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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

Additional Resources

FierceBiotech Names GlobeImmune as One of the "Fierce 15" Biotech Companies of 2008
FierceBiotech and GlobeImmune, Inc.announced today that GlobeImmune has been named to the annual FierceBiotech"Fierce 15" list, designating it as one of the top biotech companies of2008. The editors of FierceBiotech evaluated hundreds of privately heldfirms based on company vision, revenue potential, quality of deals,strength of technology, partnerships, and competitive market...
Articles 2008-06-24
Regulus Therapeutics Selected for Fierce 15 Top Biotech Companies
CAMBRIDGE, Mass. & CARLSBAD, Calif. -- Regulus Therapeutics LLC, a joint venture between Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) formed to discover, develop, and commercialize microRNA miRNA therapeutics, announced today that it has been named to the annual FierceBiotech "Fierce 15" list, designating it as...
Articles 2008-06-24
RhuDex(R) Achieves Positive Results in Clinical Phase IIa Trial
Lund, Sweden, June 24, 2008 - Active BiotechAB's (OMX Nordic:ACTI)collaboration partner MediGene AG (Frankfurt, Prime Standard: MDG)has achieved its objectives in a clinical phase IIa trial of thecandidate drug RhuDex® for the treatment of rheumatoid arthritis. In addition to positive safety data and the good adsorption afteroral administration, a...
Articles 2008-06-24
Pharsight Launches PK Accelerator™
PK Accelerator Bundled Solution Accelerates Pharmacokinetic Analysis and Reporting MOUNTAIN VIEW, Calif., June 24 /PRNewswire-FirstCall/ -- Pharsight Corporation , a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that it will be launching PK Accelerator (PKATM), a system of...
Articles 2008-06-24
EyeCyte, Inc. Secures Series A Funding from Pfizer
* "New paradigm" of drug development, combining efforts of the National Institutes of Health and The Scripps Research Institute with leading translational biotech and pharmaceutical companies EyeCyte and Pfizer * Collaboration seeks to develop new cell-based treatments for neovascular and degenerative retinal disease SAN DIEGO --...
Articles 2008-06-23
In Pain Market, Huge Unmet Needs, Tough Regulatory Environment Challenge Pharmaceutical Companies, According to MedPredict
SCOTTSDALE, Ariz., June 23 /PRNewswire/ -- MedPredict has published a new report designed to provide critical strategic insight for pharma and biotech companies hoping to identify the next blockbuster drug for pain management. The report, entitled "Thought Leader Insight & Analysis: Pain/Analgesics," is based on in-depth interviews conducted with...
Articles 2008-06-23
International Consoldiated Companies Appoints ODL Securities to Raise up to US $50 Million
International Consolidated Companies, Inc.(OTCBB: INCC) today announced that it has appointed ODL Securities Limitedof the United Kingdom to raise up to US $50 million for acquisitions inChina. INCC recently acquired, through a wholly-owned subsidiary, two China-basedcompanies, Shanghai Huaxin High Biotechnology and Sichuan Kelun Bio-TechPharmaceutical Company and is actively seeking additional...
Articles 2008-06-23
DNDi Partners With Pharma, Biotech, Academia, Public Health Institutes & NGOs to Deliver Lifesaving Drugs
Drugs for Neglected Diseases initiativeDNDi, an independent, non-profit pharmaceutical organization, will bringtogether more than 150 scientists, researchers, academics and global healthleaders from Africa, Asia, Europe, Latin America and North America on June26, 2008, to discuss how international research partnerships can bestdevelop and deliver new lifesaving drugs for neglected diseases. Immediately...
Articles 2008-06-23
Active Biotech's Novel MS Compound laquinimod Featured in the Scientific Publication The Lancet
Tomorrow's issue of the scientific journal TheLancet, Volume 371,Issue 9630, includes an article covering Active Biotech's (OMXNordic: ACTI) and Teva Pharmaceutical Industries Ltd's novel oral MSdrug laquinimod. The article, entitled "Effect of Laquinimod onMRI-monitored disease activity in patients with RRMS: a multicenter,randomized, double-blind, placebo-controlled phase IIb study", willbe available on...
