BioPharm News

Feb 11, 2009
BioPharm International
By BioPharm International Editors
The US Food and Drug Administration has launched a voluntary pilot program that will help promote the safety of drugs and active drug ingredients produced outside the United States.
Feb 11, 2009
BioPharm International
By BioPharm International Editors
Following a discussion with the US Food and Drug Administration, ImClone Systems, acquired last fall by Eli Lilly and Company (New York, NY), and Bristol-Myers Squibb (New York, NY) have withdrawn the supplemental Biologics License Application for the use of Erubitux (cetuximab) in advanced non-small cell lung cancer.
Feb 11, 2009
BioPharm International
By BioPharm International Editors
With counterfeit and adulterated medicines posing an increasing risk to patients in the United States and worldwide, the US Pharmacopeial (USP, Rockville, MD) Convention announced on February 4, new standards for two widely used drug products that have been involved in episodes of adulteration resulting in patient deaths.
Feb 11, 2009
BioPharm International
By BioPharm International Editors
Richter-Helm BioLogics GmbH & Co. KG (Hamburg, Germany) and Athera Biotechnologies AB (Stockholm, Sweden) have signed an agreement for the development and manufacturing of Annexin A5, Athera?s novel product for prevention of plaque rupture and athero-thrombosis.
Feb 11, 2009
BioPharm International
By BioPharm International Editors
The US Food and Drug Administration issued its first approval on February 6 for a biological product produced by genetically engineered animals.
Feb 11, 2009
BioPharm International
By BioPharm International Editors
Even the best biotech companies lack a crystal ball. In 2003, Genentech had a shortage of manufacturing capacity. So they started an internal campaign, called "Every Gram Counts," to produce as much as possible.
Feb 11, 2009
BioPharm International
By BioPharm International Editors
Apotex, Inc. (Toronto, Canada) and Intas Biopharmaceuticals Limited (IBPL, Ahmendabad, India) have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia (a side effect of cancer chemotherapy).
Feb 11, 2009
BioPharm International
By BioPharm International Editors
Oxford Expression Technologies (OET, Oxford, UK) and Eden Biodesign (Liverpool, UK) have signed a co-marketing agreement.
Jan 21, 2009
By BioPharm International Editors
Teva (Jerusalem, Israel), the world?s largest generics company, and Lonza (Basel, Switzerland) have formed a joint venture to develop, manufacture, and market biosimilars.
Jan 19, 2009
By BioPharm International Editors
Indian biotechnology company Intas Biopharmaceuticals (IBPL, Ahmedabad, Gujarat) has signed a memorandum of understanding (MoU) with the government of Gujarat for setting up a separate manufacturing facility for Monoclonal Antibodies (MAbs).
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