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Time, Expense, and Quality of Results Are at Issue, As Is the Relationship to Drug Pricing
Costly medications have raised questions about the role that long, complex clinical trials play in drug pricing. Approval of a drug takes, on average, 14 years, costs more than $2 billion, and has a high risk of failure. Participants are seeking alternatives.
Pharmacovigilance Forum
Elevated uric acid levels can cause crystal deposition and may lead to gout, urolithiasis, and urate nephropathy. The authors report on the case of a 34-year-old male whose hyperuricemia was associated with the antituberculous drug pyrazinamide.
Knowledge of Tumors’ Molecular Diversity Is Opening New Pathways to Treatment
Lung cancer treatment has undergone significant change in the past decade, leading to remarkable growth in the number and variety of therapeutic options. This shift reflects, in part, a significant refinement in the molecular categorization of lung cancer.
3D printing is expected to revolutionize health care through uses in tissue and organ fabrication; creation of customized prosthetics, implants, and anatomical models; and pharmaceutical research regarding drug dosage forms, delivery, and discovery.
Pipeline Plus
Treatment of Parkinson’s disease is expected to lead to $3.56 billion in global sales in 2022. Manufacturers are reformulating medications in addition to creating new ones.

Departments

Medication Errors
Here’s Why You Should Tell Stories, Too …
Telling true stories can help improve medication safety.
Prescription: Washington
However, the Agency’s Requirements Are Still Unclear
The FDA has accepted its first biosimilar application.
FDA approvals, drug indications, and updates
Idelalisib (Zydelig) for certain types of leukemia and lymphoma, peginterferon beta-1a (Plegridy) for relapsing forms of multiple sclerosis, and suvorexant (Belsomra) for insomnia
Drug Forecast
Edoxaban: an investigational factor Xa inhibitor

P&T TV

“Very Impressive Data” for Rose Bengal 10% in Intralesional Melanoma

Merrick Ross, chief of the melanoma section in the Department of Surgical Oncology at MD Anderson Cancer Center in Houston, says a phase 2 trial of Rose Bengal 10% as a chemical ablative agent injected directly into melanoma tumors yielded “very impressive data.” Even “bystander” lesions that were not injected showed good partial and complete responses, confirming the agent’s systemic value. Because of low toxicity, the treatment could be useful not only in combination with other therapies but as monotherapy for patients who aren’t good candidates for more toxic systemic treatments.

American Society of Clinical Oncology

Meetings

Nashville, TN
November 3 to November 4
Brussels, Belgium
November 12 to November 14

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