Articles 2008-06-20
Oncolytics Biotech Inc. Announces U.S. Phase 2 Clinical Trial Investigating REOLYSIN® in Combination with Paclitaxel and Carboplatin
CALGARY, June 20 /PRNewswire-FirstCall/ -- Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that following U.S. Food and Drug Administration FDA review, the Company is initiating a U.S. Phase 2 clinical trial using intravenous administration of REOLYSINR in combination with paclitaxel and carboplatin in patients with advanced head and...
Articles 2008-06-20
Media Advisory: Invitation to Attend Research Symposium on Development of New Drugs for Neglected Tropical Diseases
Drugs for Neglected Diseases initiative, anon-profit pharmaceutical organization working to develop new drugs forneglected tropical diseases, will host a public research symposium in NewYork in conjunction with the opening of its North American regional supportoffice. WHAT:"Developing New Treatments for the Most Neglected Diseases Through GlobalResearch Partnerships" -- Scientists, researchers,...
Articles 2008-06-19
Campbell Alliance Clinical Development Practice to Conduct Two Workshops at 44th DIA Annual Meeting
RALEIGH, N.C., June 17 /PRNewswire/ -- Campbell Alliance, the leading management consulting firm specializing in the pharmaceutical and biotech industry, today announced that its Clinical Development Practice will conduct two workshops at the 44th Drug Information Association DIA Annual Meeting to be held June 22 to 26, 2008, at...
Articles 2008-06-17
IMS Health Reports Global Biotech Sales Grew 12.5 Percent in 2007, Exceeding $75 Billion
NORWALK, Conn. -- Global prescription sales of biotech drugs increased 12.5 percent in 2007 to more than $75 billion, according to a new report by IMS Health (NYSE: RX), the world's leading provider of market intelligence to the pharmaceutical and healthcare industries. The global biotech market grew at nearly double...
Articles 2008-06-17
Going for Gold: Gold Leaf Awards Honour Biotech Innovation and Success from International Collaboration
BioMS Medical, Lignol Energy Corp., Xenon Pharmaceuticals Inc., Chairman of MaRS Discovery District and President of EMD Serono Canada honoured with prestigious industry awards SAN DIEGO -- BIOTECanada today formally presented the 2008 Gold Leaf awards today at the BIO International Show in San Diego. Nominated and judged...
Articles 2008-06-17
Risk-averse investors threaten drug development
New drug development by the biotechnology industry is threatened by increasingly risk-averse investors and intensifying competition from generic rivals, a survey shows. A major cause of investor wariness is the growing caution of the US Food and Drug Administration in granting marketing approval for new drugs. This...
Articles 2008-06-16
CytRx Corporation to Participate on the "Risk-Reduced Models for the Biotech Industry" Panel at BIO 2008 International Convention
LOS ANGELES -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that David Haen, Vice President of Business Development, will participate in the "Risk-Reduced Models for the Biotech Industry" panel at the BIO 2008 International Convention in San Diego on...
Articles 2008-06-16
Invitrogen to buy Applied Biosytems in mega US biotech deal
NEW YORK AFP — Invitrogen Corp. will buy Applera Corp.'s Applied Biosystems Group in a 6.7 billion dollar deal to create a biotechnology giant, the two California companies said Thursday. "This strategic combination will create a global leader in biotechnology reagents and systems generating approximately 3.5 billion dollars...
Articles 2008-06-12
AngioGenex Appoints New CEO to Direct Development of Anti-Cancer Drugs
NEW YORK, June 10 /PRNewswire-FirstCall/ -- AngioGenex Inc. (BULLETIN BOARD: AGGX.OB) a New York-based biotechnology company, and the leader in the field of Id targeted anti-angiogenic drugs, announced the appointment of William Garland PhD as Chief Executive Officer. Dr. Garland, formerly with Hoffmann La Roche, Inc.,...
Articles 2008-06-10
Effective Drug Development Metrics Link Operations With Strategy, According to Tufts Center for the Study of Drug Development
Research-based drug companies looking tostreamline the development of new medicinal products should adopt metricsthat link their R&D activities with business strategy, according to theTufts Center for the Study of Drug Development. "To be most useful to senior management, metrics should focus on in-depthanalyses of selected performance measures and provide strategic...
Articles 2008-06-10
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