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/122372/nordion-to-sell-targeted-therapies-business-to-btg-for-200-million.htmlCanada's Nordion (TSX: NDN), a provider of products and services for the prevention, diagnosis and treatment of disease, has entered into an agreement to divest its Targeted Therapies business to UK-based BTG (LSE: BTG) for a cash purchase price of $200 million. Net of cash taxes and transaction costs, Nordion expects to realize around $185 million on closing. The transaction is anticipated to be completed by the end of June 2013.http://www.thepharmaletter.com/file/122372/nordion-to-sell-targeted-therapies-business-to-btg-for-200-million.htmlFri, 24 May 2013 12:15:03 +0100http://www.thepharmaletter.com/file/122371/novo-nordisks-diabetes-drug-victoza-produced-8-weight-loss-in-ph-iii-obesity-trial.htmlDanish insulin giant Novo Nordisk (NOV: N) has released headline results from a 56-week double-blind Phase IIIa clinical trial investigating the potential of liraglutide, the active ingredient of its type 2 diabetes agent Victoza, to induce and maintain weight loss in people without diabetes who are obese or overweight with co-morbidities such as pre-diabetes, hypertension and dyslipidemia.http://www.thepharmaletter.com/file/122371/novo-nordisks-diabetes-drug-victoza-produced-8-weight-loss-in-ph-iii-obesity-trial.htmlFri, 24 May 2013 12:10:47 +0100http://www.thepharmaletter.com/file/122370/fda-allows-marketing-of-first-a1c-test-labeled-for-diagnosing-diabetes-from-roche.htmlThe US Food and Drug Administration yesterday (May 23) announced that it is allowing marketing of the Cobas Integra 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals, a product from Swiss drug major Roche (ROG: SIX). This is the first HbA1c test that the FDA has allowed to be marketed for this use.http://www.thepharmaletter.com/file/122370/fda-allows-marketing-of-first-a1c-test-labeled-for-diagnosing-diabetes-from-roche.htmlFri, 24 May 2013 12:07:16 +0100http://www.thepharmaletter.com/file/122369/brics-not-delivering-promises-of-high-growth-in-health-care-markets-says-fs.htmlHealth care organizations expanding into emerging markets such as the BRICs (Brazil, Russia, India and China) are realizing there are no shortcuts. This is proving particularly challenging, considering the current health care environment, especially in the USA. Companies must change the dialogue around BRIC, as it is now more about establishing value, customizing to local needs, and building regional partnerships to build a sustainable business, according to market research group Frost & Sullivan.http://www.thepharmaletter.com/file/122369/brics-not-delivering-promises-of-high-growth-in-health-care-markets-says-fs.htmlFri, 24 May 2013 12:03:44 +0100http://www.thepharmaletter.com/file/122365/johnson-johnson-expects-10-nda-filings-by-2017-saying-pharma-sector-poised-for-growth.htmlAt a meeting today with industry analysts, senior leaders from the Janssen pharmaceutical companies of US health care giant Johnson & Johnson (NYSE: JNJ) yesterday (May 23) announced they anticipate submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017.http://www.thepharmaletter.com/file/122365/johnson-johnson-expects-10-nda-filings-by-2017-saying-pharma-sector-poised-for-growth.htmlFri, 24 May 2013 09:14:25 +0100http://www.thepharmaletter.com/file/122364/merck-co-drops-development-of-pd-candidate-preladenant.htmlFollowing review of three separate Phase III studies of preladenant, US pharma giant Merck & Co (NYSE: MRK) said that these did not provide evidence of efficacy for this investigational adenosine A2A receptor antagonist in the treatment of Parkinson's disease (PD).http://www.thepharmaletter.com/file/122364/merck-co-drops-development-of-pd-candidate-preladenant.htmlFri, 24 May 2013 09:10:24 +0100http://www.thepharmaletter.com/file/122363/aaa-enters-supply-deal-with-eli-lilly-for-amyvid-in-france-italy-and-spain.htmlFrance-based molecular nuclear medicine firm Advanced Accelerator Applications (AAA) says it has signed a non-exclusive manufacturing and service agreement to supply US pharma major Eli Lilly's (NYSE: LLY) Amyvid (florbetapir (18F)) solution for injection in France, Italy and Spain.http://www.thepharmaletter.com/file/122363/aaa-enters-supply-deal-with-eli-lilly-for-amyvid-in-france-italy-and-spain.htmlFri, 24 May 2013 09:04:45 +0100http://www.thepharmaletter.com/file/122346/positive-new-data-on-novartis-galvus-in-elderly-type-2-diabetes-patients.htmlResults of the INTERVAL study were published on line in The Lancet today (May 23) and for the first time demonstrated the feasibility of setting and achieving individualized treatment targets in elderly patients with type 2 diabetes.http://www.thepharmaletter.com/file/122346/positive-new-data-on-novartis-galvus-in-elderly-type-2-diabetes-patients.htmlThu, 23 May 2013 16:10:45 +0100http://www.thepharmaletter.com/file/122345/alexza-deal-with-teva-sets-stage-for-adasuve-say-analysts.htmlUSA-based