18-Feb-2008 - The first European approval application for a vaccine delivered via a new intradermal (ID) microinjection system developed by BD (Becton, Dickinson & Company) has been filed by Sanofi-Pasteur, the vaccines division of the Sanofi-Aventis group.
Link to Article
in-pharmatechnologist.com
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Monday, February 18
EMEA filing for first vaccine using Soluvia microinjection system
by
Alex Hsieh on behalf of Professor Henry Wang
on Mon 18 Feb 2008 10:22 PM EST
FDA evaluated wrong Chinese drug factory
by
Lyle
on Mon 18 Feb 2008 08:45 PM EST
EMEA filing for first vaccine using Soluvia microinjection system
by
Lyle
on Mon 18 Feb 2008 01:53 PM EST
18-Feb-2008 - The first European approval application for a vaccine delivered via a new intradermal (ID) microinjection system developed by BD (Becton, Dickinson & Company) has been filed by Sanofi-Pasteur, the vaccines division of the Sanofi-Aventis group.
Link to Article In-Pharmatechnologist.com
F.D.A. Seeks to Broaden Range of Use for Drugs
by
Lyle
on Mon 18 Feb 2008 01:49 PM EST
The Food and Drug Administration’s proposed rules would allow drug and device makers to provide doctors with medical journal articles about product uses that have not been approved by the F.D.A.
Link to Article NYTimes.com
China Didn’t Check Drug Supplier, Files Show
by
Lyle
on Mon 18 Feb 2008 01:48 PM EST
An ingredient in a blood thinner linked to four deaths was made at an uncertified plant in China that was not inspected.
Link to Article NYTimes.com
GEN News Highlights - 2/15/08
by
Lyle
on Mon 18 Feb 2008 01:41 PM EST
Link to All Articles
Feb 14 2008, 11:55 AM EST Evotec to Provide $37M to CHDI in Collaboration Extension Research fees will drive search for novel drug candidates for the treatment of Huntington's disease until 2010.Full Story Feb 14 2008, 12:08 PM EST Alexion Purchases Patents Related to Approved Drug from OMRF for $10M Deal covers complement-inhibition inventions and will dismiss claims and counterclaims between the organizations.Full Story Feb 13 2008, 11:27 AM EST Dutch Center and GeneGo to Collaborate on Toxicity Testing The five-year, €25 million project will use firm's platforms for earlier identification of xenobiotic adverse effects.Full Story Feb 13 2008, 11:25 AM EST Chemizon Invests in KRIBB to Form Spin-Out The new biopharmaceutical company will conduct R&D activities in oncology, CNS, and infectious disease indications.Full Story Feb 12 2008, 01:11 PM EST Dyax and Sanofi-Aventis Ink Oncology Antibody Deal Worth $500M Terms include worldwide, exclusive rights to a preclinical candidate and nonexclusive license to phage-display technology.Full Story Feb 12 2008, 01:09 PM EST Scientists Uncover More Gene-Protein Binding Events than Previously Expected PLoS Biology paper also reports that most of the detected bindings are nonfunctional.Full Story Feb 12 2008, 01:07 PM EST BG Medicine to Mine Danish Population Research for Cardiovascular Biomarkers Copenhagen General Population Study offers opportunity for discovery of blood biomarkers in individuals who suffer a heart attack without prior history of cardiovascular disease.Full Story Feb 12 2008, 01:02 PM EST Dana-Farber Allies With Merck & Co. on Cancer Drug R&D Collaboration hopes to raise the current 95% failure rate in clinical trials through the use of genomic information.Full Story Feb 11 2008, 11:43 AM EST Newron Acquires Hunter-Fleming for $11.6M Upfront Milestones for success of CNS candidates could total over $24 million.Full Story Feb 11 2008, 11:36 AM EST Scientists Find Cellular Receptor for HIV Virus uses alpha 4 beta 7 to create a stable junction between immune cells, according to Nature Immunology paper.Full Story GenEngNews.com
Proposed Biosimilars Legislation Makes Progress
by
Lyle
on Mon 18 Feb 2008 01:39 PM EST
Washington, DC (Feb 8)—A follow-on biologics approval pathway may be on the way. US Health and Human Services Secretary Mike Leavitt accepted Sen. Charles Schumer’s (D-NY) suggestion that the US Food and Drug Administration and Congress work together to formulate legislation for such a pathway.
Link to Article Pharmaceutical Technology
Baxter Voluntarily Recalls Heparin Lots
by
Lyle
on Mon 18 Feb 2008 01:34 PM EST
Deerfield, IL and Rockville, MD (Feb. 11)—Baxter Healthcare Corporation is providing an update to its January 2008 heparin sodium injection 1000 units/mL 10 and 30 mL multi-dose vial voluntary recall of nine lots, which the company initiated as a precautionary measure due to an increase in reports of adverse reactions that may be associated with the drug.
Link to Article Pharmaceutical Technology
China plant implicated in heparin scare "never" inspected by FDA
by
Lyle
on Mon 18 Feb 2008 01:29 PM EST
14-Feb-2008 - Questions are hanging over the role of a Chinese manufacturing facility in the Baxter heparin scare after it has emerged that the US Food and Drug Administration (FDA) has never inspected the facility.
Link to Article In-Pharmatechnologist.com
Baxter suspends production of heparin after deaths
by
Lyle
on Mon 18 Feb 2008 01:26 PM EST
13-Feb-2008 - Baxter International has suspended the production of its blood-thinning drug heparin in multi-dose vials, following the deaths of four patients in the USA who were given the drug in high doses.
Link to Article In-Pharmatechnologist.com |
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