Lack of subject enrollment is a leading cause of clinical trial termination globally. Once patients become aware of clinical trials, there are a number of common reasons why some choose not to participate, including: possibility of getting placebo treatment, fear of adverse events, inconvenient location, insurance discrepancies, too many visits required, eligibility criteria restrict involvement, and more. When clinical trials are being planned and designed, patients typically get involved in the research process through representative patient advocacy groups, by serving as a patient representative on ethics committee review boards, or by aiding government agencies with grant and funding decisions. (more…)
The FDA is revisiting a longstanding policy that bans men with male sexual partners from donating blood. The ban—called a “donor deferral”— is lifelong and applies to any man who has had sex with another man (“MSM”) since 1977, even once, regardless of safe sex practices or HIV status. On December 2, the agency’s Blood Products Advisory Committee (BPAC) will discuss scientific data related to a reconsideration of the policy, which some have dubbed unwarranted and discriminatory. (more…)
From a purely scientific standpoint, the news about the Ebola outbreak has been encouraging. New genomic technologies enable unprecedented surveillance of the virus. There are drugs and vaccines in clinical trials. And in response to the urgency of the crisis, both drugmakers and regulatory agencies are making efforts to expedite the process of getting weapons against Ebola through the regulatory process and into the field, where they are needed. (See BioWorld Today, Oct. 22, 2014.) (more…)
Amgen Inc.’s moves into the biosimilar space drew attention during the company’s business review meeting, which followed the release of investor-pleasing third quarter financial results that showed the company beating estimates and included higher guidance for the full year’s earnings.
Piper Jaffray analyst Joshua Schimmer called Thousand Oaks, Calif.-based Amgen “hands down, the best large cap pipeline around. While no new data were presented, the company highlighted its late-stage product portfolio which we believe is unrivaled in its incremental revenue-generating potential.” (more…)
Compared with the relatively non-specific cytotoxic drugs currently used in most cancer treatments, a new era of cancer therapy is expected to be dominated by targeted treatments and cancer immunotherapies. Targeted and immunotherapies targeting specific pathways or receptors provide an advantage over traditional chemotherapies that act on all rapidly dividing cells, be they normal or cancerous. The side effects of chemotherapy are much greater due to their effects on normal cells, whereas targeted therapies cause little or no collateral damage to normal cells, which improves the quality of life of the cancer patient. The use of targeted therapy has also markedly changed the outcomes for some cancers. (more…)
Personalized medicine. Big data. Wellness. The growing impact of diagnostics on pharmaceuticals. The med-tech buzzwords and ideas of yesterday are actually the innovations of today. Those once abstract ideas were more tangible and were present during this year’s Cleveland Clinic Medical Innovation Summit, which was held last month. (more…)
Friedhelm Blobel, CEO, Sciclone Pharmaceutical Inc. spoke with BioWorld about the ongoing investigation related to possible violations of the U.S. Foreign Corrupt Practices Act (FCPA) in China. He also discussed the company’s resulting compliance program and confirmed that, despite these challenges, being in China outweighs all of the expenses and risks. (more…)