http://www.thepharmaletter.comThe Pharma Letter provides subscribers with daily, up-to-date news, business intelligence, comment and analysis for the Pharmaceuticals, Biotechnology and Generics sectors of the overall health care industry, backed by a team of respected writers with many years of experience in the field.Register for free for our daily...Thu, 18 Feb 2010 11:18:18 +0100All News http://www.thepharmaletter.com/file/21a9c428ce40fcf25670a699744e2ba9/transgene-signs-billion-dollar-deal-with-novartis-for-tg4010-cancer-vaccine-option-but-still-disappoints-investors.htmlTransgene has signed an exclusive option agreement with Swiss drug major Novartis for the development and commercialization of the French biotechnology firm’s targeted cancer vaccine TG4010 (MVA-MUC1-IL2), for the first-line treatment of non-small cell lung cancer (NSCLC) and other potential cancer indications.http://www.thepharmaletter.com/file/21a9c428ce40fcf25670a699744e2ba9/transgene-signs-billion-dollar-deal-with-novartis-for-tg4010-cancer-vaccine-option-but-still-disappoints-investors.htmlThu, 11 Mar 2010 12:11:09 +0100http://www.thepharmaletter.com/file/495d5c80885740810ed0f5cf537ad47e/astrazeneca-pushes-further-into-emerging-market-with-torrent-deal.htmlConfirming its ongoing interest in emerging markets, Anglo-Swedish drug major AstraZeneca has entered into a license and supply agreement with India’s Torrent Pharmaceuticals for the latter to supply a portfolio of generic medicines for which Torrent already has licenses in a range of countries. Working in partnership with Torrent, AstraZeneca says it intends to brand and market these products in many of its emerging markets, where it already has a strong commercial footprint.http://www.thepharmaletter.com/file/495d5c80885740810ed0f5cf537ad47e/astrazeneca-pushes-further-into-emerging-market-with-torrent-deal.htmlThu, 11 Mar 2010 12:06:22 +0100http://www.thepharmaletter.com/file/72ba2fab2c04932ee589a8f2e52e8ebe/us-generic-drugmakers-urge-more-funding-of-fda-especially-ogd-division.htmlThe Generic Pharmaceutical Association (GPhA) has reiterated its appeal for additional funding of the Food and Drug Administration in order that copy medicines can come to the market more quickly, as the anticipated drug “patent cliff” floods the agency with ever more applications.http://www.thepharmaletter.com/file/72ba2fab2c04932ee589a8f2e52e8ebe/us-generic-drugmakers-urge-more-funding-of-fda-especially-ogd-division.htmlThu, 11 Mar 2010 12:00:42 +0100http://www.thepharmaletter.com/file/3c491a17325142eaae4d29f027994e2e/takeda-enters-settlement-with-watson-over-actos-patent-challenge-pays-milestone-in-affymax-deal.htmlIn what is another deal that is designed to delay the entry of a copy drug on to the US market, Watson Pharmaceuticals says that it has reached a settlement agreement with Japan’s largest drugmaker Takeda, and its US subsidiary Takeda Pharmaceuticals North America, resolving outstanding patent litigation related to Watson's generic equivalent version of the type 2 diabetes drug Actos (pioglitazone) 15mg, 30mg and 45mg tablets.http://www.thepharmaletter.com/file/3c491a17325142eaae4d29f027994e2e/takeda-enters-settlement-with-watson-over-actos-patent-challenge-pays-milestone-in-affymax-deal.htmlThu, 11 Mar 2010 11:54:58 +0100http://www.thepharmaletter.com/file/9ac50a21885d3f319ad126c67dd4b85c/a-tale-of-two-markets-obesity-and-type-2-diabetes-sectors-closely-linked-but-vastly-different-in-outlook.htmlRising obesity levels across the western world could result in a near doubling of the type 2 diabetes drug market by 2018, according to Datamonitor. The independent business analyst forecasts that the antidiabetics market will be worth $37 billion by 2018 up from $20 billion in 2008.http://www.thepharmaletter.com/file/9ac50a21885d3f319ad126c67dd4b85c/a-tale-of-two-markets-obesity-and-type-2-diabetes-sectors-closely-linked-but-vastly-different-in-outlook.htmlThu, 11 Mar 2010 11:49:51 +0100http://www.thepharmaletter.com/file/ababd0b2930777c6fa8131532ae7e5af/cellzome-in-up-to-508-million-euro-deal-with-glaxosmithkline-on-inflammatory-disease.htmlAnglo-German firm Cellzome says it has formed a second strategic alliance with UK drug giant GlaxoSmithKline providing the latter with exclusive access to Cellzome's proprietary Episphere technology in the emerging field of epigenetics as applied to immune-inflammatory