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 email newsletter and to...Wed, 11 Jan 2012 13:04:46 +0100http://www.thepharmaletter.com/file/122099/iqwig-re-assessments-come-up-with-same-view-for-saxagliptin-and-different-for-crizotinib.htmlUnder the rules of the German Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed additional information to studies for two drugs, US pharma behemoth Pfizer's (NYSE: PFE) Xalkori (crizotinib) and Drug major Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca's (LSE: AZN) OnglyzaKomboglyze (saxagliptin).http://www.thepharmaletter.com/file/122099/iqwig-re-assessments-come-up-with-same-view-for-saxagliptin-and-different-for-crizotinib.htmlTue, 14 May 2013 09:26:35 +0100http://www.thepharmaletter.com/file/122022/unigene-and-nordic-bioscience-amend-jdv-accord-amgen-vectibix-china-deal.htmlUSA-based Unigene Laboratories (PINK: UGNE) has entered into an equity transfer and exclusive license agreement with Nordic Bioscience, involving three proprietary metabolic peptide analogs for type 2 diabetes, osteoarthritis and osteoporosis developed as part of a joint development vehicle (JDV) established by both companies in October 2011.http://www.thepharmaletter.com/file/122022/unigene-and-nordic-bioscience-amend-jdv-accord-amgen-vectibix-china-deal.htmlFri, 10 May 2013 09:15:50 +0100http://www.thepharmaletter.com/file/121953/diabetes-drugs-market-forecast-to-reach-553-billion-in-2017-with-further-growth-to-2023.htmlA new report by Visiongain predicts the world market for diabetes medications will reach $55.3bn in 2017. The antidiabetic medicines industry generated $35.6 billion in 2012, and its revenues will show strong growth to 2023. That sales forecast and others appear in Diabetes Treatments: World Drug Market 2013-2023.http://www.thepharmaletter.com/file/121953/diabetes-drugs-market-forecast-to-reach-553-billion-in-2017-with-further-growth-to-2023.htmlWed, 08 May 2013 09:11:15 +0100http://www.thepharmaletter.com/file/121919/sanofi-plans-acceleration-of-expansion-into-ukraine-this-year.htmlFrench drug major Sanofi (Euronext: SAN) is considering expanding its presence in Ukraine this year, amid the ongoing growth of the local pharmaceutical market.http://www.thepharmaletter.com/file/121919/sanofi-plans-acceleration-of-expansion-into-ukraine-this-year.htmlTue, 07 May 2013 08:41:12 +0100http://www.thepharmaletter.com/file/121898/bristol-myers-gets-added-indication-from-us-fda-for-sustiva-signs-second-deal-with-ambrx.htmlUS pharma major Bristol-Myers Squibb (NYSE: BMY) says that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Sustiva (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5kg.http://www.thepharmaletter.com/file/121898/bristol-myers-gets-added-indication-from-us-fda-for-sustiva-signs-second-deal-with-ambrx.htmlMon, 06 May 2013 11:33:47 +0100http://www.thepharmaletter.com/file/121861/abide-therapeutics-in-up-to-430-million-deal-with-merck-co-for-type-2-diabetes-and-metabolic-disease.htmlPrivately-held biopharma firm Abide Therapeutics has entered into a collaboration agreement with US drugs giant Merck & Co (NYSE: MRK) to discover, develop and commercialize small-molecule therapies directed against three novel targets to treat metabolic diseases with a focus on type 2 diabetes.http://www.thepharmaletter.com/file/121861/abide-therapeutics-in-up-to-430-million-deal-with-merck-co-for-type-2-diabetes-and-metabolic-disease.htmlFri, 03 May 2013 09:03:50 +0100http://www.thepharmaletter.com/file/121860/us-judge-throws-out-verdict-in-takeda-actos-case.htmlThe US subsidiary of Japan's largest drugmaker Takeda Pharmaceuticals (TYO: 4502) USA announced that, in the case of Jack Cooper, et al v Takeda Pharmaceuticals America