Navigation Links
Publication of Shire plc's Annual Report 2008
Date:3/25/2009

hares control over the planning and execution of product development with collaborative partners. The Group cannot be certain that, if clinical trials are completed, either the Group or its collaborative partners will file for, or receive, required authorizations to manufacture and/or market potential products (including a marketing authorization application or Abbreviated New Drug applications ('ANDA')) or that such application will be reviewed and approved by the regulatory authorities in a timely manner, if at all.

If the Group is unable to meet the requirements of regulators in relation to a particular product, it may be unable to develop the product or obtain or retain the necessary marketing approvals

Drug companies are required to obtain regulatory approval before manufacturing and marketing most drug products. Regulatory approval is generally based on the results of:

    - quality testing (chemistry, manufacturing and controls);

    - non-clinical testing; and

    - clinical testing.

The clinical development, manufacture, marketing and sale of pharmaceutical products is subject to extensive regulation, including separate regulation by each member state of the European Union ('EU'), the European Medicines Agency ('EMEA') itself and federal, state and local regulation in the US. Unanticipated legislative and other regulatory actions and developments concerning various aspects of the Group's operations and products may restrict its ability to sell one or more of its products or to sell those products at a profit. The generation of data is regulated and any generated data is susceptible to varying interpretations that could delay, limit or prevent regulatory approval. Required regulatory approvals may not be obtained in a timely manner, if at all. In addition, other regulatory requirements for any such proposed products may not be met.

Even if the Group obtains r
'/>"/>

SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33

Related biology technology :

