Category Press Releases

Vertex Announces Advancements of Suzetrigine (VX-548) in Acute and Neuropathic Pain

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) has unveiled significant progress in its suzetrigine pain program, potentially introducing the first new class of medication for acute and neuropathic pain in over twenty years. Suzetrigine, an oral selective NaV1.8 pain signal inhibitor (previously…

Read MoreVertex Announces Advancements of Suzetrigine (VX-548) in Acute and Neuropathic Pain

Six-Year Efficacy of Novartis Kesimpta® in Relapsing MS Treatment-Naïve Patients

Novartis has revealed findings from the ALITHIOS open-label extension study, demonstrating the sustained efficacy of continuous Kesimpta® (ofatumumab) treatment for up to six years in individuals recently diagnosed with relapsing multiple sclerosis (RMS). These individuals, termed “treatment-naïve,” initiated treatment within…

Read MoreSix-Year Efficacy of Novartis Kesimpta® in Relapsing MS Treatment-Naïve Patients

Zatolmilast Receives Orphan Medicinal Product Designation from the European Commission: Promising First-in-Class Therapy for Fragile X Syndrome

Shionogi B.V., the European arm of Shionogi & Co., Ltd., has revealed that the European Commission has granted Orphan Medicinal Product designation to zatolmilast (BPN14770), an investigational treatment for Fragile X syndrome (FXS), a prominent cause of inherited intellectual disability…

Read MoreZatolmilast Receives Orphan Medicinal Product Designation from the European Commission: Promising First-in-Class Therapy for Fragile X Syndrome

AbbVie’s New Data Confirms Atogepant (QULIPTA®) for Long-Term Migraine Prevention

AbbVie (NYSE: ABBV) has revealed interim findings from an ongoing Phase 3 extension study, spanning 156 weeks, investigating the sustained safety and tolerability of oral atogepant for migraine prevention in individuals with chronic or episodic migraine. The analysis indicates that…

Read MoreAbbVie’s New Data Confirms Atogepant (QULIPTA®) for Long-Term Migraine Prevention

WHO to Release New Guidelines for Simultaneous Treatment of Drug-Resistant Tuberculosis and Hepatitis C

In a recent announcement, the World Health Organization (WHO) has provided updates regarding the simultaneous treatment of drug-resistant tuberculosis (TB) and hepatitis C (HCV). The latest evidence suggests that administering treatment for HCV alongside multi-drug resistant or rifampicin-resistant TB (MDR/RR-TB)…

Read MoreWHO to Release New Guidelines for Simultaneous Treatment of Drug-Resistant Tuberculosis and Hepatitis C

Novartis to Seek Pre-Taxane Label Expansion for Pluvicto® in Second Half of 2024 Following Latest Data from Phase III PSMAfore Trial

Updated findings on overall survival (OS) from a planned evaluation, encompassing around 75% of data, reveal an OS hazard ratio below 1.0 (HR<1.0) within the intent-to-treat (ITT) population, not adjusted for cross-over. Consistency is observed in radiographic progression-free survival (rPFS)…

Read MoreNovartis to Seek Pre-Taxane Label Expansion for Pluvicto® in Second Half of 2024 Following Latest Data from Phase III PSMAfore Trial

Eisai Seeks FDA Approval for IV Maintenance Dosing of LEQEMBI® in Early Alzheimer’s Treatment

Eisai Co., Ltd. (based in Tokyo, CEO: Haruo Naito) and Biogen Inc. (headquartered in Cambridge, Massachusetts, CEO: Christopher A. Viehbacher) have jointly announced the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA).…

Read MoreEisai Seeks FDA Approval for IV Maintenance Dosing of LEQEMBI® in Early Alzheimer’s Treatment