An estimated 5.2 million Americans have Alzheimer's disease, and it could steal the minds of one out of eight baby boomers, according to a new report.
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Wednesday, March 19
More than 5 million have Alzheimer's in U.S.
by
Alex Hsieh on behalf of Professor Henry Wang
on Wed 19 Mar 2008 11:38 PM EDT
Commission sets out its stall on anti-counterfeiting meas
by
Alex Hsieh on behalf of Professor Henry Wang
on Wed 19 Mar 2008 11:37 PM EDT
19-Mar-2008 - Batch pedigrees, obligatory product seals, mass serialisation, mandatory audits and tighter requirements for the manufacture, import, export and transportation of medicinal products are among the legislative steps being considered by the European Commission to counter the growing threat of counterfeit drugs in the EU.
Link to Article in-pharmatechnologist.com
Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 2
by
Alex Hsieh on behalf of Professor Henry Wang
on Wed 19 Mar 2008 11:36 PM EDT
ABSTRACT A cleaning process should remove materials such as media, buffers, storage solutions, cell culture fluids, cell debris, non-active pharmaceutical ingredient, and formulations and concentrations of active pharmaceutical ingredients. Manufacturing and cleaning equipment must be designed for effective and consistent cleaning to avoid cross-contamination and the cleaning processes must be...
Link to Article BioPharm International -- Advanstar Communications Inc.
Can the FDA Live up to its Promise of a Risk-Based Approach to Compliance?
by
Alex Hsieh on behalf of Professor Henry Wang
on Wed 19 Mar 2008 11:34 PM EDT
Warren Perry In 2002, the USFood and Drug Administration decided to take a risk-based approach to inspections. Now, five years after announcing this approach, it's time to ask: how is the FDA progressing with this initiative? The quick answer is: so-so. Although the agency is doing a satisfactory job implementing...
Link to Article BioPharm International -- Advanstar Communications Inc.
FDA Encourages Quality by Design Initiatives
by
Alex Hsieh on behalf of Professor Henry Wang
on Wed 19 Mar 2008 11:31 PM EDT
Jill Wechsler The Food and Drug Administration (FDA) has been encouraging manufacturers to demonstrate how process knowledge and full understanding of critical product parameters can ensure drug quality. Such quality by design (QbD) approaches offer potential benefits and savings for manufacturers, as well as the prospect of regulatory relief. Officials...
Link to Article BioPharm International -- Advanstar Communications Inc
Takeda Seen Waving Cash At Abbott
by
Alex Hsieh on behalf of Professor Henry Wang
on Wed 19 Mar 2008 11:29 PM EDT
Japanese drug maker Takeda Pharmaceuticals' reported decision to buy Abbott Laboratories out of a joint venture suggest that although the U.S. economy is rattled, companies in other countries are looking to pick up attractive American assets at depressed-dollar prices.
Link to Article Forbes.com
FDA identifies deadly heparin contaminant
by
Lyle
on Wed 19 Mar 2008 10:26 PM EDT
Officials don't know how compound, which may have killed 19, got into drug
Link to Article MSNBC.com
Crucell, DSM hit 15g/L milestone with PER.C6 technology
by
Lyle
on Wed 19 Mar 2008 09:56 PM EDT
18-Mar-2008 - Dutch biotech Crucell and its US partner DSM Biologics have achieved a record yield of 15 grams per litre with their PER.C6 cell line technology for the production of monoclonal antibodies and recombinant proteins.
Link to Article In-Pharmatechnologist.com
Omnitrope Pen 5 ups the convenience factor
by
Lyle
on Wed 19 Mar 2008 09:55 PM EDT
18-Mar-2008 - A new, more patient-friendly presentation of the growth hormone treatment Omnitrope (rDNA somatropin) has been launched in the US by Sandoz, the generics division of Swiss-based Novartis.
Link to Article In-Pharmatechnologist.com
FDA makes progress in plans for China presence
by
Lyle
on Wed 19 Mar 2008 09:54 PM EDT
18-Mar-2008 - The US Food and Drug Administration (FDA) has alerted the media that it has taken a significant step forward in its plans to establish a presence on the ground in China.
Link to Article In-Pharmatechnologist.com
Progress Slows in Detection of New TB Cases
by
Lyle
on Wed 19 Mar 2008 09:51 PM EDT
The World Health Organization said the findings were worrisome, threatening to increase the risks of transmitting drug-resistant strains.
Link to Article NYTimes.com
New method finds networks of obesity genes
by
Lyle
on Wed 19 Mar 2008 09:50 PM EDT
Drug Maker Stays Close to Doctors and Patients
by
Lyle
on Wed 19 Mar 2008 09:49 PM EDT
Eli Lilly E-Mail Discussed Unapproved Use of Drug
by
Lyle
on Wed 19 Mar 2008 09:49 PM EDT
Tainted Drugs Put Focus on the F.D.A.
by
Lyle
on Wed 19 Mar 2008 09:43 PM EDT
Congress may finally heed calls to allocate more money to the Food and Drug Administration for inspections of overseas drug plants.
Link to Article NYTimes.com
Cutting Dosage of Costly Drug Spurs a Debate
by
Lyle
on Wed 19 Mar 2008 09:39 PM EDT
A drug for a rare enzyme deficiency can cost $300,000 a year, making the right dose a matter of public debate.
Link to Article NYTimes.com
GEN News Highlights - 3/14/08
by
Lyle
on Wed 19 Mar 2008 09:36 PM EDT
Link to All Articles
Mar 12 2008, 01:20 PM EST Wuhan Institute of Biological Products to Implement Prometic's Plasma Fractionation Platform in China The goal is to have a capacity of over 1.2 million liters per year.Full Story Mar 12 2008, 01:16 PM EST Raven Inks Manufacturing Deal with CMC to Help Advance RAV 18 into the Clinic Firm hopes to file IND in 2009.Full Story Mar 12 2008, 01:23 PM EST VistaGen Expands Stem Cell Alliance with Canadian Institutes Studies are anticipated to bolster drug testing technologies and development efforts.Full Story Mar 12 2008, 01:27 PM EST Apoptosis Protein Found to Have a Hand in Glioblastoma Spread Cancer Cell paper found that in brain cancer, when CD95L activates CD95, a process that usually triggers cancer cell death, a protein that promotes the disease was produced.Full Story Mar 11 2008, 12:55 PM EST Researchers Find a Way to Prevent Metastasis at Its Earliest Stage Paper published in Cancer Cell reports that an antibody targeting CD151 prevented cells from breaking away from their tumor.Full Story Mar 10 2008, 12:29 PM EST Wyeth Decides to End Cardiovascular Research Collaboration with Curis Preclinical activities, which focused on the Hedgehog agonist pathway, will discontinue by May.Full Story Mar 07 2008, 11:58 AM EST Abbott to Work on Tarceva-Response Diagnostic with Genentech, Roche, and OSI Firm will use its FISH technology to develop a molecular tool to assess potential of NSCLC treatment.Full Story GenEngNews.com
Panel Seeks New Limits on Anemia Drugs
by
Lyle
on Wed 19 Mar 2008 09:32 PM EDT
Yet both Amgen and Johnson & Johnson avoided the outcome they most feared: a recommendation that the drugs not be used by any cancer patients.
Link to Article NYTimes.com |
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