In the News
Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold.
Three-Drug Regimen with Daratumumab a New Standard of Care for Relapsed or Refractory Multiple Myeloma
The influence of genetics on the risk for type 2 diabetes has been suggested by previous research, but new research from the NIH has now outlined in unprecedented detail the role of common genetic variants in the risk for this disease. “Our study has taken us to the most complete understanding yet of the genetic architecture of type 2 diabetes,” said Michael Boehnke, PhD.
While testifying before the Senate Committee on Finance on July 13, 2016, Acting Administrator for CMS Andrew Slavitt said that the agency would consider delaying the implementation of MACRA to address physician and stakeholder concerns. Signed into law in 2015, MACRA will dramatically change the way in which physicians caring for Medicare beneficiaries are paid. The final rule is expected to be released in November of 2016, with an intended start date of January 1, 2017.
On April 29, 2016, the US Food and Drug Administration (FDA) approved pimavanserin (Nuplazid; Acadia), an atypical antipsychotic, for the treatment of hallucinations and delusions associated with Parkinson’s disease. Pimavanserin is the first drug approved by the FDA for hallucinations and delusions that are associated with Parkinson’s disease.
On May 27, 2016, the US Food and Drug Administration approved daclizumab (Zinbryta; Biogen), a long-acting injection, for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab can be self-administered by the patient. Daclizumab is recommended for patients who had an inadequate response to ≥2 drugs for MS, because of its safety profile.
On June 1, 2016, Netspot became the first US Food and Drug Administration–approved kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor–positive neuroendocrine tumors.
On June 1, 2016, the US Food and Drug Administration (FDA) approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in patients with NSCLC.
Last November, osimertinib (Tagrisso), a third-generation EGFR tyrosine kinase inhibitor (TKI) that targets EGFR mutations, including T790M, was approved by the US Food and Drug Administration (FDA) for the treatment of patients with metastaticEGFR T790M mutation–positive non–small-cell lung cancer (NSCLC) whose disease progressed during or after EGFR TKI therapy.
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Results 1 - 10 of 29
Results 1 - 10 of 29