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216 Resources for

biotechnology

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Stryker's Biotech Unit Gets FDA Warning Letter
CHICAGO (Reuters) - Stryker Corp (SYK) said on Friday its biotechnology division received a warning letter from U.S. health regulators regarding quality systems and compliance issues at its Hopkinton, Massachusetts, location. Stryker shares dipped on the news and were trading $3.07 ...
Tags: Stryker Corp., biotechnology, FDA, regulator, Chicago, Massachusetts, compliance, clinical trial, medical device, Thomson Reuters Corp.
News items 2008-05-02
Pfizer Invests $300 Mln in Irish Biotech Facility
LONDON (Reuters) - Pfizer Inc (PFE), the world's biggest drugmaker, is to invest 190 million euros ($297 million) establishing a new biotech plant in Ireland for the production of experimental medicines, it said on Friday. The facility, which will create around 100 permanent...
Tags: Pfizer Inc., drug company, biotechnology, Ireland, London, clinical trial, Thomson Reuters Corp., leader, manufacturing, job
News items 2008-05-02
Esperion Escapes the Pfizer Borg
Esperion Therapeutics, a biotech that Pfizer spent $1.3 billion acquiring in 2003, is free once more. And its founder, Roger Newton, is apparently putting the band back together. Newton, in fact, has just pulled off one of the rarer and most complicated moves in biotechnology -- the...
Tags: Pfizer Inc., Esperion, Biotechnology, Mergers & Acquisitions, Investment, Finance, David P. Hamilton
Blog posts 2008-05-01
Pfizer Drops Glaucoma Drug, NicOx Shares Slump
PARIS (Reuters) - Pfizer (PFE) has decided not to take NicOx's (NCOX) experimental glaucoma drug PF-03187207 into final Phase III tests after a mid-stage study failed to met its primary endpoint, sending NicOx shares tumbling. The news is a major blow for NicOx,...
Tags: Pfizer Inc., endpoint, compound, Paris, biotechnology, Thomson Reuters Corp., patient, collaboration
News items 2008-05-06
Glaxo to Buy Biotech Sirtris in $720 Mln Deal
By Ransdell Pierson NEW YORK (Reuters UK) - GlaxoSmithKline (GSK) said on Tuesday it had agreed to buy biotechnology company Sirtris Pharmaceuticals Inc (SIRT) for $720 million (360.69 million pounds) in cash, in hopes its medicines that modulate an aging-related family of enzymes will be...
Tags: Glaxo, Type 2, Regulus, Biotechnology, Alnylam Pharmaceuticals Inc., GlaxoSmithKline Plc., Isis Pharmaceuticals Inc., Sirtris Pharmaceuticals Inc.
News items 2008-04-22
Takeda Sees Big Profit Slump on Millennium Costs
TOKYO (Reuters) - Japan's Takeda Pharmaceutical Co Ltd posted a 7.7 percent fall in annual operating profit on Friday and forecast a sharp drop for the current year on costs for its $8.8 billion purchase of U.S. biotech firm Millennium...
Tags: Sales strategy, Tokyo, pharmaceutical company, Japan, acquisition, Thomson Reuters Corp., sales, Medicare, licensing agreement, R&D, analyst, U.S., tax
News items 2008-05-08
Why Biogenerics Will Survive Genzyme's Problems
The Food and Drug Administration rejected Genzyme's request to sell a version of its drug Myozyme made in a new factory, a decision some journalists and bloggers insist on casting as a black mark against the very notion of generic biotech drugs. There's just one problem: These...
Tags: FDA, Genzyme Corp., Clinical Trial, Biotech Drug, WSJ Health Blog, Biotech Industry, Biotechnology, Federal Government, Government, David P. Hamilton
Blog posts 2008-04-22
Glaxo Boosts Biotech With Regulus Deal
By Ben Hirschler LONDON (Reuters UK) - GlaxoSmithKline (GSK) boosted its position in biotech on Thursday by signing a deal that could be worth up to $600 million (303 million pounds) with Regulus Therapeutics, taking it into the hot area of RNA technology. The tie-up covers...
Tags: RNA, Inflammation, Regulus Therapeutics, MicroRNAs, Biotechnology, Alnylam Pharmaceuticals Inc., GlaxoSmithKline Plc., Isis Pharmaceuticals Inc.
News items 2008-04-17
Emergent's Vaccine Play: Biotech Can Flip-Flop, Too
For sudden twists of fate, abrupt collapses and the occasional stunning revival, it's hard to beat the biotech industry. Yesterday, for instance, the all-but-dead biotech VaxGen agreed to sell off its ailing anthrax vaccine to its East Coast rival Emergent BioSolutions --a company that spent much of this decade trying...
Tags: Biotechnology, Vaccine, Emergent Biosolutions, VaxGen, Healthcare, David P. Hamilton
Blog posts 2008-05-06
DuPont First-quarter Profit Climbs
NEW YORK (Reuters) - Chemical company DuPont Co (DD) said on Tuesday that first-quarter earnings rose, spurred by strong results from its agricultural business. The company posted quarterly net income of $1.19 billion, or $1.31 a share, up from $945 million, or $1.01...
