pfizer is getting global rights to sellt he products, except in certain countries where the firms may co-market, eg Germany, India and Malaysia. The US major will also co-market with Biocon’s existing licensees in certain emerging countries. Biocon will remain responsible for the clinical development, manufacture and supply of these biosimilars, as well as for regulatory activities to secure approval. Its recombinant human insulin formulations are approved in 27 countries in developing markets (and sold in 23), while its version of Lantus has been launched in India. Kiran Mazumdar-Shaw, managing director of the Bangalore-headquartered firm, said the…
Continue reading …Another day and another alliance for Lundbeck as it has announced a link-up with fellow Danish firm Genmab to develop antibody therapeutics. Under the terms of the agreement, Genmab will receive an upfront payment of 7.5 million euros, while Lundbeck will fully fund the development of the antibodies for disorders of the central nervous system. If all the milestones in the agreement are achieved, the deal will be worth around 38 million euros to the biotech, plus single-digit royalties. Specifically Genmab will create novel human antibodies to three targets identified by Lundbeck, for CNS disorders, and has an option to take selected antibodies into clinical development for cancer indications at its own cost, subject to the payment of milestones and single-digit royalties to Lundbeck. Peter Hongaard Andersen, head of research at Lundbeck, said Genmab’s broad antibody development expertise and his firm’s knowledge in CNS disorders “is an ideal combination for developing new treatments in this important therapeutic area”. He added that the new partnership “follows Lundbeck’s new R&D strategy to ensure we have the most efficient platform for the future discovery and development of drugs that will be able to help and treat biologically-defined groups of patients with brain diseases”….
Continue reading …Pfizer announced Tuesday an agreement to acquire King Pharmaceuticals for $3.6 billion in cash, or $14.25 per share, representing a premium of approximately 40 percent over the company’s closing share price on October 11. Pfizer CEO Jeffrey Kindler noted that the deal will allow the drugmaker “to offer a fuller spectrum” of pain treatments, and further diversifying the company’s business. The agreement, which was approved by the boards of both companies, will give Pfizer access to such pain drugs as Avinza (morphine), Embeda (morphine sulfate/naltrexone hydrochloride) and the Flector Patch (diclofenac epolamine). King is also currently developing the tamper-resistant Remoxy (oxycodone), as well as a short-acting version of the drug, Acurox (oxycodone/niacin), which < a href=” http://www.firstwordplus.com/Fws.do?articleid=A2AACAE25AF042CB86175DCC0D39CE16″>failed to win an FDA panel’s support in April. King, which generated annual revenues last year of nearly $1.8 billion, also makes specialty pharmaceuticals and animal health products. Pfizer noted that “King’s three key businesses are not only complementary…but are also strategically aligned with Pfizer’s Primary Care, Established Products and Animal Health business units, enabling a seamless combination.” Pfizer expects the acquisition to be accretive to earnings by approximately $0.02 in 2011 and 2012, and approximately $0.03 to $0.04 between 2013 and 2015. The…
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Pfizer has discontinued a Phase III trial assessing the potential of Sutent (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer after yet another disappointing performance by the drug. The world’s number one drugmaker said last night that an interim analysis of data indicates that the combination is unlikely to improve overall survival compared to prednisone alone in men whose disease had progressed despite treatment with a docetaxel-based chemotherapy regimen. “There is a great need for better therapies for prostate cancer and we are committed to working with basic scientists and clinical researchers to identify more effective treatments for this disease,” said Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit, commenting on the decision. Sutent (sunitinib) is an oral multi-kinase inhibitor currently on the market for the treatment of gastrointestinal stromal tumor (GIST; if patients are intolerant or become resistant to imatinib mesylate), and advanced/metastatic renal cell carcinoma, and the company is also currently assessing its potential as an adjuvant treatment of renal cell carcinoma in a late-stage trial. But the drugmaker’s major clinical programme for Sutent has waned considerably over the last year or so. In 2009, Pfizer…
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Anglo-Swedish drug giant AstraZeneca has kicked off a Phase III clinical trial of its newly-acquired oral syk inhibitor fostamatinib, to assess its potential as a novel treatment for rheumatoid arthritis. The drugmaker said it has now enrolled the first patient in the study, which is looking at the use of fostamatinib – bought from Rigel Pharmaceuticals in a deal worth up to $1.25 billion in February – to treat patients who have had an inadequate response to disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate (MTX). Under the clinical programme, crowned OSKIRA (Oral Syk Inhibition in Rheumatoid Arthritis), three pivotal Phase III trials will test the drug’s efficacy and tolerability, two 12-month studies will examine the effect of fostamatinib on patients not responding to DMARDs, and a six-month trial will assess the drug’s effect on patients who failed to respond to prior anti-TNF therapy. Safety will also be looked at in extension studies. Two doses of fostamatinib will be studied in programme; a 100mg twice-daily regimen and a second regimen investigating 100mg twice daily for four weeks followed by a maintenance dose of 150mg once daily. And primary outcome measures across the three studies include the standard benchmark ACR 20…
