Pharmaceutical News 2.0

FDA - Pharmaceutical News Feed

• Guidance Sets Endpoints for BPH Device Trials
  Sponsors conducting clinical trials of devices intended to treat benign prostatic hyperplasia (BPH) should conduct biocompatibility testing on the final, sterilized form of components that come in contact with patients.
• FDA: Active Controls Advised for Antibacterial Drug Trials
  Sponsors of antibacterial drug candidates to treat acute bacterial skin and skin structure infections (ABSSIs) should use either a noninferiority or superiority trial design, while superiority trial designs are recommended for milder skin infection treatment candidates, according to an FDA draft guidance.
• EMA: Pediatric Data Needed in Anti-Epileptic Drug Trials
  Pediatric epilepsy patients should be entered in exploratory add-on anti-epileptic drug (AED) studies as soon as the dose for children is established, a final guideline by the European Medicines Agency (EMA) says.
• Colorado Physician Receives Warning for Device Study
  A University of Colorado (UC) physician has been cited for failing to follow the protocol in a study of Otologics’ fully implantable MET ossicular stimulator for hearing loss.
• When Recruiting, Sites Need to Seek Diverse Population
  Sites will be asked to strive for diversity when recruiting study subjects as pressure mounts to produce trial data representative of the real world.
• Accelerated Approval Denied, Genentech Continues Trials
  Genentech has been denied accelerated approval for its investigational breast cancer treatment trastuzumab-DM1 (T-DM1) because it did not exhaust all available treatment options in the study population.
• Failure of Lilly’s Drug Raises Fears of Misguided Approach
  For the second time this year, a highly touted Alzheimer’s treatment has failed to live up to expectations in a late-stage clinical trial.
• Upcoming Meetings
• Proposed Conflict-of-Interest Rule Could Stifle Necessary Research
  NIH’s proposal to lower the monetary disclosure threshold to reduce conflicts of interest in clinical research has sparked a flurry of comments from researchers who think the threshold is too low and does not account for investigators who move between institutions.
• GAO Warns That Noninferiority Trials Could Lead to ‘Biocreep’ in Drugs
  The use of noninferiority (NI) clinical trials over time raises concerns about “biocreep,” in which successive generations of drugs approved on the basis of NI trials lead to decreasingly effective drugs, a new government report says.