FDA: Generic Skin Patch Trials

October 15, 2018

Generic drug developers that use patches, inhalers, eye drops or similar means to deliver meds should hold clinical trials to test for potential side effects of skin irritation and, in the case of patches, adhesion quality, the FDA says.

FDA Lifts Holds on Trials

October 1, 2018

The FDA has lifted holds on two sets of clinical trials, one for an experimental treatment of several cancers and the other a gene therapy targeting Duchenne’s muscular dystrophy.

Breast Cancer Trial Resumes

September 24, 2018

Mersana says it has worked out a new agreement with the FDA to resume recruiting patients for a clinical trial of its breast cancer drug months after one of the participants died.

FDA Tackles Device Uncertainty in Clinical Trials

September 10, 2018

The FDA may accept some uncertainty about the safety of a proposed medical device if sponsors carefully collect and report data after it hits the market, the agency says in new draft guidance.

FDA: Novel Trial Design Meetings

September 4, 2018

Drug sponsors wishing to take part in the FDA’s pilot meeting program to discuss complex innovative trial designs (CIDs) with agency staff may now file meeting requests.

New Scale for Tumor Treatments

August 27, 2018

Europe’s largest oncologist association has approved a new scale to measure tumor DNA mutations, a move that backers hope will simplify and standardize choices for targeted cancer treatments and clinical trials.

First Human Zika Vaccine Trial

August 20, 2018

Researchers are launching the first human trial of an experimental live Zika vaccine. The vaccine, which contains a weakened version of the virus, was de­veloped by scientists at the National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll a total of 28 healthy, non-pregnant adults, ages 18 to 50, at Johns Hopkins School of Public Health Center for Immunization Research and at the Vaccine Testing Center at Larner College of Medicine at the University of Vermont. Trial participants will be randomly assigned to receive a single subcutaneous dose of the experimental vaccine (20 participants) or a placebo (eight participants). Neither they nor investigators will know who is receiving the real thing. Participants will keep track of their tem­perature on diary cards at home – and return to the clinic for periodic checkups for about six months. Researchers will take blood samples during visits to see if they’re developing antibodies in response to the vaccine. Anna Durbin, a professor of International health at Hopkins School of Public Health, is leading the Phase I clinical trial. Most people infected with the Zika virus — primarily transmitted by certain mosquitoes — have mild to no symptoms. But it can cause serious birth defects and developmental problems in babies born to women infected during pregnancy. That’s why the Centers for Disease Control and Prevention advises women who are pregnant or planning to become pregnant not to travel to areas with a known Zika risk. “Zika virus infection remains a significant threat to pregnant women and their developing fetuses, and we can expect to see periodic outbreaks and cases in areas where Aedes aegypti mosquitoes thrive,” said NIAID Director Anthony Fauci. “NIAID remains committed to developing safe and effective Zika vaccines, and we are pleased to begin clinical testing of a live attenuated candidate.”