Inc et al., No CGC-12-518535, the judge granted Takeda's motion for non-suit. The ruling nullifies the jury's verdict last month, which had awarded plaintiffs $6.5 million in damages allegedly caused by the firm's diabetes drug Actos (pioglitazone; The Pharma Letter April 29). The trial began in February.http://www.thepharmaletter.com/file/121860/us-judge-throws-out-verdict-in-takeda-actos-case.htmlFri, 03 May 2013 08:58:54 +0100http://www.thepharmaletter.com/file/121763/gsk-returns-ipx066-rights-to-impax-merck-co-and-pfizer-link-up-on-diabetes-drug.htmlUS biotech firm Impax Laboratories (Nasdaq: IPXL) saw its shares fall 2% to $17.32 in premarket trading, after the company revealed the termination of its collaboration with UK pharma giant GlaxoSmithKline (LSE: GSK for the development and commercialization of IPX066 outside the USA and Taiwan has been terminated.http://www.thepharmaletter.com/file/121763/gsk-returns-ipx066-rights-to-impax-merck-co-and-pfizer-link-up-on-diabetes-drug.htmlTue, 30 Apr 2013 08:55:23 +0100http://www.thepharmaletter.com/file/121762/emisphere-earns-10-million-on-amended-deal-with-novo-nordisk.htmlUSA-based Emisphere Technologies (OTCBB: EMIS) says that it has agreed with Danish insulin giant Novo Nordisk (NOV: N) to amend the two companies' agreement to develop and commercialize oral formulations of Novo Nordisk's proprietary GLP-1 receptor agonists, which have the potential of treating type 2 diabetes, using Emisphere's Eligen technology (The Pharma Letter December 22, 2010).http://www.thepharmaletter.com/file/121762/emisphere-earns-10-million-on-amended-deal-with-novo-nordisk.htmlTue, 30 Apr 2013 08:51:10 +0100http://www.thepharmaletter.com/file/121723/takeda-considering-options-over-us-actos-court-ruling.htmlThe US subsidiary of Japan's largest drugmaker, Takeda Pharmaceuticals (TYO 4502), says that in the case of Jack Cooper et al versus Takeda Pharmaceuticals America, No CGC-12-518535, the jury found in favor of the plaintiffs and awarded a total of $6.5 million in damages, with respect to the company's type 2 diabetes drug Actos (pioglitazone).http://www.thepharmaletter.com/file/121723/takeda-considering-options-over-us-actos-court-ruling.htmlMon, 29 Apr 2013 08:51:37 +0100http://www.thepharmaletter.com/file/121609/hikma-in-licenses-inhaled-insulin-for-mena-advaxis-and-fusionvax-asia-deal.htmlJordan-based Hikma Pharmaceuticals (LSE: HIK) has signed a licensing and distribution agreement with USA-based Dance Biopharm for its proprietary inhaled insulin product, Dance 01, for the Middle East and Africa. Dance 01 is currently under development for the treatment of patients with diabetes, with Phase III studies expected to begin next year.http://www.thepharmaletter.com/file/121609/hikma-in-licenses-inhaled-insulin-for-mena-advaxis-and-fusionvax-asia-deal.htmlTue, 23 Apr 2013 09:19:49 +0100http://www.thepharmaletter.com/file/121532/merck-co-opens-new-120-million-manufacturing-plant-in-china.htmlUS Pharma giant Merck & Co (NYSE: MRK) has opened its new pharmaceutical manufacturing facility in Hangzhou, China, which will package Merck medicines for China and the Asia Pacific region and will become a critical part of the group's global supply chain, and involved an investment of nearly $120 million.http://www.thepharmaletter.com/file/121532/merck-co-opens-new-120-million-manufacturing-plant-in-china.htmlFri, 19 Apr 2013 09:25:55 +0100http://www.thepharmaletter.com/file/121509/brazil-to-resume-human-insulin-production-with-a-200-investment.htmlThe resumption of national human insulin production was announced in Brazil this week, at an event in Belo Horizonte attended by the country's President, Dilma Rousseff. Over the next five years, 