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Novartis has signed an agreement to sell to Warner Chilcott plc the US rights to market Enablex®* (darifenacin) extended release tablets, a medicine to treat adults with symptoms of overactive bladder. The agreement will be filed with the US Federal Trade Commission under the Hart-Scott-Rodino Act and, subject to certain closing conditions set forth in the agreement, the transaction is expected to close by the end of October 2010. Novartis will receive an upfront payment of USD 400 million from Warner Chilcott, with the potential for additional milestone payments up to USD 20 million. Novartis retains the rights to darifenacin worldwide except in the US. Warner Chilcott expects to assume manufacturing of Enablex for the US once it is transferred to Warner Chilcott’s manufacturing facility. In 2005, Novartis signed an agreement with Procter & Gamble Pharmaceuticals (PGP) to co-promote and co-develop Enablex in the US. In October 2009, Warner Chilcott acquired PGP from Procter & Gamble Company and became Novartis collaborator in the agreement. Under the terms of the deal announced today, Warner Chilcott assumes rights to solely promote and develop Enablex for the US. Enablex was approved in the US by the US Food and Drug Administration in 2004…
Continue reading …Similac:الهيئة العامة للغذاء والدواء تحذر من استهلاك شحنات معينه من حليب بودرة للأطفال
September 28, 2010 3 Commentsأعلنت شركة أبوت بتاريخ 22/9/2010م الموافق 13/10/1431هـ عن قيامها بالسحب التطوعي لشحنات معينة من حليب بودرة للأطفال powder Infant Formulas للعلامة التجارية سيميلاك Similac® المعبأة في عبوات بلاستيكية ومعدنية، وذلك لاحتمالية وجود خنافس صغيرة أو يرقاتها. وترى هيئة الغذاء والدواء الأمريكية FDA أن وجود مثل هذه الحشرات أو يرقاتها لا يؤدي إلى ضرر مباشر على الصحة وإنما قد يسبب عدم ارتياح الأطفال الرضع نتيجة استهلاك هذا المنتج الملوث. وللتعرف على الشحنات التي تم سحبها، يرجى الضغط هنا هذا وتقوم الهيئة العامة للغذاء والدواء (SFDA) وبالتنسيق مع الجهات ذات العلاقة لاتخاذ الإجراءات الوقائية الضرورية لضمان عدم دخول هذا المنتج إلى أسواق المملكة من جهة، والتحري عن وجودها وسحبها من الأسواق المحلية من جهة أخرى. وقامت الهيئة العامة للغذاء والدواء بمتابعة ما يستجد في هذا الموضوع حيث ورد إلى الهيئة في حينها معلومات رسمية من هيئة الغذاء والدواء الأمريكية باحتمال تصدير دفعات من المنتجات الملوثة إلى المملكة وعليه قامت الهيئة بمخاطبة الشركة المسئولة عن المنتج للقيام بتزويد الهيئة ما يثبت عدم تصدير هذا المنتج للملكة أو سحب المنتج الملوث في حالة تصديره لأسواق المملكة وتزويد الهيئة بما يتم من قبلهم في هذا الصدد، وبعد الرجوع لسجلات الشركة بأمريكا تبين أن هنالك كمية صغير مكونة من أربعة صناديق ( أربعة وعشرين عبوة )…
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US regulators have given the all clear to Bayer HealthCare Pharmaceuticals’ new oral contraceptive Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets), the first birth control pill to be approved with four different indications. Beyaz is comprised of the hormone components of Bayer’s veteran oral contraceptive (OC) YAZ and 451mcg of the B vitamin levomefolate calcium, and the drug has been given the nod for the prevention of pregnancy and treating symptoms of premenstrual dysphoric disorder and moderate acne in women using the ‘pill’ for birth control. But what really differentiates Beyaz from the rest of the pack is its ability to raise folate levels, and thereby reduce the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing its use. A wealth of evidence exists in support of folate supplementation as a means of reducing brain and birth defects – which happen in the very early stages of pregnancy and so often before a woman is aware she has conceived – and the company is hoping that a contraceptive pill also able to boost levels of folate will have a competitive edge over its rivals and thereby breathe new life into its franchise. “Combining…
Continue reading …قررت وزارة الصحة اليوم السبت، وقف تداول عقار «أفانديا» الذى يعالج مرضى «السكري»، و13 عقاراً أخرى، تدخل فى تصنيعها المادة الفعالة والمستخدمة فى العقار ذاته، وسحب هذه الأدوية من الصيدليات، بسبب المخاطر الصحية الناتجة عن استخدام هذه المستحضرات. ونصحت الوزارة، فى بيان لها، المرضى، بمراجعة أطبائهم لاختيار علاج جديد، خاصة عقب توصل الوكالة الأوروبية للأدوية إلى أن أضرار استخدام هذه العقاقير أكبر من فوائدها، وتقنين استخدام عقار «أفانديا» فى الولايات المتحدة الأمريكية وقصر استخدامه على المرضى الذين لا يستجيبون لأدوية السكرى الأخرى. وقال الدكتور أشرف بيومى، رئيس الإدارة المركزية للشؤون الصيدلية، بوزارة الصحة، لـ «المصرى اليوم»: إن الإدارة اتخذت القرار «الأحوط». من جانبه، قال الدكتور عمرو ممدوح، رئيس شركة «جلاكسو سميث»، المنتجة للعقار فى مصر: «إن الشركة هدفها مصلحة المريض وأنها تعاملت بشفافية مع الأمر، ومنحت وزارة الصحة كل المعلومات ونتائج الاختبارات التى توافرت حول العقار، منذ إنتاجه حتى الآن. المصدر: http://www.almasryalyoum.com/node/167512 تشير التقارير إلى حدوث 500 حالة من السكتة القلبية و300 حادثة توقف القلب شهريا بسبب هذا الدواء الذي يمكنه إحداث تلف في القلب. يعالج الدواء المذكور أفينديا السكري من النوع الثاني وتسبب بحوالي 304 حالة وفاة في العام الماضي. ويشير تقرير من إدارة الغذاء والدواء الامريكية FDA، إلى ضرورة سحب الدواء من الأسواق وينصح طبيبان في الإدارة بمنع…
Continue reading …ROCKVILLE, Md — September 23, 2010 — The US Food and Drug Administration (FDA) announced that it will significantly restrict the use of the diabetes drug rosiglitazone (Avandia) to patients with type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with rosiglitazone. On July 14, 2010, the FDA Advisory Panel voted to keep rosiglitazone on the market despite concerns over associated heart risks — 20 members voted in favour, while 12 members voted to recommend that the FDA withdraw the drug. Today, the European Medicines Agency (EMEA) recommended the suspension of the marketing authorisations for rosiglitazone-containing anti-diabetes medications in Europe (Avandia, Avandamet, and Avaglim). These medicines will stop being available in Europe within the next few months. Physicians should stop prescribing rosiglitazone-containing medicines. The current review of rosiglitazone by the Agency’s Committee for Medicinal Products for Human Use (CHMP) was initiated on July 9, 2010, following the availability of new studies questioning the cardiovascular safety of the medicine. Data from clinical trials, observational studies, and meta-analyses of existing studies that have become available…