disease. Epigenetic mechanisms play a key role in controlling immune cell differentiation and inflammatory gene expression during an excessive inflammatory response.http://www.thepharmaletter.com/file/ababd0b2930777c6fa8131532ae7e5af/cellzome-in-up-to-508-million-euro-deal-with-glaxosmithkline-on-inflammatory-disease.htmlThu, 11 Mar 2010 11:44:46 +0100http://www.thepharmaletter.com/file/a7a5d0452540a29c99ff02625cc7e15d/koreas-celltrion-develops-of-broad-spectrum-human-mab-against-major-flu-viruses-h1n1-and-h5n1.htmlinfection, which neutralize a broad spectrum of influenza viruses, including pandemic H1N1 and the deadly H5N1 avian influenza virus. Preliminary tests in laboratory animals indicate that the novel human monoclonal antibodies can be used to prevent disease when given either before or after infection.http://www.thepharmaletter.com/file/a7a5d0452540a29c99ff02625cc7e15d/koreas-celltrion-develops-of-broad-spectrum-human-mab-against-major-flu-viruses-h1n1-and-h5n1.htmlThu, 11 Mar 2010 11:40:45 +0100http://www.thepharmaletter.com/file/8d4caa41c668196f25cf87750afad9a2/antisense-pharma-gets-added-patent-protection-for-trabedersen-until-2026-raises-13-million-euros.htmlThe European Patent Office has granted German biopharmaceutical company Antisense Pharma additional patent protection for the use of its flagship product trabedersen until 2026. This gives Antisense a comprehensive marketing exclusivity for the use of this drug within the settings of tumor-illnesses, central nervous system diseases and immunosuppression, taking into consideration the effective dose.http://www.thepharmaletter.com/file/8d4caa41c668196f25cf87750afad9a2/antisense-pharma-gets-added-patent-protection-for-trabedersen-until-2026-raises-13-million-euros.htmlThu, 11 Mar 2010 11:35:21 +0100http://www.thepharmaletter.com/file/54ea4ee521c511ef2c483dddcfeb286b/generics-poised-to-drive-pharmaceutical-market-in-botswana-as-govt-aims-to-create-an-indigenous-industry.htmlThe land-locked African nation of Botswana does not yet have a pharmaceutical manufacturing industry and thus, all drugs are imported. In an attempt to improve accessibility to essential medication and diversify economic activity, the government is launching private-public partnership (PPP) initiatives to kick-start local pharmaceutical production, according to a new report from Frost & Sullivan.http://www.thepharmaletter.com/file/54ea4ee521c511ef2c483dddcfeb286b/generics-poised-to-drive-pharmaceutical-market-in-botswana-as-govt-aims-to-create-an-indigenous-industry.htmlThu, 11 Mar 2010 11:30:22 +0100http://www.thepharmaletter.com/file/12cf3dacc806dee73d846fa425cd36f4/hiv-drug-study-actg5202-overview-by-anton-pozniak.htmlOne of the largest-ever HIV trials - ACT5202, a trial carried out by the AIDS Clinical Trial Group (ACTG) which was created in 1987 by the U. based National Institute of Allergy and Infectious Disease (NIAID) to broaden the scope of its AIDS research effort - reported its findings to the Conference of Retroviruses and Opportunistic Infections (CROI) held in San Francisco, USA.http://www.thepharmaletter.com/file/12cf3dacc806dee73d846fa425cd36f4/hiv-drug-study-actg5202-overview-by-anton-pozniak.htmlThu, 11 Mar 2010 11:24:26 +0100http://www.thepharmaletter.com/file/1552da424625025ac1f755a513029ea5/abbott-labs-bids-722-for-facet-to-enhances-its-biotech-rd-pipeline-including-daclizumab.htmlUS health care major Abbott Laboratories has signed a definitive agreement for Abbott to acquire Facet Biotech, enhancing Abbott's early- and mid-stage pharmaceutical pipeline. Abbott will acquire Facet for $27 per share (a 67% premium) in cash for a net transaction value of approximately $450 million, which includes a purchase price of around $722 million less Facet's projected cash and marketable securities at closing of approximately $272 million.http://www.thepharmaletter.com/file/1552da424625025ac1f755a513029ea5/abbott-labs-bids-722-for-facet-to-enhances-its-biotech-rd-pipeline-including-daclizumab.htmlWed, 10 Mar 2010 12:41:45 +0100http://www.thepharmaletter.com/file/42330136e33ae9e1fd1246bc34ba9911/intermune-leaps-62-after-us-fda-advisory-backs-the-firms-pirfenidone-for-idiopathic-pulmonary-fibrosis.htmlOn a day that saw Nasdaq trading of US biotechnology firm InterMune’s shares halted as regulators debated approval of one of its lead drug candidates, the stock leapt 62% to $37.65 in after