430 million real ($218 million) is expected to be invested, including funds from the Ministry of Health and the Oswaldo Cruz Foundation (Fiocruz), and funding from the National Social and Economic Development Bank (BNDES).http://www.thepharmaletter.com/file/121509/brazil-to-resume-human-insulin-production-with-a-200-investment.htmlThu, 18 Apr 2013 12:15:26 +0100http://www.thepharmaletter.com/file/121445/lillys-diabetes-drug-dulaglutide-does-well-in-two-additional-trials.htmlUS drug major Eli Lilly (NYSE: LLY) has released positive top-line results of two additional Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a once-weekly treatment for type 2 diabetes.http://www.thepharmaletter.com/file/121445/lillys-diabetes-drug-dulaglutide-does-well-in-two-additional-trials.htmlTue, 16 Apr 2013 16:24:55 +0100http://www.thepharmaletter.com/file/121095/eli-lilly-views-additional-180-million-investment-to-expand-insulin-making-in-indianapolis.htmlUS pharma major Eli Lilly (NYSE: LLY) says that it is working closely with the City on a proposal to invest an additional $180 million in the company's Indianapolis-based insulin manufacturing operations.http://www.thepharmaletter.com/file/121095/eli-lilly-views-additional-180-million-investment-to-expand-insulin-making-in-indianapolis.htmlTue, 02 Apr 2013 15:45:33 +0100http://www.thepharmaletter.com/file/121081/janssen-gains-fda-approval-of-invokana-for-type-2-diabetes-files-simeprevir-nda.htmlThere were a couple of good news items for Johnson & Johnson (NYSE: JNJ) unit Janssen Pharmaceuticals on Friday (March 29), firstly, with the US Food and Drug Administration approving the firm's oral drug Invokana (canagliflozin), used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.http://www.thepharmaletter.com/file/121081/janssen-gains-fda-approval-of-invokana-for-type-2-diabetes-files-simeprevir-nda.htmlTue, 02 Apr 2013 09:37:39 +0100http://www.thepharmaletter.com/file/120994/ema-follows-fda-lead-launching-investigation-on-pancreatic-risks-with-glp-1-based-type-2-diabetes-drugs.htmlThe European Medicines Agency says it is investigating findings by a group of independent academic researchers that suggest an increased risk of pancreatitis (inflammation of the pancreas) and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with so-called GLP-1-based therapies (glucagon-like peptide 1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors).http://www.thepharmaletter.com/file/120994/ema-follows-fda-lead-launching-investigation-on-pancreatic-risks-with-glp-1-based-type-2-diabetes-drugs.htmlWed, 27 Mar 2013 09:14:41 +0100http://www.thepharmaletter.com/file/120958/regulatory-briefs-on-bayers-stivarga-boehringerlillys-empagliflozin-and-pfizers-xeljanz.htmlDrug regulator Health Canada has approved German drug major Bayer's Stivarga (regorafenib tablets), indicated for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.http://www.thepharmaletter.com/file/120958/regulatory-briefs-on-bayers-stivarga-boehringerlillys-empagliflozin-and-pfizers-xeljanz.htmlTue, 26 Mar 2013 09:21:53 +0100http://www.thepharmaletter.com/file/120938/germanys-iqwig-finds-no-added-benefit-for-astrazeneca-and-bristol-myers-forxiga.htmlIn an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the new type 2 diabetes drug Forxiga (dapagliflozin) from AstraZeneca (LSE: AZN) and Bristol-Myers Squibb (NYSE: BMY), concluding that there was no added benefit over current standard therapy, because the drug manufacturer did not present any relevant data for any of the possible therapeutic indications of dapagliflozin.http://www.thepharmaletter.com/file/120938/germanys-iqwig-finds-no-added-benefit-for-astrazeneca-and-bristol-myers-forxiga.htmlMon, 25 Mar 2013 15:54:53 +0100