Continue reading …The Procter & Gamble Company Type Public (NYSE: PG) Dow Jones Industrial Average Component Industry Consumer goods Founded 1837 Headquarters Cincinnati, Ohio, U.S. Area served Worldwide Key people Bob McDonald (President) & (CEO) Products See List of Procter & Gamble brands Revenue ▲ US$79.03 billion (2009)[1] Operating income ▲ $16.13 billion (2009)[1] Net income ▲ $13.44 billion (2009)[1] Total assets ▲ $134.83 billion (2009)[1] Total equity ▲ $63.099 billion (2009)[1] Employees 127,000 (2010) Website pg.com Procter & Gamble headquarters Procter & Gamble Co. (P&G, NYSE: PG) is a Fortune 500 American multinational corporation headquartered in Downtown Cincinnati, Ohio[2] that manufactures a wide range ofconsumer goods. It is 6th in Fortune’s Most Admired Companies 2010 list.[3] P&G is credited with many business innovations including brand management and the soap opera. According to the Nielsen Company, in 2007 P&G spent more on U.S. advertising than any other company; the $2.62 billion spent by P&G is almost twice as much as that spent by General Motors, the next company on the Nielsen list.[4] P&G was named 2008 Advertiser of the Year by Cannes International Advertising Festival.[5] Procter & Gamble is a leading member of the U.S. Global Leadership Coalition, a Washington D.C.-based coalition of over 400 major companies and NGOs that advocates for a larger International Affairs Budget, which funds American diplomatic and development efforts abroad.[6] Contents [hide] 1 History 2 Operations 2.1 Management and staff 2.2 Brands…
Continue reading …Genentech Inc., a portmanteau of Genetic Engineering Technology, Inc., is a biotechnologycorporation, which was founded in 1976 by venture capitalist Robert A. Swanson and biochemist Dr. Herbert Boyer.[1][2] It is considered to have founded the biotechnology industry.[1][2] One of its founders, Boyer, is considered to be a pioneer in the field of recombinant DNA technology. In1973, Boyer and his colleague Stanley Norman Cohen demonstrated that restriction enzymescould be used as “scissors” to cut DNA fragments of interest from one source, to be ligated into a similarly cut plasmid vector. While Cohen returned to the laboratory in academia,[1] Swanson contacted Boyer[3] to found the company.[1] Boyer worked with Arthur Riggs and Keiichi Itakurafrom the Beckman Research Institute, and the group became the first to successfully express a human gene in bacteria when they produced the hormone somatostatin in 1977. David Goeddeland Dennis Kleid were then added to the group, and contributed to its success with synthetic human insulin in 1978. As of March 2008, Genentech employed more than 11,000 people and Arthur D. Levinson was the chairman and CEO.[4] The Swiss pharmaceutical conglomerate Hoffmann-La Roche now completely owns Genentech after completing its purchase on 26 March 2009 for approximately $46.8 billion.[5][6] Contents [hide] 1 Research 2 Facilities 3 Disputes 4 Products timeline 5 Awards and recognitions 6 References 7 External links Research Genentech markets itself as a research-driven corporation that follows the science to make new innovations. They employ more than 1,100 researchers, scientists and postdocs and cover a…
Continue reading …Takeda Pharmaceutical Company Limited (武田薬品工業株式会社 Takeda Yakuhin Kōgyō Kabushiki-gaisha?) (TYO: 4502) is the largest pharmaceutical company in Japan and Asia and a top 15 pharmaceutical company. The company has over 19,000 employees worldwide and achieved $15.7 billion USD in revenue during the 2008 fiscal year.[1] The company is focused onmetabolic disorders, gastroenterology, neurology, inflammation, as well as oncology through its independent subsidiary, Millennium: The Takeda Oncology Company.[2] Contents [hide] 1 History 2 Locations 3 Products 4 References 5 External links History Takeda Pharmaceuticals was first founded on June 12, 1781 and was incorporated on January 29, 1925. Takeda’s Japanese logo In 1977, Takeda first entered the U.S. pharmaceutical market by developing a joint venture withAbbott Laboratories called TAP Pharmaceuticals.[3] Through TAP Pharmaceuticals, Takeda and Abbott launched the blockbusters Lupron (leuprolide) in 1985 and Prevacid (lansoprazole) in 1995.[4] One of the firm’s mainstay drugs is Actos, a compound in the thiazolidinedione class of drugs used in the treatment oftype 2 diabetes. Launched in 1999, Actos has become the best-selling diabetes drug in the world with $4 billion USD in sales during the 2008 fiscal year.[5] In February 2005, Takeda announced its acquisition of San Diego, California-based Syrrx, a company specializing in high-throughput X-ray crystallography, for $270 million.[6] In February 2008, Takeda acquired the Japanese operations of Amgen and rights to a dozen of the California biotechnology company’s pipeline…
Continue reading …Baxter International Inc. (NYSE: BAX), is an American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treathemophilia, kidney disease, immune disorders and other chronic and acute medical conditions. The company has sales of $12.3 billion, across three manufacturing divisions (BioScience, producing blood plasma proteins; Medication Delivery producing intravenous therapy products and liquids; and Renal producing equipment for dialysis and the treatment of kidney disorders).[1]The company is also involved in the production of a vaccine for the H1N1 influenza. The company was involved in several controversies. In 2001, malfunctioning dialysis machines resulted in several deaths; in 2008 the company supplied contaminated heparin; in 2009 lethalH5N1 avian flu virus was delivered to laboratories across Europe mixed with seasonal influenza vaccines; also, the company was charged with excessive billing of Kentucky Medicaid. Contents [hide] 1 History 2 Environmental activities 3 Structure 4 H1N1 vaccine 5 Controversies 5.1 Dialyzer crisis 5.2 2008 Chinese heparin contamination 5.3 2009 avian flu contamination 5.4 Kentucky settlement 5.5 2010 award over Hepatitis C infections 6 References 7 External links History Baxter International was founded in 1931 by Davis Baxter, a medical doctor, as a manufacturer and distributor of intravenous therapysolutions. Baxter’s interest was bought out in 1935 by Ralph Falk, who established a research and development function. In 1939 the company developed a vacuum-type collection container, extending the shelf life of blood from hours to weeks. In 1953…