hours transactions, when the Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee voted by a narrow nine to three to recommend approval of pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.http://www.thepharmaletter.com/file/42330136e33ae9e1fd1246bc34ba9911/intermune-leaps-62-after-us-fda-advisory-backs-the-firms-pirfenidone-for-idiopathic-pulmonary-fibrosis.htmlWed, 10 Mar 2010 12:35:58 +0100http://www.thepharmaletter.com/file/3f86be9aa15c997fa3f0f360030cea35/european-commission-unveils-new-research-projects-to-fight-influenza-as-pandemic-accusations-rumble-on.htmlThe European Commission yesterday announced the results of its 18 million-euro ($24.5 million) call for proposals for new research projects on influenza. Four collaborative research projects have been shortlisted for funding. They involve 52 research institutes and small to medium-sized enterprises (SMEs) from 18 European countries and three international partners (Israel, China and the USA).http://www.thepharmaletter.com/file/3f86be9aa15c997fa3f0f360030cea35/european-commission-unveils-new-research-projects-to-fight-influenza-as-pandemic-accusations-rumble-on.htmlWed, 10 Mar 2010 12:27:49 +0100http://www.thepharmaletter.com/file/17a7fc51f933a17ad1df0dc7ebef2897/us-fda-calls-for-more-data-on-actelions-zavesca-for-niemann-pick-type-c-disease.htmlSwiss biotechnology firm Actelion revealed yesterday afternoon that it has received a complete response letter from the US Food and Drug Administration for its supplemental New Drug Application for Zavesca (miglustat) requesting additional preclinical and clinical information. The sNDA had applied for approval of the drug - which is already marketed gor Gaucher’s disease - for the treatment of progressive neurological manifestations in adult and pediatric patients with Niemann-Pick type C (NP-C) disease, a rare, neurodegenerative genetic disorder.http://www.thepharmaletter.com/file/17a7fc51f933a17ad1df0dc7ebef2897/us-fda-calls-for-more-data-on-actelions-zavesca-for-niemann-pick-type-c-disease.htmlWed, 10 Mar 2010 12:21:04 +0100http://www.thepharmaletter.com/file/b48adebe6fed3364ea76c217f5990e34/ark-thera-slumps-as-it-withdraws-cerepro-maa-and-looks-at-strategic-options.htmlUK-based Ark Therapeutics’ stock tumbled 11.1% yesterday, after the company said it was withdrawing its European filing for its brain cancer drug Cerepro (sitimagene ceradenovec) and considering its options for the future, including a possible sale of the business.http://www.thepharmaletter.com/file/b48adebe6fed3364ea76c217f5990e34/ark-thera-slumps-as-it-withdraws-cerepro-maa-and-looks-at-strategic-options.htmlWed, 10 Mar 2010 12:15:25 +0100http://www.thepharmaletter.com/file/bddbbe2ee31008c34fa80e31cad0dc45/uncertainties-of-turkeys-new-drug-tracking-system-creating-problems-for-industry-and-patients-says-aifd.htmlThe Drug Tracking System (İTS), introduced to Turkey’s pharmaceutical sector as of January 1, 2010, cannot be effectively implemented by the parties due to the uncertainties with the system. The situation puts manufacturers in a tight corner while causing difficulties in the access of patients to medicines, claims the Association of Research-Based Pharmaceutical Companies, the AiFD.http://www.thepharmaletter.com/file/bddbbe2ee31008c34fa80e31cad0dc45/uncertainties-of-turkeys-new-drug-tracking-system-creating-problems-for-industry-and-patients-says-aifd.htmlWed, 10 Mar 2010 12:10:19 +0100http://www.thepharmaletter.com/file/05fda2bad4d973700992a2f04fd617eb/good-news-for-cell-thera-as-fda-clears-italian-pixantrone-production-facility.htmlThere was good news for USA-based Cell Therapeutics yesterday, in that that the Food and Drug Administration has completed its inspection of the company’s manufacturing facility in in Nerviano, Italy, that is owned by Nerviano Medical Sciences, and found it to be compliant with all the required norms.http://www.thepharmaletter.com/file/05fda2bad4d973700992a2f04fd617eb/good-news-for-cell-thera-as-fda-clears-italian-pixantrone-production-facility.htmlWed, 10 Mar 2010 12:04:11 +0100http://www.thepharmaletter.com/file/3b22175ec9e279f64ab007087b37b2f3/who-releases-new-guidelines-for-malaria-treatment-and-drug-procurement.htmlThe World Health Organization has released new guidelines for the treatment of malaria, and the first ever guidance on procuring safe and efficacious anti-malarial medicines. In recent