- FDA approves Watson's six-month Trelstar formulation for palliative treatment of advanced prostate cancer
- Abbott submits sNDA for new formulation of Lupron Depot in advanced prostate cancer
- FDA grants 510(k) clearance to Fenwal to market Amicus blood cell separator for platelet-related use
- Bayer's ciprofloxacin dry powder inhaler receives orphan drug designation for cystic fibrosis
- Allergan's Botox approved for upper limb spasticity
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
FDA committee meeting on Amgen's investigational denosumab to focus on risks, benefits
What's This?
The risks of Amgen Inc.'s investigational monoclonal antibody denosumab--especially when used as a preventative treatment for bone loss--must be weighed against its benefits, according to a Food and Drug Administration briefing document released ahead of an advisory committee meeting. The Division of Reproductive and Urological Products is scheduled meet Thursday to discuss denosumab, which has a proposed brand name of Prolia and four proposed indications: treatment of postmenopausal...
The risks of Amgen Inc.'s investigational monoclonal antibody denosumab--especially when used as a preventative treatment for bone loss--must be weighed against its benefits, according to a Food and Drug Administration briefing document released ahead of an advisory committee meeting.
The Division of Reproductive and Urological Products is scheduled meet Thursday to discuss denosumab, which has a proposed brand name of Prolia and four proposed indications: treatment of postmenopausal osteoporosis, prevention of postmenopausal osteoporosis, treatment and prevention of bone loss associated with hormone ablation therapy for breast cancer and treatment and prevention of bone loss associated with hormone ablation therapy for prostate cancer.
The briefing document noted that treatment of postmenopausal osteoporosis would be the biologic's primary indication. The document also noted that the primary safety issues seen during clinical trials of the treatment were serious infection, new malignancies, potential for tumor progression, suppression of bone remodeling and dermatologic adverse events.
"Of particular concern, in light of these safety issues, is whether the risk/benefit balance for the osteoporosis prevention indication, both for patients with and without cancer, supports approval," the FDA said.
The agency noted that, if the drug is approved, it is seeking advice from the committee on whether a risk evaluation and mitigation strategy would be needed.
BMO Markets analyst Jason Zhang was not surprised by the safety issues and said the panel will likely vote for approval of denosumab, Reuters reported. The news service added that Zhang expects the drug to have $2.4 billion in annual sales by 2012.
If approved, denosumab would be the first biologic for the prevention and treatment of postmenopausal osteoporosis and the first product for the treatment and prevention of bone loss associated with hormone ablation therapy in breast and prostate cancer.
Probability of carpal tunnel syndrome diagnosis by clinical evaluation changes little with electrodiagnostic testing, data indicate 
What's This?
After a clinical diagnosis of carpal tunnel syndrome (CTS) is made with the CTS-6 aid, conducting electrodiagnostic testing provides minimal diagnostic value to the health care professional, according to a recent study.The prospective investigation was conducted to compare the probability of a CTS diagnosis when determined by clinical evaluation or by electrodiagnostic testing.
A total of 143 patients with any upper-extremity peripheral nerve problem first...
Laminar airflow ventilation during orthopedic, abdominal procedures does not prevent surgical site infections, study suggests
What's This?
A large, retrospective study suggests that operating rooms (ORs) with laminar airflow ventilation do not prevent surgical site infections (SSIs) among patients undergoing abdominal or orthopedic surgery, and ORs with this type of ventilation may actually be associated with a significantly higher risk of severe SSIs following hip replacements as compared with ORs that use turbulent ventilation.The study included data from 63 surgery departments in 55 German...
Hypoxemia following total joint arthroplasty may predict medical complications, researchers suggest
What's This?
Anterior labroligamentous periosteal avulsion lesions may be associated with higher rate of recurrent dislocations than Bankart lesions following arthroscopic capsulolabral repair
What's This?
- Combined use of ESR, CRP effective screening tool for ruling out periprosthetic infection after TKA, researchers find
- Anterior labroligamentous periosteal avulsion lesions may be associated with higher rate of recurrent dislocations than Bankart lesions following arthroscopic capsulolabral repair
- Laminar airflow ventilation during orthopedic, abdominal procedures does not prevent surgical site infections, study suggests
- Metatarsophalangeal joint arthroscopy may reduce metatarsophalangeal joint pain in patients with hallux valgus
- Hypoxemia following total joint arthroplasty may predict medical complications, researchers suggest
- Nerve rerouting allows arm amputees to feel touch in missing limb
- Improved function maintained for years after hip replacement
- Glucosamine supplementation not likely to raise HDL levels
- "No rationale" seen for continued use of hylan in knee osteoarthritis
- Simple prediction rule identifies men at risk for osteoporosis