Continue reading …The former Schering-Plough Corporation was a global pharmaceutical company based in theUnited States. It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG inGermany. In 1971, the Schering Corporation merged with Plough (founded by Memphis area entrepreneur Abe Plough in 1908 [1]) to form Schering-Plough. Schering-Plough manufactures several pharmaceutical drugs, the most well-known of which are the allergy drugs Claritin and Clarinex, and through a collaboration with Merck & Co., Vytorin, an anti-cholesterol drug. Schering Plough also owns and operates the major foot care brand name Dr. Scholl’s and theskin care line Coppertone. As of June 2005, Schering-Plough had 1.4% market share in the U.S., placing it seventeenth in the top twenty pharmaceutical corporations by sales compiled by IMS Health. Schering-Plough is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).[2] Contents [hide] 1 History 2 Medical products 2.1 Prescription products 2.2 Over-the-counter products 3 Veterinary products 4 Exercise drug 5 Collaborative research 6 Controversy 7 References 8 External links History Schering was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany.[citation needed] Following the entry of the United States into World War II in 1941, U.S. President Franklin Delano Roosevelt ordered Schering AG’s U.S. assets be seized. These became the Schering Corporation. The company was placed under a government administratorship until 1952, when it was released and its assets sold to the private sector.[citation needed] Plough, Incorporated was founded by the Memphis, Tennessee area entrepreneur Abe…
Continue reading …Boehringer Ingelheim GmbH is a pharmaceutical company which concentrates on the development of human pharmaceuticals, biopharmaceuticals, chemicals, and animal health products. The Human Pharmaceuticals sector is the company’s largest division, accounting for about 96% of sales. This includes prescription medicines and consumer healthcare products. Boehringer Ingelheim is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).[1] Contents [hide] 1 History 2 Fields of activity 2.1 Collaborative Research 3 Operational/development sites 4 Key product lines 5 See also 6 Notes 7 External links History The company was founded in 1885 during the Gründerzeit by the German chemist Dr Albert Boehringer. Initially it produced tartaric acid from wine yeast in a small factory in Ingelheim, together with 20 employees. Today, the Boehringer Ingelheim group is one of the world’s top 20 pharmaceutical companies. For many years, Boehringer Ingelheim has been one of the fastest-growing companies in the pharmaceutical industry and one of the world’s largest manufacturers of biopharmaceuticals for industrial customers. Fields of activity The business areas consist of Human Pharmaceuticals and Animal Health. In 2008, 41,300 employees were in 138 affiliated companies worldwide, research and development (R&D) facilities were in ten countries and production plants in 16 countries. Boehringer Ingelheim’s Pharma Chemicals business has pioneered the commercial production of monomers and biodegradable polymers for more than 20 years. The mission of the…
Continue reading …Amgen Inc. (NASDAQ: AMGN, SEHK: 4332) is an international biotechnology companyheadquartered in Thousand Oaks, California. Located in the Conejo Valley, Amgen is the world’s largest independent biotech firm. The company employs approximately 17,000 staff members. Its products include Epogen, Aranesp, Enbrel, Kineret, Neulasta, Neupogen, Sensipar / Mimpara, Nplate, and Prolia. Epogen and Neupogen (the company’s first products on the market) were the two most successful biopharmaceutical products at the time of their respective releases. BusinessWeek ranked Amgen first on the S&P 500 for being one of the most “future-oriented” of those five hundred corporations.[3] BusinessWeek ostensibly calculated the ratio of research and development spending, combined with capital spending, to total outlays; Amgen had the fourth highest ratio, at 506:1000. Amgen is the largest employer in Thousand Oaks and second only to the United States Navy in terms of number of people employed in Ventura County. With plans to expand into a new campus under construction in South San Francisco, Amgen abruptly halted construction on the plans and instead put the 365,000 square feet (33,900 m2) of new space on the sublease market.[4] It is a leading member of the U.S. Global Leadership Coalition, a coalition of over 400 companies and NGOs that promotes increased funding for US diplomatic and international development programs.[5] In 2006, Amgen began sponsoring the Tour of California, one of only three major Union Cycliste Internationale events in the United States. Contents [hide] 1 History…
Continue reading …For other uses, see Eli Lilly (disambiguation). Eli Lilly and Company Type Public (NYSE: LLY) Industry Pharmaceuticals, Healthcare Founded 1876 Headquarters Indianapolis, Indiana, USA Key people Sidney Taurel, Chairman John C. Lechleiter, President & CEO Derica Rice, CFO Eli Lilly, Founder Products Prozac, Humalog, Cialis, Strattera, Darvocet Revenue ▲ US$21.8 Billion (FY 2009)[1] Operating income ▲ US$5.66 Billion (FY 2009)[1] Net income ▲ US$4.33 Billion (FY 2009)[1] Total assets ▼ US$27.5 Billion (FY 2009)[2] Total equity ▲ US$9.52 Billion (FY 2009)[2] Employees 40,360 (2010) Website www.lilly.com Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company. Eli Lilly’s global headquarters is located in Indianapolis, Indiana, in the United States. The company was founded in 1876 by a pharmaceutical chemist, Eli Lilly, after whom the company was ultimately named. Among other specialties, Lilly was the first company to mass-produce penicillin and today is the world’s largest manufacturer and distributor of psychiatric medications. Contents [hide] 1 Company profile 1.1 History 2 Collaborative research 3 Pharmaceutical brands 3.1 Cialis 3.2 Cymbalta 3.3 Gemzar 3.4 Methadone 3.5 Prozac 3.5.1 Prozac in popular culture 3.6 Secobarbital 3.6.1 Secobarbital overdoses 3.7 Thimerosal 3.8 Additional Eli Lilly therapies 4 Personnel 5 Accolades 6 Controversy 6.1 Lawsuits 6.2 Criminal prosecution 7 See also 8 References 8.1 Further references 9 External links Company profile Eli Lilly and Company’s global headquarters, in Indianapolis, Indiana, United States A Fortune 500 corporation, Eli Lilly had revenues of $20 billion in 2008, making it the 148th largest company in the United States and the 10th largest…
