Once weekly vs. once daily injections plus increased potency vs. Gattex (linaclotide) inspired Ironwood Pharmaceuticals Inc. in its $1 billion takeover of Vectivbio Holding AG, which brings aboard the phase III-stage synthetic glucagon-like peptide-2 analog apraglutide, potentially a best-in-class agent for short bowel syndrome with intestinal failure. Read More
Rain Oncology Inc.’s only asset failed a pivotal phase III study for treating dedifferentiated liposarcoma, casting shadows on the future of the small molecule and the company’s direction. Milademetan, an oral inhibitor of the MDM2-p53 complex that reactivates p53, missed the Mantra study’s primary endpoint of progression-free survival compared to the standard of care treatment, Yondelis (trabectedin, Johnson & Johnson/Pharmamar SA). Read More
Apnimed Inc. is gearing up to start phase III testing with AD-109, a once-daily combination of atomoxetine and aroxybutynin that has the potential to be the first oral therapy to treat obstructive sleep apnea, following positive results from the phase IIb Mariposa trial. Read More
With its sights firmly set on being the first company to bring a topical diabetic macular edema (DME) treatment to market, Oculis Holding AG moved a step closer to this potentially game-changing reality as its dexamethasone formulation, OCS-01, turned up a statistically significant improvement in mean BCVA – a measure of visual acuity – at the three-month mark in the phase III DIAMOND trial. Read More
As the clock ticks toward the “full,” or traditional, approval date for Biogen Inc./Eisai Co. Inc.’s Alzheimer’s drug, Leqembi (lecanemab), the U.S. Centers for Medicare & Medicaid Services (CMS) is facing increasing pressure to get the structures in place to ensure Medicare beneficiaries have access to the drug when the approval comes. Read More
Long-term brain recordings from four patients with chronic pain have led investigators at the University of California at San Francisco to identify brain signals that could serve as biomarkers for each individual patients’ pain. Read More
Hanall Biopharma Co. Ltd.’s phase III trial VELOS-3 of tanfanercept did not show effects on the central cornea of the eye or in eye dryness in the treatment of moderate to severe dry eye disease, the primary endpoints. Data from the trial did show improvements in tear production, a secondary endpoint. Read More
Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s National Medical Products Administration (NMPA) through the priority review and approval procedure. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Genome, Kymera, Moderna, Painreform, Rocket. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Pfizer, Rznomics, Sanofi, Satsuma, Sobi. Read More
