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…
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…
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)…
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has announced its plans to unveil the financial results for the first quarter of 2024 on Wednesday, May 8, 2024, at 7:00 a.m. ET through a press release. Subsequent to the release,…
ICON, a globally renowned healthcare intelligence and clinical research organization, has announced that its Chief Financial Officer, Brendan Brennan, will be stepping down from his position in the fourth quarter of this year to pursue an opportunity outside the CRO…
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)…
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).…
Bristol Myers Squibb (NYSE: BMY) has announced the successful results of the pivotal Phase 3 KRYSTAL-12 study, which evaluated KRAZATI® (adagrasib) as a monotherapy for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a…
Bristol Myers Squibb (NYSE: BMY) provided an update today following the preliminary analysis of findings from the first of two induction studies within the Phase 3 YELLOWSTONE clinical trial program, which assesses Zeposia (ozanimod) in adult patients dealing with moderate…
Novo Nordisk and Cardior Pharmaceuticals have announced a significant acquisition deal, with Novo Nordisk set to acquire Cardior for up to 1.025 billion Euros. This includes an upfront payment along with additional payments contingent upon the achievement of specific developmental…
Novo Nordisk has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion, recommending the marketing authorization for Awiqli® (the branded name for once-weekly basal insulin icodec) for the treatment of…
Gilead Sciences, Inc. (Nasdaq: GILD) has finalized its acquisition of CymaBay Therapeutics, Inc. (Nasdaq: CBAY) for an estimated total equity value of about $4.3 billion. This strategic move enhances Gilead’s liver disease portfolio by incorporating CymaBay’s leading investigational product, seladelpar,…