Continue reading …“Squibb” redirects here. It is not to be confused with Squib. Bristol-Myers Squibb Company Type Public NYSE: BMY Industry Pharmaceuticals Founded 1887 Headquarters New York, New York Key people Lamberto Andreotti, CEO Revenue ▲ US$18.8 Billion (FY 2009)[1] Operating income ▲ US$5.34 Billion (FY 2009)[1] Net income ▲ US$10.6 Billion (FY 2009)[1] Total assets ▲ US$31.0 Billion (FY 2009)[2] Total equity ▲ US$14.8 Billion (FY 2009)[2] Employees 35,000 (2009) Website www.bms.com A Bristol-Myers Squibb R&D facility in Lawrenceville, New Jersey Bristol-Myers Squibb (NYSE: BMY), often referred to as BMS, is a pharmaceutical company, headquartered in New York City. The company was formed in 1989, following the merger its predecessors Bristol-Myers and the Squibb Corporation. Squibb was founded in 1858 by Edward Robinson Squibb in Brooklyn, New York, while Bristol-Myers was founded in 1887 byWilliam McLaren Bristol and John Ripley Myers in Clinton, New York (both were graduates ofHamilton College). Lamberto Andreotti became the company’s CEO on May 4, 2010. Former CEO James M. Cornelius remains chairman of the Board of Directors. Bristol-Myers Squibb manufactures prescription pharmaceuticals in several therapeutic areas, including cancer, HIV/AIDS, cardiovascular disease, diabetes, hepatitis, rheumatoid arthritis and psychiatric disorders. Its mission is to “discover, develop and deliver innovative medicines that help patients prevail over serious diseases.” Over the past several years BMS had been upping the price of its medicines to bolster profits….
Continue reading …This article is about the corporation. For other uses of the word, see Wyeth (disambiguation). Wyeth Type Subsidiary Industry Pharmaceuticals, Healthcare Founded (1860) Philadelphia,Pennsylvania, U.S. Headquarters Madison, New Jersey, United States Key people Bernard J. Poussot, CEO, President and Vice Chairman of Wyeth Robert Essner, Chairman Joseph Mahady, President, Global Business, Wyeth Pharmaceuticals John Wyeth, Founder Products Premarin, Effexor, Enbrel, (See more products.) Revenue ▲ US$ 22.40 billion (2008) Net income ▲ US$ 4.616 billion (2008) Employees 49,732 (2005) Parent Pfizer Website www.wyeth.com Wyeth, formerly one of the companies owned by American Home Products Corporation(AHP), was one of the largest pharmaceutical companies in the world. The company was based in Madison, New Jersey, USA. They were known for manufacturing the over-the-counter (OTC) drugs Robitussin and the analgesic Advil (ibuprofen), as well as the prescription drugs Premarinand Effexor, which both boast over US$3 billion in sales annually. On January 23, 2009 The Wall Street Journal reported that Pfizer was in talks to buy Wyeth at a cost of US$68 billion.[1] On January 25, Pfizer agreed to the purchase, a deal financed with cash, shares and loans.[2] The deal was completed on October 15, 2009.[3] Contents [hide] 1 History 1.1 1860–1899 1.2 1900–1929 1.3 1930–1949 1.4 1950–1969 1.5 1970–1989 1.6 1990–1999 1.7 2000–2009 2 Divisions 2.1 Wyeth Consumer Healthcare 2.2 Wyeth Pharmaceuticals 2.3 Fort Dodge Animal Health 3 Products 3.1 Wyeth Consumer Healthcare Products 3.2 Wyeth Pharmaceuticals Products 3.3 Fort Dodge Animal Health Products 3.4 Wyeth Milk…
Continue reading …Abbott Laboratories (NYSE: ABT) is a pharmaceuticals health care company. It has 72,000 employees and operates in over 130 countries.[3] The company headquarters are in Abbott Park,Illinois, located near North Chicago, Illinois. Abbott Laboratories was founded by Chicago physician Wallace Calvin Abbott in 1888. In 2008, Abbott had over $29 billion in revenue. In 1985, the company developed the first HIV blood screening test. The company’s drug portfolio includes Humira, a drug for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,Crohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis; Norvir, a treatment for HIV; Depakote, an anticonvulsant drug; and Synthroid, a synthetic thyroid hormone. Abbott also has a broad range of medical devices, diagnostics and immunoassayproducts as well as nutritional products, including Ensure, a line of well known meal replacement shakes, and EAS, the largest producer of performance based nutritional supplements. Abbott’s in vitro diagnostics business is a world leader in immunoassays and blood screening. Abbott’s broad range of medical tests and diagnostic instrument systems are used worldwide by hospitals, laboratories, blood banks, and physician offices to diagnose and monitor diseases such as HIV, hepatitis, cancer, heart failure and metabolic disorders, as well as assess other important indicators of general health. Abbott Point-of-Care manufactures diagnostic products for blood analysis to provide health care professionals critical diagnostics information accurately and immediately at the point of patient care. In addition…
