FDAnews Drug Daily Bulletin
April 11, 2005 | Vol. 2 No. 71
The HHS has awarded a $97 million contract to sanofi pasteur to support the development of cell culture-based influenza vaccines, an advanced type of flu vaccine the agency hopes can be manufactured faster and in larger volumes than traditional egg-based vaccines.
The most reliable method for demonstrating the efficacy of a cancer drug or biologic is to show a statistically significant improvement in a clinically meaningful endpoint in blinded, randomized, controlled trials, but there are single-arm study approaches that might be successful in certain settings, explains a new FDA draft guidance.
Barr Laboratories and Kos Pharmaceuticals have initiated settlement talks to resolve their outstanding patent litigation regarding Kos' brand drug Niaspan, the companies announced.
Maxygen and Roche are completing late-stage preclinical studies and manufacturing on their collaborative effort to develop improved interferon alpha protein therapeutics to treat hepatitis C virus (HCV) and hepatitis B virus (HBV) infections, and they expect to file an investigational new drug application toward Phase I clinical trials next year, Maxygen said.
Lincolnshire-based Takeda Pharmaceuticals North America Inc. plans to relocate and expand its headquarters in Deerfield, adding 500 new jobs with help from the state of Illinois.
Drug developer Regenera will start receiving royalty income from next year after signing a licensing deal with one of the US's leading ophthalmology companies that is potentially worth up to $US140 million ($183 million).
Cardinal Health on Friday said it received a subpoena from New York state's attorney general as part of a broad industry probe into a segment of the drug wholesaling industry.
Array BioPharma today announced an expansion of a collaboration agreement with Genentech to develop small molecule drugs against an additional protein target in the field of oncology.
San Diego-based Ambrx has raised $23.4M for its protein-based medicines.
Hisamitsu Pharmaceutical and Nippon Shinyaku announced on April 7 that they have entered into a joint development agreement for HFT-290, a drug candidate for the treatment of cancer pain.
American pharmaceutical companies have called on Egyptian companies to stop manufacturing hundreds of generic versions of patented drugs, thereby blocking the World Trade Organization's (WTO) decision to let public health concerns override patents.
Novartis AG, said the US Federal Trade Commission on April 6 requested more information on its planned acquisition of generic drugmakers Eon Labs Inc of the US and Germany's Hexal AG.
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