Tags: Financial accounting, DuPont Co., earnings, biofuel, New York, developing country, biotechnology, net income, Thomson Reuters Corp., food, industry
News items 2008-04-22
Glaxo-Regulus Kicks Off an miRNA Land Grab
GlaxoSmithKline's willingness to bet up to $600 million on a tiny biotech called Regulus Therapeutics kicks off the latest pharma land grab -- this one for treatments that rely on tiny molecules called microRNAs, or miRNAs for short. New drug technologies -- or "modalities," as the industry...
Tags: Pharmaceutical Company, miRNA, Regulus Therapeutics, Glaxo, Biotechnology, David P. Hamilton
Blog posts 2008-04-18
TRIPS - What Is It and Why Is It Important to the Biotech Industry
Trade Related Aspects of Intellectual Property (TRIPS) set minimum standards for patent protection and allows certain exceptions to patent rights. This article discusses the importance of the World Trade Organization (WTO) TRIPS for the biotech industry and the current debate about the flexibility of TRIPS to balance IP rights and...
Tags: Allens Arthur Robinson, biotechnology, intellectual property, IP
White papers
Changes to the Copyright Act 1968 Directly Affect the Biotech and Health Industries
In this brief note, the author discusses moral rights and discusses how they affect the biotech and health industries. A recent development in the world of intellectual property - moral rights - directly affects the biotech and health industries. These industries and the professionals who work in them produce intellectual...
Tags: Vertical industries, Benefits, HEALTHCARE, Allens Arthur Robinson, biotechnology, health care, intellectual property, industry
White papers
Chiron Corporation: biotechnology Firm Strengthens Project Management Practices, Increases R&D Projects
Chiron Corporation is a biotechnology and pharmaceutical company based in Emeryville, California. Chiron needed to improve its time-to-market performance. It wanted better insight into project scheduling and resource allocation, along with uniform project management to help reduce project delays. Pcubed delivered the Microsoft Office Enterprise Project Management Solution to help...
Tags: Tools & Techniques, Strategy, Microsoft Corp., Chiron Corp., project management, biotechnology, data analysis, R&D, performance
Case studies
Critical Project Recovery for Genomics Alliance
Three firms - a major chemical manufacturer, an agricultural concern, and a biotechnology company - formed an alliance to implement a new high-throughput biotechnology development process. The alliance asked PRTM to facilitate interim project execution as a way to save the project. PRTM worked with each alliance core team to...
Tags: Strategy, Team management, PRTM, alliance, biotechnology, risk management, team, cost savings
Case studies
Overview of 21CFR Part 11
Pharmaceutical, medical device, biotechnology and services companies are challenged to ensure regulatory compliance through all their operations. A critical success factor is in their ability to have a common enterprise-wide solution for capturing out-of-spec/non conformance, tracking and managing the corrective action process, ensuring that the recommendations are implemented successfully and...
Tags: MetricStream Inc., medical device, regulatory compliance, biotechnology, performance
White papers
The Rise of the Paraprofessional
The loud drumbeat about the tough labor market often drowns out one fact: the need for skilled technologists, both chemical-based laboratory technicians and process technologists, is growing faster than the available pool of talent. Pharmaceutical and biopharmaceutical manufacturing companies are having a hard time hiring and retaining the skilled staff...
Tags: Workforce management, pharmaceutical company, training, biotechnology, talent, hiring
White papers
Bio-Tech Company Learns The Science Of Business In Poway, CA
Master one technology and get ready to learn the next. In the technology business, your product is always changing. Ron Hamlin knows that better than anyone. When he set out to manufacture X-ray machines that examine biological substances such as viruses and DNA, he had just received his PhD in...
Tags: Marketing research, marketing strategy, DNA, biotechnology, manufacturing, virus, marketing
Case studies
Amcham 2003 Taiwan White Paper: Pharmaceuticals
Taiwan has a healthcare-delivery infrastructure recognized for its world-class technology and the quality of its healthcare workers, but the current funding framework does not permit either key resource to be used to optimal advantage. In order to maximize profits, hospitals are driven to focus on the quantity rather than the...
Tags: HEALTHCARE, Strategy, biotechnology, pharmaceutical company, intellectual property right, intellectual property, vision, health care, environment, industry
White papers
Amcham 2003 Taiwan White Paper: Priority Issues
The attractiveness of Taiwan as an investment market for the international research-based pharmaceutical industry is under threat, as are the long-term prospects for its health care system and its appeal as a regional biotechnology player. The key issues: (1) Solve long-standing issues that deprive international firms of a level playing...
Tags: HEALTHCARE, public health, pharmaceutical company, intellectual property right, medical device, health care, biotechnology, barrier, intellectual property, patient, environment, industry
White papers
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