Continue reading …This article needs additional citations for verification. Please help improve this article by adding reliable references. Unsourced material may be challenged and removed.(March 2010) Merck & Co., Inc. (Merck Sharp & Dohme (MSD) outside the United States and Canada) Type Public (NYSE: MRK) Dow Jones Industrial Average Component Industry Pharmaceuticals Founded 1891 as a subsidiary of Merck KGaA 1917 as an independent company Headquarters Whitehouse Station, New Jersey, United States Key people Richard T. Clark, Chairman, President & CEO Stanley F. Barshay, EVP and president, Consumer Health Care Richard S. Bowles, Ph.D., chief compliance officer Willie A. Deese, EVP and president, Merck Manufacturing Kenneth C. Frazier, EVP and president, Global Human Health Mirian Graddick-Weir, Ph.D., EVP, Human Resources Peter N. Kellogg, chief financial officer Peter S. Kim, Ph.D., EVP and president, Merck Research Laboratories Raul E. Kohan, president, Animal Health Bruce N. Kuhlik, general counsel J. Chris Scalet, chief information officer, Global Services Mervyn Turner, Ph.D, chief strategy officer Products Gardasil Singulair Propecia/Proscar Zocor Vioxx Fosamax See more complete products listing. Revenue ▲ US$27.4 Billion (FY 2009)[1] Operating income ▲ US$4.83 Billion (FY 2009)[1] Net income ▲ US$12.9 Billion (FY 2009)[1] Total assets ▲ US$112 Billion (FY 2009)[2] Total equity ▲ US$59.1 Billion (FY 2009)[2] Employees 61,500 (2005) Website merck.com Merck & Co., Inc. (NYSE: MRK), also known as Merck Sharp & Dohme or MSD outside theUnited States and Canada, is one…
Continue reading …This article needs additional citations for verification. Please help improve this article by adding reliable references. Unsourced material may be challenged and removed.(October 2009) AstraZeneca plc Type Public limited company (LSE: AZN,NASDAQ: AZN,OMX: AZN) Industry Pharmaceutical Founded 6 April 1999 by merger Headquarters London, United Kingdom Key people Louis Schweitzer, Chairman David R. Brennan, Chief Executive Officer Products Pharmaceutical products for humans Revenue $32,804 million (2009)[1] Operating income $11,543 million (2009)[1] Net income $7,544 million (2009)[1] Total assets ▼ US$46.8 Billion (FY 2009)[2] Total equity ▲ US$15.9 Billion (FY 2009)[2] Employees 62,000 (2010)[3] Website astrazeneca.com AstraZeneca plc[4] (LSE: AZN, NYSE: AZN, OMX: AZN) is a global pharmaceutical andbiologics company headquartered in London, United Kingdom. It is the world’s seventh largest pharmaceutical company measured by revenues and has operations in over 100 countries.[5][6] It has a portfolio of products for major disease areas including cancer, cardiovascular,gastrointestinal, infection, neuroscience, respiratory and inflammation.[3] Its primary listing is on the London Stock Exchange and it is a constituent of the FTSE 100 Index. It has secondary listings on the New York Stock Exchange and the OMX exchange. Contents [hide] 1 History 2 Operations 3 Products 4 Controversies 4.1 Seroquel: adverse effects and trial procedures 4.2 Late-stage trial failures 4.3 MedImmune takeover 4.4 Nexium 4.5 Malaria drugs 4.6 Corporate sexual harassment 4.7 Bildman fraud 4.8 Nobel Prize investigation 2008 4.9 Transfer mispricing 5 Senior management 6 See also 7 References 8 External links [edit]History Astra AB was founded in 1913 by 400 doctors and apothecaries in Södertälje, Sweden.[7] In 1949 the company developed Xylocaine, a local anesthetic.[clarification needed] In 1994 the company formed a joint venture with Merck to…
Continue reading …F. Hoffmann–La Roche Ltd. is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX Swiss Exchange (SIX: ROG). The company headquarters are located in Basel and the company has many sites around the world – including: Nutley, NJ, Palo Alto, California, Pleasanton, Branchburg, Fishers, Indiana,Florence, South Carolina, Boulder, Colorado and Ponce, Puerto Rico in the US, Welwyn Garden City and Burgess Hill in the UK, Clarecastle in Ireland, Mannheim and Penzberg in Germany,Mississauga and Laval in Canada, and Shanghai in China. The company also owns the American biotechnology company Genentech, which is a wholly owned subsidiary, and the Japanese biotechnology company Chugai Pharmaceuticals as well as the Tucson, Arizona based Ventana. Roche’s revenues during fiscal year 2008 were CHF 49.05 billion.[1] Descendants of the founding Hoffmann and Oeri families own half of the company.[1] Swiss pharma firm Novartis owns 33% of the company.[1] F. Hoffmann–La Roche is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).[3] Contents [hide] 1 History 2 Creation of the first anti-depressant 3 Vitamin price fixing 4 Products 5 Oseltamivir Controversy 6 Collaborative research 7 Additional key persons 8 Bibliography 9 References 10 External links [edit]History Founded in 1896 by Fritz Hoffmann-La Roche, the company was early on known for producing various vitamin preparations and derivatives. In 1934, it became the first company to mass produce synthetic vitamin C, under the brand name Redoxon. In 1957 it introduced the class oftranquilizers known as benzodiazepines (with Valium and Rohypnol being the best known…
Continue reading …Sanofi-Aventis (Euronext: SAN, NYSE: SNY), headquartered in Paris, France, is a multinational pharmaceutical company, the world’s fourth-largest by prescription sales.[2][3]Sanofi-Aventis engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the firm also developsover-the-counter medication. Sanofi-Aventis covers 7 major therapeutic areas: cardiovascular,central nervous system, diabetes, internal medicine, oncology, thrombosis and vaccines (it is the world’s largest producer of the latter through its subsidiary Sanofi Pasteur).[4] The company is a full member of the European Federation of Pharmaceutical Industries and Associations(EFPIA).[5] Contents [hide] 1 History 1.1 Sanofi-Aventis 1.2 Sanofi-Synthélabo 1.3 Aventis 2 Business 2.1 Products 2.2 Management 2.3 Stockholders 3 Collaborative research 4 Aventis Foundation 5 See also 6 References 7 External links ]History []Sanofi-Aventis This article needs additional citations for verification. Please help improve this article by adding reliable references. Unsourced material may be challenged and removed. (April 2009) Sanofi-Aventis was formed in 2004 when Sanofi-Synthélabo acquired Aventis. In early 2004, Sanofi-Synthélabo made a hostile takeover bid worth €47.8 bn for Aventis. Initially, Aventis rejected the bid because it felt that the bid offered inferior value based on the company’s share value. The three-month takeover battle concluded when Sanofi-Synthélabo launched a friendly bid of €54.5 bn in place of the previously rejected hostile bid. French government intervention also played an active role. The French government, desiring what they called a “local solution”, put heavy pressure on Sanofi-Synthélabo to raise…
