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Panel: No failure limits on birth control pills
The government shouldn't set failure limits on birth control pills because that could put less-effective but still beneficial contraceptives off limits to women, federal health advisers recommended Wednesday. The FDA scheduled meetings both Tuesday and Wednesday with its outside experts to gather advice on future guidelines that drug makers could follow in seeking approval for new hormonal contraceptives. The FDA is looking at how well studies done prior to approval of new birth control pills reflected their "real-world" use. Typically, that use is less consistent and reliable than it is in clinical studies. Also, newer versions of the pill aren't being tested on women who reflect the broader population. The women in clinical trials are younger, skinnier and healthier than are U.S.
DUSA Pharmaceuticals Announces Exclusive Agreeme nt with Daewoong ... WILMINGTON, Massachusetts, Jan. 8, 2007--(CCNMatthews) - DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA), announced today that it has entered into an exclusive marketing, distribution and supply agreement for certain Asian territories with Daewoong Pharmaceutical Co., Ltd., a market leader in prescription drugs in the region for dermatology. The agreement covers current and future uses of DUSA's proprietary Levulan(R) Kerastick(R) for photodynamic therapy (PDT) in dermatology. The Agreement, which has an initial term of ten years, (subject to earlier termination and extension provisions) will further expand the distribution of Levulan beyond the North, Central, and South American markets. Effective with the signing of the Agreement, Daewoong will complete final integration and submission of regulatory data to the Korean Food and Drug Administration with subsequent approval and market launch expected in 2008.
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