FDA Turns Away New Indication for CF Drug Kalydeco

(Reuters) -- The U.S. Food and Drug Administration has denied the expanded use of Vertex Pharmaceutical's bestseller, Kalydeco (ivacaftor), in certain cystic fibrosis patients, the company said on Friday.

The regulator rejected the company's application for using the drug in cystic fibrosis patients ages 2 or older, who have one of 23 residual function mutations.

Cystic fibrosis is caused by …

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Earlier May Be Better for Flu Vax in Pregnant Women

Action Points

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

ATLANTA -- The flu vaccine was linked to slightly better protection for pregnant women in the first trimester compared with later in pregnancy because of an …


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Antibodies Predict RA Response to Orencia (CME/CE)

Action Points

  • Note that this European registry study of patients with rheumatoid arthritis found that those with rheumatoid factor or anti-citrullinated peptide antibodies were more likely to continue treatment with abatacept.
  • Be aware that lack of drug discontinuation is an imperfect surrogate for efficacy.

Patients with rheumatoid arthritis (RA) who were positive for rheumatoid factor (RF) or anticitrullinated …


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MERS Virus Targets Lungs (CME/CE)

Action Points

  • The lungs are the main target of the coronavirus that causes Middle East Respiratory Syndrome (MERS), according to the results of the first autopsy performed on a victim of the disease.
  • Note that the report is a single case and more autopsies could turn up different findings, illustrating how little pathological data has been collected since

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Sequential, Alternating Drug Regimens Both Effective in Myeloma (CME/CE)

Action Points

  • Note that this randomized trial comparing sequential and alternating courses of VMP and Rd among patients with newly diagnosed multiple myeloma showed that both approaches have similar good effiacy.
  • Be aware that this study was conducted in Spain, which might limit the generalizability of the results.

The sequential and alternating administration of bortezomib (Velcade) plus melphalan …