1. Bionovo Announces Publication of Positive Phase 2 Trial Results for Menerba(TM)
2. Sopherion Therapeutics, LLC Announces Publication of Phase I/II Myocet(R) (Nonpegylated Liposomal Doxorubicin) Data in Advanced Breast Cancer Patients
3. InVitria Among Leading Innovators in Cell Culture Media According to Top Biotechnology Publication
4. BioTrends Releases TreatmentTrends(TM): US Nephrology, an Ongoing Syndicated Publication Providing Insight into Physician Perceptions and Management of Renal Anemia, Hyperphosphatemia, and Secondary Hyperparathyroidism
5. New Publications Show Noninvasive Magnetic Resonance-Guided Focused Ultrasound to be a Potentially Safe, Effective Pain-Relieving Treatment for Bone Metastases
6. PharmSource and BioProcess Technology Consultants Announce Publication of New Market Report: Cell Culture Manufacturing Capacity: Trends and Outlook through 2013
7. Webcast Alert: Regulus Therapeutics, Alnylam Pharmaceuticals and Isis Pharmaceuticals Announce New Nature Publication on miR-21 Conference Call
8. Genomic Health Announces Publication of a Study Demonstrating the Oncotype DX(R) Breast Cancer Assay Influences Chemotherapy Treatment Recommendation in 44 Percent of Patients Evaluated
9. Publication on Tregitopes in Blood Journal of October 2008
10. Repligen Announces Publication of Positive Results with Proprietary HDAC Inhibitor in Huntingtons Disease Model
11. ABMAC Foundation Announces Publication of an Historic Volume Documenting the Creation of a National Health Care System in Taiwan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/26/2015)... , Aug. 26, 2015  Platform therapeutic company ... has received a $1.5M Phase II SBIR grant ... further develop its therapeutic agent to reduce arteriovenous ... in end stage renal disease (ESRD) patients undergoing ... Institute of Diabetes and Digestive and Kidney Diseases ...
(Date:8/26/2015)... and BEIJING , August 26, 2015 ... Scene with Impressive Acheivements  DiaCardio wins 1 st ... The competition, led in Israel ... featured 21 startups from countries including the US, China ... and Latin America .  Impressive ...
(Date:8/26/2015)... OXFORD, England , August 26, 2015 ... P2i Ltd against Europlasma NV relating to P2i ... parties have resolved their dispute in the United ... or liability on the part of either party. As a ... the Central District of California dismissed ...
(Date:8/26/2015)... Bruno, CA. (PRWEB) , ... August 26, 2015 , ... ... major conferences to develop new business relationships with local sponsors in southern California. The ... to facilitate their drug development processes and regulatory pathways., , ...
Breaking Biology Technology:Symic Biomedical Awarded $1.5MM NIH Phase II SBIR Grant to Develop its Proteoglycan Mimetic Therapeutics to Reduce Vascular Access Failures in ESRD 2Symic Biomedical Awarded $1.5MM NIH Phase II SBIR Grant to Develop its Proteoglycan Mimetic Therapeutics to Reduce Vascular Access Failures in ESRD 3Israeli Startup Takes First Place at Shengjing Global Innovation Awards 2015 2Israeli Startup Takes First Place at Shengjing Global Innovation Awards 2015 3Israeli Startup Takes First Place at Shengjing Global Innovation Awards 2015 4Israeli Startup Takes First Place at Shengjing Global Innovation Awards 2015 5Israeli Startup Takes First Place at Shengjing Global Innovation Awards 2015 6P2i Settles United States Litigation 2PRC Clinical To Attend Major Industry Conferences And Meet Sponsor Companies In The San Diego Biotech Hub 2PRC Clinical To Attend Major Industry Conferences And Meet Sponsor Companies In The San Diego Biotech Hub 3
... - Dr. Brad Thompson, President,and CEO of Oncolytics ... a,corporate overview of the company at Toronto CFA ... being held at the National Club, 303 Bay,Street, ... Inc. Oncolytics is a Calgary-based biotechnology company ...
... Nov. 15 Imaging,Diagnostic Systems, Inc., (OTC Bulletin Board: ... announced that its CT Laser,Mammography (CTLM(R)) system, designed as ... its future clinical applications were featured in,a cover story ... magazine. This,major article was contributed by Eric Milne, MD, ...
... Nov. 14 Advanced Life Sciences,Holdings, Inc. (Nasdaq: ... the,discovery, development and commercialization of novel drugs in ... today,announced its financial results for the third quarter ... The net loss for the three months ...
Cached Biology Technology:Media Advisory - Oncolytics Biotech Inc. to Present at Toronto CFA Society 2New Optical Breast Cancer Imaging Technology Garners Cover Story in National Radiology Magazine 2New Optical Breast Cancer Imaging Technology Garners Cover Story in National Radiology Magazine 3Advanced Life Sciences Announces Third Quarter 2007 Financial Results 2Advanced Life Sciences Announces Third Quarter 2007 Financial Results 3Advanced Life Sciences Announces Third Quarter 2007 Financial Results 4Advanced Life Sciences Announces Third Quarter 2007 Financial Results 5Advanced Life Sciences Announces Third Quarter 2007 Financial Results 6Advanced Life Sciences Announces Third Quarter 2007 Financial Results 7Advanced Life Sciences Announces Third Quarter 2007 Financial Results 8Advanced Life Sciences Announces Third Quarter 2007 Financial Results 9
(Date:8/20/2015)... NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" ... the growing mobile commerce market and creator of the ... Card Alliance and the EMV Migration Forum.  ... Card Alliance Latin America (SCALA) Chapter provides NXT-ID, Inc. ... leaders promoting adoption of smart card technology. ...
(Date:8/12/2015)... , Aug. 12, 2015   MedNet Solutions ... the entire spectrum of clinical research, is proud to ... the company,s comprehensive SaaS-based eClinical technology platform, has led ... the first two quarters of 2015.   Q2 2015 ... largest quarters measured by contract value sold in the ...
(Date:8/10/2015)... and TELTOW, Germany , August 10, ... (SMI), a world leader in Eye Tracking Technology for ... its OEM Eye Tracking Platform for integration into all ... contains reference designs for seamless integration of eye tracking ... reality HMDs and augmented reality smart glasses. Omnivision,s leading ...
Breaking Biology News(10 mins):NXT-ID, Inc. Joins Smart Card Alliance and EMV Migration Forum 2NXT-ID, Inc. Joins Smart Card Alliance and EMV Migration Forum 3NXT-ID, Inc. Joins Smart Card Alliance and EMV Migration Forum 4MedNet Solutions Experiences Explosive Corporate Growth 2SMI Completes OEM Eye Tracking Platform to Cover All Consumer Displays 2SMI Completes OEM Eye Tracking Platform to Cover All Consumer Displays 3
... LA JOLLA, CAThe seeds sprouting in your spring garden may still ... a finite energy pack contained within each seed. Once those resources ... on a "green" photosynthetic program. Researchers at the Salk Institute for ... relayed. In a study published in the May 24, 2011, ...
... 18, 2011 The Initiative for a Competitive Inner City ... 100 list of the fastest-growing inner city companies in the ... year,s list.  The Inner City 100 program recognizes successful inner ... innovative business practices and job creation in America,s urban communities. ...
... A nationwide network to monitor and maintain honeybee health ... five-year, $5 million program funded by the U.S. Department ... led by Penn State. The Bee Informed Partnership ... management practices and use them to develop best practices ...
Cached Biology News:It's not easy being green 2It's not easy being green 3Prometheus Research Ranked #3 in 13th Annual ICIC and Fortune Magazine's Inner City 100 2Prometheus Research Ranked #3 in 13th Annual ICIC and Fortune Magazine's Inner City 100 3Penn State leads in honey bee health initiative 2
... save space and organize gloves, ... other garb. They are the ... small parts used in labs, ... Many other sizes and custom ...
... Quixell, manufactured by Stoelting, selects single ... control. In no time at all, a ... on the keypad...the cell is collected into ... individual wells of a microtiter plate. Quixells ...
... microRNA expression profiling and built on ... on-chip synthesis platform. These microarrays are ... microRNA Expression Profiling Service. ... Microarray contains all known fish microRNAs ...
... for genome-wide microRNA expression profiling and ... Paraflo microfluidic on-chip synthesis platform. These ... our comprehensive microRNA Expression Profiling Service. ... Maize microRNA Microarray contains all known ...
Biology Products: