Not all companies had such a positive week, however.
POZEN Inc. announcedthe receipt of an Advice/Information Request letter from the FDA regarding itsulcer drug. After a preliminary review of POZEN's results of a Phase I study todetermine the bioequivalence of PA32540 to enteric-coated aspirin 325 mg usingacetylsalicylic acid as the analyte, the FDA announced that it did not agreethat bioequivalence of PA32540 to enteric-coated aspirin 325 was properlydemonstrated based on the provided information. The FDA also advised thecompany that for the development of a combination product with 81 mg aspirin,an
in-vivo bioequivalence study would berequired unless justification for a biowaiver could be provided. The company'sshares fell following the news.
Sanofi also hit a regulatory roadblock with one of itsdrugs. The company failed to move semuloparin, its drug for preventing bloodclots in chemotherapy patients, forward when an FDA panel voted that the drugdoes not provide enough of a benefit to outweigh its risks. The panel voted14-1 against, and supported an FDA staff report released on June 18 that statedthe provided data did not "provide meaningful support for the approval" as avenous thromboembolism treatment for high-risk patients undergoingchemotherapy.
In addition,
Celgene Corporation announced that it was withdrawingthe new indication submission to the Committee for Medicinal Products for HumanUse for REVLIMID. The drug was intended for the maintenance treatment of newlydiagnosed multiple myeloma patients who have not progressed following initialtreatment with other options. The company announced that in response to thecommittee's request, it will be resubmitting at a later date with more maturedata.
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