BioPharm International - Articles on bioprocessing methods, regulatory compliance, and biotech strategies

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Recent Trends In Fusion Proteins As Therapeutics
Sept 9, 2008
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India Today
The Visible Hand: Government Supports the Biopharmaceutical Industry

Disposables Advisor
Disposables Open Up Possibilities in Facility Design

Compliance Notes
Coming to a Biotech Near You: Quality by Design Part 2: Design Space in Development and Manufacturing

Final Word
Connecting the Manufacturing Process to Patient Wellness

Chemists Developing Fully-Synthetic Form of Heparin
August 18, 2008
Chemists are reporting a major advance toward developing a safer, fully-synthetic version of heparin, the widely used blood thinner currently produced from pig intestines.
Genentech Rejects Roche Proposal
August 14, 2008
The American biotech giant Genentech, Inc. has rejected an offer by the Swiss drug-maker Roche to acquire the 44% of Genentech it does not already own, but said it would be willing to consider a higher bid.
Pfizer to Close Manufacturing Plant in Ireland
August 12, 2008
Pfizer (New York, NY) has announced plans to close its manufacturing plant located at Little Island, Ireland, after a failed attempt to find a buyer for the facility.
FDA Issues Six Draft Guidance Documents
August 12, 2008
On August 6, the FDA released a guidance entitled Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States.
HHS and DHS Announce Guidance on Pandemic Vaccination Allocation
August 12, 2008
The US Departments of Health and Human Services (HHS) and Homeland Security (DHS) have released guidance on allocating and targeting pandemic influenza vaccine.
FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15)
FDA Approves First Drug for Treatment of Chorea in Huntington's Disease
FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
FDA Approves 2008-2009 Flu Vaccines
FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
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20th Anniversary Interviews
16 Episodes with Industry Experts on Downstream processing, QbD, Contract manufacturing, Biosimilars, and more

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FDA Seeks Active System for Monitoring Adverse Events
Expanded access to healthcare data will modernize drug-safety assessment and product development.
BioPharm International - August 1, 2008
Biotech Innovation Boosts Orphan Drug Development
Economic incentives and regulatory flexibility can spur development of treatments for small patient populations.
BioPharm International - July 1, 2008
Healthcare Reform Threatens Biotech Coverage and Access
Biotech companies fear comparative effectiveness analysis will emphasize product costs over value.
BioPharm International - June 1, 2008
Final Bulk Inspection of Solid-Dose Pharmaceuticals
August 20, 2008
Global Biochemical Profiling for Bioprocessing Optimization
June 13, 2008
Characterization of anti-HCP Antibodies by 2D-HPLC
May 12, 2008
Asset Management for Growing Biotech Companies
May 9, 2008
Cleaning Validation: On-Site Trials of SpotView(R)
April 14, 2008
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