LONDON – The alchemy of induced pluripotent cells has broken another barrier, delivering a model of the earliest preimplantation stages of human development, when fertilized eggs form a blastocyst. Read More
The rapid development of mRNA vaccines to combat COVID-19 has highlighted the importance of this single-stranded molecule. Although there have been some costly developmental bumps along the way, interest in RNA-targeted therapies is once again surging. Read More
Libtayo (cemiplimab-rwlc) became the first PD-1 therapy to score a phase III win in cervical cancer, a pleasing development not only for investors in Regeneron Pharmaceuticals Inc. and partner Sanofi SA but for patients with the stubborn disease. Read More
DUBLIN – Immatics NV reported unexpected signs of efficacy in a first cut of data from several phase I trials of its autologous engineered T-cell therapies in heavily pretreated patients with recurrent or refractory solid tumors. Read More
A data-blocking rule set to go into effect in the U.S. April 5 could make it easier for sponsors to get the real-world data they need to demonstrate postmarket evidence of the safety and efficacy of their drugs and devices and to develop future products. Read More
LONDON – Targeted protein degradation (TPD) specialist Amphista Therapeutics Ltd. has delivered yet another demonstration of investor interest in the field, closing a $53 million series B. Read More
HONG KONG –Uni-Bio Science Group Ltd. and Dotbio Pte. Ltd. formed a partnership to develop therapeutics for patients with retinal diseases, such as age-related macular degeneration, diabetic macular edema, retinal vein occlusion and myopic choroidal neovascularization. Read More
Responding to concerns about last-minute changes the Trump administration made to the Part D Payment Modernization Model for calendar year 2022, the Centers for Medicare & Medicaid Services (CMS) said March 16 that it is not moving forward with the formulary flexibilities that could have restricted Medicare patients’ access to necessary drugs. Read More
Merck & Co. Inc. is bringing in Amathus Therapeutics Inc. to collaborate on developing small molecules to treat neurodegenerative disease. The deal is one of several in the past 18 months that has expanded Merck’s presence in the space. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alessa, Erx, Eyenovia, GT, Harmony, Sage, Spruce, Versantis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Algernon, Ambrx, Merck. Read More