years, the WHO points out, a new type of treatment - artemisinin-based combination therapy (ACTs) - has transformed the treatment of malaria, but warns that, if not used properly the medicine could become ineffective.http://www.thepharmaletter.com/file/3b22175ec9e279f64ab007087b37b2f3/who-releases-new-guidelines-for-malaria-treatment-and-drug-procurement.htmlWed, 10 Mar 2010 11:58:00 +0100http://www.thepharmaletter.com/file/4ab2d9f7fa26619c0e3f09e77bd0cf23/herceptin-as-an-add-on-to-standard-chemotherapy-set-to-be-clinical-gold-standard-for-gastric-cancer.htmlRoche/Genentech/Chugai's gastric cancer drug Herceptin (trastuzumab), as an add-on to standard chemotherapy earns advisory firm Decision Resources' proprietary clinical “gold standard” status in 2013, following its approval for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive gastric cancer in 2010.http://www.thepharmaletter.com/file/4ab2d9f7fa26619c0e3f09e77bd0cf23/herceptin-as-an-add-on-to-standard-chemotherapy-set-to-be-clinical-gold-standard-for-gastric-cancer.htmlWed, 10 Mar 2010 11:53:35 +0100http://www.thepharmaletter.com/file/0f45dabf0bf1d045d471330d154d8eb1/lay-line-genomics-re-launches-antitrka-project-for-the-treatment-of-chronic-pain.htmlRome-based Lay Line Genomics SpA says that, after the termination of the exclusive license agreement with fellow Italian firm BioXell SpA, all rights to the humanized antiTrkA monoclonal antibody named BXL1H5 are now fully back in its hands.http://www.thepharmaletter.com/file/0f45dabf0bf1d045d471330d154d8eb1/lay-line-genomics-re-launches-antitrka-project-for-the-treatment-of-chronic-pain.htmlWed, 10 Mar 2010 11:47:38 +0100http://www.thepharmaletter.com/file/b735b7c03dd013440f1664e30f737940/glaxosmithkline-looking-for-alliancesacquisitions-in-india-says-ceo-as-he-dedicates-albendazole-facility-in-nashik.htmlUK drug giant GlaxoSmithKline, like many other pharmaceutical majors, is looking to increase its presence in the fast-growing Indian market. "We are looking for acquisitions in India which are attractive to us. We are a very financially strong company," GSK chief executive Andrew Witty told reporters after inaugurating the company's facility for manufacturing albendazole, an anti-parasitic drug, at the Nashik site in India, yesterday.http://www.thepharmaletter.com/file/b735b7c03dd013440f1664e30f737940/glaxosmithkline-looking-for-alliancesacquisitions-in-india-says-ceo-as-he-dedicates-albendazole-facility-in-nashik.htmlTue, 09 Mar 2010 13:38:16 +0100http://www.thepharmaletter.com/file/5aac533b0acb29d8b6d7d85ab273ba01/genmab-shares-plunge-30-as-zalutumumab-fails-in-ph-iii-study-of-refractory-head-and-neck-cancer-patients.htmlDenmark’s Genmab A/S, which has already seen its stock fall 45% in the last five months, plunged as much as 30% yesterday, settling down 20.4% at 73.50 Danish kroner, after the company revealed that a Phase III trial of its zalutumumab had failed to improve survival in patients with refractory head and neck cancer.http://www.thepharmaletter.com/file/5aac533b0acb29d8b6d7d85ab273ba01/genmab-shares-plunge-30-as-zalutumumab-fails-in-ph-iii-study-of-refractory-head-and-neck-cancer-patients.htmlTue, 09 Mar 2010 13:33:38 +0100http://www.thepharmaletter.com/file/08df603729cbe507221c892cc90e8d8f/lilly-buys-pfizers-european-animal-health-assets-as-the-latter-bids-for-ratiopharm-control-sanofimerck--co-animal-health-combo.htmlElanco, the animal health division of US drug major Eli Lilly has signed an agreement to acquire the European rights to a portfolio of certain Pfizer Animal Health products. The products, including vaccines, parasiticides and feed additives, are used in both the production animal and companion animal markets. Terms of the transaction are not disclosed.http://www.thepharmaletter.com/file/08df603729cbe507221c892cc90e8d8f/lilly-buys-pfizers-european-animal-health-assets-as-the-latter-bids-for-ratiopharm-control-sanofimerck--co-animal-health-combo.htmlTue, 09 Mar 2010 13:28:23 +0100http://www.thepharmaletter.com/file/fad824c04cda1fedd18415e6eaa3edda/astrazeneca-alleged-to-have-breached-uk-code-of-practice-with-seroquel-ads.htmlAnglo-Swedish drug major AstraZeneca is under investigation for breaches of the UK Prescription Medicines Code of Practice Authority (PMCPA) rules relating to the promotion of its blockbuster anti-psychotic drug Seroquel (quetiapine).http://www.thepharmaletter.com/file/fad824c04cda1fedd18415e6eaa3edda/astrazeneca-alleged-to-have-breached-uk-code-of-practice-with-seroquel-ads.htmlTue, 09 Mar 2010 13:24:07 +0100http://www.thepharmaletter.com/file/fd1467d00511a36f726311f0f31b64dd/russian-governments-drug-reimbursement-program-encouraged-increase-in-drug-consumption-and-sales.htmlBetween 2003-2008, Russia witnessed robust economic growth, attributed mainly to strong ruble and high oil prices in the international market. The growth was also supported by surge in domestic demand and increased investment in the country.http://www.thepharmaletter.com/file/fd1467d00511a36f726311f0f31b64dd/russian-governments-drug-reimbursement-program-encouraged-increase-in-drug-consumption-and-sales.htmlTue, 09 Mar 2010 13:09:16 +0100http://www.thepharmaletter.com/file/48b36f769579644ee6012ec09c37f184/south-africas-delayed-registration-of-antiretrovirals-keeping-cheaper-drugs-off-the-market.htmlDelays by South Africa’s pharmaceutical regulators in registering antiretrovirals (ARVs) may keep cheaper, more patient-friendly drugs out of reach as the country prepares to launch the world's largest tender for medicines to treat HIV/AIDS, comments the United Nation’s IRIN news service.http://www.thepharmaletter.com/file/48b36f769579644ee6012ec09c37f184/south-africas-delayed-registration-of-antiretrovirals-keeping-cheaper-drugs-off-the-market.htmlTue, 09 Mar 2010 12:57:33 +0100http://www.thepharmaletter.com/file/11613b1cf47e6b9d1593cc017ee14790/us-biotech-posts-gain-in-february-as-broader-markets-strengthen-notes-burrill-report.htmlThe biotechnology in the USA maintained its positive climb in February in lockstep with the general markets which, despite a few bumps in the road, also continued to strengthen, according to San Francisco, USA-based life science venture capital group Burrill & Co.http://www.thepharmaletter.com/file/11613b1cf47e6b9d1593cc017ee14790/us-biotech-posts-gain-in-february-as-broader-markets-strengthen-notes-burrill-report.htmlTue, 09 Mar 2010 12:45:47 +0100http://www.thepharmaletter.com/file/c6f8dccc2a0e49837d4c536eb346972a/the-implications-of-dimebon-phase-iii-failure---expert-independent-analysts-comment.htmlPhase III failure last week for Medivation/Pfizer's Dimebon (latrepirdine) is a major setback, however hope remains for Alzheimer’s sufferers and their carers, says Ben Greener, lead health care analyst at Datamonitor.http://www.thepharmaletter.com/file/c6f8dccc2a0e49837d4c536eb346972a/the-implications-of-dimebon-phase-iii-failure---expert-independent-analysts-comment.htmlTue, 09 Mar 2010 12:32:25 +0100http://www.thepharmaletter.com/file/61f904faee9d6751e192910a3915779f/us-senators-unveil-details-of-patent-reform-agreement-gets-mixed-reaction-from-pharma-industry.htmlLeaders of the US Senate Judiciary Committee last week announced details of an agreement on long-pending legislation to make reforms to the nation’s patent system. The new bill ostensibly makes significant steps toward resolving longstanding differences in legislative efforts to modernize US law for patent quality and efficiency, and make it more compatible with international laws.http://www.thepharmaletter.com/file/61f904faee9d6751e192910a3915779f/us-senators-unveil-details-of-patent-reform-agreement-gets-mixed-reaction-from-pharma-industry.htmlMon, 08 Mar 2010 12:18:55 +0100http://www.thepharmaletter.com/file/0ea1b2d4109a8d98bc5aa140a88a02b2/disappointments-for-astrazeneca-as-recentin-fails-in-ph-iiiii-and-for-rochebiogen-as-ra-drug-crelizumab-causes-deaths.htmlDrug majors AstraZeneca and Roche, with partner Biogen Idec, suffered setbacks in late-stage drug developments as the former saw its cancer drug Recentin (cediranib) fail to meet primary endpoints, while for the Swiss firm an independent Crelizumab RA & Lupus Data and Safety Monitoring Board advised that treatment with its ocrelizumab should be halted because the drug had caused deaths.http://www.thepharmaletter.com/file/0ea1b2d4109a8d98bc5aa140a88a02b2/disappointments-for-astrazeneca-as-recentin-fails-in-ph-iiiii-and-for-rochebiogen-as-ra-drug-crelizumab-causes-deaths.htmlMon, 08 Mar 2010 12:12:47 +0100http://www.thepharmaletter.com/file/3184af6882b703551ffcb82c325930f0/takeda-loses-sole-lead-among-admired-japanese-pharmaceutics-companies---by-p-reed-maurer.htmlInternational Alliances Limited (IAL), headed by Japanese drug industry veteran P Reed Maurer, has presented the