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- Maxiom Group to Host ePedigree Workshop to Help Life Sciences Companies Comply with Changing FDA and State Requirements
- WALTHAM, Mass. -- Maxiom Consulting Group, Inc., a leading strategic business and IT consulting firm exclusively serving the life sciences industry, today announced that it will host a free ePedigree workshop to help life sciences companies comply with evolving U.S. Food and Drug Administration FDA measures, and increased regulatory efforts...
- Research articles 2006-09-21
- Active pharmaceutical ingredient watch. (Markets: Life Sciences).(multiple topics)(Brief Article)
- AVENTIS has received Food and Drug Administration FDA approval for Taxotere docetaxel as first-line therapy for advanced or metastatic non-small cell lung cancer. CORIXA Corp. and GlaxoSmithKline PLC report that the FDA has determined the AVENTIS has received...
- Research articles 2002-12-09
- Maxiom Group to Host ePedigree Workshop to Help Life Sciences Companies Comply with Changing FDA and State Requirements
- PRINCETON, N.J. -- Maxiom Consulting Group, Inc., a leading strategic business and IT consulting firm exclusively serving the life sciences industry, today announced that it will host a free ePedigree workshop to help life sciences companies comply with evolving U.S. Food and Drug Administration FDA measures, and increased regulatory efforts...
- Research articles 2006-10-10
- AstraZeneca's Crestor gets FDA okay.(Life Sciences)(Brief Article)
- ASTRAZENECA PLC has gained US marketing approval for its anti-cholesterol drug Crestor rosuvastatin. Last week, the Food and Drug Administration FDA approved the drug in a 10 mg once-daily dose with an available dose range of 5 to 40 mg. ASTRAZENECA PLC...
- Research articles 2003-08-18
- Biogen gains FDA nod for US manufacturing. (Markets: life sciences).
- BIOGEN Inc. has received Food and Drug Administration FDA approval for its new $173 million large-scale manufacturing plant in Research Tri-angle Park, N.C. The site will be dedicated to the commercial production of its psoriasis drug Amevive (al BIOGEN Inc. has received Food and...
- Research articles 2003-08-11
- Corixa gains FDA nod for Bexxar. (Life Sciences).(Brief Article)
- CORIXA CORP and GlaxoSmithKline PLC GSK have received Food and Drug Administration FDA approval for non-Hodgkin's lymphoma NHL drug Bexxar (tositumomab and iodine I 131 tositumomab). CORIXA CORP and GlaxoSmithKline PLC GSK have received Food and Drug Administration FDA approval for non-Hodgkin's...
- Research articles 2003-07-14
- Genentech seeks early approval for oncology drug.(Life Sciences)
- GENENTECH INC. is seeking early approval for its newest oncology product Avastin bevacizumab with its filing of a completed biologics license application with the Food and Drug Administration FDA last week. The company is requesting priority re GENENTECH INC. is seeking early approval for...
- Research articles 2003-10-06
- Schering-Plough, Merck score big. (Life Sciences).(receives FDA approval for cholesterol drug, Zetia)
- THE $19 BILLION cholesterol market has been jolted by Food and Drug Administration FDA approval of Zetia ezetimibe, the first new class of drug behind a 15-year reign by statins. The development is good news for Schering-Plough Corp. SHP and THE $19 BILLION...
- Research articles 2002-11-04
- Idec Pharmaceuticals breaks ground for biologics facility. (Markets: Life Sciences).(Brief Article)(Statistical Data Included)
- IDEC PHARMACEUTICALS Corp. broke ground for a new 60 acre $400 million biologics manufacturing facility at Oceanside, Calif. The company plans to begin occupying the facility in 2004 and achieve Food and Drug Administration FDA approval and licen IDEC PHARMACEUTICALS Corp. broke ground for...
- Research articles 2002-06-10
- Sanofi's Eloxatin gains FDA approval. (Market: Life Sciences).(Brief Article)
- SANOFI-SYNTHELABO has pulled a stroke ahead of troubled ImClone Systems Inc. in the race for the US colorectal cancer market. Last week the Food and Drug Administration FDA approved Sanofi's Eloxatin oxaliplatin for injection after a 46-day pri SANOFI-SYNTHELABO has pulled a stroke ahead...
