FDAnews Drug Daily Bulletin
Jan. 19, 2005
| Vol.
2 No.
13
The FDA has published a draft guidance to provide drugmakers with recommendations on how to convert OTC drug monograph labeling to OTC "Drug Facts" format. The FDA has issued a warning letter to the Respi Care Group of Puerto Rico alerting the company it has committed "serious violations" of the Federal Food, Drug, and Cosmetic Act. A coalition of 10 large pharmaceutical firms has launched a discount card program that could help millions of uninsured Americans save about 25 to 40 percent on commonly used prescription drugs. Andrx Pharmaceuticals has filed a citizen's petition with the FDA requesting that the agency seek the advice of the FTC and the Justice Department on the contentious issue of authorized generics. Addex Pharmaceuticals has entered an exclusive worldwide research collaboration and license agreement with Ortho-McNeil Pharmaceutical, a Johnson & Johnson company, to discover, develop and commercialize novel compounds modulating allosterically G-Protein Coupled Receptors for the treatment of anxiety, depression, schizophrenia and Alzheimer's disease. Albany Molecular Research has established a wholly owned subsidiary, Albany Molecular Research Singapore Research Centre. PPD has struck a deal to buy the biomarker business of Menlo Park, Calif.-based SurroMed. Specialty chemical distributor Aceto is making its first major foray into drug production, through a deal with Three Rivers Pharmaceuticals to bring three generic products to market. Cambrex has announced that its subsidiary Cambrex Bio Science Wokingham has signed an agreement for the purchase of conditionally immortalized cell lines, related intellectual property and equipment of Xcellsyz, Newcastle Upon Tyne, UK. Cambrex Bio Science Walkersville, also a subsidiary of Cambrex, has entered into license agreements for Geron's proprietary telomerase technology and complementary conditional immortalization technology from the Ludwig Institute for Cancer Research (LICR). Mitsui has announced that it will establish a joint venture with Medical System Network Feb. 14. Fieldglass announced today an $11 million round of funding, led by new investor Grotech Capital Group, a diversified private equity firm. ChemDiv (Chemical Diversity), a leading provider of discovery chemistry services, with headquarters located in San Diego, Calif., has entered into a collaborative agreement with the University of Maryland Greenebaum Cancer Center (UMGCC) in Baltimore, Md. |
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