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Office of Pharmaceutical Science CDER FDA _ L "v Fhe 2&h Annua! IN ^ ^ PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance D. Office of Pharmaceutical Science, CDER, FDA FDA/ISPE Guidance Workshop Mumbai, India February 25, 2005 Analysis: Big Pharma gets a driving lesson from carmakers 2011 By Ben Hirscblsr a-nd Ltrdw g Bungar LONDON (Reuters) - Big dragmakers.
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G'ajoSmilfrKlinc, lor cjejnplc, teamed wiD> McLaren in September Id gel innovation and pioeoss know-how hum its Foomula One enqin aers m Irmrino a 2009 move by AstraZan sea In l.i p man., faetyn no antarusa from Jaguar L a ad Rover, pa rl of US PhRMA 2008 Biotech Report Roche and Genentech: Avastin as a thought leader... Numira(r) Abbott Laboratories mAb ulcerative colitis Phase III adalimumab Abbott Park, tL (847) 937-6100 Avastin(r) bevacizumab mAb AVASTIN' (bevacizumab) For Intravenous Use H". VJfcnr vit kVJ, *"Uknm, iij-rvu u*V5"rtirrn.i| Genentech .SourA San Francisco, CA colorectal cancer (adjunctive treatment), diffuse large B-celt lymphoma (first-line therapy), fallopian tube cancer, gastric cancer (combination therapy), gastrointestinal stromal tumors (GlST), ovarian cancer, pancreatic cancer (combination therapy, first-line therapy), peritoneal cancer, prostate cancer, renal cancer metastatic brain cancer, glioblastoma, liver cancer, multiple myeloma (combination therapy), non-Hodgkin's lymphoma, pancreatic cancer, small-cell lung cancer (SClC) Phase ill (b50) 225-1000 Phase II (650) 225-1000 solid tumors Phase I t£>50) 225-1000 Major Roche Group Submissions JS3 2011 AYasLn EC adj HER.24 Aeastn HSCLC Edj •Aeastin 4 Hcrmonta -nBE hER 2-lat line Aeastin ghabl-astoma 1" line V nbThcra/nitiJKHn 4 Af c Sir NhL age e1: ve Tarce.-n NSCLE ndj f T-E Wi (RGasCiCl A f deleetrapib A U 3 E h EH 24 •?*!&* fine (ELy I tiyafipieenia ) post 2012 Unless ststed orhenwise subm ss ons will ECOLT in US ard EU 1 The ELI sjbr^ EE or s =o Deludes ncbatons fcr MTX-na ve snd P-.D. Sialus SE o'" June 30 2000 Roche Half-year results 2009 July 23, 2009 Basel, London Roche offers Germany a pay-for- performance deal on Avastin Article I 31 October 2011 (c)PrintThis ShareThis In Germany's tight market for new and existing drugs to gain reimbursement, Swiss drug major Roche (ROG: SIX) is proposing to refund hospitals and public insurers in Germany for the cost of Avastin (bevacizumab) if initial courses of the cancer drug fail to help patients, according to Michael Fitzhugh, writing in California, USA, investment bank Burrill & Co's Burrill Report last week. LCbIiuiblood WSBiOl Avastin in Germany costs about $4,584 (€3.300) per patient each month, immap phentermine making public expenditures on the drug an easy target for criticism in a country where a value-based drug-pricing scheme has been implemented.
To continue reading you The Pharma Letter 31 October 2011 Value Our immap phentermine Focus Medically differentiated therapies Significant opportunity to address unmet medical needs i Significant value capture from medically differentiated therapies v Significant opportunity to capitalise on the breakthroughs in science Differentiation Roche Half-year results 2009 July 23, 2009 Basel, London Herceptin HER 2 Diagnosis The National Institute for Clinical Excellence (Nice) has been criticised for ruling that Avastin is not cost- effective enough to be prescribed on the immap phentermine NHS. The Guardian, March 2011 After the Patent Expiry Cliff Dealing with Price Pressure Expanding the Global Market 1 Changing Global Regulations Facilities of the Future Challenges & Opportunities "In the past, Western drugmakers thrived on innovation while firms in emerging markets made cheap copies of their products.
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