Waxman to Head Key House Committee
In a sharp break with Washington tradition, Rep. Henry Waxman (D-Calif) unseated long-time top Democrat on the House Energy & Commerce Committee, John Dingell (D-Mich), to become the panel's new chairman.
Waxman to Head Key House Committee
In a sharp break with Washington tradition, Rep. Henry Waxman (D-Calif) unseated long-time top Democrat on the House Energy & Commerce Committee, John Dingell (D-Mich), to become the panel’s new chairman. The House Democratic caucus backed Waxman for the job after a hotly contested campaign in which Waxman claimed to be better positioned to work with the new Obama administration to enact environmental and health care legislation.
The change puts a long-time critic of the pharmaceutical industry at the helm of this all-important panel. All health care legislation fall under its purview, along with measures affecting the Food and Drug Administration and other federal health agencies. However, Waxman differs with Dingell more notably on environmental and clean air policy and less on health issues, making the change less dramatic for pharma and health care entities. Both Dingell and Waxman have long championed universal health care, and a top priority for the new chairman will be to pursue health reform legislation vigorously.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
