Link to All Articles

Mar 27 2008, 11:45 AM EST
Otsuka Allies with MethylGene for R&D in Ocular Diseases other than Cancer
Payments to MethylGene include $3.875 million in the first 18 months, further research and milestone fees, and an equity investment of up to $3 million.Full Story

Mar 27 2008, 11:39 AM EST
PharmAthene Retains GTC's Manufacturing Services for Protexia
Product is intended for victims of chemical nerve agent attack.Full Story

Mar 27 2008, 11:50 AM EST
Avanir to Get $40M to Complete Trial on Drug for Pseudobulbar Affect
Study will use lower dose of Zenvia to address safety concerns brought up in the FDA's approvable letter.Full Story

Mar 26 2008, 12:24 PM EST
Lilly Beefs Up Biomarker Analysis Deal with HistoRx
Lilly will leverage the Aqua tool in more therapeutic programs, and HistoRx will work on customized assays.Full Story

Mar 25 2008, 12:09 PM EST
Metabolon and the Harvard-Partners Healthcare Collaborate to Refine Warfarin Theranostic
Metabolomic profile will be assessed along with genetic information to optimize dosing.Full Story

Mar 25 2008, 12:04 PM EST
Ceragenix Hands Over Rights to Preclinical HIV Pipeline to FirstPoint Biotech
The compounds will be evaluated for their use as drugs as well as incorporation into devices.Full Story

Mar 25 2008, 12:06 PM EST
ESA Biosciences and Waters to Provide Software to Integrate Respective Technologies
Data-interface module will better combine ESA's Corona CAD HPLC detector with Waters' Empower 2 chromatography platform.Full Story

Mar 24 2008, 11:11 AM EST
Scientists Uncover Protein Involved in Maintaining ES Cell Pluripotency
Nature paper shows that REST inhibits miR-21, which suppresses stem-cell self renewal and induces differentiation.Full Story

Mar 24 2008, 11:08 AM EST
Rosetta Genomics Identifies Source of Cancer of Unknown Primary with miRNAs
Overall sensitivity of this panel was approximately 85%, according to research in Nature Biotechnology.Full Story

GenEngNews.com

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

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.

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.

Meds OK'd right on deadline are 4 times more likely to have major problems

Link to Article

MSNBC.com

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

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

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

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

In January, at the World Economic Forum in Davos, Switzerland, movers and shakers lined up to spit into test tubes -- the first step to having snippets of their DNA analyzed by 23andMe, a personalized gene-testing company that for $999 promises to help people "search and explore their genomes."

Link to Article

www.washingtonpost.com