results of its 11th annual survey of Japan’s most admired pharmaceutical companies. This covered 30 companies, 15 of which are Japanese and 15 affiliates of foreign drugmakers. They included:http://www.thepharmaletter.com/file/3184af6882b703551ffcb82c325930f0/takeda-loses-sole-lead-among-admired-japanese-pharmaceutics-companies---by-p-reed-maurer.htmlMon, 08 Mar 2010 12:05:02 +0100http://www.thepharmaletter.com/file/a48917440cb61a9d7b6a91f247f2c3f4/important-pharmaceutical-ip-issues-at-the-fore-in-brazil.htmlIntellectual property IP matters are once again attracting the attention of the Brazilian population. This is mainly due to two important events to be debated this month that may affect the pharmaceutical industry and international trade.http://www.thepharmaletter.com/file/a48917440cb61a9d7b6a91f247f2c3f4/important-pharmaceutical-ip-issues-at-the-fore-in-brazil.htmlMon, 08 Mar 2010 12:00:38 +0100http://www.thepharmaletter.com/file/35499583ca1fcc595e00825da3406e13/us-fda-should-to-strengthen-oversight-of-criminal-and-misconduct-investigations-says-critical-gao-report.htmlThe US Food and Drug Administration came in for criticism from the Government Accountability Office, which last week issued a report saying that the agency is not fulfilling its oversight obligation regarding its Office of Criminal Investigation. The report is the result of a review called for in 2009 by Senator Charles Grassley (Republican, Iowa), Ranking Member of the Senate Committee on Finance.http://www.thepharmaletter.com/file/35499583ca1fcc595e00825da3406e13/us-fda-should-to-strengthen-oversight-of-criminal-and-misconduct-investigations-says-critical-gao-report.htmlMon, 08 Mar 2010 11:54:39 +0100http://www.thepharmaletter.com/file/3f09f07ff2ae1d5417516930526c7464/osi-pharmaceuticals-board-under-investigation-over-possible-breach-of-fiduciary-duty.htmlAn investigation on behalf of current long-term shareholders in US drugmaker OSI Pharmaceuticals over potential breaches of fiduciary duty and other violations of state law in connection with an alleged unfair takeover proposed by Japan’s Astellas (The Pharma Letter March 1) has been announced by the advocacy group the Shareholders Foundation.http://www.thepharmaletter.com/file/3f09f07ff2ae1d5417516930526c7464/osi-pharmaceuticals-board-under-investigation-over-possible-breach-of-fiduciary-duty.htmlMon, 08 Mar 2010 11:50:23 +0100http://www.thepharmaletter.com/file/73e014172003dd64b9b247bc5be2d535/usas-phrma-urges-support-for-international-standards-in-russian-medicines-law.htmlAn amended version of the draft Federal Law "On Circulation of Medicines" was recently placed on the web site of the Russian Ministry of Healthcare and Social Development and has attracted much attention and criticism. Many suggestions were made to improve the initial Draft Law so as to ensure the effective functioning of the Russian pharmaceutical market, and this has now passed its first reading in the Duma, the nation’s Parliament. Russia is one of the BRIC (Brazil, Russia, India and China) countries which is currently attracting a great deal of attention from the pharmaceutical industry.http://www.thepharmaletter.com/file/73e014172003dd64b9b247bc5be2d535/usas-phrma-urges-support-for-international-standards-in-russian-medicines-law.htmlMon, 08 Mar 2010 11:45:48 +0100http://www.thepharmaletter.com/file/3bcdfac28807478dfac118ddcd27327e/belgian-pharma-trade-group-takes-issue-with-press-reports-on-drug-costs-market-set-to-shrink-as-patents-laps.htmlThe Belgian pharmaceutical trade group pharma.be has issued a strong rebuttal of an article published last week in the local newspaper Le Soir, saying that drug spending by the country’s Health Insurance Agency, the INAMI, of 3.2 billion euros ($4.37 billion) increased 12.5% in 2008 compared to 2007 and volume (4.2 billion in 2008) had seen a rise of 6%. Le Soir thus concludes that the average cost per unit of medicine has increased significantly, it points out.http://www.thepharmaletter.com/file/3bcdfac28807478dfac118ddcd27327e/belgian-pharma-trade-group-takes-issue-with-press-reports-on-drug-costs-market-set-to-shrink-as-patents-laps.htmlMon, 08 Mar 2010 11:40:29 +0100http://www.thepharmaletter.com/file/7002ea08957b4f49e54e382f290c4611/common-osteoporosis-drugs-are-associated-with-a-decrease-in-risk-of-breast-cancer.htmlWomen who take some types of bone-building drugs used to prevent