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news.Caisson Biotech seeks buyer for HEPtune drug-delivery platform
The proprietary platform centers on the use of a naturally occurring sugar polymer, heparosan, which is produced by the body and is naturally biodegradable. The platform includes a
The proprietary platform centers on the use of a naturally occurring sugar polymer, heparosan, which is produced by the body and is naturally biodegradable. The platform includes a
Titled INSIGHT-MM, the study aims to enroll 5,000 patients over three years with a goal of following each patient for a minimum of five years in an effort
The settlement relates to a patent infringement litigation brought by Forest and Adamas in response to Amneal's abbreviated new drug application (ANDA) seeking approval to market generic versions
Among the changes, the FDA is requiring boxed warnings – the FDA’s strongest warning – and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines
The PINNACLE study enrolled 145 patients with extensive-stage SCLC who had not received prior treatment. Topline data from the Phase 2 trial are expected to be reported at
ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib. The Company
LINKS now allows the Company to broaden its existing repertoire of immune checkpoint targets, which already includes a few myeloid targets, predicted by algorithms and methodologies previously developed
These minutes confirmed the FDA’s acceptance of Tonix’s proposed Phase 3 studies and the planned New Drug Application (NDA) data package to support the registration of TNX-102 SL
The study met all primary and secondary endpoints at 12 months. The data showed that treatment with Prolia for 12 months, compared to risedronate, led to significantly greater
The extension covers services for one of the products in the pharmaceutical company’s development portfolio. BioInvent president and CEO Michael Oredsson said: “We are pleased that we have been contracted