Following positive results in a phase IV clinical trial, Astrazeneca is making moves to apply for full approval for its anticoagulant reversal drug Andexxa earlier than expected. Data from the trial, which is being ended early based on outside recommendations, showed that the drug was effective in […]
Molecular Templates’ Multiple Myeloma Trial Partial Hold Lifted
Molecular Templates’ clinical trial for MT-0169, its experimental multiple myeloma therapeutic, is back on, following the US Food and Drug Administration (FDA) lifting a partial hold. The hold was placed on the trial following two adverse events experienced by patients, who both recovered. The move […]
Accelerating and Improving Clinical Trials with Real-World Data
The ubiquitous adoption of electronic health records (EHR) has supported the explosion of real-world data (RWD) applications in clinical trials. RWD has the potential to accelerate and optimize clinical trials while expanding their reach. In a new Life Science Leader article, learn more about the […]
PTC’s Phenylketonuria Treatment Meets Phase III Endpoint
PTC Therapeutics announced positive results from a phase III clinical trial for its drug sepiapterin in the treatment of phenylketonuria (PKU), a rare disease causing excessive accumulation of the amino acid phenylalanine. The drug met the primary endpoint of reducing blood levels of phenylalanine […]
EQRx Dashes Plans to Drive US Drug Pricing Reform
EQRx is moving on from its previous goal to change the drug pricing landscape in the US, letting go of over half its employees in the process. The company’s mission was to cut costs through developing drugs in categories with known safety profiles, cutting research timelines and expenses by up to […]
How to Overcome Challenges When Backing Regulatory Submissions with Real-World Data
Clinical developers and regulatory approval agencies are increasingly relying on real-world data (RWD) and the real-world evidence (RWE) generated from it in decision-making. However, clinical research organizations (CROs) often run into significant pitfalls when using RWD, complicating the process […]
Potential Partnerships Between Retailers and Real-World Data Firms Could Advance Clinical Trials
Major retail chains like CVS, Walgreens, and Kroger are increasingly entering the clinical trials space, effectively creating a swath of new recruitment sites for clinical research partners. According to COTA CEO and president Miruna Sasu, PhD, there is fertile ground for partnerships between […]
FDA Panel Votes for Limited Approval of AstraZeneca and Merck’s Lynparza
AstraZeneca and Merck’s Lynparza looks set for a narrow approval as part of a combination therapy for metastatic castration-resistant prostate cancer (mCRPC). In an 11 to 1 vote, a Food and Drug Administration (FDA) panel supported approval of the drug in combination with a corticosteroid and […]
ICER Issues Final Report on Alzheimer’s Drug Leqembi
Following a session of public comments, the Institute for Clinical and Economic Review (ICER) has issued its final evidence report on Eisai’s Alzheimer’s drug Leqembi (lecanemab). The independent organization valued the treatment between $8,900 - $21,500 per year. This is notably lower than the […]
FDA Gives Abbvie’s Qulipta the Nod for Chronic Migraine Prevention
The US Food and Drug Administration (FDA) approved the use of Abbvie’s Quilipta as a preventive treatment for chronic migraines. This approval gives AbbVie a leg up on Pfizer, whose migraine drug Nurtec ODT is not officially approved for chronic migraines. The decision was made based on data from a […]