and treat osteoporosis may be at lower risk of breast cancer, according to a study by US researchers published in the British Journal of Cancer.http://www.thepharmaletter.com/file/7002ea08957b4f49e54e382f290c4611/common-osteoporosis-drugs-are-associated-with-a-decrease-in-risk-of-breast-cancer.htmlMon, 08 Mar 2010 11:35:22 +0100http://www.thepharmaletter.com/file/fb66a96cbac952bd09125e1ce833c049/glaxosmithkline-slashes-cervical-cancer-vaccine-price-in-nigeria.htmlUK drug giant GlaxoSmithKline announced a 50% reduction in the price of its cervical cancer vaccine Cervarix in Nigeria, to allow more women and girls to be vaccinated against the deadly disease, reports the local newspaper The Day.http://www.thepharmaletter.com/file/fb66a96cbac952bd09125e1ce833c049/glaxosmithkline-slashes-cervical-cancer-vaccine-price-in-nigeria.htmlMon, 08 Mar 2010 11:30:47 +0100http://www.thepharmaletter.com/file/184afcfc5d6530f01ff02b35b224f966/bristol-myers-squibb-post-plavix-2013-eps-forecast-to-drop-to-195-but-still-exceeds-expectations-promising-rd-pipeline.htmlAt an investment community meeting yesterday, US drug major Bristol-Myers Squibb provided a business overview highlighting its pipeline and an earnings forecast for 2013 which exceeded analysts’ consensus forecasts by as much as 13%. The company said that it expects to generate minimum non-GAAP earnings per share of $ 1.95 in 2013, the first full year after losing US patent exclusivity for its blood thinning drug Plavix (clopidogrel, co-marketed with French drug major Sanofi-Aventis, the drug’s originator) in 2012.http://www.thepharmaletter.com/file/184afcfc5d6530f01ff02b35b224f966/bristol-myers-squibb-post-plavix-2013-eps-forecast-to-drop-to-195-but-still-exceeds-expectations-promising-rd-pipeline.htmlFri, 05 Mar 2010 11:40:29 +0100http://www.thepharmaletter.com/file/d05180f2a8c878a0a56116997a94c882/australian-judge-rules-against-merck--cos-vioxx-saying-the-pain-drug-is-not-fit-for-sale.htmlThe Federal Court in Melbourne, Australia, this morning published its judgment in the Peterson case, finding against US drug giant Merck & Co’s local subsidiary Merck Sharp & Dohme Australia on two claims under Australian statutory provisions. However, the Court dismissed all claims against the US parent specifically finding that Merck was not negligent in its development, scientific study and sale of its former blockbuster arthritis pain killer, the COX-2 inhibitor Vioxx (rofecoxib).http://www.thepharmaletter.com/file/d05180f2a8c878a0a56116997a94c882/australian-judge-rules-against-merck--cos-vioxx-saying-the-pain-drug-is-not-fit-for-sale.htmlFri, 05 Mar 2010 11:33:17 +0100http://www.thepharmaletter.com/file/d6c98ef1feff8179cd3e3cef74860346/market-access-for-pharma-pulling-in-the-same-direction--a-uk-perspective-from-alan-crofts.htmlThere has been a spate of recent articles in the pharmaceutical press describing market access and the need for the corporate sector to align marketing and relationship strategies to meet the organisational developments in the customer base, notes Alan Crofts. Health care director at the UK’s NB Group, a medical communications company specializing in market access communications and strategy for health care firms. This debate is necessary and timely: the organization of National Health Service buying policy is evolving with decision making apportioned to emerging departments that encompass both clinical and non-clinical functions, he says.http://www.thepharmaletter.com/file/d6c98ef1feff8179cd3e3cef74860346/market-access-for-pharma-pulling-in-the-same-direction--a-uk-perspective-from-alan-crofts.htmlFri, 05 Mar 2010 11:26:04 +0100http://www.thepharmaletter.com/file/21615d9b5611617afec2d311c21f7ca1/sanofi-aventis-reports-ph-iii-data-on-cabazitaxel-improving-survival-30-making-it-a-strong-contender-in-prostate-cancer-market.htmlFrench drug major Sanofi-Aventis has reported results from a Phase III trial which demonstrated that its cabazitaxel, an investigational compound, plus prednisone/prednisolone significantly improved overall survival and progression-free survival in patients with metastatic hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel-based chemotherapy. The TROPIC trial compared the combination of cabazitaxel plus prednisone/prednisolone to the active agent mitoxantrone plus