NEJM – How Much Would You Give to Save a Dying Bird? Patient Advocacy and Biomedical Research
By LISA ROSENBAUM Click HERE to read the full article
Inside Health Policy – FDA Official: Breakthrough Designation Brings High Bar, Costly Investment
By NANCI BOMPEY The head of FDA’s office of new drugs warned drug companies looking to use the newly created breakthrough therapy designation that they will face a “high bar” compared with priority reviews and the process will require significant investment from both the agency and sponsors. Those companies that do qualify for the designation…
Inside Health Policy – FDA Official: Breakthrough Designation Brings High Bar, Costly Investment
By NANCI BOMPEY The head of FDA’s office of new drugs warned drug companies looking to use the newly created breakthrough therapy designation that they will face a “high bar” compared with priority reviews and the process will require significant investment from both the agency and sponsors. Those companies that do qualify for the designation…
Bloomberg – Genetics May Help Explain Placebo Effect, Researchers Say
By MEG TIRRELL A patient’s genetic makeup may explain the “placebo effect,” in which people perceive that a fake treatment makes them feel better, according to a study that may help researchers design better clinical trials. Patients with a certain variation on a gene linked to release of dopamine, a brain chemical that affects emotions…
Bloomberg – Genetics May Help Explain Placebo Effect, Researchers Say
By MEG TIRRELL A patient’s genetic makeup may explain the “placebo effect,” in which people perceive that a fake treatment makes them feel better, according to a study that may help researchers design better clinical trials. Patients with a certain variation on a gene linked to release of dopamine, a brain chemical that affects emotions…
Inside Health Policy – Regulatory Science Centers Push Forward Despite Funding Uncertainty
By NANCI BOMPEY Leaders of two academic centers tapped last year to pilot FDA’s Centers of Excellence in Regulatory Science and Innovation program said they are concerned about possible loss of funding due to sequestration or a constrained fiscal environment but are moving ahead while also remaining hopeful that some of the work would continue…
Inside Health Policy – Regulatory Science Centers Push Forward Despite Funding Uncertainty
By NANCI BOMPEY Leaders of two academic centers tapped last year to pilot FDA’s Centers of Excellence in Regulatory Science and Innovation program said they are concerned about possible loss of funding due to sequestration or a constrained fiscal environment but are moving ahead while also remaining hopeful that some of the work would continue…
WSJ – Longtime Former Sen. Arlen Specter Dies
By KRIS MAHER Arlen Specter was a five-term U.S. senator representing Pennsylvania, first as a Republican and then as a Democrat, who won admirers and critics for his independence and willingness to cross party lines. Mr. Specter, 82 years old, died Sunday morning at his home in Philadelphia because of complications from non-Hodgkin’s lymphoma, his…
WSJ – Longtime Former Sen. Arlen Specter Dies
By KRIS MAHER Arlen Specter was a five-term U.S. senator representing Pennsylvania, first as a Republican and then as a Democrat, who won admirers and critics for his independence and willingness to cross party lines. Mr. Specter, 82 years old, died Sunday morning at his home in Philadelphia because of complications from non-Hodgkin’s lymphoma, his…
NYT – Glaxo Opens Door to Data on Research
By KATIE THOMAS GlaxoSmithKline plans to open up much of its drug research in an apparent effort todeflect criticism that important information gathered in clinical trials often does not see the light of day. The move, a first for a major pharmaceutical company, is scheduled to be announced on Thursday by its chief executive,…
