26-Mar-2008 - Drug regulator Health Canada has published its draft guidelines for pharmaceutical firms seeking to gain approval for biosimilars or "subsequent entry biologics."
Link to Article
in-pharmatechnologist.com
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Thursday, March 27
Health Canada issues draft rules for subsequent entry biologics
by
Alex Hsieh on behalf of Professor Henry Wang
on Thu 27 Mar 2008 11:42 PM EDT
Congress Proposes Biosimilars Pathway
by
Alex Hsieh on behalf of Professor Henry Wang
on Thu 27 Mar 2008 11:39 PM EDT
Untitled Document Washington, DC (Mar. 27)—US Representatives Anna G. Eshoo (D-CA) and Joe Barton (R-TX) introduced legislation this month week to create a regulatory pathway for biosimilars, or follow-on biologics. The so-called Pathway for Biosimilars Act would allow the US Food and Drug Administration to determine “whether the biosimilar is...
Link to Article Pharmaceutical Technology -- Advanstar Communications Inc.
Nanotechnological Delivery System Circumvents Body's Defenses
by
Alex Hsieh on behalf of Professor Henry Wang
on Thu 27 Mar 2008 11:38 PM EDT
Untitled Document Houston, TX (Mar. 2)—In a press release, the University of Texas announced that Mauro Ferrari, of the University’s Health Science Center at Houston, presented a proof-of-concept study of a new multistage delivery system (MDS) for imaging and therapeutic applications. Ferrari described the study in an article featured in...
Link to Article Pharmaceutical Technology -- Advanstar Communications Inc.
Rush decisions by FDA may subvert drug safety
by
Lyle
on Thu 27 Mar 2008 06:45 PM EDT
Meds OK'd right on deadline are 4 times more likely to have major problems
Link to Article MSNBC.com
Congress Proposes Biosimilars Pathway
by
Lyle
on Thu 27 Mar 2008 06:40 PM EDT
Washington, DC (Mar. 27)—US Representatives Anna G. Eshoo (D-CA) and Joe Barton (R-TX) introduced legislation this month week to create a regulatory pathway for biosimilars, or follow-on biologics. The so-called Pathway for Biosimilars Act would allow the US Food and Drug Administration to determine “whether the biosimilar is interchangeable with the reference product, and gives the FDA the flexibility to determine what clinical testing—if any—is required for approval,” according to a release from Rep. Eschoo.
Link to Article Pharmaceutical Technology
Growth in US Prescription Drug Market Hits 40-Year Low
by
Lyle
on Thu 27 Mar 2008 06:38 PM EDT
Norwalk, CT (Mar. 12)—The US market for prescription pharmaceutical grow only 3.8% in 2007, the lowest growth rate in more than 40 years, according to a recent analysis by IMS Health. This is a strong drop in growth from 2006, when the market expanded by 8%.
Link to Article Pharmaceutical Technology
Small World, Big Dreams
by
Lyle
on Thu 27 Mar 2008 06:37 PM EDT
The US Food and Drug Administration (FDA) appears to be taking a cautious, deliberative approach as it approaches the myriad of scientific and regulatory issues involving nanobiotechnology and nanomedicine. After nearly a year of study, the FDA’s Nanotechnology Task Force is merely recommending the agency study the matter more fully and consider developing guidance for industry to assess the benefits and risks of drugs and medical devices using nanotechnology.
Link to Article Drug Discovery & Development
New US biosimilars bill a disappointing distraction, says GPhA
by
Lyle
on Thu 27 Mar 2008 06:35 PM EDT
26-Mar-2008 - The generic pharmaceutical industry has given short shrift to the latest congressional attempt to construct a viable approval pathway for biosimilars in the US.
Link to Article In-Pharmatechnologist.com |
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