prednisone/prednisolone.http://www.thepharmaletter.com/file/21615d9b5611617afec2d311c21f7ca1/sanofi-aventis-reports-ph-iii-data-on-cabazitaxel-improving-survival-30-making-it-a-strong-contender-in-prostate-cancer-market.htmlFri, 05 Mar 2010 11:20:19 +0100http://www.thepharmaletter.com/file/bf6e02fa1cc0d633e5ac01cdc3ed669b/us-court-upholds-fdas-grant-of-five-year-market-exclusivity-for-shires-adhd-drug-vyvanse.htmlThe US District Court for the District of Columbia has upheld the Food and Drug Administration’s decision reaffirming that UK drugmaker Shire’s Vyvanse (lisdexamfetamine) is entitled to 5-year market exclusivity for the treatment of attention-deficit hyperactivity disorder (ADHA).http://www.thepharmaletter.com/file/bf6e02fa1cc0d633e5ac01cdc3ed669b/us-court-upholds-fdas-grant-of-five-year-market-exclusivity-for-shires-adhd-drug-vyvanse.htmlFri, 05 Mar 2010 11:15:27 +0100http://www.thepharmaletter.com/file/0774dfe8fb79e9d07f2fca99ab2b68a0/watson-to-acquire-us-rights-to-columbia-labs-crinone-and-prochieve-for-up-to-92-million.htmlUS drugmaker Watson Pharmaceuticals has entered into an agreement to expand its Women's Health brand product portfolio with the acquisition of the exclusive US rights to Columbia Laboratories’ bioadhesive progesterone gel products currently marketed under the trade names Crinone and Prochieve for the indications of infertility and secondary amenorrhea.http://www.thepharmaletter.com/file/0774dfe8fb79e9d07f2fca99ab2b68a0/watson-to-acquire-us-rights-to-columbia-labs-crinone-and-prochieve-for-up-to-92-million.htmlFri, 05 Mar 2010 11:09:25 +0100http://www.thepharmaletter.com/file/c756061fe03e7a2669bbd5e373b4dabd/merck--cos-combo-asthma-drug-sees-positive-results-in-ph-iii.htmlUS drug major Merck & Co presented positive data from two Phase III trials of a combination of mometasone furoate and formoterol fumarate at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting yesterday. A New Drug Application for the combination is currently under review by the US Food and Drug Administration and Merck has also submitted a Marketing Authorization Application to the European Medicines Agency (EMEA).http://www.thepharmaletter.com/file/c756061fe03e7a2669bbd5e373b4dabd/merck--cos-combo-asthma-drug-sees-positive-results-in-ph-iii.htmlFri, 05 Mar 2010 11:03:50 +0100http://www.thepharmaletter.com/file/0cf6a2f4a3badda0d45ec216855388f8/drugs-effect-on-reduction-of-new-hip-fractures-is-greatest-influence-on-rxing-decisions-says-dr-report.htmlA drug's effect on reduction of new hip fractures is the attribute that most influences, according to research findings from Decision Resources. Clinical data and the opinions of interviewed thought leaders indicate Eli Lilly's Forteo (teriparatide; brand name Forsteo in Europe) has advantages over patient-share leader alendronate (Merck & Co's Fosamax, Teijin's Bonalon) on this attribute.http://www.thepharmaletter.com/file/0cf6a2f4a3badda0d45ec216855388f8/drugs-effect-on-reduction-of-new-hip-fractures-is-greatest-influence-on-rxing-decisions-says-dr-report.htmlFri, 05 Mar 2010 10:59:07 +0100http://www.thepharmaletter.com/file/97c261d502be70d010584eb95a744d46/lithuania-amendment-to-the-pharmacy-act-to-introduce-regulations-to-non-subsidized-drugs-proposed.htmlThe 2010 outlook for Lithuania's pharmaceutical market is fairly negative, according to Business Monitor International. Despite an almost inevitable uptick in relation to an extremely poor 2009, where the country was one of only a few globally to witness sales contractions, the road to recovery will likely be long.http://www.thepharmaletter.com/file/97c261d502be70d010584eb95a744d46/lithuania-amendment-to-the-pharmacy-act-to-introduce-regulations-to-non-subsidized-drugs-proposed.htmlFri, 05 Mar 2010 10:54:03 +0100http://www.thepharmaletter.com/file/4975319d093541c0e24d26534656e5d0/uks-doh-has-open-mind-on-generic-substitution-plans.htmlFinal decisions on whether generic substitution will be introduced in England have yet to be made, the UK government has insisted, comments Tom Moberly writing for HealthcareRepublic. Responses to the current consultation (The Pharma Letters passim) on whether pharmacists in England should be allowed to switch drugs prescribed by brand to generic alternatives will inform any decision, the Department of Health said.http://www.thepharmaletter.com/file/4975319d093541c0e24d26534656e5d0/uks-doh-has-open-mind-on-generic-substitution-plans.htmlFri, 05 Mar 2010 10:48:46 +0100