Alexza Pharmaceuticals' (Nasdaq: ALXA) US marketing deal with Israel-headquartered Teva Pharmaceutical Industries (NYSE: TEVA) for Adasuve (orally-inhaled Staccato loxapine; The Pharma Letter May 9) enhances the product's US sales prospects given Teva's expertise in the psychiatric and hospital markets, say analysts at Edison Investment Research.http://www.thepharmaletter.com/file/122345/alexza-deal-with-teva-sets-stage-for-adasuve-say-analysts.htmlThu, 23 May 2013 16:05:39 +0100http://www.thepharmaletter.com/file/122344/exec-appointments-at-biogen-idec-and-halozyme-succession-plan-for-forest-labs.htmlUS biotech firm Biogen Idec (Nasdaq: BIIB) announced that Spyros Artavanis-Tsakonas, has been named chief scientific officer. Dr Artavanis-Tsakonas had served as interim CSO while on sabbatical from Harvard Medical School.http://www.thepharmaletter.com/file/122344/exec-appointments-at-biogen-idec-and-halozyme-succession-plan-for-forest-labs.htmlThu, 23 May 2013 16:01:44 +0100http://www.thepharmaletter.com/file/122343/positive-clinical-results-for-zensuns-neucardin-chf-patients.htmlUSA and China-based Zensun Science & Technology has revealed positive results of four completed Phase II clinical trials including three double-blind, placebo-controlled studies conducted in China and Australia and interim results from the US Phase II trial for Zensun's innovative "first-in-class" anti-heart failure drug, Neucardin, which has just been licensed to the USA's SciClone Pharmaceuticals (Nasdaq: SCLN) for Greater China (The Pharma Letter May 20).http://www.thepharmaletter.com/file/122343/positive-clinical-results-for-zensuns-neucardin-chf-patients.htmlThu, 23 May 2013 15:57:35 +0100http://www.thepharmaletter.com/file/122342/health-care-reforms-not-keeping-pace-with-needs-of-canadians-says-report.htmlThe Health Council of Canada today (May 23) released Progress Report 2013: Health care renewal in Canada, highlighting the progress achieved by governments in five key areas: wait times, primary health care and electronic health records, pharmaceuticals management, disease preventionhealth promotion and Aboriginal health. The report finds that, overall, efforts at reform are not keeping pace with the changing health care needs of Canadians. There is variability of access to services across the country.http://www.thepharmaletter.com/file/122342/health-care-reforms-not-keeping-pace-with-needs-of-canadians-says-report.htmlThu, 23 May 2013 15:54:26 +0100http://www.thepharmaletter.com/file/122340/netherlands-first-to-approve-astellas-vesomni.htmlThe European subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) says that the Dutch Medicines Evaluation Board (MEB) has granted marketing authorization for Vesomni in the Netherlands, the first clearance for the drug, for treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy.http://www.thepharmaletter.com/file/122340/netherlands-first-to-approve-astellas-vesomni.htmlThu, 23 May 2013 12:23:56 +0100http://www.thepharmaletter.com/file/122339/alchemia-and-merck-serono-collaborate-on-ha-irinotecan-with-erbitux.htmlAustralian drug developer Alchemia (ASX: ACL) and Merck Serono, a subsidiary of Germany's Merck KGaA (MRK: DE) have agreed to collaborate by supporting the initiation of a new clinical trial of HA-Irinotecan which will be conducted by principal investigator associate Professor Peter Gibbs. Financial terms were not disclosed.http://www.thepharmaletter.com/file/122339/alchemia-and-merck-serono-collaborate-on-ha-irinotecan-with-erbitux.htmlThu, 23 May 2013 12:19:17 +0100http://www.thepharmaletter.com/file/122337/is-the-diabetes-market-facing-a-blockbuster-free-future.htmlJapanese drug major Takeda's (TYO: 4502) recently announced positive late-stage results for new type 2 diabetes drug, fasiglifam, has prompted excitement within the industry and raised hopes of reviving Takeda's diabetes treatment business, following last year's patent expiration of hit product Actos (pioglitazone). But as drugs continue to improve without the addressing the biggest unmet needs of the current therapy landscape, an analyst with research and consulting firm GlobalData asks, are we entering an era without blockbuster diabetes drugs?http://www.thepharmaletter.com/file/122337/is-the-diabetes-market-facing-a-blockbuster-free-future.htmlThu, 23 May 2013 12:12:25 +0100http://www.thepharmaletter.com/file/122336/ema-makes-key-recommendations-to-tackle-the-issue-of-medication-errors.htmlThe European Medicines Agency yesterday issued six key recommendations to tackle the issue of medication errors causing harm in the European Union. These recommendations are described in the medication-errors workshop report, which is available on the Agency's web site.http://www.thepharmaletter.com/file/122336/ema-makes-key-recommendations-to-tackle-the-issue-of-medication-errors.htmlThu, 23 May 2013 12:08:52 +0100http://www.thepharmaletter.com/file/122333/us-fda-advisory-panel-backs-approval-of-merck-cos-suvorexant-but-only-at-lower-doses.htmlThe US Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee yesterday voted 13 to three to approve drug giant Merck & Co's (NYSE: MRK) investigational insomnia medicine suvorexant at doses of 15mg and 20mg, but voted eight to seven (with one abstention) against the 30mg and 40mg doses, saying that these were not safe.http://www.thepharmaletter.com/file/122333/us-fda-advisory-panel-backs-approval-of-merck-cos-suvorexant-but-only-at-lower-doses.htmlThu, 23 May 2013 09:17:24 +0100http://www.thepharmaletter.com/file/122332/ranbaxy-highlights-its-actions-on-improved-business-and-quality-assurance.htmlIndian drugmaker Ranbaxy Laboratories (BSE: 500359), whose US subsidiary was the subject of the biggest generics drugmaker settlement with the US Department of Justie over felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy's manufacturing facilities in India (The Pharma Letter May 14), has issued a statement highlighting some of the major specific actions the company has been taking in recent years to address certain conduct of the past and to ensure the safety and efficacy of all of its products currently available in the global market. These actions include:http://www.thepharmaletter.com/file/122332/ranbaxy-highlights-its-actions-on-improved-business-and-quality-assurance.htmlThu, 23 May 2013 09:11:25 +0100http://www.thepharmaletter.com/file/122331/grifols-gains-global-rights-to-aradigms-pulmaquin.htmlSpanish drugmaker Grifols (GRLS: MC) has signed an exclusive, worldwide license for USA-based Aradigm's (OTC BB: ARDM.OB) proprietary formulations of inhaled ciprofloxacin (brand names Pulmaquin and Lipoquin) for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis (BE). Aradigm has completed Phase IIb clinical trials in BE patients with Pulmaquin and Lipoquin.http://www.thepharmaletter.com/file/122331/grifols-gains-global-rights-to-aradigms-pulmaquin.htmlThu, 23 May 2013 09:05:52 +0100http://www.thepharmaletter.com/file/122316/pfizer-to-split-off-remaining-80-interest-in-zoetis.htmlZoetis Inc (Nasdaq: ZTS), the animal health business of which US pharma behemoth Pfizer (NYSE: PFE) spun out 20% in an initial public offering raising $2.2 billion (The Pharma Letter January 20), intends to file a Registration Statement on Form S-4 with the Securities and Exchange Commission (SEC) in connection with the proposed exchange offer announced by Pfizer.http://www.thepharmaletter.com/file/122316/pfizer-to-split-off-remaining-80-interest-in-zoetis.htmlWed, 22 May 2013 16:11:48 +0100http://www.thepharmaletter.com/file/122315/glaxosmithkline-gets-200-million-barda-award-to-develop-new-antibiotics.htmlUK pharma giant GlaxoSmithKline (LSE: GSK) and the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), have agreed to a first of its kind collaboration that will support the development of several antibiotics to fight antibiotic resistance and bioterrorism.http://www.thepharmaletter.com/file/122315/glaxosmithkline-gets-200-million-barda-award-to-develop-new-antibiotics.htmlWed, 22 May 2013 16:08:04 +0100http://www.thepharmaletter.com/file/122314/italys-pharma-market-slump-set-to-continue-warns-globaldata.htmlThe value of Italy's pharmaceutical market will continue to fall in the foreseeable future, due to government support of generics and a stringent drug pricing policy, states the latest report from research and consulting firm GlobalData.http://www.thepharmaletter.com/file/122314/italys-pharma-market-slump-set-to-continue-warns-globaldata.htmlWed, 22 May 2013 16:04:21 +0100http://www.thepharmaletter.com/file/122313/swedish-registry-questions-superiority-of-bivalirudin-over-heparin-in-patients-undergoing-pci-for-nste-acs.htmlResults from a large observational study reported at EuroPCR 2013 (the official annual meeting of the European Association for Percutaneous Cardiovascular Interventions; EAPCI) this week question whether bivalirudin - The Medicines Company's (Nasdaq: MDCO) Angiomax - is superior to heparin in the absence of GPIIbIIIa blockade, showing similar 30-day mortality in patients with non-ST segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).http://www.thepharmaletter.com/file/122313/swedish-registry-questions-superiority-of-bivalirudin-over-heparin-in-patients-undergoing-pci-for-nste-acs.htmlWed, 22 May 2013 15:59:33 +0100http://www.thepharmaletter.com/file/122310/boehringer-ingelheim-gets-fda-warning-letter-on-cgmp-failures.htmlGerman family-owned drug major Boehringer Ingelheim today (May 22) revealed that the US Food and Drug Administration issued a warning letter concerning its manufacturing practices following an agency inspection in Ingelheim, Germany, in November 2012. The matter also concerned foreign particles detected in batches of active pharmaceutical ingredients.http://www.thepharmaletter.com/file/122310/boehringer-ingelheim-gets-fda-warning-letter-on-cgmp-failures.htmlWed, 22 May 2013 12:39:18 +0100