- Research articles 2002-08-19
- Novartis's Zelnorm receives FDA nod. (Life Sciences).(Brief Article)
- NOVARTIS AG has received Food and Drug Administration FDA approval for irritable bowel syndrome IBS drug Zelnorm tegaserod. The approval is important for Novartis, which had received an FDA non-approvable letter for Zelnorm last year. NOVARTIS AG has received Food and Drug...
- Research articles 2002-08-05
- FluMist is latest entry in vaccine market. (Markets: Life Sciences).(Brief Article)
- THE VACCINES market has a new entry in FluMist, an influenza vaccine delivered as a nasal mist. The product, developed by MedImmune Inc. and Wyeth, received Food and Drug Administration FDA approval in mid-June, and some analysts are projecting b THE VACCINES market has...
- Research articles 2003-06-30
- Pfizer delays NDA filing of pregabalin. (Markets: Life Sciences).(Brief Article)
- PFIZER INC. will delay filing its new drug application NDA with the Food and Drug Administration FDA for neuropathic pain drug pregabalin to conduct toxicological studies. Analysts revised earnings per share EPS estimates on a one-year holdup PFIZER INC. will delay filing its new...
- Research articles 2002-09-16
- Active pharmaceutical ingredient watch. (Markets: Life Sciences).(new drug approvals)(Brief Article)
- ABBOTT Laboratories has filed applications with US and European regulatory authorities to market the rheumatoid arthritis drug D2E7 adalimumab. SG Cowen projects a launch in the third quarter of 2003 and sales in 2005 of $800 million. BARR ...
- Research articles 2002-04-15
- U.S. FDA dedicates its new life sciences facility in White Oak
- The U.S. Food and Drug Administration's planned consolidation of scattered facilities into a unified campus in White Oak really took shape yesterday with the dedication of the first building, the $43 million Life Sciences Laboratory, a 124,000-square-foot building that will house approximately 130 scientists, researchers and others. The 2.1 million-square-foot...
- Research articles 2003-12-12
- Biogen targets Amevive launch. (Life Sciences).(plans to introduce psoriasis treatment drug)(Brief Article)(Statistical Data Included)
- BIOGEN INC. is picking up the pace in its race with Amgen Inc. for the $5 billion psoriasis market. In September, the Food and Drug Administration FDA committed to a six-month review of Biogen's biologics license application BLA for Amevive (al BIOGEN INC. is...
- Research articles 2002-09-23
- BMS moves forward on Abilify. (Life Sciences).(Bristol-Myers Squibb Co.'s schizophrenia drug)(Brief Article)
- BRISTOL-MYERS Squibb Company BMS and Otsuka Pharmaceutical Co. Ltd. have received an approvable letter from the Food and Drug Administration FDA for their schizophrenia drug Abilify aripiprazole. The drug, a next-generation atypical antipsych BRISTOL-MYERS Squibb Company BMS and Otsuka Pharmaceutical Co. Ltd. have...
- Research articles 2002-09-09
- Leading Pharmaceutical and Life Sciences Facilities Actively Deploying Sensicast for FDA 21 CFR Part 11 Compliance
- Sensicast® Systems, the world's leading provider of turnkey wireless sensor network systems, today announced it has seen rapidly accelerating demand for its SensiNetTM solutions from pharmaceutical labs, drug manufacturers, and bio-test facilities seeking to improve and accelerate the process of FDA 21 CFR Part 11 compliance.
- Research articles 2007-08-28
- Fertin Pharma Plant Goes Live With Life Sciences for Microsoft Dynamics AX Technology to Adhere to FDA Regulations.
- LONDON, May 3 /PRNewswire/ -- LONDON, May 3 /PRNewswire/ --
- Research articles 2006-05-03
- BMS's Abilify gains FDA nod. (Markets: Life Sciences).(Bristol-Myers Squibb Co.)(United States Food and Drug Administration)
- BRISTOL-MYERS Squibb Company BMS has received Food and Drug Administration approval for its schizophrenia drug Abilify aripiprazole. The news is a positive for BMS, though its timing is expected, with no impact on analyst projections. BRISTOL-MYERS Squibb Company BMS has received Food...
- Research articles 2002-11-25
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