Explore

Trendline Trendline
Bristol Myers Squibb Positions Cobenfy as a Safer Option for Alzheimer's Psychosis

Bristol Myers Squibb Positions Cobenfy as a Safer Option for Alzheimer's Psychosis

Bristol Myers Squibb Positions Cobenfy as a Safer Option for Alzheimer's Psychosis
Trendline Trendline
FDA Launches Real-Time Clinical Trial Pilot with AstraZeneca and Amgen

FDA Launches Real-Time Clinical Trial Pilot with AstraZeneca and Amgen

FDA Launches Real-Time Clinical Trial Pilot with AstraZeneca and Amgen
Rapid Read Rapid Read
FDA Advisory Committee to Review AstraZeneca's Cancer Drug Applications Amid Concerns

FDA Advisory Committee to Review AstraZeneca's Cancer Drug Applications Amid Concerns

The FDA is set to hold its first drug-related advisory committee meeting in nine months to evaluate AstraZeneca's applications for two cancer drugs. The meeting will focus on the oral SERD drug camizestrant for HR-positive, HER2-negative breast cancer and the AKT inhibitor Truqap for metastatic hormone-sensitive prostate cancer. The FDA has raised questions about the clinical benefits and trial designs of these drugs, particularly regarding the validity of results and the timing of treatment interventions. The advisory panel will assess whether AstraZeneca has provided sufficient evidence to support the clinical benefits of these drugs.
Trendline Trendline
Sprout Pharmaceuticals Recognized by TIME for Influential Role in Health and Life Sciences

Sprout Pharmaceuticals Recognized by TIME for Influential Role in Health and Life Sciences

Sprout Pharmaceuticals Recognized by TIME for Influential Role in Health and Life Sciences
Trendline Trendline
FDA Halts Newron's Schizophrenia Study After Patient Death, Safety Review Underway

FDA Halts Newron's Schizophrenia Study After Patient Death, Safety Review Underway

FDA Halts Newron's Schizophrenia Study After Patient Death, Safety Review Underway
Rapid Read Rapid Read
FDA Halts Newron's U.S. Enrollment in Schizophrenia Study After Patient Death

FDA Halts Newron's U.S. Enrollment in Schizophrenia Study After Patient Death

The FDA has temporarily paused Newron Pharmaceuticals' enrollment of new patients in the U.S. for its Phase 3 ENIGMA-TRS 2 trial, following a patient death. The trial is testing evenamide, an antipsychotic agent for treatment-resistant schizophrenia. The death occurred outside the U.S. and was deemed unrelated to the drug. Despite the pause in the U.S., the trial continues in other countries, including India and Argentina. Evenamide works by modulating glutamate levels in the brain, and previous studies have shown it reduces schizophrenia symptoms. Newron is also conducting another trial, ENIGMA-TRS 1, across multiple regions.
Rapid Read Rapid Read
FDA Grants Priority Review for Gilead's New HIV Treatment, Potentially Transforming Care

FDA Grants Priority Review for Gilead's New HIV Treatment, Potentially Transforming Care

Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for a novel HIV treatment combining bictegravir and lenacapavir. This investigational, once-daily single-tablet regimen is designed for adults with virological suppression. The FDA has granted a priority review, setting a Prescription Drug User Fee Act (PDUFA) action date for August 27, 2026. The combination aims to provide sustained virologic suppression with a high barrier to resistance, particularly benefiting those with complex treatment histories or comorbidities. The NDA is supported by positive Phase 3 trial data, demonstrating efficacy in maintaining virological suppression and improving patient-reported treatment satisfaction.
Trendline Trendline
Pfizer's ELREXFIO Shows Promise in Treating Relapsed Multiple Myeloma

Pfizer's ELREXFIO Shows Promise in Treating Relapsed Multiple Myeloma

Pfizer's ELREXFIO Shows Promise in Treating Relapsed Multiple Myeloma
Rapid Read Rapid Read
Norgine Secures EU Approval for WHIM Syndrome Therapy, Expanding Treatment Options

Norgine Secures EU Approval for WHIM Syndrome Therapy, Expanding Treatment Options

Norgine has received approval from the European Commission for Xolremdi, an oral CXCR4 antagonist, to treat WHIM syndrome in patients aged 12 and over. WHIM syndrome is a rare congenital immunodeficiency characterized by low neutrophil counts, caused by a mutation in the CXCR4 gene. The drug, licensed from X4 Pharma, works by mobilizing white cells from the bone marrow into the blood. With fewer than 500 known cases in the EU, the actual number may be higher due to underdiagnosis. Norgine's CEO, Janneke van der Kamp, emphasized the significance of this approval for WHIM patients and the company's commitment to making the drug available quickly. The approval follows a successful phase 3 trial and marks a milestone in expanding treatment options for rare diseases.
Trendline Trendline
Chiesi Acquires KalVista for $1.9 Billion, Expanding Rare Disease Portfolio

Chiesi Acquires KalVista for $1.9 Billion, Expanding Rare Disease Portfolio

Chiesi Acquires KalVista for $1.9 Billion, Expanding Rare Disease Portfolio
Trendline Trendline
Biogen Prepares to Transition Alzheimer's Patients from Lilly's Kisunla to Leqembi

Biogen Prepares to Transition Alzheimer's Patients from Lilly's Kisunla to Leqembi

Biogen Prepares to Transition Alzheimer's Patients from Lilly's Kisunla to Leqembi
Rapid Read Rapid Read
Paradigm Health and FDA Collaborate to Enhance Clinical Trial Review Process

Paradigm Health and FDA Collaborate to Enhance Clinical Trial Review Process

Paradigm Health has announced a collaboration with the U.S. Food & Drug Administration (FDA) to develop a new model for accelerating clinical trial execution and regulatory review. This initiative utilizes Paradigm Health's technology-enabled Study Conduct platform, which automates data collection and analysis, allowing for real-time review by the FDA. The collaboration aims to reduce the burden of monitoring, data entry, and trial costs, thereby speeding up regulatory review and improving the efficiency of U.S. clinical trials. The model is currently being tested in a Phase 2 trial sponsored by AstraZeneca and a Phase 1b trial sponsored by Amgen. The platform captures data from electronic health records and other sources, evaluates it algorithmically, and transmits only critical signals to the FDA and trial sponsors.