Continue reading …Not to be confused with S.C. Johnson. Johnson & Johnson Type Public (NYSE: JNJ) Dow Jones Industrial Average Component Industry Major drugs Health care Soaps Shampoos Founded 1886 Founder(s) Robert Wood Johnson I James Wood Johnson Edward Mead Johnson Headquarters New Brunswick, NJ, U.S. Area served Worldwide Key people William C. Weldon (Chairman) & (CEO) Products Pharmaceuticals Medical devices Health care products Toiletries Soaps Shampoos, etc. Revenue ▲ US$61.9 Billion (FY 2009)[1] Operating income ▲ US$15.7 Billion (FY 2009)[1] Net income ▲ US$12.3 Billion (FY 2009)[1] Total assets ▲ US$94.7 Billion (FY 2009)[2] Total equity ▲ US$50.6 Billion (FY 2009)[2] Employees 118,700 (2009)[3] Website JNJ.com also JJ.com Johnson & Johnson (NYSE: JNJ) is a global American pharmaceutical, medical devices and consumer packaged goods manufacturer founded in 1886. Its common stock is a component of the Dow Jones Industrial Average and the company is listed among the Fortune 500. Johnson & Johnson is known for its corporate reputation, consistently ranking at the top of Harris Interactive‘s National Corporate Reputation Survey,[4] ranking as the world’s most respected company by Barron’s Magazine,[5] and was the first corporation awarded the Benjamin Franklin Award for Public Diplomacy by the U.S. State Department for its funding of…
Continue reading …GlaxoSmithKline plc (LSE: GSK NYSE: GSK), often abbreviated to GSK, is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom. It is the world’s third largest pharmaceutical company measured by revenues (after Johnson & Johnson and Pfizer).[3] It has a portfolio of products for major disease areas including asthma, cancer, virus control, infections, mental health, diabetes and digestive conditions.[4] It also has a large consumer healthcare division which produces and markets oral healthcare products, nutritional drinks and over-the-counter medicines, including Sensodyne, Horlicks and Gaviscon.[4] Its primary listing is on the London Stock Exchange and it is a constituent of the FTSE 100 Index. It has a secondary listing on the New York Stock Exchange. Contents [hide] 1 History 1.1 GlaxoWellcome 1.2 SmithKline Beecham 1.3 Recent developments 2 Operations 3 Products 4 Initiatives to eradicate disease 5 Global locations 6 Corporate governance 7 Diversity 8 Controversy 8.1 Legal 8.1.1 Paroxetine 8.1.2 Ribena 8.1.3 Avandia 9 Announced policy change 10 See also 11 References 12 External links History Former GlaxoSmithKline building in Hamburg, Germany GSK was formed in 2000 by the merger of GlaxoWellcome plc (formed from the acquisition of Wellcome plc by Glaxo plc), and SmithKline Beecham…
Continue reading …This article is about the chemical and pharmaceutical company. For other uses, see Bayer (disambiguation). Not to be confused with Beyer. Bayer AG Type Public (FWB: BAYN, TYO: 4863) Industry Pharmaceuticals, chemicals Founded 1863 Founder(s) Friedrich Bayer, Johann Friedrich Weskott Headquarters Leverkusen, Germany Key people Werner Wenning (CEO), Manfred Schneider (Chairman of the supervisory board) Products Veterinary drugs, diagnostic imaging, general and specialty medicines, women’s health products, over-the-counter drugs, diabetes care, pesticides, plant biotechnology, polymers, coatings, adhesives Revenue €31.168 billion (2009)[1] Operating income ▲ €3.006 billion (2009)[1] Profit ▲ €1.359 billion (2009)[1] Employees 108,400 (2009)[1] Subsidiaries Bayer MaterialScience, Bayer USA, Bayer Schering Pharma, Bayer HealthCare Pharmaceuticals, Bayer CropScience Website www.bayer.com Bayer AG (German pronunciation: [ˈbaɪə]) (FWB: BAYN, TYO: 4863) is a chemical and pharmaceutical company founded in Barmen, Germany in 1863. Today it is headquartered in Leverkusen, North Rhine-Westphalia, Germany. It is well-known for its original brand of aspirin. History Advertisement for Aspirin, Heroin, Lycetol, Salophen Bayer AG was founded in Barmen (today a part of Wuppertal), Germany in 1863 by Friedrich Bayer and his partner, Johann Friedrich Weskott. Bayer’s first major product was acetylsalicylic acid (originally discovered by French chemist Charles Frederic Gerhardt in 1853), a modification of salicylic…
Continue reading …Novartis International AG is a multinational pharmaceutical company based in Basel, Switzerland, ranking number three in sales among the world-wide industry, which accounted 36.173 billon in 2008.[3] It currently is the sixth largest pharmaceutical company in terms of revenue ($41.5 billion in 2009) with a profit margin of about 20%, which is the same as its industry competitors. Their profits were down by 31% from 2007 levels.[4] Novartis manufactures drugs such as clozapine (Clozaril), diclofenac (Voltaren), carbamazepine (Tegretol), valsartan (Diovan), imatinib mesylate (Gleevec / Glivec), ciclosporin (Neoral / Sandimmun), letrozole (Femara), methylphenidate (Ritalin), terbinafine (Lamisil), and others. Renamed to Novartis following an acquisition by Ciba-Geigy, it owns Sandoz, a large manufacturer of generic drugs. The company formerly owned the Gerber Products Company, a major infant and baby products producer, but sold it to Nestlé on 1 September 2007.[5][6][7][8] Novartis is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) [9] and of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) [10] Collaborative research In addition to internal research and development activities Novartis is also involved in publicly funded collaborative research projects, with other industrial and academic partners. One example in the area of non-clinical…
