Amphivena Therapeutics Inc., of South San Francisco, closed on a $62 million series C that will allow the company to continue its study of selective myeloid-derived suppressor cell (MDSC) removal in hematologic and solid cancers and to advance its lead candidate, AMV-564, a bivalent, bispecific T-cell engager in a phase I trial for treating patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes. Read More
Proteon Therapeutics Inc.'s inventorying of options after the phase III failure with vonapanitase in chronic kidney disease (CKD) ended in a merger deal with Artara Therapeutics Inc., a startup that has hung its main hat on TARA-002, a therapy for lymphatic malformations (also called lymphangiomas) that has already gained validation by way of a similar product in Japan. Read More
This year there has been a significant resurgence of interest in public biopharmaceutical companies that are focused on developing therapies to treat neurological diseases. As a result, the sector got out of the gate quickly and, by the end of June, the BioWorld Neurological Diseases index, a price-weighted index of representative companies operating in that therapeutic area, had climbed in value to over 26%, well ahead of the performance of the general markets and blue-chip biopharma companies. Read More
SUZHOU, China – The Hong Kong Stock Exchange (HKEX) chief proposed to unleash China's rich data resources to advance big health care, after he steered a groundbreaking move last year to welcome pre-revenue biotech companies, a move that has become a hot topic for the industry at home and abroad. Read More
SUZHOU, China – The rare disease space continues to be an area of focus across the sector worldwide, and China is no exception, with regulators rolling out long-awaited incentives and drugmakers viewing the field as a promising area to drive growth. Read More
PERTH, Australia – Melbourne-based Aravax Pty Ltd. is progressing its peanut allergy immunotherapy to phase II trials after reporting positive phase I data for lead candidate PVX-108. Read More
Cumberland Pharmaceuticals Inc., of Nashville, Tenn., said it was awarded just over $1 million in funding from the FDA through the Orphan Drug Grant program to support a phase II study testing ifetroban, a thromboxane-prostanoid receptor antagonist, in cardiomyopathy associated with Duchenne muscular dystrophy in patients, 7 and older. Read More
Bioasis Technologies Inc., of Guilford, Conn., said it intends to complete a brokered private placement financing of units for gross proceeds of approximately $4 million. The company intends to use the net proceeds for manufacturing, IND-enabling studies and for general working capital purposes. Read More
Avexis Inc.'s manipulation of raw data in a mouse potency assay used as a product release test during the early clinical development of gene therapy Zolgensma (onasemnogene abeparvovec) allegedly involved two senior executives who altered or instructed others to alter a small amount of the data, the Novartis AG subsidiary said in an Aug. 23 response to an FDA Form 483 inspection report. Read More
With an eye to preparing for potential threats, the FDA has granted approval for the first live, non-replicating vaccine to prevent smallpox and monkeypox. Developed by Bavarian Nordic A/S and branded as Jynneos, after a priority review it was approved for prevention of the diseases in adults determined to be at high risk for the viral infections. Read More
