A compilation of recent notable news developments that pertain to the clinical trials industry.
Inato, a global industry marketplace that matches research sites to the right clinical trial protocols, announced over 500 sites across more than 30 countries are participating in its Marketplace. Sanofi and Merck KGaA, Darmstadt, Germany have also joined the Marketplace, which Inato says will further its mission to accelerate the pace of medical innovation to improve people’s lives.
Using a data-driven approach—coupled with a high-touch qualification and support process—the Inato Marketplace provides research sites the opportunity to search and match for trials based on their qualifications, interests, and patient needs. By matching sites and trials on a global scale, the Marketplace enables trial sponsors to work with a broader range of qualified sites and rapidly expand the pool of patients engaged in their trials.
Senators Edward J. Markey (D-Mass.), Thom Tillis (R-N.C.), Gary Peters (D-Mich.), and Susan Collins (R-Maine) have introduced the Research Investment to Spark the Economy (RISE) Act to authorize nearly $25 billion in support to US researchers who have been impacted by the COVID-19 pandemic.
Although coronavirus-related research is a current federal government priority, most other research has been delayed due to closures of campuses and laboratories. The people who comprise the research workforce—graduate students, postdocs, principal investigators, and technical support staff—face financial and other hardships from the disruption of their research activities. The RISE Act would provide necessary relief to preserve the current scientific workforce and ensure that the US is prepared to continue its global scientific leadership once this crisis ends.
GCSA Intrinsic is supporting the UK clinical research industry by providing an internationally-recognized quality benchmark for sites focused on attracting commercial clinical trials.
The GCSA gold standard has been ratified by a global advisory board of industry experts from a broad range of global and UK organizations. According to Board members, GCSA will either enhance existing standards that some UK research centers have, or it will help improve and raise the standards of those centers that are trying to build their research capacity, thus allowing these centers to promote themselves as global competitors
Jazz Pharmaceuticals plc and GW Pharmaceuticals plc have entered into a definitive agreement for Jazz to acquire GW for $220 per American Depositary Share (ADS), in the form of $200 in cash and $20 in Jazz ordinary shares, for a total consideration of $7.2 billion, or $6.7 billion net of GW cash. The transaction is expected to close in the second quarter.
The combined company will be among the leaders in neuroscience. GW has a scientific platform and a deep pipeline of cannabinoid product candidates, as well as highly specialized manufacturing expertise. GW’s lead product, Epidiolex oral solution, is approved in patients one-year and older for the treatment of seizures.
—Staff and wire reports
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.