Continue reading …Despite GHB being a popular date rape drug, the US Food and Drug Administration has revealed it believes it to be effective in treating fibromyalgia, say documents released ahead of today’s marketing review. Jazz Pharmaceuticals is seeking to market gamma hydroxybutyrate under the brand name Rekinla as a treatment for the pain disorder fibromyalgia. According to clinical studies, Jazz claims the drug, which is a powerful nervous system depressant, is also effective at reducing fibromyalgia pain. According to documents released ahead of the review, the FDA believes the drug has proved to be effective in treating the pain condition. As a reflection of this news, the company’s share price rose. However, the documents also cite continual concerns over the safety of the drug, which has been linked to numerous incidents where victims have had their drinks spiked. GHB though is already available on the market under the brand name Xyrem as a treatment for narcolepsy. Sold by Jazz, the drug is only available under tight conditions where only registered patients and doctors are allowed access and then it is only sold via a central pharmacy to avoid criminals. The company has proposed selling Rekinla with similar restrictions, with it being…
Continue reading …The pressure of Eli Lilly’s looming patent cliff has been reduced after a US Committee has recommended expanding the pain indication for its top selling drug Cymbalta (duloxetine HCL). The US Food and Drug Administration Anesthetic and Life Support Drugs Advisory Committee voted 8-6 in favour of expanding the pain indication for the drug. However, the broader pain population is yet to be defined by the FDA if it does approve this. Cymbalta is currently approved to treat major depressive disorder and generalised anxiety disorder and to manage diabetic peripheral neuropathic pain and fibromyalgia. The Committee reviewed efficacy and safety data from three new Cymbalta studies in chronic low back pain and two new studies in chronic pain due to osteoarthritis of the knee. In split votes for the different indications, most panellists were supportive of the evidence for chronic low back pain but not osteoarthritic pain. The committee also voted there was insufficient evidence of significant additional efficacy of 120mg compared with 60mg in these conditions. In addition, the Committee voted positively regarding the overall safety profile of Cymbalta, including potential liver toxicity, with the majority agreeing that the risk/benefit profile warrants an expanded indication. Meanwhile, the Committee has…
Continue reading …Eli Lilly has won a small victory in its defence of Strattera’s patent after a judge in the US District Court in New Jersey placed a temporary ban on the sale of copycat forms of the attention deficit hyperactivity disorder drug. The company has reportedly won a two-week breather from the launch of generic versions of Strattera (atomoxetine) to allow it to seek further injunctions from the US Court of Appeals for the Federal Circuit, given that the District judge denied Lilly’s primary request for a ban until the patent suit is settled. The Indianapolis-based drugmaker could be facing generic competition far sooner than expected for Strattera, second-quarter sales of which topped $142 million, after a US court ruled earlier this month that a key patent protecting the drug is invalid. The Court ruled against the company in its litigation with generic drugmaker Actavis over the validity of Lilly’s ‘590, or method-of-use, patent on Strattera, which had originally been expected to expire in 2017. Lilly has said it will be taking “every reasonable step” to protect its intellectual property rights, but given the threat of near-term generic competition has cut its sales forecast to growth in the low-to-mid single digits…
Continue reading …Swiss drugmaker Roche has snapped up US digital pathology solutions group BioImagene for $100 million in a move that will strengthen its presence in tissue-based cancer diagnostics and research. The Basel-headquartered group announced this morning that is has signed an agreement under which Ventana Medical Systems, a member of the Roche Group, will acquire 100% of privately-held BioImagine, and that the deal is expected to close “in the coming weeks”. According to Roche, BioImagene is an innovative leader in the field of digital pathology workflow and analysis, and its products create high-resolution, whole-slide digital images from glass microscope slides as well as provide the means to analyse these images via a computer, “taking pathology beyond traditional microscope applications”. “The increasing complexity of new tests and technologies creates tremendous need for more sophisticated tools for tissue analysis and diagnosis,” explained Daniel O’Day, chief operating officer of Roche Diagnostics, and he noted that BioImagene’s products “will complement and strengthen our current offering in image analysis and information management.” “Through this acquisition, Ventana is uniquely positioned to improve laboratory efficiency and help pathologists improve patient care,” added Hany Massarany, President of Ventana, and further explaining the strategic fit said that with BioImagene’s current…
Continue reading …TEMPO study further demonstrates the benefits of Azilect® in early Parkinson’s disease patients
August 9, 2010 1 CommentH. Lundbeck A/S (Lundbeck) and Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) have announced newly published long-term data on Azilect® (rasagiline tablets) from the TEMPO study and its open-label extension. The findings confirm the long-term efficacy, safety and tolerability of Azilect® in patients with Parkinson’s disease (PD) and further demonstrate the benefits obtained with early treatment initiation. The data was published in the June 2010 issue of the International Journal of Neuroscience.
Continue reading …Detailed pictures showing how a new type of experimental antibiotic can kill bacteria already resistant to existing treatments.(1) The findings could ultimately help scientists to develop new antibiotics to tackle the bacteria responsible for many hospital and community-acquired infections. Using an imaging technique called x-ray crystallography, a team of researchers from GlaxoSmithKline (GSK) captured a snapshot of the new compound latched on to the enzyme topoisomerase. This enzyme is part of the bacteria’s internal machinery and helps the bacteria produce proteins and replicate. Stopping this enzyme prevents the bacteria from reproducing. Medicines, known as the quinolones, that target the enzyme have been successfully used as antibiotics since 1962, however bacteria are increasingly developing resistance to this class of drugs.
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