Full-Life Technologies Ltd. announced Sept. 29 the completion of a $77 million financing, comprising $50 million in series C equity and $27 million in debt financing, which will be used to advance a portfolio of radiopharmaceuticals and radionuclide-drug conjugates worldwide.
Among severe insulin-deficient diabetes patients, 12 weeks of 100-mg, once-daily dosing of Biomea Fusion Inc.’s icovamenib lowered hemoglobin A1c by 1.8% from placebo at the 52-week timepoint, an increased benefit over and above what was seen at 26 weeks.
Arcus Biosciences Inc. has announced five new research programs for autoimmune and inflammatory diseases, and is targeting initiation of the first clinical studies next year.
Impaired fracture healing is a clinical management challenge. Fracture healing can be impaired due to several factors, such as aging, chronic inflammation or metabolic abnormalities. Osteoclasts play a crucial role in bone tissue reconstruction, but their abnormal activation can lead to impaired fracture healing. In a recent publication in Frontiers in Immunology, researchers from Naval Military Medical University and collaborators searched for crucial regulatory genes in the process of bone fracture healing.
With U.S. President Donald Trump’s administration vocally opposed to abortion, the U.S. FDA has approved a new generic version of the pill that makes the procedure possible medically: mifepristone, once better known as RU-486.
The U.S. FDA has approved the priority sNDA for a new first-line maintenance therapy in extensive-stage small-cell lung cancer from Jazz Pharmaceuticals plc. Zepzelca (lurbinectedin) can now be combined with Tecentriq (atezolizumab, Roche AG) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Roche) as a maintenance therapy for adults who haven’t progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
Taho Pharmaceuticals Ltd. announced an NDA submission to the U.S. FDA for TAH-3311, developed as the world’s first oral dissolving film formulation of apixaban, marking a regulatory milestone for the Taipei-based biotech.
Full-Life Technologies Ltd. announced Sept. 29 the completion of a $77 million financing, comprising $50 million in series C equity and $27 million in debt financing, which will be used to advance a portfolio of radiopharmaceuticals and radionuclide-drug conjugates worldwide.
A U.S. FDA complete response letter (CRL) citing manufacturing concerns has stepped into the way of a rare genetic disorder treatment. Fortress Biotech Inc. and its subsidiary, Cyprium Therapeutics Inc., said the letter in response to the NDA for CUTX-101, an injectable formulation of copper histidinate, noted cGMP deficiencies at the facility where the Menkes disease treatment is manufactured.
Patients with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment now have a new oral treatment option, with the U.S. FDA’s approval of Novartis AG’s Rhapsido (remibrutinib), a Bruton’s tyrosine kinase inhibitor administered by pill twice daily.
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