Well, it has been a mostly quiet week and the weather has been beautiful. The cherry blossoms are long gone, as are most of the lilacs. The hydrangeas are about to burst onto the scene in the Beltway and we hunker down to wait the end of the democratic process as far as primaries are concerned. In the meantime, here is a bit of what happened this week on our front:
- Wyeth Gets an Approvable Letter – Wyeth announced yesterday that the FDA has issued an approvable letter for the first-in-class antibiotic TYGACIL® (tigecycline) for the treatment of adult patients with community-acquired pneumonia (CAP). According to the company’s press release, the agency asked for additional analyses to support the safety and efficacy of the product and specifically information regarding the benefit/risk of TYGACIL for any potential of liver toxicity. Curiously, the release also reads that "Wyeth recently provided that information to the agency during the review period and believes that its response adequately addresses the issues raised by the FDA. However, the agency acknowledged in its letter that it had not yet reviewed that information."
- FDA Issues New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding – Yesterday, the FDA proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding. The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.
- FDA Reviewers Say Glaxo Drug Falls Short – GlaxoSmithKline today has an experimental drug up before the Oncologic Drugs Advisory Committee panel for approval consideration, but reviewer documents from FDA reveal that staff does not feel the Promacta significantly lowers bleeding in patients with a rare blood disorder that prevents patients’ blood from clotting, causing excessive bruising and bleeding.
That’s it for me this week folks. It was a short week. Have a good weekend!