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View Article  FDA probing suicide risks from asthma drug
U.S. regulators on Thursday said they are probing a possible connection between Merck & Co's Singulair asthma drug and suicidal behavior.

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MSNBC.com
View Article  UK pharma industry set to lose business offshore
26-Mar-2008 - The pharmaceutical industry has lost confidence in the UK as a place to do business to an "alarming degree" and the situation is only set to deteriorate, reveals new research.

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in-pharmatechnologist.com
View Article  Health Canada issues draft rules for subsequent entry biologics
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."

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in-pharmatechnologist.com
View Article  Growth in US Prescription Drug Market Hits 40-Year Low
Untitled Document Norwalk, CT (Mar. 12)—The US market for prescription pharmaceuticals grew 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%. Total US...

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Pharmaceutical Technology -- Advanstar Communications Inc.
View Article  Congress Proposes Biosimilars Pathway
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...

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Pharmaceutical Technology -- Advanstar Communications Inc.
View Article  Nanotechnological Delivery System Circumvents Body's Defenses
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...

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Pharmaceutical Technology -- Advanstar Communications Inc.
View Article  FDA Investigates Suicide With Merck Drug
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NYTimes.com
View Article  F.D.A. to Seek More Safety Data on Stents
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NYTimes.com
View Article  FDA probing suicide risks from asthma drug
Merck's Singulair linked to behavior changes, officials say

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MSNBC.com
View Article  FDA wants long-term studies of stents
Officials urge makers of drug-coated device to track patients for up 5 years

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MSNBC.com
View Article  Rush decisions by FDA may subvert drug safety
Meds OK'd right on deadline are 4 times more likely to have major problems

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MSNBC.com
View Article  Concern over cancer study’s ‘Big Tobacco’ ties
Disclosure of $3.6 million in tobacco cash reignites industry influence fears

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MSNBC.com
View Article  Congress Proposes Biosimilars Pathway
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.

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Pharmaceutical Technology
View Article  Growth in US Prescription Drug Market Hits 40-Year Low
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%.

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Pharmaceutical Technology
View Article  Small World, Big Dreams
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.

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Drug Discovery & Development
View Article  New US biosimilars bill a disappointing distraction, says GPhA
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.

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In-Pharmatechnologist.com
View Article  Cigarette Company Paid for Lung Cancer Study
The revelation that a researcher’s study was underwritten by a tobacco company has caused an appearance of bias.

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NYTimes.com